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Novel Approaches to the Management of Advanced Peripheral Artery Disease: Perspectives on Drug-Coated Balloons, Drug-Eluting Stents, and Bioresorbable Scaffolds
Abstract
Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.
... Beyond striking surgical arterial reconstructions [76][77][78][79], new tapered nitinol [81], drug-eluting stents (DES) [82], and original drugeluting balloon, (DEB) [83] were imagined. Novel or redesigned directional or rotational atherectomy devices [84], together with latest "bioresorbable scaffolds" technologies [85], represent few additional of numerous achievements that challenge today ancient technical barriers [1,29,75,[81][82][83][84][85][86]]. ...
... Beyond striking surgical arterial reconstructions [76][77][78][79], new tapered nitinol [81], drug-eluting stents (DES) [82], and original drugeluting balloon, (DEB) [83] were imagined. Novel or redesigned directional or rotational atherectomy devices [84], together with latest "bioresorbable scaffolds" technologies [85], represent few additional of numerous achievements that challenge today ancient technical barriers [1,29,75,[81][82][83][84][85][86]]. ...
... The complex cascade of tissue regeneration needs precise circumstances to unfold [85]. Beyond high-performance techniques in reconstructing arterial flow [72][73][74][75][76][77][78][79][80][81][82][83][84][85][86], new strategies about "when" and "where" to perform appropriate revascularization emerge today [1,27,30,35]. ...
During the recent decades, soaring progresses in vascular disease knowledge, particularly in critical limb ischemia (CLI) treatment, enhanced novel diagnostic and interventional strategies with high serviceableness in patient’s selection, arterial recanalization, and dedicated ischemic ulcer follow-up. However, despite undeniable advances in medical technology and clinical judgment, limb salvage, the ambulation recovery, and patient’s survival seem only scarcely affected in this heterogeneous CLI group, particularly concerning the diabetic and renal patients. Innovative strategies such as “end artery occlusive disease” treatment or “wound-targeted revascularization” were equally proposed by following the angiosomal anatomical distribution associating individual foot collateral assessment in a unified macro- and micro-circulatory judgment. However, despite encouraging clinical results, prospective evidence still lacks on this concern. It also appears that specific wounds could not always stand for the lowest perfusion areas according to current CLI criteria, since severe neuropathy, inflammatory swelling, local infection, and skin trauma may add complementary hindrances to tissue viability.
The present chapter endeavor to summarize main available treatment principles for ischemic ulcer recovery that every modern practitioner eventually disposes in an updated contemporary view.”
During the recent decades, soaring progresses in vascular disease knowledge, particularly in critical limb ischemia (CLI) treatment, enhanced novel diagnostic and interventional strategies with high serviceableness in patient’s selection, arterial recanalization, and dedicated ischemic ulcer follow-up. However, despite undeniable advances in medical technology and clinical judgment, limb salvage, the ambulation recovery, and patient’s survival seem only scarcely affected in this heterogeneous CLI group, particularly concerning the diabetic and renal patients. Innovative strategies such as “end artery occlusive disease” treatment or “wound-targeted revascularization” were equally proposed by following the angiosomal anatomical distribution associating individual foot collateral assessment in a unified macro- and micro-circulatory judgment. However, despite encouraging clinical results, prospective evidence still lacks on this concern. It also appears that specific wounds could not always stand for the lowest perfusion areas according to current CLI criteria, since severe neuropathy, inflammatory swelling, local infection, and skin trauma may add complementary hindrances to tissue viability.
At a higher level of the superior ankle, other angiosomes were described, such as the antero-lateral malleolar owning its correspondent antero-medial malleolar angiosomes (both from the anterior tibial artery), and the pstero-medial malleolar angiosome following correspondent branch from the posterior tibial artery, respectively [23–26, 91–93].
... 17,18 The condition occurs in 30% of patients with bare-metal stents. 19 While the development of drug-coated stents in recent years has lowered restenosis incidence to ~25% within one year of implantation, this rate is still relatively high. 20 Therefore, the prevention of restenosis after stenting remains a major problem that needs resolving. ...
Purpose: This study aimed to identify potential diagnostic markers of restenosis after stent implantation and to determine their association with immune checkpoint, ferroptosis, and N6-methyladenosine (m6A).
Patients and methods: Microarray data were downloaded from the National Center for Biotechnology Information (NCBI: GSE46560 and GSE48060 datasets) to identify differentially expressed genes (DEGs) between in-stent restenosis and no-restenosis samples. We then conducted systematic functional enrichment analyses of the DEGs based on Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG), and further predicted the interactions of different proteins using the Search Tool for the Retrieval of Interacting Genes (STRING). We used the MCC and MCODE algorithms in the cytoHubba plug-in to screen three key genes in the network, and employed receiver operating characteristic (ROC) curves to determine their diagnostic significance using a multiscale curvature classification algorithm. Next, we investigated the relationships between these target genes, immune checkpoint, ferroptosis, and m6A. Finally, quantitative real-time polymerase chain reaction (qRT-PCR) was used to verify the above results.
Results: We identified 62 upregulated genes and 243 downregulated genes. Based on GO, KEGG, and screening results, EEF1D, RPL36, and RPSA are promising genes for predicting restenosis. In addition, the methylation of YTHDF2, the ferroptosis-related gene GLS2, and the immune checkpoint-related gene CTLA4 were observed to be associated with restenosis. The qRT-PCR test confirmed that RPSA and RPL36 are useful diagnostic markers of the restenosis that can provide new insights for future studies on its occurrence and molecular mechanisms.
Conclusion: We found that RPSA and RPL36, as useful diagnostic markers of restenosis, can provide new insights for future studies on its occurrence and molecular mechanisms.
... As long as DES do not show better outcomes technical and clinical as compared to DCB without or with stenting they might remain the second choice. 34 ...
Over the past decade, the treatment of peripheral artery disease poses a number of technical challenges for the physician. The primary rationale of this article is to review the available literature on the current practices involved in the treatment of peripheral artery disease (PAD), particularly the femoropopliteal lesions. It is evident from the landmark clinical trials that the use of self-expanding drug-eluting stents (DES) has become the most favored clinical strategy for treating peripheral lesions above the knee. It is chiefly due to higher patency rates, and minimal in-stent restenosis and stent fracture rates associated with the use of DES. The technical evolution in the endovascular approach from the use of bare nitinol stents to DES for treating PAD and the factors responsible for this transformation have also been reviewed with their respective justification. Presently there is a need of DES technology for the treatment of femoropopliteal lesions, which can reduce the risk of stent fracture and in-stent restenosis for longer lesions while maintaining patency during long-term follow-up. To conclude, this review establishes that self-expanding DES and drug coated balloons using anti-proliferative drugs like sirolimus and paclitaxel are currently the most effective method of treating the femoropopliteal lesions in PAD.
... Second-generation balloons for angioplasty and stents, which are coated with drugs to prevent early restenosis, are currently under development. [21][22][23] The efficiency of such drug-coated balloons and drug eluting stents can be investigated by directly monitoring the concentration and long-term release spectroscopically, as the active compounds also exhibit distinct spectroscopic properties. 24,25 The applied conditions of several seconds of nonfocused laser illumination at 100 mW within the artery did not lead to any noticeable alterations of the walls of the blood vessels, as confirmed by subsequent histopathological staining. ...
Intravascular imaging techniques provide detailed specification about plaque appearance and morphology, but cannot deliver information about the biochemical composition of atherosclerotic plaques. As the biochemical composition is related to the plaque type, important aspects such as the risk of a plaque rupture and treatment are still difficult to assess. Currently, various spectroscopic techniques are tested for potential applications for the chemical analysis of plaque depositions. Here, we employ Raman spectroscopy in combination with optical coherence tomography (OCT) for the characterization of plaques on rabbits in vivo. Experiments were carried out on New Zealand white rabbits treated with a fat- and cholesterol-enriched diet, using a Raman probe setup with a 785-nm multimode laser as an excitation source. Subsequently, OCT images were acquired with a swept source at 1305±55 nm at 22.6 mW. Raman spectra were recorded from normal regions and regions with early plaque formations. The probe positioning was monitored by x-ray angiography. The spectral information identified plaque depositions consisting of lipids, with triglycerides as the major component. Afterward, OCT images of the spectroscopically investigated areas were obtained. The spectral information correlates well with the observed intravascular morphology and is in good agreement with histology. Raman spectroscopy can provide detailed biochemical specification of atherosclerotic plaques.
... As a consequence, PGG may not be given as a systemic drug, and has to be delivered locally. Today, drug-coated balloons (DCBs) and drugeluting stents (DESs) exists for the treatment of atherosclerotic peripheral and coronary artery disease [22,23], and such devises could potentially be developed for aortic dimensions. Tensiometric measurements of human AAA walls may then be needed to clarify at which pressure the drug will be eluted. ...
Background:
The vast majority of abdominal aortic aneurysms found in screening programs are small, and as no effective treatment exits, many will expand until surgery is indicated. Therefore, it remains intriguing to develop a safe and low cost treatment of these small aneurysms, that is able to prevent or delay their expansion. In this study, we investigated whether intraluminal delivered pentagalloyl glucose (PGG) can impair the early AAA development in a porcine model.
Methods:
The infrarenal aorta was exposed in thirty pigs. Twenty underwent an elastase based AAA inducing procedure and ten of these received an additional intraluminal PGG infusion. The final 10 were sham operated and served as controls.
Results:
All pigs who only had an elastase infusion developed macroscopically expanding AAAs. In pigs treated with an additional PGG infusion the growth rate of the AP-diameter rapidly returned to physiological values as seen in the control group. In the elastase group, histology revealed more or less complete resolution of the elastic lamellae in the media while they were more abundant, coherent and structurally organized in the PGG group. The control group displayed normal physiological growth and histology.
Conclusion:
In our model, intraluminal delivered PGG is able to penetrate the aortic wall from the inside and impair the early AAA development by stabilizing the elastic lamellae and preserving their integrity. The principle holds a high clinical potential if it can be translated to human conditions, since it, if so, potentially could represent a new drug for stabilizing small abdominal aneurysms.
Objective
The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease.
Methods
Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the “-limus” devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study’s secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038.
Findings
Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar.
Conclusion
Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures.
Clinical Impact
The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.
Despite a lack of solid evidence in applying the angiosome concept (AC) in current chronic limb threatening ischemia (CLTI) treatment, several encouraging results for improved wound healing and less for limb preservation were reported in various consistency studies. Direct revascularization (DR) fol- lowing the foot angiosomes distribution (whenever feasible) may afford better clinical results compared to angiosome indifferent, or indirect revascularization (IR), however without clear benefit on survival and for major adverse limb events (MALE). Inside this interrogation, the notable influence of the remnant collaterals, the foot arches, the wound characteristics, and the type of revascularization (bypass versus endovascular) still remain ardent topics. Current evidence suggests that applying DR in daily vascular practice requires practitioners to be committed to every individual hemodynamic variable in a thorough macro- and micro-vascular evaluation of the ischemic foot. It be- comes clearer nowadays that not all CLTI foot ulcers hold same ischemic burden and seemingly need specific DR. In the same setting, a novel wound targeted revascularization (WTR) design was proposed assembling wider circulatory targets than genuine DR notion, as used by some authors. Beyond specific angiosomal artery reperfusion, WTR associates the available arches, the large- and medium-sized collaterals, and the arterial-arterial communicants, in an intentional “source artery” and “collateral” topographic foot re- vascularization. However, up to date, the notion of angiosome wound-guided revascularization (DR and WTR) detains only a reserved level of confirmation. As for DR, the WTR equally needs higher levels of evidence allowed by standardized definition, uniform indications, and pertinent results from multicenter larger prospective analysis, before large application.
Endovaskuläre selbstexpandierbare Stentgrafts können neben der klassischen Indikation der Aneurysma-Ausschaltung und Überdeckung von Gefäßlazerationen mit Blutung auch zur Behandlung einer arteriellen Verschlusskrankheit im iliakalen und femoropoplitealen Stromgebiet eingesetzt werden. Nach Einführung moderner Stents und der medikamentenfreisetzenden Ballons ist der Stentgraft Methode der 2. Wahl in der primären Therapie und bei der In-Stent-Restenose. Der Stentgraft kann bei akuten Verschlüssen, insbesondere bei koinzidentem (v. a. Popliteal-) Aneurysma, primär anstelle oder in Kombination mit einer Lysetherapie eingesetzt werden. Die Edge-Stenose ist die wichtigste die Offenheitsrate beeinflussende Komplikation und bedarf besonderer Beachtung. Bei der Implantation gilt es, auf eine exakte Dimensionierung und die Einhaltung von Hygieneregeln zu achten.
There are many drug delivery system technologies applied to endovascular intervention. For vascular lesion, drug-eluting stents are widely used in percutaneous coronary intervention, and drug-eluting balloons are gradually used both in coronary artery disease and peripheral artery disease. For tumor lesion, drug delivery system technologies are widely used in trans-catheter arterial chemoembolization for the treatment of hepatocellular carcinoma. In this article, we will review these technologies and mention to our approach to apply drug delivery system technologies to the endovascular treatment of cerebral aneurysms. © 2017, Japan Society of Drug Delivery System. All rights reserved.
The objective of this study was to use instrumental variable (IV) analyses to evaluate the clinical effectiveness of percutaneous stent revascularization versus bypass surgery in the treatment of peripheral artery disease (PAD) among type 2 diabetic patients. Type 2 diabetic patients who received peripheral artery bypass surgery (n = 5,652) or stent revascularization (n = 659) for lower extremity arterial stenosis between 2000 and 2007 were identified from the Taiwan National Health Insurance claims database. Patients were followed from the date of index hospitalization for 2 years for lower-extremity amputation, revascularization, and hospitalization for medical treatment. Analysis using treatment year, patients’ monthly income level, and regional difference as IVs were conducted to reduce unobserved treatment selection bias. The crude analysis showed a statistically significant risk reduction in favor of stent placement in lower extremity amputation and in the composite endpoint of amputation, revascularization, or hospitalization for medical treatment. However, peripheral artery stent revascularization and bypass surgery had similar risk of lower limb amputation and composite endpoints in the analyses using calendar year or patients’ monthly income level as IVs. These two treatment modalities had similar risk of lower limb amputation among DM patients with PAD.
Introduction:
Drug-eluting stents promise to reduce restenosis following endovascular treatment of diseased arteries, but technologies used in peripheral arteries of the leg have not yet achieved desired success rates.
Areas covered:
The rationale behind the development of the Eluvia(TM) Drug-Eluting Vascular Stent (Boston Scientific, Marlborough, MA) is described and current preclinical and clinical evidence related to use of the stent is reviewed.
Expert opinion:
Stents remain an important endovascular treatment option for femoropopliteal lesions, especially those that are long, occluded, and calcified. Drug-eluting stent technologies show promise to improve patency rates, potentially shifting the primary treatment preference away from balloon-based treatment. The available preclinical and clinical data on treatment with Eluvia(TM) suggest that prolonged paclitaxel elution in the femoropopliteal arteries prevents restenosis and may reduce the need for reintervention.
AIMS: Several studies suggest good procedural and similar clinical outcomes between everolimus-eluting bioresorbable stents (BRS) ABSORB versus conventional drug-eluting stents (DES), but the evidence is not definitive. We performed a systematic review and meta-analysis to investigate the effects of BRS versus conventional drug eluting and bare metallic stents on the cardiovascular endpoints and all-cause mortality.
METHODS AND RESULTS: The follow-up in the included studies was up to 13 months. The following endpoints were evaluated: all-cause mortality, cardiac death, patient-oriented major adverse cardiac events (POCE), device-oriented major adverse cardiac events (DOCE), any cause myocardial infarction (MI), target vessel MI (TVMI), target vessel revascularization (TVR) and target lesion revascularization (TLR). The results of 10 studies with 5773 subjects showed statistically significant increase in risk of TVMI between BRS and conventional stents (odds ratio [OR]: 1.45, 95% confidence interval [CI]: 1.03, 2.05, p=0.032). None of the other differences reached statistical significance: all-cause mortality (OR: 0.67, 95%CI: 0.30, 1.49, p=0.333), cardiac death (OR: 1.00, 95%CI: 0.47, 2.12, p=0.996), POCE (OR: 0.91, 95%CI: 0.68, 1.22, p=0.546), DOCE (OR: 1.12, 95%CI: 0.86, 1.46, p=0.387), any-cause MI (OR: 1.34, 95%CI: 0.98, 1.82, p=0.064), TVR (OR: 0.99, 95%CI: 0.73, 1.33, p=0.934) and TLR (OR: 0.92, 95%CI: 0.66, 1.29, p=0.641). Similar results were observed after restricting the meta-analysis to the comparison of BRS vs EES.
CONCLUSIONS: Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions, are required to confirm or refute our findings.
Objectives: To assess the safety and effectiveness of the Stellarex™ drug-coated angioplasty balloon (DCB) to inhibit restenosis in the superficial femoral (SFA) and/or popliteal artery. Background: Treatment of peripheral arterial disease is challenged by restenosis, requiring revascularization procedures to maintain patency. DCBs are designed to deliver an anti-proliferative drug to the vessel wall in order to diminish smooth muscle cell proliferation and maintain patency. Methods: This prospective, single-arm, multi-center study enrolled 50 patients with 58 lesions in the first cohort that required pre-dilatation with an uncoated angioplasty balloon prior to inflation of the DCB. The primary effectiveness endpoint was 6-month late lumen loss (LLL). The major secondary endpoint was major adverse event (MAE) rate at 6 months, defined as cardiovascular death, amputation and/or ischemia-driven target lesion revascularization. Results: The mean lesion length was 7.2cm and baseline stenosis was 75.1%. Calcification was present in 62.1% of lesions and 13.8% were occluded. Both endpoints met their pre-specified performance goals; at 6 months, the MAE rate was 4% and the mean LLL was 0.54mm. The primary patency rate was 89.5% at 12 months and 80.3% at 24 months. The freedom from clinically-driven target lesion revascularization rate, per Kaplan-Meier estimate, was 90.0% at 12 months and 85.8% at 24 months. Additionally, there were no amputations or cardiovascular deaths reported through 24 months. Conclusions: The Stellarex DCB provides safe and durable clinical outcomes for treatment of femoropopliteal artery disease through 24 months. This article is protected by copyright. All rights reserved.
© 2015 Wiley Periodicals, Inc.
Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery.
Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 +/- 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 +/- 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within 610% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year.
Results: The median follow-up was 12.3 months (mean 12.3 +/- 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/ device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement.
Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. Oneyear primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
Objectives
To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease.
Background
Bare metal stents (BMS), drug‐eluting stents (DES), and drug‐coated balloons (DCB) are associated with lower target lesion revascularization (TLR) probabilities than percutaneous transluminal angioplasty (PTA), but the economic impact is unknown.
Methods
In December 2012, PubMed and Embase were systematically searched for studies with TLR as an endpoint. The 24‐month probability of TLR for each treatment was weighted by sample size. A decision‐analytic Markov model was used to assess the budget impact from payers' and facility‐providers' perspectives of the four index procedure strategies (BMS, DES, DCB, and PTA). Base cases were developed for U.S. Medicare and the German statutory sickness fund perspectives using current 2013 reimbursement rates.
Results
Thirteen studies with 2,406 subjects were included. The reported probability of TLR in the identified studies varied widely, particularly following treatment with PTA or BMS. The pooled 24‐month probabilities were 14.3%, 19.3%, 28.1%, and 40.3% for DCB, DES, BMS, and PTA, respectively. The drug‐eluting strategies had a lower projected budget impact over 24 months compared to BMS and PTA in both the U.S. Medicare (DCB: $10,214; DES: $12,904; uncoated balloons $13,114; BMS $13,802) and German public health care systems (DCB €3,619; DES €3,632; BMS €4,026; PTA €4,290).
Conclusions
DCB and DES, compared to BMS and PTA, are associated with lower probabilities of target lesion revascularization and cost savings for U.S. and German payers. © 2014 Wiley Periodicals, Inc.
Objectives
The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).
Background
The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up.
Methods
From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months.
Results
During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05).
Conclusions
The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.
Objectives:
A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement.
Background:
Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established.
Methods:
In the RCT, patients were randomly assigned to primary DES implantation (n = 236) or PTA (n = 238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n = 61) or BMS (n = 59) placement. The single-arm study enrolled 787 patients with DES treatment.
Results:
Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 26.5%, p < 0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT.
Conclusions:
Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678).
Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.
Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.
We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.
The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.
In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).
Drug-eluting stents reduce restenosis in coronary arteries, but clinical trials have failed to prove their efficacy in peripheral arteries. We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg.
In a small, multicenter trial, we randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium, or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at 6 months.
The mean (+/-SD) age of the patients was 68+/-8 years, 24% were smokers, and 49% had diabetes. Twenty-seven percent of the lesions were total occlusions, and 36% were restenotic lesions. The mean lesion length was 7.4+/-6.5 cm. There were no significant differences in baseline characteristics between the groups. There were no adverse events attributable to the paclitaxel-coated balloons. At 6 months, the mean late lumen loss was 1.7+/-1.8 mm in the control group, as compared with 0.4+/-1.2 mm (P<0.001) in the group treated with paclitaxel-coated balloons and 2.2+/-1.6 mm (P=0.11) in the group treated with paclitaxel in the contrast medium. The rate of revascularization of target lesions at 6 months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons (P<0.001 vs. control), and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium (P=0.41 vs. control); at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively.
Use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. No significant benefit is seen with the use of a paclitaxel-containing contrast medium. (ClinicalTrials.gov number, NCT00156624 [ClinicalTrials.gov].).
To prospectively determine whether cutting balloon angioplasty, when compared with conventional balloon angioplasty (CBA), improves morphologic and clinical outcome in patients with femoropopliteal in-stent restenosis.
Patients with symptomatic femoropopliteal in-stent restenosis were randomly assigned to undergo CBA or peripheral cutting balloon angioplasty (PCBA) for treatment of lesions up to 20 cm in length. Patients were followed up clinically and with duplex ultrasonography (US) at 1, 3, and 6 months for occurrence of a restenosis of 50% or higher. The Fisher exact test and Mann Whitney U test were used for statistical analyses.
Forty patients were enrolled; one patient was lost to follow-up. In the remaining patients, CBA was performed in 22 patients; PCBA was used in 17 patients. Average lesion length was 80 mm +/- 68 (standard deviation). Restenosis rates at 6 months were 65% (11 of 17; 95% confidence interval: 42%, 88%) after PCBA versus 73% (16 of 22; 95% confidence interval: 54%, 92%) after CBA (P = .73). Ankle brachial index (0.83 vs 0.75, P = .26) and maximum walking capacity on the treadmill (117 m vs 103 m, P = .97) at 6 months were also not significantly different between the two groups.
PCBA failed to prove superiority compared with CBA for treatment of femoropopliteal in-stent restenosis in this pilot study. In restenotic lesions with an average length of approximately 8 cm, both treatment modalities yielded disappointing 6-month patency rates.
Objectives:
This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA).
Background:
Drug-eluting BVS has shown promise in coronary arteries.
Methods:
The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication.
Results:
Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet.
Conclusions:
The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).
Background:
The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.
Methods:
In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.
Results:
The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention.
Conclusions:
Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).
Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of < 15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.
To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions.
Sixty patients (34 men; mean age 70.7±10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial (ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months.
At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51±0.72 vs. 1.04±1.00 mm, p=0.033) and binary restenosis (11.5% vs. 34.6%, p=0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p=0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p=0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported.
The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon.
© The Author(s) 2015.
The purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).
The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).
In 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control). The primary endpoint was 6-month late lumen loss (LLL). Secondary endpoints included freedom from target lesion revascularization (TLR), binary restenosis rate, and amputation. The 5-year FU compares outcomes in patients treated with PCB and control subjects. Additionally, LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length.
Over the 5-year period, the cumulative number of patients with TLR remained significantly lower in the PCB group (21%) than in the control group (56%, p = 0.0005). In the small group of patients with angiographic and duplex sonographic follow-up, PCB was associated with a lower rate of binary restenosis (17% vs. 54%; p = 0.04). No signs of aneurysm formation or constrictive fibrosis were detected. Whereas LLL at 6-month FU did not differ between men and women in the PCB group, the TLR rate was lower in men than in women at 5-year FU. A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length.
The reduced TLR rate following PCB treatment was maintained over the 5-year FU period. No signs of drug-related local vessel abnormalities were detected. (Thunder Trial-Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [THUNDER]; NCT00156624).
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.
A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group.
The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively.
At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).
-Drug-coated balloons (DCB) have shown promise in improving outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and/or popliteal artery disease.
-The IN.PACT SFA Trial is a prospective, multicentre, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain due to superficial femoral and/or popliteal peripheral artery disease (PAD) were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy endpoint was primary patency, defined as freedom from restenosis or clinically-driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and percent of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=.82) and 25.8% and 19.5% (P=.22), respectively. DCB resulted in higher primary patency vs. PTA (82.2% vs. 52.4%; P<.001). The rate of clinically-driven target lesion revascularization was 2.4% in the DCB arm compared with 20.6% in the PTA arm (P<.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA (P=.10)). There were no device- or procedure-related deaths and no major amputations.
-In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal PAD. Clinical Trial Registration Information-ClinicalTrials.gov. Identifiers: NCT01175850 and NCT01566461.
Purpose:
To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions.
Methods:
A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories.
Results:
In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category.
Conclusion:
DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.
This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm(2) paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions.
Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm(2) formulated differently have shown promising results with reduced restenosis.
Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics.
Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 ± 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 ± 1.13 mm) than for the control group (1.09 ± 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUCall) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%.
Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813).
Purpose:
To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries.
Methods:
The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up. Furthermore, target lesion revascularizations (TLR) were documented up to 2 years.
Results:
In each group, 24 (56%) patients had a dissection after the intervention. At the 6-month follow-up, patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss (0.4 mm) than patients with dissection after treatment with uncoated balloons (1.9 mm, p=0.001) and a lower degree of stenosis (20% vs. 51%, respectively; p=0.003). Patients with severe dissection (grades C, D, or E) especially seemed to benefit from the PCBs, with late lumen loss of 0.4 mm vs. 2.4 mm for controls (p=0.05). The binary restenosis rate was also markedly lower in the PCB group (20%) than in the uncoated group (55%, p=0.02). In the 2-year follow-up, TLR was performed in 56% of patients in the control group compared to 10% of patients in the PCB group (p=0.002).
Conclusion:
The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation.
The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than BMS in long femoro-popliteal artery disease was tested.
While endovascular treatment of short SFA lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.
In a prospective, randomized, single-blind, multicenter study 141 patients with symptomatic PAD were assigned to treatment with heparin-bonded, covered stents (VIABAHN®, 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12-months.
Mean lesion length was 19.0±6.3cm versus 17.3±6.6cm in the VIABAHN® versus BMS group. Major complications within 30-days were observed in 1.4%. The 12-months primary patency rates in the VIABAHN® and BMS group were: ITT 70.9% (95%CI, 0.58-0.80) and 55.1% (95%CI, 0.41-0.67; log rank p=0.11), TPP 78.1% (95%CI, 0.65-0.86) and 53.5% (95%CI, 0.39-0.65) (HR 2.23, 95%CI, 1.14-4.34; log rank p=0.009). In lesions ≥20cm (TASC D) the 12-months patency rate was significantly longer in VIA patients in the ITT-analysis (VIA 71.3% versus BMS 36.8%; p=0.01) and the TPP-analysis (VIA 73.3% versus BMS 33.3%; p=0.004). Freedom from target lesion revascularization was 84.6% for VIABAHN® (95%CI, 0.72-0.91) versus BMS 77.0% (95%CI, 0.63-0.85; p=0.37). The ankle-brachial index in the VIABAHN® group significantly increased to 0.94±0.23 (versus BMS 0.85±0.23; p<0.05) at 12-months.
This randomized trial in symptomatic PAD patients who underwent endovascular treatment for long femoro-popliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared to BMS in lesions ≥20cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which however was diluted by 8.5% major protocol violations, the difference was not significant (Reg.Nr. ISRCTN48164244). Clinical trial ID: VIASTAR; http://www.controlled-trials.com/ISRCTN48164244; ISRCTN48164244.
This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).
ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.
This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.
Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.
Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).
The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup.
The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D.
The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%.
The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.
Background:
Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty.
Methods and results:
Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0 ± 5.3 and 6.6 ± 5.5 cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01 mm [95% CI, -0.29; 0.26] versus 0.65 mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02).
Conclusions:
Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up.
Clinical trial registration:
URL http://www.clinicaltrials.gov. Unique identifier: NCT01083030.
The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).
The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents.
From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months.
Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year.
The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.
In disease of the femoropopliteal artery, paclitaxel-coated balloon (PCB) therapy improved angiographic outcomes as compared with uncoated balloon (UCB) angioplasty. Nevertheless, it remains uncertain whether PCB may reduce the need for reintervention.
We searched Medline, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session abstracts, and relevant web sites for trials of PCB versus UCB angioplasty. Key words were: "superficial femoral artery," "popliteal artery," "angioplasty," "drug-eluting balloon," "paclitaxel-eluting balloon," and "randomized trial." Inclusion criteria were: (1) randomized design; (2) intention-to-treat analysis; and (3) ≥6-month follow-up. Exclusion criteria were: (1) vessel treated other than femoropopliteal artery; (2) device used other than PCB/UCB; and (3) irretrievable or duplicated data. No restrictions (language, publication date, or status) were applied. The primary end point was target lesion revascularization. Secondary end points were: angiographic binary restenosis and late lumen loss and all-cause mortality. A total of 381 patients enrolled in 4 randomized trials were included (PCB, n=186 versus UCB, n=195). Median follow-up was 10.3 months. Angioplasty with PCB versus UCB reduces target lesion revascularization (12.2% versus 27.7%; OR, 0.22; 95% CI, 0.13-0.38; P<0.00001), angiographic restenosis (18.7% versus 45.5%; OR, 0.26; 95% CI, 0.14-0.48; P<0.0001), and late lumen loss (range, -0.05 to 0.50 mm versus 0.61-1.7 mm; weighted mean difference, -0.75 mm; 95% CI, -1.06 to -0.45; P<0.00001). No mortality difference was observed for PCB versus UCB (2.1% versus 3.2%; OR, 0.99; 95% CI, 0.39-2.49; P=0.98).
In femoropopliteal arterial disease, PCB therapy is associated with superior antirestenotic efficacy as compared with UCB angioplasty with no evidence of a differential safety profile.
This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.
Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described.
This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.
The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up.
PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.
To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).
The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.
Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.
These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.
Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease.
Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457).
Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.
Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation.
A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization.
In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.
To report our experience with a catheter system (The Outback catheter) designed to allow fluoroscopically controlled re-entry after subintimal guide wire passage during recanalization of chronically occluded femoro-popliteal arteries.
Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49-98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques.
Median lesion length was 200 +/- 102 mm. Recanalization of the arterial occlusion was successful in 57 of 65 treated lesions (88%). One patient died of myocardial infarction after delayed femoral bleeding possibly due to extensive recanalization attempts. There were no further procedure-related complications.
Use of the Outback re-entry catheter system is a valuable option for interventional therapy of chronically occluded femoro-popliteal arteries following failed standard antegrade recanalization attempt.
The suggestion was made in the 1870s that mechanical irritation of the arterial wall is a cause of atherosclerosis, because the changes were chiefly found at points "exposed to the full stress and impact of the blood." The mechanical damage theory persisted until well into the 20th century when, with interest increasing in multidisciplinary research, two fluid mechanical proposals were advanced for the patchy distribution of the lesions. One advocated high- and the other low-wall shear. Arterial wall shear stress levels appeared, however, insufficiently high to damage the endothelium. In contrast, examination of cadaver human arteries, combined with flow studies in models and casts of arteries, implied that the lesions occurred preferentially in regions expected to experience low-wall shear; a mechanism, involving arterial wall lipid metabolism and shear-dependent blood-wall mass transport, was suggested to account for that distribution. These proposals helped stimulate extensive investigation of arterial fluid mechanics/mass transport and vascular biology/pathology, revealing mechanisms that may explain the now widely confirmed preferred occurrence of atherosclerosis in low wall shear regions in adult human beings.
The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery.
This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3+/-1.1 versus 5.2+/-1.0 mm), degree of stenosis (84+/-11% versus 84+/-16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5+/-1.1 versus 1.0+/-1.1 mm; P=0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P=0.002). Improvement in Rutherford class was greater in the coated balloon group (P=0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating.
In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.
The author presents an alternative statistical analysis of the results of the University of Toronto series of percutaneous transluminal angioplasty (PTA) of the femoral and popliteal arteries (n = 254). After recalculation of the data with the Kaplan-Meier method, the postprocedure success rate ranged from 88.8% +/- 2.0 at 1 month to 35.7% +/- 4.8 at 6 years. With Cox multiple regression analysis, the type of femoropopliteal lesion and the runoff were the variables that were useful to predict late results. For stenoses with good runoff, the success rate was 53% at 5 years; with poor runoff, 31% at 5 years. For occlusions with good runoff, the success rate was 36% at 5 years; with poor runoff, 16% at 5 years. In initially successful cases, ongoing clinical success at 1, 3, and 5 years was better in patients with good runoff at the time of PTA than in those with poor runoff. Now that more recent studies have documented improved technical success in femoropopliteal PTA, a comparative study of the relative safety, long-term clinical efficacy, and cumulative cost of PTA versus surgery seems warranted.
Controversy still exists whether polytetrafluoroethylene is equivalent to vein as bypass graft material for the above-knee femoropopliteal bypass. Therefore, a prospective randomized trial was performed to compare vein with polytetrafluoroethylene for femoropopliteal bypasses with the distal anastomosis above the knee.
Between January 1993 and December 1996, 151 above-knee femoropopliteal bypasses were performed. The indications for operation were severe claudication in 120 cases, rest pain in 20 cases, and ulceration in 11 cases. After randomization, 75 reversed saphenous venous bypasses and 76 polytetrafluoroethylene bypasses were performed.
No perioperative mortality was seen, and 5% of the patients had minor infections of the wound, not resulting in loss of the bypass, the limb, or life. After 5 years, 38% of the patients had died and 7% were lost to follow-up. Only once was the saphenous vein necessary for coronary artery bypass grafting. Primary patency rates after 5 years were 75.6% for venous bypass grafts and 51.9% for polytetrafluoroethylene grafts (P =.035). Secondary patency rates were 79.7% for vein and 57.2% for polytetrafluoroethylene bypasses (P =.036). In the venous group, 14 bypasses failed, leading to five new bypasses. In the polytetrafluoroethylene group, 29 bypasses failed, leading to 16 reinterventions. For these 16 new bypasses, in four cases, the ipsilateral preserved saphenous vein was used. In both groups, one above-knee amputation and one below-knee amputation had to be performed.
We conclude after 5 years of follow-up of this randomized controlled trial that a bypass with saphenous vein has better patency rates at all intervals and needs fewer reoperations. Saphenous vein should be the graft material of choice for above-knee femoropopliteal bypasses and should not be preserved for reinterventions. Polytetrafluoroethylene is an acceptable alternative if the saphenous vein is not available.
The aim of this study was to investigate the occurrence and the clinical impact of stent fractures after femoropopliteal stenting.
The development of femoral stent fractures has recently been described; however, there are no data about the frequency and the clinical relevance.
A systematic X-ray screening for stent fractures was performed in 93 patients. In total, 121 legs treated by implantation of self-expanding nitinol stents were investigated after a mean follow-up time of 10.7 months. The mean length of the stented segment was 15.7 cm.
Overall, stent fractures were detected in 45 of 121 treated legs (37.2%). In a stent-based analysis, 64 of 261 stents (24.5%) showed fractures, which were classified as minor (single strut fracture) in 31 cases (48.4%), moderate (fracture of >1 strut) in 17 cases (26.6%), and severe (complete separation of stent segments) in 16 cases (25.0%). Fracture rates were 13.2% for stented length < or =8 cm, 42.4% for stented length >8 to 16 cm, and 52.0% for stented length >16 cm. In 21 cases (32.8%) there was a restenosis of >50% diameter reduction at the site of stent fracture. In 22 cases (34.4%) with stent fracture there was a total stent reocclusion. According to Kaplan-Meier estimates, the primary patency rate at 12 months was significantly lower for patients with stent fractures (41.1% vs. 84.3%, p < 0.0001).
There is a considerable risk of stent fractures after long segment femoral artery stenting, which is associated with a higher in-stent restenosis and reocclusion rate.
In femoropopliteal bypass surgery, the use of saphenous vein grafts is preferable, but synthetic grafts are widely used above the knee. The objective of this meta-analysis was to assess the long-term patency of femoropopliteal bypass grafts classified as above-knee polytetrafluoroethylene, above-knee saphenous vein, or below-knee saphenous vein.
Studies published from 1986 through 2004 were identified from electronic databases and reference lists; 73 articles contributed 1 or more series that used survival analysis, assessed femoropopliteal bypasses in one of the foregoing configurations, reported a 1-year graft patency rate, and included at least 30 bypasses. The series with a predominance of claudicant patients were included in meta-analysis C, and the series in which critical ischemia predominated were included in meta-analysis CI. Pooled survival curves of graft patency were constructed.
In meta-analysis C, the pooled primary graft patency was 57.4% for above-knee polytetrafluoroethylene, 77.2% for above-knee vein, and 64.8% for below-knee vein at 5 years; there was a significant difference between above-knee grafts at 3, 4, and 5 years (P < .05). The corresponding pooled secondary graft patency was 73.2%, 80.1%, and 79.7%, respectively (P > .05). In meta-analysis CI, the pooled primary graft patency was 48.3% for above-knee polytetrafluoroethylene, 69.4% for above-knee vein, and 68.9% for below-knee vein at 5 years; there was a significant difference between above-knee grafts until 4 years (P < .05). The corresponding pooled secondary graft patency was 54.0%, 71.9%, and 77.8%, respectively, with a significant difference between above-knee grafts at 2, 3, and 4 years (P < .05).
The great saphenous vein performs better than polytetrafluoroethylene in femoropopliteal bypass grafting and should be used whenever possible.
Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year.
Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease.
In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.
A single-arm clinical study of the safety and effectiveness of the zilver® ptx® drug-eluting peripheral stent: twelve-month results
- M Dake
- M Bosiers
- F Fanelli
- Z Kavteladze
- A Lottes
- A Ragheb
Heparin-bonded covered stents versus bare metal stents for symptomatic peripheral arterial disease: the VIASTAR trial
- J Lammer
- T Zeller
- K Hausegger
- P Schaefer
- M Gschwendtner
- S Mueller-Huelsbeck
Randomized trial of paclitaxel-coated balloon for femoropopliteal artery disease. NEJM 2015, in press. This is the largest study confirming the mid-term benefit of DCB compared to plain balloon angioplasty in the treatment of short femoro-popliteal lesions
- K Rosenfield
- Mr Jaff
- Cj White
- K Rocha-Singh
- C Mena-Hurtado
- Dc Metzger
- M Brodmann
- E Pilger
- T Zeller
- P Krishnan
- R Gammon
- S Müller-Hülsbeck
- Mr Nehler
- Jf Benenati
- D Scheinert