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Incidence and Endovascular Treatment of Isolated Atherosclerotic Popliteal Artery Disease: Outcomes from the IPAD Multicenter Study
Abstract
Purpose:
To report the incidence and long-term outcomes following endovascular treatment of symptomatic, atherosclerotic isolated popliteal artery disease (IPAD).
Materials and methods:
This retrospective, multicenter study included all patients who underwent endovascular treatment of IPAD between January 2010 and December 2016 because of intermittent claudication or critical limb ischemia (CLI), in three tertiary University Hospitals. In total, 4717 peripheral arterial disease (PAD) procedures were analyzed. The study's primary outcome measures were: IPAD incidence, binary restenosis rate and freedom from target lesion revascularization (TLR). Secondary outcome measures included technical success, limb salvage rate and the identification of predictors of outcomes.
Results:
The incidence of IPAD was 0.98% (46/4717 PAD procedures). In total, 46 patients (38 male; mean age 73 ± 12 years) underwent plain balloon (69.5%) or bail-out stenting (30.5%) procedures. Most patients suffered from CLI (65.2%). Mean lesion length was 52.5 ± 32.0 mm and 45.6% of the cases were occlusions. Severe calcifications were noted in 26.1%. Technical success was 100%. Mean time follow-up was 32.6 ± 25.6 months. According to Kaplan-Meier analysis, restenosis was 15.8, 40.9, 45.8% and TLR-free rate was 90.5, 79.0, 74.1%, at 1, 2 and 3 years, respectively. Survival and limb salvage rates were 73.6 and 88.1%, at 5 years, respectively. The major amputation rate for CLI patients was 10.0% (3/29 limbs), while no major amputations occurred in the claudication subgroup. Cox multivariable analysis detected baseline occlusion as an independent predictor of increased restenosis (HR 5.3; 95% CI 0.21-0.66, p = 0.02).
Conclusions:
Isolated popliteal lesions requiring treatment appear in nearly 1% of patients with PAD. Balloon angioplasty and bail-out stenting resulted in acceptable long-term clinical outcomes. Treatment of occlusions was correlated with increased restenosis rate.
... This strategy, however, is not reflected in current guidelines, incorporating the popliteal artery into the femoro-popliteal segment without further differentiation, likely underappreciating the unique properties of this anatomical region [7,8,9,10,11]. So far, data validating the performance of angioplasty and bail-out stenting in popliteal artery disease are limited to few moderately sized analyses [13,14]. ...
... Max. balloon pressure (bar) mean ±SD 13.4±10.5 the endovascular approach in the hands of experienced vascular specialists is feasible and even surpasses many previously published data [13,14,17,18,19,20]. This may also be linked to the fact that the majority of interventions (75%) in the present trial was performed in an antegrad cannulation technique (i.e. a sheath being inserted in the ipsilateral common femoral artery) providing superior maneuverability of interventional devices compared to a crossover approach. ...
... It is noteworthy, that no major complication (death, surgical revision) was observed. This compares well with other trials evaluating endovascular therapy for popliteal artery disease reporting complications rates between 2.4% and 13% [13,14,17,18]. Surgical revascularization, however, comes along with significantly higher rates of perioperative complications, which were reported to be as high as 12-57% [21,22], with these complications usually originating from the surgical procedure itself and the need for general anesthesia (i.e. ...
Background: Finding the appropriate endovascular revascularization strategy for patients with peripheral artery disease and a popliteal artery lesion remains particulary challenging. Data regarding predictors for a beneficial outcome are scarce. Patients and methods: All endovascular procedures of popliteal artery lesions (n=227) performed in 197 patients between February 2009 and May 2018 at our institution were retrospectively analyzed. Hemodynamically relevant restenosis represented the primary endpoint. Results: The overall technical success rate was 98% and yielded 99% for stenoses (n=145) and 97% for occlusions (n=82). In a median follow-up of 10 months, the overall rate of restenosis was 23%. After 1 and 2 years, the primary patency rates were 76% and 55% and the secondary patency rate was 100%, respectively. The estimated probability of restenosis was significantly higher in stented lesions (stent vs. no stent; 36.0% vs. 19.1%; p=0.030). Multivariate analysis identified stent implantation (hazard ratio: 2.4; overall P=0.010) and diabetes (hazard ratio 2.0; P=0.023) as significant predictors for the development of restenosis. Conclusions: Endovascular therapy for popliteal artery disease was associated with high technical success rates and accompanied with a promising mid-term outcome, particularly in lesions treated with balloon angioplasty alone.
... However, publications are heterogeneous in terms of arterial runoff and the type of radiological intervention used. [1][2][3][4][5][6][7] Although percutaneous transluminal angioplasty (PTA) with a plain or drug-coated balloon plus or minus bare-metal stenting is the most commonly applied treatment method, [1,2,4,[7][8][9][10][11] reports have outlined stentgraft implantation [12] and atherectomy [3,4,13]. However, studies also appear to be inconsistent in terms of the composition of deployed (mainly self-expanding) stents. ...
... [1,2,5,[7][8][9]11] The mid-and long-term efficacy of endovascular procedures can be characterized by the restenosis rate. Depending on radiological intervention types, the restenosis rate of popliteal endovascular therapy is approximately 5-70%, [1][2][3][4][5][6] which is slightly better than the restenosis rate of femoropopliteal interventions (40-70%; most likely because femoral lesions are almost always longer than popliteal lesions, and the longer the treated lesion, the greater the probability of restenosis) [14,15]. Therefore, the goal of this study was to examine mid-term results of endovascular methods and identify predictors of restenosis in a single-center, homogeneous population in terms of crural runoff arteries and implanted stent type. ...
... [1-7, 13] For the majority of studies (similar to this study), PTA with plain balloons and stenting (either primary or selective) with bare-metal stents was the technique of choice. [1,2,[5][6][7]10] The type of stents implanted varies from study to study. [1,2,[5][6][7][8][9][10][11] In the present patient population, only Astron Pulsar stents have been deployed, which has the advantage over other stents that in most cases the intervention can be executed through a 4F sheath. ...
Background and Aim
There is only a limited number of major publications on the outcome of interventions for isolated popliteal artery stenosis. The purpose of this study was to report our results on mid-term patency and predictors of restenosis.
Patients and Methods
This single-center retrospective study included 61 symptomatic patients (males, N=33; median age, 65.1 years [IQR, 60.7–71.9 years]; Rutherford grade 4–6, N=14) with at least two patent crural arteries, whose atherosclerotic stenoses/occlusions were treated with percutaneous transluminal angioplasty (PTA) or stenting (using self-expanding bare-metal Astron Pulsar stents) between 2011 and 2018.
Results
Twenty-six patients had PTA, while 35 underwent stenting. The median follow-up was 29 months (IQR, 10–47 months). The primary patency rates were not significantly different ( P = 0.629) between PTA and stenting groups. Restenosis developed in nine patients (34.6%) in the PTA group, and in 12 (34.3%) in the stenting group. Restenotic lesions required re-intervention in nine cases (100%) in the PTA group, and in eight (66.7%) in the stenting group. Restenosis developed significantly less frequently ( P = 0.010) in patients with a popliteal/P1 stent; the primary patency rates were also significantly better ( P = 0.018) in patients with a popliteal/P1 stent when compared to popliteal/P2 plus multi-segment stents. Cox regression analysis identified lesion location as a predictor of in-stent restenosis (HR, 2.5; 95% CI, 1.2–5.5; P = 0.019).
Conclusion
Stenting was not superior when compared to PTA (if selective stenting was not considered as loss of patency). Follow-up should be more thorough in patients undergoing popliteal/P2 or multi-segment stenting.
... Popliteal lesions were detected in 8.8% of atherosclerotic lesions in 417 diabetic patients presenting with critical limb ischemia [3] . Isolated popliteal lesions were reported in 0.98% of patients presenting with peripheral arterial disease [4] . Angioplasty of popliteal artery atherosclerotic lesions are challenging due to the unique biomechanical properties including compression, flexion and twisting which may increases the risk of stent deformation or fracture and affect vessel patency [5] . ...
... Spiliopoulos et al. reported restenosis after angioplasty of isolated popliteal artery disease to occurr in 15.8, 40.9, and 45.8% at 1, 2 and 3 years, respectively. popliteal artery occlusion was the only independent predictor of restenosis (HR 5.3; p = 0.02) [4] . In a study by Schillinger et al., restenosis occurred in 39% of after 1 year of angioplasty of femoropopliteal lesions. ...
... 2,3 Isolated atherosclerotic popliteal artery lesions are also common in patients with PAD. 4 Treating isolated popliteal artery lesions using endovascular methods (eg, angioplasty, stenting) has been a particular clinical challenge. Because of knee flexion, the popliteal artery is under continuous stress by various biomechanical forces. ...
... However, only scarce evidence has been reported regarding the outcomes after endovascular treatment of isolated popliteal lesions. 4 The popliteal artery is subject to very considerable forces during ambulation. Furthermore, popliteal atherosclerotic lesions will often be calcified. ...
Background
Mid term results following treatment of isolated popliteal lesions are limited. The aim of this study is to report mid-term outcomes following endovascular treatment of isolated atherosclerotic popliteal artery lesions.
Methods
A multicentre (15 hospitals, 5 countries) retrospective cohort study was performed. Between June 2016 and June 2021, we included 651 consecutive patients treated for isolated popliteal lesions using endovascular means exclusively were included. Six techniques were identified, including plain balloon angioplasty (PTA), (286, 43.9%), drug coated balloon (DCB) angioplasty (98, 15.1%), stenting with low-chronic outward force (COF) stents (84, 12.9%), stenting with high-COF stents (76, 11.7%), atherectomy alone (17, 2.6%), and directional atherectomy with DCB (DAART) (90, 13.8%). Primary outcomes measures were primary and secondary patency, and freedom from clinically-driven target lesion revascularization (F-CDTLR).
Results
Mean age was 74.5 years. Most of patients had a chronic limb-threatening ischemia (CLTI) (409, 62.9%). Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. Median follow-up was 26 months (range: 6-42). Actuarial rate for all patients at 26 months (per outcome measure) was: primary patency, 73.9%; secondary patency, 88%; F-CDTLR, 76.5%. When comparing PTA vs. all other treatments in an adjusted regression, F-CDTLR was 75.2% for PTA vs. 76.5% for all other treatments, HR: 1.06, 95% CI: 0.75-1.48, P=.46 (adjusted regression); secondary patency was also not statistically different (85.7% for PTA vs. 88%, p=0.20). In an adjusted Kaplan Meier analysis, estimated primary patency was inferior for PTA in pairwise comparisons vs. other treatments (<.001 vs. atherectomy; .002 vs. DAART; .002 vs. low-COF stenting).
Conclusions
Endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and CD-TLR in the mid-term.
... Isolated popliteal artery lesions account for only a small proportion of lesions. 11 However, the popliteal artery is involved in approximately one-third of femoral or infrapopliteal lesions. In the popliteal artery, primary patency after BA alone is known to be considerably lower than after primary stenting. ...
... After BA, bailout stenting is needed in about one-third of lesions. 11,12 On the other hand, the artery is highly exposed to biomechanical forces, increasing the risk of in-stent restenosis and stent fractures, even in case of woven wire design. 13,14 The small size of a single Tack implant and gaps between multiple implants preserves the flexibility of the popliteal artery and decreases the risk of fracture. ...
Purpose: To assess the practical application and acute outcomes of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting. Materials and Methods: Fifty-one consecutive patients who underwent endovascular revascularization for symptomatic peripheral artery disease and experienced 63 dissections requiring treatment were included in the prospective, single-center, single-arm study between January and June 2019. Thirty-nine (76.5%) lesions were ≥10 cm in length, 33 (64.7%) were totally occluded, and 13 (25.5%) were severely calcified. Fifty-six (88.9%) dissections were classified as severe. Dissections were treated either by means of the 6-F above-the-knee (ATK) or the 4-F below-the-knee (BTK) Tack Endovascular System. Observational outcomes were conditions and scopes of application. Clinical outcomes were acute technical and procedural success as well as safety. Results: Lesions were revascularized with 2.3±0.8 attempts such as standard balloon angioplasty, drug-coated balloon angioplasty, atherectomy, and/or lithotripsy. The Endovascular System was applied in 60 (95.2%) of 63 dissections. All dissections of the femoral artery were treated with the ATK system, and all infrapopliteal dissections with the BTK system. Both systems were successfully applied in popliteal artery dissections. Dissection length predicted the number of Tack implants deployed. Technical success was achieved in 98.3% (59 of 60 dissections). No major adverse event or device-related complication occurred during the procedure. Conclusion: Acute results in effectiveness and safety of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting are promising.
... Spiliopoulos és mtsai 4717 LEADesetet vizsgáltak meg, melyek közül csak 46 esetben igazolódott izolált a. poplitea érbetegség (0,98%). Ered-ményeik alapján az a. poplitea ballonos angioplasztika és provizorikus sztentelés mellett az első évben 15,8% restenosis alakult ki, az esetek 90,5%-ában azonban nem volt szükség reintervencióra [18]. A Rastan és mtsai által végzett prospektív randomizált tanulmány (ETAP study) is igazolta a popliteasztentek jobb nyitvamaradását a ballonos angioplasztikával szemben az egyéves nyitvamaradás tekintetében (67,4% versus 44,9%; p = 0,002) [19]. ...
Introduction: The incidence of peripheral arterial diseases and the rate of chronic limb-threatening ischaemia are increasing year by year. Minimally invasive peripheral interventions have gradually replaced traditional operations. Earlier steno-occlusion of the popliteal artery was an indication for femoropopliteal bypass below the knee. Nowadays, endovascular procedures are also used, but the indication of the stent placement into the popliteal artery is controversial.
Aim: We have been using Jaguar stent for the treatment of popliteal artery steno-occlusion since January 2016. The aim of our study was to evaluate the efficacy of this treatment.
Method: We included patients who underwent popliteal artery angioplasty with Jaguar stent placement between 1 January 2016 and 31 December 2017 in our department. During the one-year follow-up, we examined the popliteal stent patency, amputation-free survival and risk factors that influence stent patency.
Statistical analysis: For the comparison of mean values, two-sided t-tests were used. Categorical data were analyzed by using chi-square test.
Results: 33 patients underwent popliteal or femoropopliteal endovascular intervention with Jaguar stent placement into the popliteal artery. Postoperative complications that required surgical treatment occurred in 2 patients. At the end of the follow-up, the primary patency of the popliteal stents was 58.1%, the secondary patency was 74.2% and amputation-free survival was 96.8%.
Conclusion: Compared with international data, the primary patency of the Jaguar stents in our study is relatively lower, but amputation-free survival is much better, and in most cases there is less operative strain compared with traditional operations. Orv Hetil. 2020; 161(15): 588–593.
... Angioplasty and bailout stenting for popliteal lesions present a restenosis incidence of 15.8, 40.9, and 45.8% at 1, 2, and 3 years of follow-up, respectively, with acceptable outcomes regarding amputation rates (10.0% in the subgroup of patients suffering from critical limb ischemia). 17 In this multicenter study published in 2018, stent indication was reserved for cases with suboptimal angioplasty result (>30% remaining stenosis and flow-limiting type C dissection), and SENS were used in all cases. The subgroup analysis of stenting versus plain balloon angioplasty demonstrated similar TLR-free and restenosis rates at 1-year follow-up. ...
Background:
Reports our experience for the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment.
Methods:
This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery. Also, a follow-up of 36 months is reported.
Results:
The mean preoperative ankle-brachial index increased from 0.38 ± 0.37 before intervention to 0.63 ± 0.46 postoperatively at 12 months (P = 0.014), 0.66 ± 0.39 at 24 months (P = 0.023), and 0.74 ± 0.46 at 36 months (P = 0.029). Primary patency at 12, 24, and 36 months were 89.6%, 72.3%, and 70.2%, and primary assisted patency was 93.8%, 87.2%, and 85.1%, respectively, by Kaplan-Meier estimates. After 3 years of follow-up, age <75 years (P = 0.034) and Trans-Atlantic Inter-Society Consensus (TASC)-II D lesions (P = 0.041) constituted risk factors for stent occlusion. During the follow-up of the patients, none of them developed stent fracture as evidenced on plain radiographs during follow-up. Implantation defects did not constitute a risk factor for stent restenosis.
Conclusions:
Based on the results of this study, Supera stent has shown an excellent 3-year patency in this difficult-to-treat anatomic segment. In our experience, younger patients and complex lesions (TASC-II type D) were positive significant predictors for restenosis. In our cohort, post deployment stent conformation did not influence patency. Nevertheless, further investigations, including randomized studies comparing the Supera stent with other stent platforms, drug eluting angioplasty, or atherectomy devices, are mandatory.
Objectives
Clinically driven target lesion revascularization (CD-TLR) frequently occurs after endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI). The total thrombus-formation analysis system (T-TAS) can quantitatively evaluate thrombogenicity. Therefore, we aimed to elucidate the association of T-TAS parameters with CD-TLR.
Methods
We analyzed 34 CLTI patients and 62 Non-CLTI patients who underwent EVT. Blood samples collected on the day of EVT were used in T-TAS to compute the thrombus formation area under the curve (PL24-AUC10 in the platelet chip and AR10-AUC30 in the atheroma chip). After the EVT procedure, clinical follow-up was performed, and the presence of CD-TLR was assessed.
Results
During the follow-up period (median 574 days), 10 patients (29%) in the CLTI group and 11 patients (18%) in the Non-CLTI group showed CD-TLR. In the CLTI group, patients who showed CD-TLR had a higher AR10-AUC30 than those who did not (1694 [1657, 1799] vs. 1561 [1412, 1697], p=0.01). In contrast, the PL24-AUC10 showed no significant differences depending on CD-TLR in both groups. For the CLTI patients, multivariable Cox regression analysis using propensity scores revealed that the AR10-AUC30 was an independent predictor of CD-TLR even after adjusting for baseline demographics, lesion characteristics, and anticoagulant use (HR=2.04, 95%CI=1.18-3.88, p=0.01; per 100 increase). In contrast, in Non-CLTI patients, neither the AR10-AUC30 and nor the PL24-AUC10 was significantly associated with CD-TLR. Receiver operating characteristics curve analysis identified an AR10-AUC30 level of 1646 as an optimal cutoff value to predict CD-TLR (AUC = 0.85, sensitivity = 0.93, specificity = 0.56).
Conclusions
In CLTI patients, but not in Non-CLTI patients, the AR10-AUC30 showed a potential to predict CD-TLR. This finding suggests that hypercoagulability may play a predominant role in the progression of CLTI and anticoagulants may be useful in preventing revascularization.
Purpose:
To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease.
Methods:
This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound-defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed.
Results:
Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline.
Conclusion:
This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.
Purpose:
To determine the predictors of restenosis, major adverse limb events (MALEs), postoperative death (POD), and all-cause mortality after repeat endovascular treatment of superficial femoral artery (SFA) restenosis.
Materials and methods:
This was a retrospective review of 440 patients with 518 SFA lesions who were treated between January 2002 and October 2011. Ninety-six limbs were treated for restenosis with bare metal stents (BMSs) or percutaneous transluminal angioplasty (PTA), of which 28 limbs developed another restenosis requiring a third procedure. The interaction measured in this study was between the second and third intervention. Predictors of SFA patency, MALEs, POD, and all-cause mortality after SFA restenosis treatment were identified.
Results:
Patients who were treated with BMSs (n = 51) had similar rates of restenosis compared with patients who were treated with PTA (n = 45) (hazard ratio [HR] 1.40; 95% confidence interval [CI] 0.68-2.90; P = .37). Patients in the BMS group who took statins had a significantly lower risk of restenosis than patients who did not take statins (HR 0.13; 95% CI 0.04-0.41; P < .001). Stage 4-5 chronic kidney disease (CKD) (n = 12) was associated with a significantly higher risk of MALE + POD (HR 6.17; 95% CI 1.45-26.18; P = .014) and all-cause mortality (HR 2.83; 95% CI 1.27-6.33; P = .01). Clopidogrel was protective against all-cause mortality (HR 0.41; 95% CI 0.20-0.80; P = .01).
Conclusions:
Patients in the BMS group who took statins at the time of intervention had a significantly lower risk of developing restenosis. Stage 4-5 CKD was a risk factor for MALE + POD and all-cause mortality, while clopidogrel decreased all-cause mortality risk.
Background
Superficial femoral artery chronic total occlusion (SCTO) is a common type of peripheral arterial disease (PAD). Endovascular therapy is a treatment approach that has a poor long-term success rate in this group. The aim of this study was to compare the mid-term results of two different uses of nitinol stents in long SCTO lesions (>100 mm): the use of one long stent or two shorter stents.
Material/Methods
Of 154 patients who underwent percutaneous infrainguinal interventions from 2011 to 2014, a total of 170 CTO lesions were selected for this retrospective study analysis. The mean age of the study population was 63.4±10.4 years (range 29–89 years); 71.8% of the patients were male.
Results
Patients were divided into two groups according to the number of stents used. Patients treated with a single stent were placed into group A and patients treated with two stents were placed into group B. The stent fracture rate was significantly higher in group B compared to group A (29.2% vs. 42%). Type 1 and 2 fracture rates were higher in group A, but type 3 and 5 fracture rates were significantly higher in group B. The rate of stent restenosis was significantly higher in group B compared to group A (45.1% vs. 54.5%, p=0.05).
Conclusions
Mid-term patency rate was low in patients with long totally occluded superficial femoral artery (SFA) lesions. Using a long single stent had an acceptable mid-term patency rate compared to using a two stent strategy. Stent fracture seemed to be the main reason for in-stent restenosis in cases of multiple stenting. A long single stent strategy may be more appropriate and reasonable than a two stent strategy in the treatment of long SFA lesions.
Purpose:
To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery.
Methods:
Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR).
Results:
The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99).
Conclusion:
In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.
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.
Current clinical classification of superficial femoral artery (SFA) occlusions as defined by TASC II guidelines is limited to length and calcifications analysis on 2D angiograms, while state-of-the-art cross-sectional imaging like computed tomography angiography (CTA) and magnetic resonance angiography (MRA) provides much more detailed anatomical information than traditional invasive angiography: quantitative morphological analysis of these advanced imaging techniques could therefore be the basis of a refined classification.
Forty-six patients (65% men, 68±11.6 years) that underwent lower limb CTA were retrospectively included, totalizing 60 SFA occlusions. Lesions were classified as TASC II stage A in 3% of cases, stage B in 20%, stage C in 2% and stage D in 75%. For each pathological artery, curved multiplanar reconstructions following the occluded SFA course were used to measure the total length and the mean diameter of the occluded segment. Color-coded map provided an accurate estimation of calcifications' volume. Thirty-nine percent of the occlusions were total. Mean occluded segment length was 219±107 mm (range, 14-530 mm); mean occluded segment diameter was 6.1±1.6 mm (range, 3.4-10 mm); mean calcifications' volume in the occluded segment was 1,265±1,893 mm(3) (range, 0-8,815 mm(3)), corresponding to a percentage of 17.4%±20% (range, 0-88.7%). Shrinked occluded occlusions were defined by a mean diameter under 5 mm and heavily calcified occlusions by a mean percentage of calcifications above 4%. Use of these thresholds allowed the distinction of four groups of patients: heavily calcified occlusions with preserved caliber (56%), non-calcified occlusions with preserved caliber (19%), non-calcified occlusions with small caliber (15%) and heavily calcified occlusions with small caliber (10%).
SFA OCCLUSIONS ARE DISPARATE: this simple morphological study points out TASC II classification weaknesses for SFA occlusions, as quantitative cross-sectional imaging analysis with measurement of mean occluded diameter and percentage of calcifications can refine it. This could be particularly useful in the management of TASC II type D lesions, for which new endovascular revascularization techniques are arising, and where a CTA or MRA-based morphological classification could provide support in choosing between them.
Computer-assisted image processing; femoral artery; multidetector computed tomography; magnetic resonance angiography (MRA); peripheral arterial disease.
Purpose:
To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life.
Methods:
A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5-22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire.
Results:
Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months' follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % (p = 0.84) and 40.8 versus 46.7 % (p = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life.
Conclusion:
Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.
We wanted to evaluate the status of self-expandable nitinol stents implanted in the P2 and P3 segments of the popliteal artery in Korean patients.
We retrospectively analyzed 189 consecutive patients who underwent endovascular treatment for stenoocclusive lesions in the femoropopliteal artery from July 2003 to March 2009, and 18 patients who underwent stent placement in popliteal arterial P2 and P3 segments were finally enrolled. Lesion patency was evaluated by ultrasound or CT angiography, and stent fracture was assessed by plain X-rays at 1, 3, 6 and 12 months and annually thereafter.
At the 1-month follow-up, stent fracture (Type 2) was seen in one limb (up to P3, 1 of 18, 6%) and it was identified in seven limbs at the 3-month follow-up (Type 2, Type 3, Type 4) (n = 1: up to P2; n = 6: P3). At the 6-month follow-up, one more fracture (Type 1) (up to P3) was noted. At the 1-year follow-up, there were no additional stent fractures. Just four limbs (up to P2) at the 2-year follow-up did not have stent fracture. The primary patency was 94%, 61% and 44% at 1, 3 and 6 months, respectively, and the group with stent implantation up to P3 had a higher fracture rate than that of the group that underwent stenting up to P2 (p < 0.05).
We suggest that stent placement up to the popliteal arterial P3 segment and over P2 in an Asian population can worsen the stent patency owing to stent fracture. It may be necessary to develop a stent design and structure for the Asian population that can resist the bending force in the knee joint.
Symptomatic atherosclerotic disease of the popliteal artery presents challenges for endovascular therapy. We evaluated the technical success, complications, and midterm outcomes of atherectomy and angioplasty involving the popliteal segment.
We conducted a retrospective review of outcomes of popliteal artery intervention using atherectomy or angioplasty performed between 2003 and 2008.
A total of 56 patients (36% women, age 72.8 +/- 12.2 years, 77% critical limb ischemia) underwent popliteal atherectomy (n = 18) or angioplasty (n = 38). These patients had similar clinical characteristics, TransAtlantic Intersociety Consensus (TASC)/ TASC II classification, mean lesion length, and runoff scores. We observed a trend toward higher rates of technical success defined as <30% residual stenosis after atherectomy compared to angioplasty (94% vs 71%, P = .08). While angioplasty was associated with a higher frequency of arterial dissection (23% vs 0%, P = .003), atherectomy was associated with a higher rate of thromboembolic events (22% vs 0%, P = 0.01). Adjunctive stenting was used more frequently following angioplasty compared to atherectomy (45% vs 6%, P = .005). Thrombolysis was used to treat embolization in 4 patients in the atherectomy group. The improvement in the ankle-brachial index (ABI) was similar between the 2 treatment groups. Primary patency of the popliteal artery at 3, 6, and 12 months was 94%, 88%, and 75% in the atherectomy group and 89%, 82%, and 73% in the angioplasty group (P = not significant [NS]). There were no significant differences in limb salvage and freedom from reintervention at 1 year between the atherectomy and angioplasty groups.
Our experience with popliteal artery endovascular therapy indicates a distinct pattern of procedural complications with atherectomy compared to angioplasty but similar midterm patency, limb salvage, and freedom from intervention.
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.).
Purpose:
To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA).
Methods:
This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed.
Results:
Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001).
Conclusion:
The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.
Objective:
To evaluate efficacy, safety, and midterm patency of endovascular treatment of obstructive popliteal artery (PA) disease.
Methods:
A retrospective evaluation of patients with atherosclerotic PA disease who underwent percutaneous transluminal balloon angioplasty and provisional stent, based on both conventional and dynamic angiographies, was conducted from June 2011 to June 2014. Forty-three patients were included in the study, and most patients had limited surgical revascularization options. Demographic characteristics, angiographic findings, interventional data, complications, vessel patency, limb salvage rates, and survival rates were analyzed.
Results:
The median lesion length was 5 cm with 72.1% having total occlusions. The second popliteal segment (P2) was involved most frequently (60.5%, n = 26). Critical limb ischemia was present in 69.8%. The technical success rate was 92.9% (42/43 limbs), with 29 cases requiring adjunctive nitinol stents after balloon angioplasty (47.6% based on conventional angiography, 21.4% based on dynamic angiography, and 4.8% additional stents based on dynamic angiography). Complications included thromboembolism (2.3%), perforation (2.3%), pseudoaneurysm (2.3%), and myocardial infarction (2.3%). Stent fracture was present in three cases (7.1%) during the mean follow-up period of 18.3 months. The baseline ankle-brachial index significantly improved after the intervention, from 0.49 ± 0.11 to 0.92 ± 0.14 (P < .01). The Rutherford-Becker class decreased from 3.95 ± 0.76 to 1.76 ± 0.95 (P < .01) at 12 months. The 1-year primary, primary-assisted, and secondary patency rates were 75.2% ± 6.8%, 82.4% ± 6.0%, and 89.9% ± 4.8%, respectively. The limb salvage and amputation-free survival rates at 12 months were 91.6% and 87.0%, respectively.
Conclusions:
Balloon angioplasty with a provisional stent based on dynamic angiography is a feasible, safe, and effective therapy for patients with obstructive PA disease. Although the occurrence of stent fracture is still inevitable, patients with critical limb ischemia who have limited surgical options may get more benefits from the endovascular treatment of PA obstructive diseases.
The prevalence of peripheral artery disease (PAD) continues to increase worldwide. It is important to identify patients with PAD because of the increased risk of myocardial infarction, stroke, and cardiovascular death and impaired quality of life because of a profound limitation in exercise performance and the potential to develop critical limb ischemia. Despite effective therapies to lower the cardiovascular risk and prevent progression to critical limb ischemia, patients with PAD continue to be under-recognized and undertreated. The management of PAD patients should include an exercise program, guideline-based medical therapy to lower the cardiovascular risk, and, when revascularization is indicated, an "endovascular first" approach. The indications and strategic choices for endovascular revascularization will vary depending on the clinical severity of the PAD and the anatomic distribution of the disease. In this review, we discuss an evidence-based approach to the management of patients with PAD. (C) 2016 by the American College of Cardiology Foundation.
The prevalence of peripheral artery disease (PAD) continues to increase worldwide. It is important to identify patients with PAD because of the increased risk of myocardial infarction, stroke, and cardiovascular death and impaired quality of life because of a profound limitation in exercise performance and the potential to develop critical limb ischemia. Despite effective therapies to lower the cardiovascular risk and prevent progression to critical limb ischemia, patients with PAD continue to be under-recognized and undertreated. The management of PAD patients should include an exercise program, guideline-based medical therapy to lower the cardiovascular risk, and, when revascularization is indicated, an “endovascular first” approach. The indications and strategic choices for endovascular revascularization will vary depending on the clinical severity of the PAD and the anatomic distribution of the disease. In this review, we discuss an evidence-based approach to the management of patients with PAD.
Purpose:
To provide a qualitative analysis and quantitative synthesis of randomized controlled trials (RCTs) investigating paclitaxel-coated balloons (PCBs) in the femoropopliteal artery.
Methods:
PubMed, EMBASE, AMED, Scopus, CENTRAL, online content, and abstracts from international meetings were last screened in April 2015 for eligible RCTs using the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool, and quality of evidence was evaluated with the GRADE system. Outcome measures included late lumen loss (LLL) at 6 months and event rates of major limb amputations, binary lesion restenosis, and target lesion revascularization (TLR). Pooled treatment effects were analyzed in a random effects model to account for clinical heterogeneity; the outcomes are presented as the rate ratios (RRs) and their 95% confidence intervals (CIs). Extensive meta-regression was performed to analyze potential confounders. The review was registered in the PROSPERO database (CRD42015023938; www.crd.york.ac.uk/PROSPERO).
Results:
Eleven RCTs with 1609 subjects (1403 claudicants and 206 patients with critical limb ischemia) with medium-length femoropopliteal lesions (mean range 5.1-11.9 cm) were included. There was consistently high-quality evidence supporting the clear superiority of PCBs in terms of reduced LLL (mean difference -0.89 mm, 95% CI -1.14 to -0.64, p<0.001), less binary restenosis (RR 0.47, 95% CI 0.37 to 0.61, p<0.001), and fewer TLR events (RR 0.33, 95% CI 0.22 to 0.49, p<0.001). Major amputations were rare in both active and control arms (pooled event rate: 0.7%, 95% CI 0.3% to 1.2%). Results were stable across all potential risk modifiers and in the presence of stents as well. There was high-quality evidence that the dose of paclitaxel was related to the magnitude of the treatment effect; standard dose (3.0-μg and 3.5-μg) PCBs were significantly more effective compared with low-dose 2-μg PCB in reducing both restenosis (RR 2.1, 95% CI 1.2 to 3.4, p<0.001) and TLR (RR 2.5, 95% CI 1.9 to 3.8, p<0.001).
Conclusion:
PCBs reduce by more than half the rates of restenosis and TLR in the femoropopliteal artery regardless of stent placement. Biologic effect size may vary according to paclitaxel bioavailability.
Purpose:
To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery.
Methods:
In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality.
Results:
The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation.
Conclusion:
In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.
To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.
This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.
From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0 %) were chronic total occlusions. Technical success was achieved in all cases (100 %). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2 % with an 86.1 ± 5.9 % freedom from TLR and 87 ± 5.0 % AFS (K-M estimates).
The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.
To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery.
The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death).
In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups.
In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting.
© The Author(s) 2015.
Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845).
Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity.
Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years).
Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.
Endovascular interventions for critical limb ischemia are associated with inferior limb salvage (LS) rates in most randomized trials and large series. This study examined the long-term outcomes of selective use of endovascular-first (endo-first) and open-first strategies in 302 patients from March 2007 to December 2010.
Endo-first was selected if (1) the patient had short (5-cm to 7-cm occlusions or stenoses in crural vessels); (2) the disease in the superficial femoral artery was limited to TransAtlantic Inter-Society Consensus II A, B, or C; and (3) no impending limb loss. Endo-first was performed in 187 (62%), open-first in 105 (35%), and 10 (3%) had hybrid procedures.
The endo-first group was older, with more diabetes and tissue loss. Bypass was used more to infrapopliteal targets (70% vs 50%, P = .031). The 5-year mortality was similar (open, 48%; endo, 42%; P = .107). Secondary procedures (endo or open) were more common after open-first (open, 71 of 105 [68%] vs endo, 102 of 187 [55%]; P = .029). Compared with open-first, the 5-year LS rate for endo-first was 85% vs 83% (P = .586), and amputation-free survival (AFS) was 45% vs 50% (P = .785). Predictors of death were age >75 years (hazard ratio [HR], 3.3; 95% confidence interval [CI], 1.7-6.6; P = .0007), end-stage renal disease (ESRD) (HR, 3.4; 95% CI, 2.1-5.6; P < .0001), and prior stroke (HR, 1.6; 95% CI, 1.03-2.3; P = .036). Predictors of limb loss were ESRD (HR, 2.5; 95% CI, 1.2-5.4; P = .015) and below-the-knee intervention (P = .041). Predictors of worse AFS were older age (HR, 2.03; 95% CI, 1.13-3.7; P = .018), ESRD (HR, 3.2; 95% CI, 2.1-5.11; P < .0001), prior stroke (P = .0054), and gangrene (P = .024).
At 5 years, endo-first and open-first revascularization strategies had equivalent LS rates and AFS in patients with critical limb ischemia when properly selected. A patient-centered approach with close surveillance improves long-term outcomes for both open and endo approaches.
Background:
Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery.
Methods and results:
This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Target-lesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31).
Conclusions:
Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting.
Clinical trial registration url:
http://www.clinicaltrials.gov. Unique identifier: NCT00712309.
Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions.
We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention.
Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months.
In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.
While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of runoff on long-term outcomes of these interventions in patients with rest pain and tissue loss is unclear. Runoff is known to negatively effect graft patency. The aim of this study is to examine the impact of distal runoff on long-term outcomes of SFA interventions for critical ischemia.
A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classification 4, 5, and 6 were selected. Patients with concomitant tibial interventions were excluded. Pre-operative angiograms were reviewed in all cases to assess distal popliteal and tibial runoff and were scored according to modified Society of Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1 and maximum 19). Three runoff score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed.
Three hundred six limbs in 241 patients (57% male, mean age 68 years) underwent endovascular treatment for critical ischemia (44% rest pain and 56% tissue loss.) Technical success was 96% with 61% SFA undergoing angioplasty, 37% SFA primary stenting and 2% SFA an atherectomy. Overall mortality was 1% and overall morbidity was 16% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly worse cumulative patency (82 +/- 9%, 56 +/- 4%, and 52 +/- 7% for good, compromised, and poor runoffs, respectively, mean +/- standard error of the mean [SEM]). Freedom from recurrent symptoms (65 +/- 8%, 39 +/- 9%, and 18 +/- 9% for good, compromised, and poor runoffs, respectively) and limb salvage (65 +/- 5%, 41 +/- 4%, and 20 +/- 6% for Good, Compromised, and Poor runoffs, respectively) were incrementally curtailed by worsening runoff with significant decreases as runoff category deteriorated.
In patients presenting with rest pain and tissue loss who are treated with SFA percutaneous interventions, patency is negatively affected by compromised and poor runoffs in keeping with the bypass literature. More importantly, freedom from recurrent symptoms and limb salvage are incrementally curtailed as runoff scores worsen. These findings are consistent with the bypass literature.
Society of interventional radiology standards of practice committee. Quality improvement guidelines for diagnostic arteriography
- S R Dariushnia
- A E Gill
- L G Martin
- SR Dariushnia
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improvement guidelines for diagnostic arteriography. J Vasc
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Novel nitinol stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries: 24-month results from the tigris randomized trial
- J R Laird
- T Zeller
- C Loewe
- JR Laird