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A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry
Abstract
Background:
The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.
Methods:
All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.
Results:
A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).
Conclusion:
The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.
... S tem pa je tudi potrdila smiselnosti nadaljnjega opredeljevanja uporabe DEB. (30,44). Zaradi drugačne farmakodinamike in farmakokinetike bi lahko Magic Touch pomenil velik korak naprej pri razvoju DEB. ...
... Zaradi drugačne farmakodinamike in farmakokinetike bi lahko Magic Touch pomenil velik korak naprej pri razvoju DEB. Ocenjen je bil z odprto prospektivno, multicentrično študijo Nanoluté (44). Ta je vključila 332 bolnikov s 356 spremembami v zdravljenje z Magic Touch DEB (Concept Medical Research Private Limited, India). ...
... Bolniki, ki so bili vključeni v študijo, so bili starejši od 18 let in imeli stabilno angino pektoris, tiho ishemijo, akutni koronarni sindrom, ISR, bolezen koronarnih žil manjšega premera (premer žil v študiji je bil 1,5 do 4,00 mm), bifurkacijske spremembe, večžilno bolezen, pa tudi bolniki, zdravljeni s hibridnimi strategijami. Glede na objavljene rezultate so pokazali možnost in varnost uporabe DEB s sirolimusom v različnih vrstah sprememb (44). ...
Od prve koronarne angioplastike leta 1977 preko femoralnega pristopa je intervencijska kardiologija drastično spremenila zdravljenje ishemične bolezni srca. Prvotna perkutana transluminalna angioplastika z uporabo navadnih balonskih katetrov je sčasoma postala le pomožna tehnika za pripravo žilne spremembe in optimiziranje vstavljene žilne opornice. S pojavom navadnih žilnih opornic smo izboljšali rezultate na račun zmanjšanega elastičnega odsunka, poškodbe in konstriktivnega remodeliranja koronarnih arterij, z razvojem antiagregacijske terapije pa dosegli manjše število tromboz v žilnih opornicah. Ob nadaljnjih raziskavah neointimalne hiperplazije so se pojavile metode za lokalno apliciranje antiproliferacijskih zdravil. Razvile so se z zdravili prevlečene opornice, ki so leta 2019 postale novi zlati standard. Ob uporabi modernejših materialov so poskrbele za izboljšanje rezultatov na račun zmanjšanja neointimalne hiperplazije in števila zapletov. A kljub temu so še vedno tujek v žilni steni, ki spodbuja kronično vnetje, neoaterosklerozo, s tem pa restenozo ter zelo pozne pojave tromboze. To spoznanje zadnja leta vodi v razvijanje tehnik, ki bi za sabo pustile čim manj tujega materiala oziroma bi bil le-ta čimbolj biološko kompatibilen. Ob razvoju razgradljivih žilnih opornic so ena obetajočih terapevtskih možnosti z zdravili prevlečeni balonski katetri, ki razširijo žilno svetlino in lokalno aplicirajo antiproliferativno zdravilo na samo mesto spremembe brez uporabe opornice, ki bi ostala v žilni steni in spodbujala vnetje.
... A first indirect comparison between the MagicTouch SCB and PCB could not find significant differences in terms of safety and efficacy; at multivariable analysis, diabetes remained the only independent predictor of MACE [29]. The SCB used in our study is the first sirolimus-based balloon marketed in EU and has beenXXXrevioussly tested in small registries also in complex scenarios like ACS patients [30][31][32][33]. Two RCTs have been conceived to test the MagicTouch balloon [34,35]. ...
Background
The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.
Aims
To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).
Methods
We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2–5 bleedings.
Results
Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91–2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95–3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92–1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09–4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.
Conclusions
In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.
... A registry of 277 patients who had SCB (Magic Touch TM balloon) treatment for both de novo (55.42%) and ISR (44.58%) revealed a major adverse cardiac event (MACE) rate of 5.38% in the 186 patients who have so far undergone 12 months of clinical follow-up. Nevertheless, there are currently no official angiographic follow-up statistics available [56]. Another study was published in 2020 and provided more detail on its efficiency. ...
The possibility of injectable biomaterials being used in the therapy of peripheral artery disease (PAD) is investigated in this article. We conducted a thorough review of the literature on the use and efficacy of biomaterials (BMs) and drug-coated balloons (DCBs). These BMs included hydrogels, collagen scaffolds, and nanoparticles. These BMs could be used alone or in combination with growth factors, stem cells, or gene therapy. The treatment of peripheral artery disease with DCBs is increasingly common in the field of interventional angiology. Studies have been carried out to examine the effectiveness of paclitaxel-coated balloons such as PaccocathTM in lowering the frequency with which further revascularization operations are required. PCB angioplasty and angioplasty without paclitaxel did not significantly vary in terms of mortality, according to the findings of a recent meta-analysis that included the results of four randomized controlled studies. On the other hand, age was found to be a factor that predicted mortality. There was a correlation between the routine utilization of scoring balloon angioplasty along with DCBs and improved clinical outcomes in de novo lesions. In both preclinical and clinical testing, the SelutionTM DCB has demonstrated efficacy and safety, but further research is required to determine whether or not it is effective and safe over the long term. In addition, we reviewed the difficulties involved in bringing injectable BMs-based medicines to clinical trials, including the approval processes required by regulatory bodies. Injectable BMs have a significant amount of therapeutic promise for PAD, which highlights the need for more research and clinical studies to be conducted in this field. In conclusion, this research focuses on the potential of injectable BMs and DCBs in the treatment of PAD as well as the hurdles that must be overcome in order to translate these treatments into clinical trials. In this particular field, there is a demand for further research as well as clinical trials.
... With its long and successful history in coronary drug-eluting stents (DES), sirolimus has attracted the attention of researchers investigating new DCB technologies. Sirolimus-coated balloons have so far shown promising results in inhibition of restenosis after percutaneous coronary interventions (PCIs) in a small number of patients included in clinical studies [4][5][6][7][8]. Furthermore, a wide range of other drugs with potential antiproliferative, anti-inflammatory, or antithrombotic actions might be candidates for balloon coating. ...
Background:
Although controversially discussed, paclitaxel is the only clinically proven drug that inhibits restenosis when released from drug-coated balloons (DCBs). Limus drugs are currently being explored as alternatives. The aim of the preclinical studies was to investigate drug candidates beyond paclitaxel considered for balloon coating.
Methods:
Drugs were tested with respect to dissolution in organic solvents, coating on balloons, and drug transfer to the vessel wall. Inhibition of neointimal proliferation was tested in the porcine model of coronary in-stent stenosis. Intravascular drug treatment was achieved by DCBs at the time of stent implantation.
Results:
Coating had to be adjusted for each drug. Doses on the balloons ranged from 1.0 to 8.6 μg/mm2 balloon surface. Satisfactory amounts of drug ranging from 5% to 29% of initial doses were transferred into the vessel wall. Angiographic parameters such as late lumen loss (LLL) at 4 weeks did not show reduction of in-stent neointimal proliferation by treatment with arsenic trioxide (0.87 ± 0.44 mm), betamethasone dipropionate (1.00 ± 0.54 mm), bortezomib (1.74 ± 0.46 mm), green tea extract (1.24 ± 0.51 mm), fantolon, an epothilone (0.86 ± 0.61 mm), methotrexate (1.09 ± 0.72 mm), and thalidomide (1.59 ± 0.55 mm) compared to treatment with uncoated balloons (1.07 ± 0.60 mm), while coatings with paclitaxel reliably reduced in-stent stenosis (LLL = 0.36 ± 0.25 mm).
Conclusions:
Despite the proven antiproliferative and/or anti-inflammatory effect of the drugs, none of the coatings significantly reduced LLL compared to uncoated balloons and thus, based on the results presented here, none of the tested coatings may be considered a substitute for the paclitaxel-based coatings currently in clinical use.
... Preclinical animal studies on delivery of sirolimus using MagicTouch ™ have also demonstrated successful delivery of the drug into the inner layer of arterial vessels, with some degree of penetration into the adventitia (Lemos et al. 2013). Outcomes of the MagicTouch ™ SCB in the cardiac literature as captured by the Nanolute Registry also demonstrated high procedural success rates of up to 99.7% with low device-related adverse events at 4.2% and TLR at 3.6% (Dani et al. 2019). In the first direct comparison between PCB and SCB for treatment of instent restenosis for coronary disease, Ali et al. (Ali et al. 2019) found that sirolimus was non-inferior to paclitaxel with both DCB demonstrating equivalent 6-month performance. ...
Sirolimus-coated balloons (SCB) have demonstrated much promise as an alternative drug eluting device to the existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD). They have been well tested pre-clinically and have demonstrated anti-restenotic effects as well as clinical safety in its use for treatment of coronary artery disease. The existing approved SCBs have thus far demonstrated good short-term patency (12-months) and did not exhibit any major adverse events or device related shortcomings in its use for treatment of PAD. There are several studies ongoing which aim to further investigate the efficacy of existing SCBs and establish a direct comparison of its outcomes compared with plain balloon angioplasty. Also, SCB utility to salvage failing arteriovenous fistulas for haemodialysis patients has also been explored. We review the current progress made in the establishment of SCB in the treatment of PAD as well as highlight ongoing studies investigating the role of SCB in various settings.
... Pre-clinical assessment of safety and efficacy showed that the most appropriate identification of the best nanoparticle structure is associated with an extremely efficient drug transfer to all layers of the vessel wall, achieving high tissue concentrations that persisted for days after the application, with low systemic drug leaks [29]. The Nanoluté registry was designed to observe the clinical performance of Magic Touch for the treatment of coronary de novo and restenotic lesions [30]. A total of 394 Magic Touch DEBs at Indian centers were used in 332 patients to treat 356 lesions. ...
... Town, South Africa outcomes in de novo lesions, 6 we did not use any DEBs containing sirolimus in our cohort of patients. Rotablation or rotational atherectomy has been practiced worldwide and standard protocols have been developed to improve the clinical outcomes of patients with calcified lesions. ...
Aim:
The aim was to assess the safety and efficacy of rotational atherectomy followed by drug-eluting balloon (DEB) in patients with a high risk of bleeding.
Methods:
A retrospective review was carried out of hospital records of consecutive patients who underwent the hybrid procedure.
Results:
The average age of the 23 patients was 74 years. Risk factors for bleeding included renal failure (35%), oral anticoagulation use (26%) and peptic ulcer disease (35%). All patients had procedural success. No bleeding was reported over the 24-month follow-up period. Dual antiplatelet therapy was stopped successfully in six patients (26%) at three months. Two patients had confirmed target-lesion failure (restenosis). Two patients died over the study period but the cause of death was not known to be cardiovascular disease related.
Conclusions:
For patients at high risk of bleeding who require rotablation, the use of a drug-eluting balloon may be a safe, effective alternative.
... Studie na zvířecím modelu prokázala, že jen 10 % takto vázaného sirolimu je ztraceno z povrchu balonkového katétru v průběhu transportu, kolem 56 % se uvolní při jeho první insuflaci, dalších 20 % se může uvolnit při případné druhé insuflaci a pouze 14 % zůstává na balonku. Koncentrace sirolimu v krvi dosahuje maxima za 30 min a zcela vymizí do 24 hod, zatímco jeho účinná koncentrace MagicTouch (Concept Medical, Miami, USA).Pokud je klinicky tolerována, je oproti PEB doporučována delší doba insuflace (až 60 sec.)(18). ...
Drug-eluting balloon catheters allow local delivery of an effective antiproliferative agent which reduces neointimal hyperplasia into the vessel wall. Due to its easy binding to the surface of the balloon catheter and rapid penetration into tissues, paclitaxel is mainly used as the active substance. However, sirolimus-eluting balloon catheters, similarly to sirolimus-eluting stents, could be more effective than paclitaxel.
... In other applications such as in the coronary circulation, sirolimus has shown better longterm safety and efficacy compared to paclitaxel [14]. The drug is generally seen to be better than paclitaxel because of better late lumen loss and reduced restenosis rates [22]. Both sirolimus and paclitaxel can impact endothelial function, but while paclitaxel inhibits cell viability (cytotoxic), sirolimus (or analogs) have a cytostatic mode of action with a greater margin of safety, and additional anti-inflammatory properties [23]. ...
Background:
The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention.
Methods:
Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months.
Results:
47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients' underlying co-morbidities.
Conclusions:
SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.
... The Nanolute registry recently reported 12-month clinical outcomes of the novel sirolimus-coated balloon (SCB) called MagicTouch (Concept Medical Inc, Tampa, FL, USA) for the treatment of de novo coronary artery lesions and in-stent restenosis (ISR). 20 Sirolimus is encapsulated in nanocarriers and coated onto the hydrophilic surface of the balloon. There was a high procedural success rate (99.7%) with bailout stenting required in only 6.6% lesions. ...
Background:
Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications.
Objectives:
This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.
Methods:
EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.
Results:
A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).
Conclusions:
EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).
Background:
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications.
Design:
TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.
Conclusions:
The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.
Cardiovascular diseases (CVDs) remain the leading cause of health problems worldwide. Nanotechnology, based on its unique properties, provides novel solutions to the diagnosis and therapy of CVDs. In order to identify and further promote the development of nanotechnology in CVDs, we here provide a comprehensive review of this important field by using the method of bibliometric analysis. In this review, an overview of the publication trends, countries/institutes, referenced sources, and research hotspots of all the literature about nanotechnology in the CVD field are identified and analyzed. Further, a comprehensive review of the major biomedical applications of nanotechnology in CVDs including diagnosis (biosensor and imaging) and therapy (drug delivery and tissue engineering) are provided. Finally, the limits and future prospects of nanoparticles in CVDs are proposed. This review aims to help readers to grasp the general research trends of nanotechnology in CVD applications and to further promote the development of this important field.
Objective
Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty.
Background
Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI). A comparison between PCB and SCB is still lacking.
Methods
We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (Aachen Resonance, Germany) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up.
Results
After propensity score matching, a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis, insulin-dependent diabetes was the only predictor of MACE.
Conclusions
In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings.
Data collected by the Pan-African Society of Cardiology for the World Heart Federation's Cardiovascular Diseases Scorecard project in Africa are presented. We summarise the strengths, threats, weaknesses and priorities identified from the collected data for South Africa, which need to be considered in conjunction with the associated sections in the accompanying infographic. Data sets that were used include open-source data available online and government publications. In the section on priorities and the way forward, we highlight the multifactorial health challenges with which South Africa has had to deal and the progress that has been made.
Data collected for the World Heart Federation's Scorecard project regarding the current state of cardiovascular disease prevention, control and management, along with related non-communicable diseases in Ethiopia are presented. Furthermore, the strengths, threats, weaknesses and priorities identified from these data are highlighted in concurrence with related sections in the accompanying infographic. Information was collected using open-source data sets from the World Bank, the World Health Organization, the Institute for Health Metrics and Evaluation, the International Diabetes Federation and relevant government publications.
Aims
The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD).
Study design
The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021.
Conclusions
The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD.
Clinical Trial Registration URL: https://clinicaltrials.gov.
Unique identifier: NCT03913832.
Aims:
The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up.
Methods:
EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months.
Results:
Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008).
Conclusion:
The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.
Objectives:
To test the long-term efficacy of a sirolimus-coated balloon (SCB).
Background:
Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.
Methods:
All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI).
Results:
A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%).
Conclusion:
The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.
The advent of drug-coated balloons (DCBs) provides a novel means to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. The widespread use of these devices in the clinical arena is contemporary with the introduction and adoption of paclitaxel eluting stents for peripheral vascular intervention. However, DCB remain highly attractive approach as the long-term consequences of permanent metallic implants in peripheral applications are still unknown. Notably, the clinical value of DCB is supported by robust pre-clinical evidence regarding safety and efficacy. Likewise, the clinical value of DCB in patients has also been demonstrated by multiple randomized clinical trials in the superficial femoral artery (SFA) and proximal popliteal artery territory. However, the widespread clinical adoption of DCB into routine clinical practice remains elusive. The evidence on the value of DCB has been summarized in consensus documents and in clinical practice guidelines. In the coronary field, currently available information has been summarized in two comprehensive Experts' Consensus Documents and the European Society of Cardiology (ESC) guidelines on coronary revascularization.1–3 These documents emphasized that not all DCB are created equal and that a ‘class effect’ cannot be anticipated as the results obtained with different DCB are not uniform. This remains a major challenge since many CE marked devices are currently available yet many of these have not been supported by robust clinical results.
In the peripheral territory, the information regarding the clinical use of DCB is scarce. Moreover, no previous consensus document exists describing the clinical applications and indications for the use of this technology …