Drug-coated Devices Research Articles

Long-term safety of drug-coated devices for peripheral revascularisation.

Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. We aimed to assess long-term mortality in patients treated with drug-coated versus non-drug-coated devices who are insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. We analysed data from an MA administrative claims data source that includes both inpatient and outpatient femoropopliteal artery revascularisation procedures. Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015-12/2017 were studied using Optum's De-identified Clinformatics Datamart Database. Mortality was assessed up to December 2019 using Kaplan-Meier cumulative mortality curves and Cox proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups. Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02-3.52). Treatment with drug-coated devices was associated with similar long-term mortality to non-drug-coated devices (adjusted HR 1.03, 95% CI: 0.96-1.10; p=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00, 95% CI: 0.92-1.08; p=0.96) or stents (adjusted HR 1.02, 95% CI: 0.88-1.18; p=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction p>0.05 for all). In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.

The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions.

Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid))that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLRDCB.

Assessment of Mortality and Factors Affecting Outcome of Use of Paclitaxel-Coated Stents and Bare Metal Stents in Femoropopliteal PAD.

The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES). Objective: The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up. Materials and methods: In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality). Results: Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% (p = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%, p = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank p = 0.575). No association was found with mortality and treatment with DES or BMS. Conclusions: The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality.

CRT-200.07 Natural Vascular Scaffolding Promotes Post-Femoropopliteal PTa Patency Without Stent Implantation

Despite reduced revascularization rates with currently marketed drug-coated devices in the treatment of peripheral artery disease (PAD), results remain sub-optimal in complex lesion morphologies, and their use has fallen over concerns of increased risk of late mortality. New treatment modalities are

Drug Coated Balloons vs. Conventional Balloon Angioplasty for Bypass Vein Graft stenosis – A Randomized Controlled Trial

Introduction - Stenosis and restenosis are known complications of endovascular treatment of native arteries and bypass vein grafts in peripheral arterial disease (PAD). (1,2) This may lead to loss of the bypass graft, which can be a problem due to the limited availability of autologous vein material. Drug-coated balloons seem to be effective in the treatment of native artery stenosis (3). The biomechanical and anatomical properties of vein grafts differ greatly from native arteries, and less is known about the potential of drug-coated devices in this field. One randomized trial did not demonstrate benefit from use of DCBs over BA in bypass vein grafts. (4) Similar results were observed in a retrospective study comparing BA to DCB in peripheral grafts (5). The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of vein graft stenoses. Design: Single-center, parallel, randomized controlled trial. Block randomized by sealed envelope 1:1. Methods - 60 patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to drug-coated balloon (DCB) (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1 year. Primary outcome measures were target lesion revascularization (TLR) and graft occlusion. Primary assisted patency and secondary patency were also assessed. Results - 57 cases were ultimately included in the study. 3 randomized cases were excluded due to primary technical failure (graft rupture during predilatation and bail-out stenting (N=2), aborted procedure (N=1)). Six patients died during follow-up (DCB 4, BA 2) and one patient underwent major amputation (BA group). 23 patients underwent re-revascularization of the same segment (DCB 10/29, 34.5 % vs. BA 13/28, 46.4 %, p=0.333). The overall TLR-rate at one year was 34.5 % and 46.4 % in the DCB and BA groups respectively (p=0.33). 5/57 (8.8 %) grafts occluded during the follow-up, 1/29 (3.4 %) and 4/28 (14.3 %) in the DCB and BA groups respectively (p=0.36). Secondary patency was 100 % in the DCB group compared to 89.3% in the BA group (p=0.076). In subanalysis including only de novo lesions TLR was significantly lower in grafts that were treated with DCB compared to BA (15 % vs. 18.9 %, P=0.03). Conclusion - There is a trend toward benefit from DCBs in the treatment of graft stenosis; this difference is significant in previously untreated lesions. There has been hesitation towards using drug-coated balloons as a first choice in the treatment of graft stenosis. Our results suggest that this hesitation might be unfounded, especially in de novo lesions. More data is needed to accurately select which lesions will benefit from DCBs. Furthermore; histological studies on paclitaxel uptake and response in the arterialized venous wall are warranted.

Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?

Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.

Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices

In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up. To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization. This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017. Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon). The primary outcome was all-cause mortality analyzed through the end of follow-up. Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48). In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.