S-EPMC6594002 - Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial. - OmicsDI

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Dataset Information

Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial.

ABSTRACT:

Objectives

To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort.

Background

Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations.

Methods

IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months.

Results

One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group.

Conclusions

Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.

SUBMITTER: Iida O

PROVIDER: S-EPMC6594002 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial.

Iida Osamu O Soga Yoshimitsu Y Urasawa Kazushi K Saito Shigeru S Jaff Michael R MR Wang Hong H Ookubo Hiroko H Yokoi Hiroyoshi H

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20190212 4

<h4>Objectives</h4>To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort.<h4>Background</h4>Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains ...[more]

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Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

Project description:BackgroundPeripheral arterial disease (PAD) is a common and highly morbid disease. Although there have been recent advancements in the endovascular modalities to treat PAD, comparisons of these strategies, especially in the popliteal region, remain underinvestigated. The objective of this study was to compare midterm outcomes in patients with PAD undergoing treatment with both novel and SS compared with drug-coated balloon (DCB) angioplasty.MethodsAll patients at a multi-institution health system treated for PAD in the popliteal region from 2011 to 2019 were identified. Presenting features, operative details, and outcomes were included in the analysis. Patients who underwent popliteal revascularization with stents were compared with DCB. SS were compared separately with novel dedicated stents. Two-year primary patency was the primary outcome.ResultsWe included 408 patients (72.7 ± 11.8 years old; 57.1% men) in the analysis. There were 221 (54.7%) patients who underwent popliteal stenting and 187 (45.3%) who underwent popliteal DCB. There were high rates of tissue loss in both groups (57.9% vs 50.8%; P = .14). Stented patients had longer lesions (112.4 ± 3.2 vs 100.2 ± 5.8 mm; P = .03) and higher rates of concomitant superficial femoral artery treatment (88.2% vs 39.6%; P < .01). Chronic total occlusions accounted for the majority of lesions treated (stent 62.4%, DCB 64.2%). Perioperative complications were similar between groups. Primary patency for the stented group was higher at two years than the DCB group (61.0% vs 46.1%; P = .03). When evaluating stented patients only, SS had higher 2-year patency than novel stents in the popliteal segment (69.6% vs 51.4%; P = .04). On multivariable analysis, stenosis, as opposed to chronic total occlusion, was associated with improved patency (hazard ratio, 0.49; 95% confidence interval, 0.25-0.96; P = .04), whereas novel stents were associated with worse primary patency (hazard ratio, 2.01; 95% confidence interval, 1.09-3.73; P = .03).ConclusionsIn a population of patients with severe vascular disease, stents do not have inferior patency and limb salvage rates compared with DCB angioplasty when treating the popliteal region. For patients with advanced vascular disease, and especially tissue loss, stents and DCB are both beneficial when treating popliteal lesions.

Project description:BackgroundPeripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for "hard" clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.MethodsIn this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective "hard" outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.DiscussionBy focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative ("all-comer") population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial registrationClinicalTrials.gov NCT04238546.