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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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?

SUBMITTER: Iida O

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

REPOSITORIES: biostudies-literature

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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: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:BackgroundPercutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses.MethodsDuring a period of 18?months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77?years (range, 35-96?years). Median length of the treated lesions was 10.5?cm (range, 1.0-50?cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis.ResultsROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p?>?0.05). Results of reader C were significantly better in the assessment of monochromatic images (p?=?0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (??=?0.486 vs. ??=?0.459).ConclusionsIn this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement.

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.