Abstract
BackgroundEndovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty.MethodsThis randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months.DiscussionAlthough concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated.Trial registrationClinicalTrials.govNCT04475783. Registered on 17 July 2020EUDAMED No. CIV-20-11-035172, DRKS00022452
Highlights
Background and rationale {6a} Lower limb peripheral arterial disease (PAD) is a common syndrome that affects an estimated 27 million adults in Europe and North America
We hypothesize that sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty regarding both efficacy and safety
Endovascular revascularization has become the standard treatment for peripheral artery disease and paclitaxel-coated balloon angioplasty had been shown to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis in the femoropopliteal segment [22,23,24,25,26,27]
Summary
Background and rationale {6a} Lower limb peripheral arterial disease (PAD) is a common syndrome that affects an estimated 27 million adults in Europe and North America. PAD is associated with significant morbidity and mortality. Symptomatic PAD initially presents as claudication and may progress into chronic limb-threatening ischemia (CLTI), defined as presence of rest pain in the affected limb and/or tissue loss (ulcers, gangrene). Mortality in CLTI patients is 20% in the first year after presentation. Long-term data suggest an increase of mortality up to 50% at 5 years [1]. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty
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