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Randomized Controlled Trial
. 2024 May 13;17(9):1134-1144.
doi: 10.1016/j.jcin.2024.03.015.

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions

Tim Wittig  1 , Andrej Schmidt  2 , Torsten Fuß  3 , Marcus Thieme  4 , Lars Maiwald  5 , Sandra Düsing  2 , Manuela Konert  2 , Axel Fischer  2 , Dierk Scheinert  2 , Sabine Steiner  6
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Free article
Randomized Controlled Trial

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions

Tim Wittig et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions.

Objectives: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms.

Methods: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms.

Results: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization.

Conclusions: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Keywords: paclitaxel-eluting devices; patency; peripheral artery disease; restenosis; vessel preparation.

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Conflict of interest statement

Funding Support and Author Disclosures BEST-SFA is an investigator-initiated study, and the study sponsor is the University of Leipzig with an industry-independent funding through the Medical Faculty of the University of Leipzig and the Helmholtz Institute for Metabolism, Obesity and Vascular Research. Dr Schmidt is a consultant for Abbott, Boston Scientific, Cook Medical, Cordis, CR Bard, ReFlow Medical, and Upstream Peripheral Technologies. Dr Fuß is a consultant for Abbott, Biotronik, Terumo, Boston Scientific, and BD. Dr Konert is a consultant for Inari Medical. Dr Scheinert is a consultant or on the Advisory Board for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. Dr Steiner is a consultant or on the Advisory Board for Boston Scientific, Cook Medical, and iThera Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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