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Randomized trial comparing a stent-avoiding with a stent-preferred strategy in complex femoropopliteal lesions.
JACC-Cardiovasc. Interv. 17, 1134-1144 (2024)
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)
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Publikationstyp
Artikel: Journalartikel
Dokumenttyp
Wissenschaftlicher Artikel
Schlagwörter
Paclitaxel-eluting Devices ; Patency ; Peripheral Artery Disease ; Restenosis ; Vessel Preparation; Drug-coated Balloon; Bare Metal Stents; Eluting Stent; Angioplasty; Disease; Atherectomy; Outcomes
ISSN (print) / ISBN
1936-8798
e-ISSN
1876-7605
Zeitschrift
JACC: Cardiovascular Interventions
Quellenangaben
Band: 17,
Heft: 9,
Seiten: 1134-1144
Verlag
Elsevier
Verlagsort
Ste 800, 230 Park Ave, New York, Ny 10169 Usa
Nichtpatentliteratur
Publikationen
Begutachtungsstatus
Peer reviewed
Institut(e)
Helmholtz Institute for Metabolism, Obesity and Vascular Research (HI-MAG)