Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.
JACC Cardiovasc Interv
; 17(9): 1134-1144, 2024 May 13.
Article
em En
| MEDLINE
| ID: mdl-38749594
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 11 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).Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Artéria Poplítea
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Fármacos Cardiovasculares
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Materiais Revestidos Biocompatíveis
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Stents Farmacológicos
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Artéria Femoral
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Doença Arterial Periférica
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article