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

JACC Cardiovasc Interv. 2024 May 13;17(9):1134-1144. doi: 10.1016/j.jcin.2024.03.015.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation
  • Cardiovascular Agents* / administration & dosage
  • Cardiovascular Agents* / adverse effects
  • Coated Materials, Biocompatible*
  • Drug-Eluting Stents*
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel* / administration & dosage
  • Peripheral Arterial Disease* / diagnostic imaging
  • Peripheral Arterial Disease* / physiopathology
  • Peripheral Arterial Disease* / therapy
  • Pilot Projects
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Prosthesis Design*
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Access Devices
  • Vascular Patency*

Associated data

  • ClinicalTrials.gov/NCT03776799