Trial reportJACC. Cardiovascular interventions2024
Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.
Trial report in JACC. Cardiovascular interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03776799 (BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (Study Arm) Versus Stent-preferred (Control Arm) Approach Within a Prospective, Randomized, Multi-center Trial
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Performance of stenting in femoropopliteal disease: a systematic literature review and meta-analysis of proportions.Journal of comparative effectiveness research · 2026Pooled it
- Long-term outcomes of the "pave-and-crack" technique for severely calcified femoropopliteal chronic total occlusions.CVIR endovascular · 2026Article
- State-of-the-Art Definitive Femoropopliteal Lesion Treatment: A Case-Based Systematic Approach.Journal of cardiovascular development and disease · 2026Review
- Endovascular Treatment for Femoropopliteal Arterial Lesions with a Focus on Long-Term Limb Prognosis.Annals of vascular diseases · 2026Review
- Clinical Utility of the Rotational and Orbital Atherectomy System in the Endovascular Therapy of Severely Calcified Femoropopliteal Lesions.Circulation reports · 2025Article
- Femoropopliteal Interventions for Peripheral Artery Disease: A Review of Current Evidence and Future Directions.Interventional cardiology clinics · 2025Review
- Randomized trial comparing a stent-avoiding with a stent-preferred strategy in complex femoropopliteal lesions.Cardiovascular diagnosis and therapy · 2024Article
- The best devices for superficial femoral artery, with "limited" cases and vessel preparations.Cardiovascular diagnosis and therapy · 2024Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLimited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions.
objectivesIn 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.
methodsWithin 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.
resultsIn 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.
conclusionsBoth 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).
Indexed as
Identifiers
38749594What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.