Contemporary Femoropopliteal Stents: Reporting Gaps of Randomized Trials

Endovascular literature has been under scrutiny due to perceived poor-quality data. This has been attributed to multiple reasons, including but not limited to smaller sample size, absence of standardization of reporting methodology and investigational treatment protocols, and limited funding resources. The goal of the current study was to review the design of randomized controlled trials investigating contemporary stents for the femoropopliteal segment, with reported >70-80% primary efficacy rate and address issues with their respective reporting methodology.

This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (CRD42024508602). The Medline (PubMed), Scopus, and Cochrane databases were reviewed for randomized controlled trials reporting on the safety and efficacy of femoropopliteal Zilver PTX, Eluvia, Viabahn, and Supera stents through February 2024. Data were collected regarding baseline, lesion, and procedural characteristics and postprocedural outcomes.

17 articles were identified, presenting the results of 11 trials. 80% of the studied individuals were males having intermittent claudication (overall 81%; Rutherford class (RC) 2; 8 trials; 29%; RC 3; 8 trials; 46%). The mean preprocedural ankle-brachial index (ABI) was 0.64 (0.56-0.72). Details about run-off vessels, inflow or outflow disease treatment, and antithrombotic regimen compliance were missing in most papers. Only 3 trials had long-term data (≥36 months). Critical information about postprocedural and during follow-up ABI values, amputation rates, and stent fracture rates were not reported in 6, 5, and 13 articles, respectively. The definition of the primary efficacy endpoint was similar in all studies, although the peak systolic velocity (PSV) ratio cutoff that was used ranged from 2.0 to 2.5 (1 study: 2.5; 6 studies: 2.4; 5 studies: 2.0). Post-treatment clinical benefit was often defined as improvement in RC and/or ABI, although individual values were not always provided.

The studies exhibited considerable variation in assessment of outcomes and reporting methodology. Standardized reporting methods for lesion or procedural characteristics and post-treatment clinical benefit need to be established to facilitate translation of clinical trials results to actual practice.