Contemporary Femoropopliteal Stents: Reporting Gaps of Randomized Trials

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Biomedical Engineering

Background:

• Endovascular literature faces scrutiny due to perceived data quality issues.
• Contributing factors include small sample sizes, lack of standardized reporting, and limited funding.
• This study addresses the need for improved methodology in randomized controlled trials (RCTs) for femoropopliteal stents.

Purpose of the Study:

• To review the design of RCTs investigating contemporary femoropopliteal stents.
• To assess reporting methodologies in trials with high primary efficacy rates (>70-80%).
• To identify and address inconsistencies in outcome assessment and data reporting.

Main Methods:

• Systematic review and meta-analysis adhering to PRISMA guidelines.
• Searched Medline (PubMed), Scopus, and Cochrane databases for RCTs on femoropopliteal stents (Zilver PTX, Eluvia, Viabahn, Supera) through February 2024.
• Collected data on baseline, lesion, procedural characteristics, and postprocedural outcomes.

Main Results:

• 17 articles representing 11 trials were analyzed, predominantly featuring male patients with intermittent claudication (81%).
• Significant data gaps were identified regarding run-off vessels, inflow/outflow disease, antithrombotic compliance, and long-term outcomes (only 3 trials ≥36 months).
• Critical outcome data (ABI values, amputation rates, stent fractures) were missing in a substantial number of reports; primary efficacy endpoint definitions were consistent, but PSV ratio cutoffs varied (2.0-2.5).

Conclusions:

• Significant variability exists in outcome assessment and reporting methodology across femoropopliteal stent RCTs.
• Standardized reporting for lesion characteristics, procedural details, and post-treatment clinical benefit is crucial.
• Standardization will enhance the translation of clinical trial findings into actual clinical practice.