Comparative efficacy of endovascular interventions for femoropopliteal in-stent restenosis: A systematic review and meta-analysis.
Enrique M San Norberto, José Antonio Brizuela, Sergio Fernández-Bello et al.
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In 30 seconds
This systematic review and meta-analysis compared endovascular treatments for femoropopliteal in-stent restenosis (ISR) with standard percutaneous transluminal angioplasty (PTA/POBA). It included 24 studies: nine randomized trials (942 participants) in quantitative analyses and 15 additional studies in qualitative synthesis. Drug-coated balloon (DCB) angioplasty reduced 12-month target lesion revascularization versus PTA/POBA (OR 0.164; 95% CI 0.103-0.263; P < 0.001) and also reduced recurrent ISR at 6 months. Evidence for other approaches was less robust, and no significant mortality difference was observed within available follow-up.
Key findings
- DCB reduced 12-month target lesion revascularization versus PTA/POBA (OR 0.164; 95% CI 0.103-0.263; P < 0.001; 6 RCTs, n = 475).
- DCB reduced recurrent ISR at 6 months versus PTA/POBA (OR 0.223; 95% CI 0.129-0.385; P < 0.001).
- ELA-based strategies with adjunctive DCB were associated with lower odds of TLR versus PTA in two RCTs (OR 0.396; 95% CI 0.248-0.630; P < 0.001), but outcome definitions differed.
- No significant all-cause mortality difference was observed (pooled OR 0.725; 95% CI 0.276-1.904); follow-up was median 12 months and maximum 24 months.
Why it matters
ISR can require repeat intervention, so comparative evidence on lesion-directed treatments is clinically relevant. The review finds consistent randomized support for DCB over standard PTA in reducing repeat revascularization and recurrent restenosis. By contrast, results for several alternative or adjunctive devices rely on small trials or observational evidence, making their comparative benefits less certain.
What to keep in mind
Evidence for several interventions came from small trials, registries, or retrospective comparisons; the ELA-plus-DCB estimate combined non-identical outcome definitions. No trial followed patients beyond 24 months.