Cilostazol after endovascular therapy for femoropopliteal peripheral arterial disease: A systematic review and meta-analysis.

Background: Endovascular therapy (ET) outcomes for femoropopliteal peripheral arterial disease (FP-PAD) remain suboptimal. Cilostazol therapy may improve patency rates and decrease major adverse limb events after ET for FP-PAD. Our goal was to analyze published studies evaluating the use of cilostazol after ET for FP-PAD.

Methods: We searched MEDLINE, EMBASE, and CENTRAL for randomized and observational studies (OSs) evaluating cilostazol therapy after ET for FP-PAD. We only included OSs adjusting for confounding variables. We analyzed observational and randomized studies separately and explored heterogeneity by estimating an I statistic. A fixed-effects model was chosen if the I statistic was low. If the two-sided probability of observing the difference between groups under a true null hypothesis was <5%, we considered this difference statistically significant.

Results: We screened 2171 studies and included 26 papers in our analysis (5 randomized controlled trials and 21 OSs). All randomized studies were open label. In randomized studies, the odds of restenosis were lower in patients treated with cilostazol (pooled odds ratio, 0.28; 95% confidence interval [CI], 0.18-0.43; P < .01; I = 0%). The odds of target lesion revascularization (TLR) were also lower in patients treated with cilostazol (pooled odds ratio, 0.35; 95% CI, 0.22-0.65; P < .01; I = 0%). In OSs, we also identified associations between peri-interventional treatment with cilostazol and lower rates of restenosis (pooled hazard ratio [pHR], 0.57; 95% CI, 0.51-0.65; P < .01; I = 34%), TLR (pHR, 0.53; 95% CI, 0.36-0.79; P < .01; I = 0%), and amputation (pHR, 0.54; 95% CI, 0.32-0.90; P = .02; I = 30%).

Conclusions: In randomized open-label studies, peri-interventional treatment with cilostazol after ET for FP-PAD decreased the odds of restenosis and TLR (Level 1A). Similarly, in OSs that adjusted for confounding, peri-interventional cilostazol therapy was associated with lower rates of restenosis, TLR, and amputation (Level 2A).