Effectiveness of cilostazol treatment in femoropopliteal artery disease after drug-coated balloon therapy: Subanalysis of the POPCORN study.

Abstract

This study was performed to determine the effect of cilostazol treatment on restenosis risk in patients undergoing drug-coated balloon therapy for symptomatic femoropopliteal artery disease. This was a subanalysis of the POPCORN (PrOsPective multiCenter registry Of dRug-coated ballooN for femoropopliteal disease) study, a prospective multicenter study investigating patients undergoing first-generation drug-coated balloon therapy. Clinical limb outcomes were evaluated in subgroups of the cohort with and without cilostazol treatment using the propensity score-matching method. A primary outcome was defined as freedom from restenosis, and secondary outcomes were defined as target lesion revascularization and limb salvage. We investigated 441 pairs after propensity score matching. Cilostazol was associated with a significantly higher rate of freedom from restenosis than the control (86.3% [95% confidence interval, 82.7%-90.1%] vs 84.0% [80.2%-88.0%] at 1 year, and 67.6% [62.1%-73.6%] vs 58.5% [52.7%-64.8%] at 3 years; P < .037). The rate of freedom from target lesion revascularization was also higher in cases treated with cilostazol (79.3% [75.0%-83.8%] vs 71.9% [67.1%-77.0%] at 3 years; P = .012). Dual antiplatelet therapy only had a significant interaction effect on the association between cilostazol use and restenosis risk (P = .043). Cilostazol treatment significantly reduced risk of restenosis and target lesion revascularization after first-generation drug-coated balloon therapy, whereas there was no significant effect on limb salvage rate.