Drug-eluting stenting for femoropopliteal lesions, followed by cilostazol treatment, reduces stent restenosis in patients with symptomatic peripheral artery disease

Abstract

Background: Cilostazol improves clinical endovascular therapy outcomes for femoropopliteal (FP) lesions in patients with symptomatic peripheral arterial disease, but whether it also has clinical benefits for patients after drug-eluting stent implantation remains unclear.

Methods: This study is a subanalysis of the ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy (ZEPHYR) study, a prospective multicenter study investigating FP lesions treated with the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent. The present study analyzed 475 lesions in 459 limbs of 399 patients who maintained therapy with aspirin and thienopyridine, with or without cilostazol, during the 1-year follow-up period.

Results: Restenosis rates at 1 year were assessed with duplex ultrasound imaging (peak systolic velocity ratio >2.4) or angiography (≥50% diameter stenosis) and compared in the groups with and without cilostazol. Propensity score matching was performed to minimize intergroup differences in baseline characteristics. The present study included 93 cilostazol-treated and 382 cilostazol-free cases. Among the patients, 71% had diabetes mellitus and 31% were on dialysis. Critical limb ischemia accounted for 29% of cases. The prevalence of de novo lesions was 76%, and in-stent restenosis was present in 15%. Propensity score matching was performed in 91 pairs. The 1-year restenosis rate was 33% (95% confidence interval [CI], 23%-43%) in the cilostazol-treated group and 51% (95% CI, 41%-62%) in the cilostazol-free group (P = .008). The odds ratio was 0.5 (95% CI, 0.3-0.8).

Conclusions: The propensity score-matching analysis demonstrated that additional cilostazol administration was associated with a significantly lower restenosis incidence 1 year after drug-eluting stent implantation for FP lesions.