Drug-Eluting Versus Bare-Metal Stent Implantation With or Without Cilostazol in the Treatment of the Superficial Femoral Artery: The DEBATE in SFA Study

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Background:New-generation bare-metal nitinol (BNS) and drug-eluting stents have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions. Furthermore, cilostazol reduces in-stent restenosis (ISR) after first-generation BNS implantation for femoropopliteal lesions.Methods and Results:We studied 255 patients with femoropopliteal lesions treated at 25 cardiovascular centers. Patients were randomly assigned to the BNS group (Misago stent implantation without cilostazol), BNS with cilostazol group (Misago stent implantation with cilostazol), or drug-eluting stents group (Zilver PTX stent implantation without cilostazol). Primary end point was 1-year restenosis noted using duplex ultrasound (peak systolic velocity ratio, >2.0). Secondary end point was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding). During the 1-year follow-up, 12 patients (4.7%) died and 237 (92.9%) had relevant ultrasound findings. The 1-year ISR rate did not differ significantly among the BNS, BNS with cilostazol, and drug-eluting stents groups (28.4% versus 12.2% versus 21.0%; P=0.052). Although the 1-year ISR rate was significantly lower in the BNS with cilostazol group than in the BNS group, it was similar to that in the drug-eluting stents group (P=0.16). Major adverse limb event was significantly higher in the BNS group (16.9% versus 6.5% versus 6.3%; P=0.034); however, target lesion revascularization and major bleeding were similar (9.7% versus 5.1% versus 3.6%; P=0.25, 4.8% versus 1.2% versus 2.4%; P=0.37, respectively).Conclusions:Misago stent implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX. Cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation BNS.Clinical Trial Registration:URL: http://www.umin.ac.jp/ctr/. Unique identifier: UMIN 000010071.

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