DEBATE in SFA Study Compares Nitinol Bare-Metal Stents With or Without Cilostazol Versus DES

August 29, 2018—In Circulation: Cardiovascular Interventions, Takashi Miura, MD, et al published findings from DEBATE in SFA, a study of drug-eluting stent (DES) versus nitinol bare-metal stent (BMS) implantation with or without cilostazol in the treatment of disease of the superficial femoral artery (SFA). The study, led by principal investigator Yusuke Miyashita, MD, was sponsored by Shinshu University Hospital in Asahi Matsumoto-shi, Japan.

According to the investigators, the background of the study is that new-generation nitinol BMSs and DESs have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions and that cilostazol reduces in-stent restenosis (ISR) after first-generation nitinol BMS implantation for femoropopliteal lesions.

The study was composed of 255 patients with femoropopliteal lesion who were treated at 25 cardiovascular centers. The patients were randomly assigned to the nitinol BMS group (Misago RX self-expanding peripheral stent [Terumo Interventional Systems] implantation without cilostazol), nitinol BMS with cilostazol group (Misago RX stent implantation with cilostazol), or the DES group (Zilver PTX stent [Cook Medical] implantation without cilostazol).

The primary endpoint was 1-year restenosis determined by duplex ultrasound (peak systolic velocity ratio, > 2.0) and the secondary endpoint was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding).

As summarized in Circulation: Cardiovascular Interventions, 12 (4.7%) patients died and 237 (92.9%) patients had relevant ultrasound findings at 1-year follow-up. The investigators reported:

• ISR rate did not differ significantly among the nitinol BMS, nitinol BMS with cilostazol, and DES groups (28.4% vs 12.2% vs 21%; P = .052). Whereas the ISR rate was significantly lower in the nitinol BMS with cilostazol group than in the nitinol BMS alone group, it was similar to that in the DES group (P = .16).
• Major adverse limb event was significantly higher in the nitinol BMS group (16.9% vs 6.5% vs 6.3%; P = .034).
• Rates were similar regarding target lesion revascularization (9.7% vs 5.1% vs 3.6%; P = .25) and major bleeding (4.8% vs 1.2% vs 2.4%; P = .37).

The findings demonstrated that Misago nitinol BMS implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX DES implantation; additionally, cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation nitinol BMS, concluded the investigators in Circulation: Cardiovascular Interventions.