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Restenosis after stent implantation for superficial femoral artery disease in patients treated with cilostazol

Background: Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self‐expandable nitinol stent. Methods: The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(−)) after procedure. Propensity‐score analyses matched 281 cilostazol(+) with 281 cilostazol (−) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all‐cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex. Results: Mean follow‐up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5‐year, P = 0.02). In‐stent re‐occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5‐year, P = 0.09) compared with control. No significant difference of all‐cause mortality (21.4% vs. 18.3% at 5‐year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5‐year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis. Conclusions: Cilostazol reduced restenosis after SFA stenting with self‐expandable nitinol stent and it seems to be more effective in high‐risk patients for restenosis. © 2011 Wiley Periodicals, Inc.