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.