Cilostazol Reduces Angiographic Restenosis after Endovascular Therapy for Femoropopliteal Lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study

Abstract

Background—It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy (EVT) for femoropopliteal (FP) lesions, also reduces angiographic restenosis.

Methods and Results—The Sufficient Treatment Of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after PTA with provisional nitinol stenting for FP lesions. Two hundred patients with FP lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomized 1:1 to receive oral aspirin with or without cilostazol. The primary endpoint was 12-month angiographic restenosis rate. Secondary endpoints were restenosis rate on duplex ultrasound and of major adverse cardiac events (MACE), and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the endpoints in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment was 128±86 mm and 5.4±1.4 mm, respectively. Frequency of stent used was similar between groups (88% versus 90% in the cilostazol and non-cilostazol group, respectively, p=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the non-cilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus. 71%, p=0.02), although cardiovascular event rates were similar in both groups.

Conclusions—Cilostazol reduced angiographic restenosis after PTA with provisional nitinol stenting for FP lesions.

Clinical Trial Registration Information—URL: http://www.clinicaltrials.gov. Identifier: NCT00912756; https:// www.umin.ac.jp Unique identifier : UMIN000002091