Cilostazol Reduces Angiographic Restenosis After Endovascular Therapy for Femoropopliteal Lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol Study

Abstract

Background-It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal 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 percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol 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 noncilostazol 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 percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www. umin.ac.jp. Unique identifier: UMIN000002091.

Cilostazol increases patency and reduces adverse outcomes in percutaneous femoropopliteal revascularisation: a meta-analysis of randomised controlled trials

“…A smaller study in 2009 15 also found similar results with restenosis rates (43% vs 70.3%). These findings were validated in a larger multicentre study in 2013 with 200 patients 16 that demonstrated an angiographic restenosis rate at 12 months of 20% in cilostazol group versus 49% in the non-cilostazol group.…”

“…The main characteristics of individual studies can be found in Table 2 illustrates baseline characteristics of populations in the individual studies. All baseline variables including stenting ratio were similar in all studies with the exception of preprocedural Ankle Brachial Index (ABI) in Iida et al 16 ; despite both groups having the ABI on the moderate disease range it was higher on the cilostazol group (0.71 vs 0.66).…”

Clinical Efficacy and Safety of Cilostazol: A Critical Review of the Literature

“…Concerns over the high risk of cardiovascular (CV) mortality in patients with PAD have prompted studies evaluating the effect of cilostazol on CV outcomes. Importantly, recent evidence from randomized trials has established the benefits of cilostazol to prevent restenosis and reocclusion after peripheral endovascular procedures [24,25]. Further, cilostazol has proven efficacy and safety in reducing target lesion revascularization in those patients receiving hemodialysis after procedures for PAD [26][27][28].…”

“…The most recent randomized controlled trial published in this area is the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study [25]. This multicenter, open-label, prospective study randomized 200 Japanese patients with symptomatic PAD to receive aspirin 100 mg daily plus cilostazol 200 mg daily compared to aspirin alone to determine the 12-month effect of cilostazol on restenosis after EVT with provisional stenting for FP lesions.…”

“…This multicenter, open-label, prospective study randomized 200 Japanese patients with symptomatic PAD to receive aspirin 100 mg daily plus cilostazol 200 mg daily compared to aspirin alone to determine the 12-month effect of cilostazol on restenosis after EVT with provisional stenting for FP lesions. All patients enrolled had symptomatic PAD with Table 3 Characteristics of studies utilizing cilostazol after endovascular intervention for peripheral arterial disease References Iida [24] Soga [28] Soga [42] Soga [84] Ikushima [85] Iishi [27] Iida [ Table 3 continued References Iida [24] Soga [28] Soga [42] Soga [84] Ikushima [85] Iishi [27] Iida [25] Limb Provisional stenting was allowed per investigator preference at time of EVT. If nitinol stents were implanted, additional antiplatelet therapy was used for 1 month post procedure for the prevention of acute stent closure.…”