Key result
Cilostazol significantly improved 3-year primary patency compared to no cilostazol (69% vs 54%, p=0.026) in patients undergoing endovascular treatment for femoropopliteal disease.
Why the study?
Does cilostazol added to aspirin improve primary patency in claudicant patients undergoing endovascular treatment for femoropopliteal disease?
RCT (n=200)
1:1
Yes
Does cilostazol added to aspirin improve primary patency in claudicant patients undergoing endovascular treatment for femoropopliteal disease?
The addition of cilostazol to aspirin significantly improves 3-year primary patency and reduces target lesion revascularization after endovascular treatment of femoropopliteal lesions.
Supports cilostazol addition to aspirin after endovascular femoropopliteal therapy; extends randomized evidence for adjunctive antiplatelet strategies in PAD.
PURPOSE: To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy. METHODS: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test. RESULTS: The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95). CONCLUSION: These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.
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Soga et al. (2018) conducted an RCT in Femoropopliteal disease (n=200). Cilostazol vs. No cilostazol was evaluated on Primary patency at 3 years (p=0.026). Cilostazol significantly improved 3-year primary patency compared to no cilostazol (69% vs 54%, p=0.026) in patients undergoing endovascular treatment for femoropopliteal disease.
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