O-035 - EFFICACY AND SAFETY OF SUSTAINED-RELEASE SARPOGRELATE IN FEMORO-POPLITEAL ARTERY INTERVENTION COMPARED TO CLOPIDOGREL: SAFE MULTICENTER RANDOMIZED CONTROLLED TRIAL

TOPIC:
Peripheral Occlusive Arterial Disease
AUTHORS:
Min S. (Seoul National University Hospital ~ Seoul ~ Korea, Republic of) , Han A. (Seoul National University Hospital ~ Seoul ~ Korea, Republic of) , Lee T. (Bundang Seoul National University Hospital ~ Seongnam ~ Korea, Republic of) , Song S. (Gangnam Severance Hospital ~ Seoul ~ Korea, Republic of) , Lee S. (Pusan National University Yangsan Hospital ~ Busan ~ Korea, Republic of) , Jung I.M. (Seoul Metropolitan Government-Seoul National University Boramae Medical Center ~ Seoul ~ Korea, Republic of) , Kang J.M. (Gil Hospital, Gachon University of Medicine and Science ~ Incheon ~ Korea, Republic of) , Gwon J.G. (Korea University Hospital ~ Seoul ~ Korea, Republic of) , Yun W. (Yeungnam University Medical Center ~ Daegu ~ Korea, Republic of) , Cho Y. (Asan Medical Center ~ Seoul ~ Korea, Republic of) , Ko H. (Kyung Hee University Hospital ~ Seoul ~ Korea, Republic of) , Park Y. (Samsung Medical Center ~ Seoul ~ Korea, Republic of)
Introduction:
Optimal antiplatelet therapy after endovascular therapy (EVT) for peripheral artery disease (PAD) remains in controversy. New sustained-release (SR) sarpogrelate is available in the market and expected to reduce restenosis by protecting from oxidative stress and vascular endothelial dysfunction as well as by acting as an antiplatelet agent. The aim of this trial was to show that sarpogrelate plus aspirin was non-inferior in preventing early restenosis after femoropopliteal (FP) EVT compared to clopidogrel plus aspirin.
Methods:
This is an open label, multicenter, prospective randomized controlled clinical trial. Total 272 patients were enrolled after successful EVT for FP lesions. Patients in each group received aspirin 100 mg and clopidogrel 75 mg or SR sarpogrelate 300 mg (Anplone®) orally once a day for 6 months. The primary outcome is the restenosis rate at 6 mo ( > 50% luminal reduction by angiography). Secondary outcomes include target lesion revascularization, major bleeding, ipsilateral major amputation, all-cause mortality, and all adverse events at 6 months.
Results:
Baseline patient characteristic and EVT patterns was similar, except significantly more inflow procedures in sarpogrelated group, and more outflow procedures in clopidogrel group. Sarpogrelate group showed a tendency of less restenosis at 6 months than clopidogrel group (13% vs. 19%) without statistical difference. Secondary endpoints of safety outcomes were very rare in both groups, showing that both dual antiplatelet therapy regimens are safe after FP EVT. Interestingly in subgroup analysis, clopidogrel plus aspirin showed better effect on reducing restenosis in patients with coronary artery disease compared to sarpogrelate plus aspirin. Although statistically not significant, patients on hemodialysis and poor BK runoff may benefit more by clopidogrel. Multivariate analysis revealed TASC C/D lesions and balloon angioplasty only are significant risk factors for restenosis at 6 months.
Conclusion:
Sarpogrelate plus aspirin was non-inferior in preventing early restenosis after FP EVT compared to clopidogrel plus aspirin. Multinational trial with multiethnicity in larger population is needed to generalize these findings.
References:
1. Ahn S, Lee J, Min S-K, et al. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials 2017;18:439. 2. Lee D-H, Chun EJ, Hur JH, et al. Effect of sarpogrelate, a selective 5-HT2A receptor antagonist, on characteristics of coronary artery disease in patients with type 2 diabetes. Atherosclerosis 2017;257:47-54.