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A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention

Authors
 Ahram Han  ;  Taeseung Lee  ;  Joongyub Lee  ;  Suk-Won Song  ;  Sang-Su Lee  ;  In Mok Jung  ;  Jin Mo Kang  ;  Jun Gyo Gwon  ;  Woo-Sung Yun  ;  Yong-Pil Cho  ;  Hyunmin Ko  ;  Yang-Jin Park  ;  Seung-Kee Min 
Citation
 SCIENTIFIC REPORTS, Vol.13(1) : 2502, 2023-02 
Journal Title
SCIENTIFIC REPORTS
Issue Date
2023-02
MeSH
Aspirin / therapeutic use ; Clopidogrel / therapeutic use ; Delayed-Action Preparations ; Drug Therapy, Combination ; Femoral Artery / surgery ; Humans ; Peripheral Arterial Disease* / drug therapy ; Platelet Aggregation Inhibitors* / therapeutic use ; Prospective Studies ; Treatment Outcome
Abstract
Optimal antiplatelet therapy after endovascular therapy (EVT) for peripheral artery disease is controversial. This trial aimed to evaluate whether sarpogrelate plus aspirin was non-inferior for preventing early restenosis after femoropopliteal (FP) EVT compared to clopidogrel plus aspirin. In this open-label, prospective randomized trial, 272 patients were enrolled after successful EVT for FP lesions. Patients in each group received aspirin 100 mg and clopidogrel 75 mg or sarpogrelate 300 mg orally once per day for 6 months. The primary outcome was target lesion restenosis at 6 months, tested for noninferiority. Patient characteristics and EVT patterns were similar, except for increased inflow procedures in the sarpogrelate group and increased outflow procedures in the clopidogrel group. The sarpogrelate group showed a tendency of less restenosis at 6 months than the clopidogrel group (13.0% vs. 19.1%, difference 6.1 percentage points, 95% CI for noninferiority - 0.047 to 0.169). Secondary endpoints related to safety outcomes were rare in both groups. Risks of target lesion restenosis of the two intervention arm were uniform across most major subgroups except for those with coronary artery disease. In conclusion, Sarpogrelate plus aspirin is non-inferior to clopidogrel plus aspirin in preventing early restenosis after FP EVT. Larger multi-ethnic trials are required to generalize these findings. Trial registration: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02959606; 09/11/2016). © 2023. The Author(s).
Files in This Item:
T999202354.pdf Download
DOI
10.1038/s41598-023-29006-z
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Thoracic and Cardiovascular Surgery (흉부외과학교실) > 1. Journal Papers
Yonsei Authors
Song, Suk Won(송석원) ORCID logo https://orcid.org/0000-0002-9850-9707
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198156
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