Abstract
Optimal medical therapy following endovascular therapy (EVT) for femoropopliteal (FP) lesions remains unclear. Therefore, we investigated whether sarpogrelate improves primary patency after EVT for FP lesions. This study was performed as a multicenter, randomized, open-label clinical trial. 186 patients (mean age 75 ± 9 years, 78 % men) with Rutherford class 2–5 due to an FP lesion were randomly assigned to receive or not receive sarpogrelate in addition to aspirin. Primary endpoint was 1-year primary patency and the secondary endpoints were target lesion revascularization (TLR) and secondary patency. Primary patency was defined as a treated vessel without restenosis or repeat revascularization. Restenosis was defined as >2.5 of peak systolic velocity ratio. Patient, lesion, and procedural characteristics did not differ significantly between two groups (mean lesion length 156 ± 94 mm, total occlusion 35 %). Stenting was performed in 133 patients (76 %). Eighty-four (94 %) could ingest sarpogrelate during follow-up period. Primary patency was 66 % in sarpogrelate group and 56 % in non-sarpogrelate group, showing no significant difference between the groups (p = 0.33). The incidence of TLR did not differ in both groups (sarpogrelate 24 % vs non-sarpogrelate 32 %, p = 0.12). Secondary patency also did not differ (sarpogrelate 90 % vs non-sarpogrelate 92 %, p = 0.43). When the interaction of sarpogrelate with the primary patency was analyzed in previously established subgroups, no interactions were noted for any subset. Sarpogrelate did not improve primary patency after EVT for FP disease in this study.
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Acknowledgments
We acknowledge the expertise of Dr. Fumitoshi Toyoda (Chidoribashi Hospital), Dr. Yuki Imoto (Fukuoka Wajiro Hospital), Dr. Tatsuya Nakama (Miyazaki Medical Association Hospital), Dr. Masasto Taniguchi (Fukuyama), Dr. Toshinobu Ishikwa (Oita Oka Hospital), Dr. Hideki Doi (Kumamoto Rosai Hospital), Dr. Yuki Uehara (Urasoe General Hospital), Dr. Kenji Iwamoto (Iwakuni Medical center), and the medical staff and clinical research coordinators in all the participating centers.
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Association for Establishment of Evidence in Interventions, 2-5-3 New-Hamamatsu building, Hamamatsucho, Minato-ku, Tokyo 105-0013, Japan.
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Soga, Y., Shintani, Y., Hamasaki, T. et al. Effectiveness of sarpogrelate after endovascular treatment for femoropopliteal artery disease: ESPALIER study. Cardiovasc Interv and Ther 32, 325–332 (2017). https://doi.org/10.1007/s12928-016-0414-0
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DOI: https://doi.org/10.1007/s12928-016-0414-0