Yoshimitsu Soga1, Mitsuyoshi Takahara2, Osamu Iida3, Yasutaka Yamauchi4, Keisuke Hirano5, Masashi Fukunaga6, Kan Zen7, Kenji Suzuki8, Yoshiaki Shintani9, Yusuke Miyashita10, Taketsugu Tsuchiya11, Terutoshi Yamaoka12, Kenji Ando13. 1. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. Electronic address: soga@circulation.jp. 2. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. 3. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan. 4. Department of Cardiology, Takatsu General Hospital, Kawasaki, Japan. 5. Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. 6. Cardiovascular Division, Morinomiya Hospital, Morinomiya, Japan. 7. Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan. 8. Department of Cardiology, Saiseikai Central Hospital, Tokyo, Japan. 9. Department of Cardiology, Shin-Koga Hospital, Kurume, Japan. 10. Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine, Matsumoto, Japan. 11. Division of Trans-Catheter Therapeutics, Kanazawa Medical University Hospital, Kahoku, Japan. 12. Department of Vascular Surgeon, Matsuyama Red Cross Hospital, Matsuyama, Japan. 13. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Abstract
BACKGROUND: Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients. METHODS: This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events. RESULTS:A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol + aspirin group and 81% in the aspirin group, with no significant difference (P = 0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group (P = 0.73). In addition, no significant difference was observed in any secondary points. CONCLUSIONS:Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.
RCT Entities:
BACKGROUND: Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients. METHODS: This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events. RESULTS: A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol + aspirin group and 81% in the aspirin group, with no significant difference (P = 0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group (P = 0.73). In addition, no significant difference was observed in any secondary points. CONCLUSIONS:Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.
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