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Original Article

Cilostazol Reduces Angiographic Restenosis after Endovascular Therapy for Femoropopliteal Lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study

Osamu Iida, Hiroyoshi Yokoi, Yoshimitsu Soga, Naoto Inoue, Kenji Suzuki, Yoshiaki Yokoi, Daizo Kawasaki, Kan Zen, Kazushi Urasawa, Yoshiaki Shintani, Akira Miyamoto, Keisuke Hirano, Yusuke Miyashita, Taketsugu Tsuchiya, Norihiko Shinozaki, Masato Nakamura, Takaaki Isshiki, Toshimitsu Hamasaki, Shinsuke Nanto
and on behalf of the STOP-IC investigators
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https://doi.org/10.1161/CIRCULATIONAHA.112.000711
Circulation. 2013;CIRCULATIONAHA.112.000711
Originally published May 7, 2013
Osamu Iida
Kansai Rosai Hospital, Hyogo, Japan
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  • For correspondence: iida.osa@gmail.com
Hiroyoshi Yokoi
Kokura Memorial Hospital, Kitakyushu, Japan
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Yoshimitsu Soga
Kokura Memorial Hospital, Kitakyushu, Japan
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Naoto Inoue
Sendai Kousei Hospital, Sendai, Japan
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Kenji Suzuki
Sendai Kousei Hospital, Sendai, Japan
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Yoshiaki Yokoi
Kishiwada Tokushukai Hospital, Kishiwada, Japan
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Daizo Kawasaki
Hyogo College of Medicine, Hyogo, Japan
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Kan Zen
Omihachiman Community Medical Center, Omihachiman, Japan
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Kazushi Urasawa
Tokeidai Memorial Hospital, Tokeidai, Japan
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Yoshiaki Shintani
Shin-Koga Hospital, Kurume, Japan
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Akira Miyamoto
Kikuna Memorial Hospital, Yokohama, Japan
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Keisuke Hirano
Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan
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Yusuke Miyashita
Shinshu University Graduate School of Medicine, Matsumoto, Japan
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Taketsugu Tsuchiya
Kanazawa Medical University Hospital, Kahoku, Japan
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Norihiko Shinozaki
Tokai University School of Medicine, Isehara, Japan
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Masato Nakamura
Toho University, Ohashi Medical Center, Tokyo, Japan
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Takaaki Isshiki
Teikyo University Hospital, Tokyo, Japan
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Toshimitsu Hamasaki
Osaka University Graduate School of Medicine, Osaka, Japan
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Shinsuke Nanto
Osaka University Graduate School of Medicine, Osaka, Japan
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Abstract

Background—It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy (EVT) for femoropopliteal (FP) lesions, also reduces angiographic restenosis.

Methods and Results—The Sufficient Treatment Of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after PTA with provisional nitinol stenting for FP lesions. Two hundred patients with FP lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomized 1:1 to receive oral aspirin with or without cilostazol. The primary endpoint was 12-month angiographic restenosis rate. Secondary endpoints were restenosis rate on duplex ultrasound and of major adverse cardiac events (MACE), and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the endpoints in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment was 128±86 mm and 5.4±1.4 mm, respectively. Frequency of stent used was similar between groups (88% versus 90% in the cilostazol and non-cilostazol group, respectively, p=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the non-cilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus. 71%, p=0.02), although cardiovascular event rates were similar in both groups.

Conclusions—Cilostazol reduced angiographic restenosis after PTA with provisional nitinol stenting for FP lesions.

Clinical Trial Registration Information—URL: http://www.clinicaltrials.gov. Identifier: NCT00912756; https:// www.umin.ac.jp Unique identifier : UMIN000002091

  • Nitinol stent
  • cilostazol
  • angioplasty
  • peripheral artery disease
  • restenosis
  • Received December 20, 2012.
  • Revision received April 9, 2013.
  • Accepted April 17, 2013.
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    Cilostazol Reduces Angiographic Restenosis after Endovascular Therapy for Femoropopliteal Lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study
    Osamu Iida, Hiroyoshi Yokoi, Yoshimitsu Soga, Naoto Inoue, Kenji Suzuki, Yoshiaki Yokoi, Daizo Kawasaki, Kan Zen, Kazushi Urasawa, Yoshiaki Shintani, Akira Miyamoto, Keisuke Hirano, Yusuke Miyashita, Taketsugu Tsuchiya, Norihiko Shinozaki, Masato Nakamura, Takaaki Isshiki, Toshimitsu Hamasaki and Shinsuke Nanto on behalf of the STOP-IC investigators
    Circulation. 2013;CIRCULATIONAHA.112.000711, originally published May 7, 2013
    https://doi.org/10.1161/CIRCULATIONAHA.112.000711

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    Cilostazol Reduces Angiographic Restenosis after Endovascular Therapy for Femoropopliteal Lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study
    Osamu Iida, Hiroyoshi Yokoi, Yoshimitsu Soga, Naoto Inoue, Kenji Suzuki, Yoshiaki Yokoi, Daizo Kawasaki, Kan Zen, Kazushi Urasawa, Yoshiaki Shintani, Akira Miyamoto, Keisuke Hirano, Yusuke Miyashita, Taketsugu Tsuchiya, Norihiko Shinozaki, Masato Nakamura, Takaaki Isshiki, Toshimitsu Hamasaki and Shinsuke Nanto on behalf of the STOP-IC investigators
    Circulation. 2013;CIRCULATIONAHA.112.000711, originally published May 7, 2013
    https://doi.org/10.1161/CIRCULATIONAHA.112.000711
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