CLINICAL RESEARCH: PERIPHERAL VASCULAR DISEASE
Efficacy of Cilostazol After Endovascular Therapy for Femoropopliteal Artery Disease in Patients With Intermittent Claudication
Yoshimitsu Soga, MD*,
Hiroyoshi Yokoi, MD*,*,
Tomohiro Kawasaki, MD ,
Hitoshi Nakashima, MD ,
Masanori Tsurugida, MD ,
Yutaka Hikichi, MD|| and
Masakiyo Nobuyoshi, MD, FACC, FAHA*
* Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan
Department of Cardiology, Shin-Koga Hospital, Kurume, Japan
National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan
Department of Cardiology, Fujimoto Hayasuzu Hospital, Miyakonojyo, Japan
|| Division of Cardiology, Saga University, Saga, Japan
Manuscript received June 25, 2008;
revised manuscript received September 8, 2008,
accepted September 22, 2008.
* Reprint requests and correspondence: Dr. Hiroyoshi Yokoi, Department of Cardiology, Kokura Memorial Hospital, 1-1 Kifune-machi, Kokurakita-ku, Kitakyushu 802-8555, Japan (Email: hyokoi{at}bu.iij4u.or.jp).
Objectives: The purpose of this study was to investigate whether cilostazol reduces restenosis and revascularization after endovascular therapy (EVT) for femoropopliteal lesions.
Background: Cilostazol improves walking distance in patients with intermittent claudication and reduces restenosis after coronary intervention, but its efficacy remains unclear after EVT for femoropopliteal disease.
Methods: This study was performed as a multicenter, randomized, open-label clinical trial. Eighty patients (mean age 70.7 ± 6.2 years, 84% men) with intermittent claudication due to a femoropopliteal lesion were randomly assigned to receive or not receive cilostazol in addition to aspirin. The primary end point was freedom from target vessel revascularization, and the secondary end points were the rate of restenosis and freedom from target lesion revascularization and major adverse cardiovascular events, defined as all-cause death, myocardial infarction, stroke, repeat revascularization, and leg amputation.
Results: Clinical follow-up information was obtained in all patients. Patient, lesion, and procedural characteristics did not differ significantly between the 2 groups. Stenting was performed in 36 patients (cilostazol, 16; control, 20; p = 0.36). Freedom from target vessel revascularization at 2 years after EVT was significantly higher compared with the control group (84.6% vs. 62.2%, p = 0.04). The rate of restenosis was lower in the cilostazol group (43.6% vs. 70.3%, p = 0.02), and freedom from target lesion revascularization and major adverse cardiovascular events was higher in the cilostazol group (87.2% vs. 67.6%, p = 0.046, 76.8% vs. 45.6%, p = 0.006, respectively). There was no major bleeding in either group during follow-up period.
Conclusions: Cilostazol reduced restenosis and repeat revascularization after EVT in patients with intermittent claudication due to femoropopliteal disease.
Key Words: femoropopliteal arterial disease • target vessel revascularization • restenosis • endovascular therapy
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Abbreviations and Acronyms
| | EVT = endovascular therapy | | IC = intermittent claudication | | MACE = major adverse cardiovascular events | | MI = myocardial infarction | | PAD = peripheral arterial disease | | %DS = percent diameter stenosis | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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