Efficacy of Cilostazol After Endovascular Therapy for Femoropopliteal Artery Disease in Patients With Intermittent Claudication - Efficacy of Cilostazol After Endovascular Therapy for Femoropopliteal Artery Disease in Patients With Intermittent Claudication


The goal of the trial was to evaluate treatment with cilostazol compared with control in patients with claudication who were undergoing endovascular therapy for femoropopliteal disease.


Cilostazol would be more effective in preventing target vessel revascularization.

Study Design

  • Randomized
  • Parallel

Patients Screened: 80
Patients Enrolled: 78
Mean Follow Up: 24 months
Mean Patient Age: 72 years
Female: 13%

Patient Populations:

  • Patients 18-80 years of age with intermittent claudication due to femoralpopliteal artery disease who were undergoing endovascular therapy
  • Ankle-brachial index ≤0.9
  • Percent diameter stenosis of at least 50%


  • Previous lower extremity bypass surgery or endovascular therapy in the involved limb
  • Acute onset of limb ischemia
  • Rutherford classification of 4, 5, or 6

Primary Endpoints:

  • Freedom from target vessel revascularization

Secondary Endpoints:

  • Rate of restenosis
  • Freedom from target lesion revascularization
  • Major adverse cardiac events, defined as death, myocardial infarction, stroke, repeat revascularization, and leg amputation

Drug/Procedures Used:

Patients with intermittent claudication due to femoropopliteal disease treated with endovascular therapy were randomized to cilostazol (n = 39) versus control (n = 39).

Concomitant Medications:

All patients were treated with aspirin (81-100 mg daily) and ticlopidine (200 mg daily) prior to randomization. Ticlopidine was stopped in patients treated with balloon angioplasty, whereas it was continued for 4 weeks in patients who received a stent.

Patients received intraprocedural unfractionated heparin (3000-5000 U) to obtain an activated clotting time greater than 200 seconds.

Principal Findings:

Overall, 78 patients were randomized. In the cilostazol group, the mean age of participants was 70 years, and 21% were women. Procedural success was obtained in 97%. Stents were used in 41% of the cilostazol group and 51% of the control group. In the cilostazol group, the mean lesion length was 121 mm, percent diameter stenosis of the lesion was 79%, mean reference vessel diameter was 4.8 mm, and a chronic total occlusion was observed in 26%. There was no difference in baseline or procedural details between the groups. There was 90% medication compliance in the cilostazol group.

The primary outcome, freedom from target vessel revascularization, occurred in 84.6% of the cilostazol group versus 62.2% of the control group (p = 0.038). Binary restenosis occurred in 43.6% versus 70.3% (p = 0.02), and freedom from major adverse cardiac events occurred in 79.5% versus 48.7% (p = 0.006), respectively, for cilostazol versus control.

For individual outcomes: the number of deaths was 1 versus 2, number of nonfatal myocardial infarctions was 0 versus 0, number of strokes was 0 versus 1, number of leg amputations was 0 versus 0, and number of major bleeds was 0 versus 0, respectively, for cilostazol versus control. At follow-up, ankle-brachial index was 0.72 in the cilostazol group versus 0.81 in the control group (p = 0.046).


Among patients with intermittent claudication due to femoralpopliteal disease who underwent endovascular therapy (balloon angioplasty or stent implantation according to operator discretion), the use of cilostazol was associated with improved freedom from target vessel revascularization and freedom from major adverse cardiac events. Restenosis was also significantly reduced in the cilostazol group. Compliance to cilostazol was approximately 90%, and there were no major bleeds in either group.

Target vessel revascularization due to restenosis remains a significant problem after endovascular therapy for peripheral arterial disease. The optimal therapy to prevent this complication remains uncertain. While the results of this trial are compelling, the small sample size and open-label use of cilostazol pose a significant methodological limitation. The use of cilostazol to prevent restenosis will need to be evaluated in large, blinded, randomized trials.


Soga Y, Yokoi H, Kawasaki T, et al. Efficacy of cilostazol after endovascular therapy for femoropopliteal artery disease in patients with intermittent claudication. J Am Coll Cardiol 2008;53:48-53.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine, Chronic Angina

Keywords: Intermittent Claudication, Stroke, Myocardial Infarction, Platelet Aggregation Inhibitors, Coronary Restenosis, Ankle Brachial Index, Peripheral Arterial Disease, Constriction, Pathologic, Leg, Tetrazoles, Stents, Medication Adherence

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