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Cilostazol for Restenosis - CREST
Description:
The goal of the CREST trial was to evaluate treatment with oral cilostazol compared with placebo on restenosis in patients who underwent successful stent implantation.
Hypothesis:
Treatment with oral cilostazol will be associated with a reduction in restenosis compared with placebo in patients who underwent successful stent implantation.
Study Design
Study Design:
Patients Enrolled: 2,502
Mean Follow Up: 4 years
Mean Patient Age: 69.1 years
Female: 37
Patient Populations:
Successful bare stent implantation
Primary Endpoints:
Minimum luminal diameter (MLD) of the first lesion stented in each patient
Secondary Endpoints:
MLD in all lesions, mean percent stenosis, binary restenosis, target lesion revascularization, and major adverse coronary events
Drug/Procedures Used:
Following successful percutaneous coronary intervention (PCI) with stent implantation, patients were randomized to cilostazol (100 mg bid; n=354) or placebo (n=351) treatment for 6 months. Quantitative angiography was performed after PCI and at 6 month follow-up using matched views.
Concomitant Medications:
Aspirin and clopidogrel
Principal Findings:
In-segment MLD was larger in the cilostazol arm vs the placebo arm at 6 month angiographic follow-up (1.77 mm vs 1.62 mm, p=0.01). Likewise, late loss was smaller in the cilostazol arm compared with placebo (0.57 mm vs 0.75, p<0.01). both="" in-segment="" restenosis="" (22.0%="" vs="" 34.5%,="" p="0.002)" and="" in-stent="" restenosis="" was="" smaller="" in="" the="" cilostazol="" arm="" (20.9%="" vs="" 31.4%,="" p="0.01)." in-segment="" restenosis="" in="" diabetic="" patients="" in="" the="" cilostazol="" arm="" was="" 17.7%="" compared="" with="" 37.7%="" among="" diabetics="" in="" the="" placebo="" arm="" (p="0.01)." there="" was="" no="" difference="" in="" mace="" (19%="" each)="" or="" bleeding="" between="" the="" treatment="" arms.="" both="" in-segment="" restenosis="" (22.0%="" vs="" 34.5%,="" p="0.002)" and="" in-stent="" restenosis="" was="" smaller="" in="" the="" cilostazol="" arm="" (20.9%="" vs="" 31.4%,="" p="0.01)." in-segment="" restenosis="" in="" diabetic="" patients="" in="" the="" cilostazol="" arm="" was="" 17.7%="" compared="" with="" 37.7%="" among="" diabetics="" in="" the="" placebo="" arm="" (p="0.01)." there="" was="" no="" difference="" in="" mace="" (19%="" each)="" or="" bleeding="" between="" the="" treatment="">
Interpretation:
Among patients who underwent successful PCI with bare stent implantation, treatment with the platelet-aggregation inhibitor cilostazol for 6 months was associated with a reduction in the primary endpoint of MLD at 6 month follow-up compared with placebo. Notable reductions were observed in the subgroups of diabetic patients. The recently reported RACTS trial compared cilostazol plus aspirin vs ticlopidine plus aspirin but showed no difference in angiographic and clinical outcomes. However, the two trial differs in that all patients in the CREST trial received both aspirin and clopidogrel in addition to the randomized therapy, unlike RACTS where only the control arm received ticlopidine.
References:
Douglas JS, et al. Coronary Stent Restenosis in Patients Treated With Cilostazol. Circulation. 2005;112:2826-2832.
Presented by Dr John S Douglas Jr at AHA 2003, Orlando, FL
Keywords: Follow-Up Studies, Platelet Aggregation Inhibitors, Ticlopidine, Blood Platelets, Fibrinolytic Agents, Tetrazoles, Vasodilator Agents, Bronchodilator Agents, Stents, Percutaneous Coronary Intervention, Neuroprotective Agents, Carotid Stenosis, Diabetes Mellitus, Phosphodiesterase 3 Inhibitors
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