Stent Antithrombotic Regimen Study - STARS-Antithrombotic
Antiplatelet vs. anticoagulant therapy for death/MI/CABG after stenting.
To evaluate antiplatelet and anticoagulation regimens after intracoronary stenting.
Patients Screened: Not given
Patients Enrolled: 1,652
Mean Follow Up: 1 year
Patients undergoing optimal stenting
Death, emergency CABG, Q-wave myocardial infarction, and subacute closure with repeat revascularization.
Aspirin, aspirin plus Coumadin, or aspirin plus ticlopidine.
Of the 1652 patients enrolled, 557 were randomized to aspirin alone, 550 to aspirin and warfarin therapy, and 546 to aspirin with ticlopidine.
Cumulative events (any target vessel revascularization, Q wave MI, or death) at six months was lower for aspirin with ticlopidine compared to the other two groups 8.2% vs 11.6% aspirin with Coumadin and 13.1% for aspirin alone. The difference was statistically significant for the aspirin with ticlopidine group compared to the two other arms combined (8.2% vs 12.4%, p=0.01).
The per-lesion clinical restenosis endpoint, defined as target vessel revascularization or death after 30 days, was evaluated in 91% of patients with 6-month or greater follow-up. There was a mild trend in lower clinical restenosis for aspirin with ticlopidine compared to the other two groups 9.2% vs 11.2%, p=0.24).
At 9 months, there remained a significant difference between the aspirin with ticlopidine and aspirin alone groups (10.6% vs 14.9%, p=0.04). The cumulative event rate for the aspirin with warfarin arm was 12.6%.There was no significant difference in the clinical restenosis endpoint between the three arms.
A multivariate regression analysis found the predictors of clinical restenosis to be final MLD, reference artery size, diabetes mellitus, advancing age, and number of stents placed. Predictors of the clinical event composite outcome were final minimum lumen diameter, number of stents placed, diabetes mellitus, and age.
Aspirin and ticlopidine after intracoronary stenting provide superior acute and long-term results compared to aspirin and warfarin or aspirin therapy alone. It has no effect on late restenosis. Evidence of clinical restenosis may require 9 to 12 months to observe; only 60% of the restenosis rate was observable at 6 months.
1. Circulation 1997;95:762. Preliminary results
2. Circulation 1997;96(Suppl I):I-594. Late clinical results
Keywords: Coronary Artery Disease, Follow-Up Studies, Platelet Aggregation Inhibitors, Warfarin, Ticlopidine, Regression Analysis, Diabetes Mellitus, Stents
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