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Randomized Evaluation of Anticoagulation Versus Antiplatelet Therapy After Coronary Stent Implantation in High-Risk Patients: The Multicenter Aspirin and Ticlopidine Trial After Intracoronary Stenting - MATTIS
Description:
The goal of the study was to assess the safety and efficacy of dual antiplatelet therapy with ticlopidine and aspirin versus aspirin and oral anticoagulation among high-risk patients after coronary stent implantation.
Hypothesis:
Because the combination of aspirin and ticlopidine had been shown to be superior to aspirin plus oral anticoagulation after coronary artery stenting in low-risk patients, it was hypothesized that the same would be true for high-risk patients.
Study Design
Study Design:
Patients Enrolled: 350
Mean Follow Up: 30 days
Mean Patient Age: Mean 60.4 ± 9.9 years
Female: 24
Patient Populations:
Patients were eligible to participate in this study if they met at least one of the following criteria after their coronary stenting procedure: bailout stenting for acute vessel closure or dissection, suboptimal stenting result (i.e., >20% residual stenosis within the stent, residual dissection, >30% stenosis immediately proximal or distal to the stent, or reduced flow after stent implantation), ≥3 stents placed within the same vessel, total length of stents ≥45 mm, or maximal nominal balloon diameter used was ≤2.5 mm.
Exclusions:
The exclusion criteria included: recent myocardial infarction, persistent ischemia at the time of randomization, age <18 years, pregnancy, difficulties with follow-up, use of glycoprotein (GP) IIb/IIa antagonists in the periprocedure period or the planned use of GP IIb/IIa antagonists during the follow-up period, need for oral anticoagulation, contraindications to any of the study medications, and participation in another study within the prior 30 days.
Primary Endpoints:
The composite primary endpoint was cardiovascular events at 30 days. Cardiovascular events were defined as the occurrence of cardiovascular death, myocardial infarction, or repeat revascularization.
Secondary Endpoints:
The secondary endpoints of this study were major bleeding or vascular complications. These were defined as the need for surgical repair of the vascular access site, bleeding with a subsequent decrease in hemoglobin by ≥4 g/dl, or requiring a transfusion of ≥2 units of blood, or retroperitoneal or intracranial hemorrhage.
Drug/Procedures Used:
Eligible patients were randomized to receive either dual antiplatelet therapy with aspirin and ticlopidine or aspirin and oral anticoagulation therapy in an open-label fashion. Those randomized to the dual antiplatelet therapy group received aspirin 250 mg/day and ticlopidine 250 mg BID, with the entire daily dose of 500 mg given as a single dose on the first day.
Individuals in the aspirin and oral anticoagulation group received aspirin 250 mg/day and oral anticoagulation to a target international normalized ratio (INR) of 2.5 to 3.0. Intravenous heparin was continued until the target INR was achieved in two consecutive measurements separated by ≥24 hours.
Principal Findings:
There was a strong trend toward a reduction in the primary cardiac endpoint in patients in the dual antiplatelet group compared to those receiving aspirin and oral anticoagulation (5.6% vs. 11%; relative risk [RR] 1.9; 95% confidence interval [CI] 0.9 to 4.1; p=0.07). There was a significant reduction in the incidence of major vascular and bleeding complications among patients receiving dual antiplatelet therapy versus those in the aspirin plus oral anticoagulation group (1.7% vs. 6.9%; RR 4.1; 95% CI 1.2-14.3; p=0.02).
Interpretation:
Among high-risk patients undergoing coronary artery stenting, dual antiplatelet therapy with aspirin and ticlopidine was associated with a strong trend toward a reduction in the primary endpoint of cardiac events during the 30-day follow-up period compared to patients receiving aspirin and oral anticoagulation therapy. Additionally, dual antiplatelet therapy was associated with a significant reduction in the incidence of major bleeding and vascular complications.
These findings suggest that, in high-risk patients undergoing coronary artery stent implantation, dual antiplatelet therapy with aspirin and ticlopidine is superior to the combination of aspirin and oral anticoagulation.
References:
Urban P, Macaya C, Rupprecht HJ, et al. Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS). Circulation 1998;98:2126-32.
Keywords: Risk, Follow-Up Studies, Platelet Aggregation Inhibitors, Heparin, Ticlopidine, Constriction, Pathologic, Stents, International Normalized Ratio, Coronary Vessels, Coronary Thrombosis, Confidence Intervals
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