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Randomized Efficacy Study of Tirofiban for Outcome and Restenosis - RESTORE
Description:
Tirofiban for death/MI/recurrent ischemia in percutaneous interventions.
Hypothesis:
To assess the effect of tirofiban in patients undergoing coronary interventions (balloon angioplasty or directional atherectomy) within 72 hours of presentation with an acute coronary syndrome (unstable angina pectoris or acute myocardial infarction).
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2,212
Mean Follow Up: 6 months
Mean Patient Age: 59.2
Female: 28
Patient Populations:
Patients undergoing coronary interventions (balloon angioplasty or DCA)
Within 72 hours of presentation with an acute coronary syndrome (unstable angina pectoris or acute MI).
Exclusions:
Thrombolytic therapy within 24 hours
Contraindication to anticoagulation
History of a platelet disorder or thrombocytopenia
History of stroke or other intracranial pathology
Scheduled for elective stent placement
Planned angioplasty using a rotablator or transluminal extraction catheter device
Primary Endpoints:
Composite of death from any cause, myocardial infarction, coronary bypass surgery due to angioplasty failure or recurrent ischemia, repeat target-vessel angioplasty for recurrent ischemia, and insertion of a stent due to actual or threatened abrupt closure of the dilated artery.
Drug/Procedures Used:
Tirofiban, 10 mcg/kg bolus, then 0.15 mcg/kg/min for 36 hours, or placebo.
Concomitant Medications:
Aspirin, heparin
Principal Findings:
The incidence of the composite end point at 2 days was reduced from 8.7% to 5.4%, and at 7 days the tirofiban group had a 27% relative reduction in the composite end point (P = .022).
At 30 days, there was a 16% relative reduction in the primary composite end point (10.3% tirofiban vs 12.2% placebo, p=0.16).
At 6 months, the composite end point occurred in 1,070 placebo group patients (27.1%) and 1,071 tirofiban group patients (24.1%, p = 0.11).
Quantitative analysis of 6-month coronary arteriograms showed no significant difference between placebo- and tirofiban-treated patients in restenosis or vessel diameter.
Major bleeding, including transfusion, was not significantly different between the two groups (3.7% in the placebo group and 5.3% in the tirofiban group; P = .096).
Thrombocytopenia was similar in the placebo and tirofiban groups (0.9% for the placebo group versus 1.1% for the tirofiban group; P = .709).
Interpretation:
In patients undergoing coronary angioplasty for acute coronary syndromes, tirofiban reduces the incidence of early adverse cardiac events. The 3% absolute reduction in the composite end point at 2 days was preserved, but not extended, at 6 months. Tirofiban did not reduce the incidence of restenosis at 6 months.
References:
1. Circulation 1997;96:1445-53. Final results
2. J Am Coll Cardiol 1998;32:28-34. 6-month follow-up
Keywords: Platelet Aggregation Inhibitors, Atherectomy, Coronary Disease, Angioplasty, Balloon, Coronary, Tyrosine, Survival Rate, Cardiopulmonary Bypass, Confidence Intervals, Mitral Valve Annuloplasty, Myocardial Infarction, Stroke, Acute Coronary Syndrome, Mitral Valve Insufficiency, Myocardium, Equipment Failure, Percutaneous Coronary Intervention, Renal Insufficiency, Reoperation, Coronary Angiography, Heart Failure, Intention to Treat Analysis, Cardiac Surgical Procedures, Coronary Artery Bypass, Heart Ventricles, Ventricular Dysfunction, Left, Thrombocytopenia, Diabetes Mellitus
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