The RESTORE study (n=2141) was a randomized, controlled comparison of AGGRASTAT and placebo, each added to heparin, in patients undergoing PTCA or atherectomy within 72 hours of presentation with unstable angina or acute myocardial infarction. The mean age of the population was 59 years; 27% were female. Two-thirds of patients underwent angioplasty for unstable angina and the remainder in association with acute myocardial infarction. Exclusions included anatomy not amenable to angioplasty, contraindications to anticoagulation (see CONTRAINDICATIONS), platelet count <150,000/mm³, and creatinine >2.0 mg/dL. AGGRASTAT (with heparin) was initiated immediately prior to the angioplasty/ atherectomy at a dose of 10 mcg/kg bolus (over 3 minutes) followed by an infusion of 0.15 mcg/kg/min along with a heparin bolus (bolus of 10,000 U, or 150 U/kg for patients <70 kg). The infusion dose of AGGRASTAT is 50% higher than the dose used in the PRISM-PLUS trial. AGGRASTAT was administered for a total of 36 hours. In general, heparin was to be discontinued at the conclusion of the angioplasty/atherectomy. Reasons for continued heparin included: imperfect outcome (e.g., large tear, intraluminal filling defect, or residual stenosis >40%), large thrombus load, continuing rest angina through the procedure, abrupt closure or very active artery during the procedure, or side branch occlusion. The primary endpoint was the composite of all deaths, non-fatal myocardial infarctions, and all repeat revascularization procedures at 30 days. For results see Table 3. A sub-study in RESTORE of angiograms after approximately 6 months found that AGGRASTAT had no significant effect on the extent of coronary artery restenosis following angioplasty.

Table 3: Cardiac Ischemia Events

The risk reduction in the composite endpoint at 180 days is shown in the Kaplan-Meier curve below.

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