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J Am Coll Cardiol, 2002; 39:377-386 © 2002 by the American College of Cardiology Foundation |
* Cleveland Clinic Foundation, Cleveland, Ohio, USA
Staedtische Kliniken, Kassel, Germany
Royal Victoria Hospital, Belfast, Ireland
MetroHealth Medical Center, Cleveland, Ohio, USA
|| Duke Medical Center, Durham, North Carolina, USA
¶ Schering-Plough Research Institute, Kenilworth, New Jersey, USA
# COR Therapeutics, South San Francisco, California, USA
Manuscript received August 2, 2001; revised manuscript received October 26, 2001, accepted November 7, 2001.
* Reprint requests and correspondence: Dr. Sorin J. Brener, 9500 Euclid Ave., Desk F-25, Cleveland, Ohio 44195, USA
breners{at}ccf.org
OBJECTIVES: This study was designed to test the hypothesis that eptifibatide and reduced-dose tissue plasminogen activator (t-PA) will enhance infarct artery patency at 60 min in patients with acute myocardial infarction (AMI).
BACKGROUND: Combination fibrin and platelet lysis improves epicardial and myocardial reperfusion in AMI.
METHODS: Patients were enrolled in a dose finding (Phase A, n = 344) followed by a dose confirmation (Phase B, n = 305) protocol. All patients received aspirin and weight-adjusted heparin and underwent angiography at 60 and 90 min. In Phase A, eptifibatide in a single or double bolus (30 min apart) of 180, 180/90 or 180/180 µg/kg followed by an infusion of 1.33 or 2.0 µg/kg per min was sequentially added to 25 or 50 mg of t-PA. In Phase B, patients were randomized to: 1) double-bolus eptifibatide 180/90 (30 min apart) and 1.33 µg/kg per min infusion with 50 mg t-PA (Group I); 2) 180/90 (10 min apart) and 2.0 µg/kg per min with 50 mg t-PA (Group II); or 3) full-dose, weight-adjusted t-PA (Group III).
RESULTS: In Phase A, the best rate of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved using 180/90/1.33 µg/kg per min eptifibatide with 50 mg t-PA: 65% and 78% at 60 and 90 min, respectively. In Phase B, the incidence of TIMI flow grade 3 at 60 min was 42%, 56% and 40%, for Groups I through III, respectively (p = 0.04, Group II vs. Group III). The median corrected TIMI frame count was 38, 33 and 50, respectively (p = 0.02). TIMI major bleeding was reported in 8%, 11% and 6%, respectively; intracranial hemorrhage occurred in 1%, 3% and 2% of patients (p > 0.5 for both). The incidences of death (4%, 5% and 7%), reinfarction or revascularization at 30 days were similar among the three treatment groups.
CONCLUSIONS: In comparison with standard t-PA regimen, double-bolus eptifibatide (10 min apart) with a 48-h infusion and half-dose t-PA (Group II) is associated with improved quality and speed of reperfusion. The safety profile of this therapy is similar to that of other combination regimens.
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