Abciximab and Heparin versus Bivalirudin for Non–ST-Elevation Myocardial Infarction
Topic: Anticoagulation in acute coronary syndrome (direct thrombin inhibitors)
Aim:
- Compare combination of glycoprotein IIb/IIIa inhibitors and heparin with bivalirudin in patients with NSTEMI undergoing PCI.
Design:
- Prospective, multi-centered, double blinded, randomized clinical trial
Treatment:
- Abciximab (0.25mg/kg IV bolus followed by infusion of 0.125 ug/kg/min for 12 hours) and unfractionated heparin (70 U/kg IV bolus)
Control:
- Bivalirudin (0.75mg/kg, followed by infusion of 1.75 mg/kg/hr for duration of the procedure)
Cohort:
- 1,721 patients
Inclusion criteria:
- 19-80 years with accelerating angina or angina > 20 minutes within preceding 48 hours
- Cardiac biomarkers above the upper limit of normal
- Coronary stenosis requiring PCI
- Received 325-500 mg aspirin and 600 mg clopidogrel prior to receiving study drug
Exclusion criteria:
- STEMI or shock
- Troponin T > 0.03 or CK-MB > upper limit of normal
- Active or prior bleeding
- Creatinine clearance < 30 mL/min
- Recent anticoagulation use
- Blood pressure > 180/110
- Endocarditis, pericarditis, aortic dissection
Follow up:
- 30 days
Primary endpoint:
- Composite of death, large recurrent myocardial infarction, urgent target-vessel revascularization, or major bleeding (CNS bleed, retroperitoneal bleed, 4g decrease in Hg, transfusion of 2 or more units of blood product).
Secondary endpoint:
- Composite of death, any recurrent MI, or urgent target-vessel revascularization and a safety end point of major bleeding.
Main results:
- Mean age 67, 77% were men.
- The primary end point occurred in 94 patients (10.9%) in the abciximab group and 95 patients (11.0%) in the bivalirudin group (RR 0.99; CI 0.74-1.32; P=0.94).
- The secondary efficacy end point occurred in 110 patients (12.8%) in the abciximab group and 115 patients (13.4%) in the bivalirudin group (RR 0.96; CI 0.74-1.25; P=0.76).
- Major bleeding occurred in 40 patients (4.6%) in the abciximab group and 22 patients (2.6%) in the bivalirudin group (RR 1.84; CI 1.10-3.07; P=0.02).
- Profound thrombocytopenia developed in 10 patients (1.2%) in the abciximab group and in none of the patients in the bivalirudin group (P=0.002).
TAKE AWAY: Abciximab with unfractionated heparin failed to reduce the rate of the primary endpoint and was associated with more bleeding and thrombocytopenia compared to bivalirudin alone in patients with NSTEMI treated with PCI.
