Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention
Topic: Anticoagulation in acute coronary syndrome (direct thrombin inhibitors)
- Bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo PCI after pretreatment with clopidogrel.
- Prospective, multi-centered, double blinded, randomized clinical trial
- Bivalirudin (IV bolus of 0.75 mg/kg plus infusion of 1.75 mg/kg/hr for duration of procedure)
- Unfractionated heparin (140 U/kg bolus plus placebo infusion for duration of procedure)
- 4,570 patients
- > 18 years old undergoing PCI
- Received 600mg loading dose of clopidogrel and 325-500mg of aspirin at least 2 hours before intervention
- 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
- 30 days
- Composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization.
- Composite of death, myocardial infarction, or urgent target-vessel revascularization.
- Mean age 67, 77% were men.
- Primary end point was reached by 190 patients in the bivalirudin group (8.3%) and 199 patients in the unfractionated heparin group (8.7%) (RR 0.94; CI 0.77-1.15;
- The secondary end point occurred in 134 patients in the bivalirudin group (5.9%) and 115 patients in the unfractionated heparin group (5.0%) (RR 1.16; CI 0.91-1.49; P=0.23).
- Definite stent thrombosis occurred in 12 patients in the bivalirudin group (0.5%) and 9 in the unfractionated-heparin group (0.4%, P=0.52).
- Major bleeding was significantly reduced in bivalirudin group (3.1%) compared to the unfractionated heparin group (4.6%) (RR 0.66; CI 0.49-0.90).
TAKE AWAY: Bivalirudin compared to unfractionated heparin did not provide a net clinical benefit compared in patients with unstable or stable angina undergoing PCI, although it reduced incidence of bleeding.