Unfractionated Heparin Outperforms Bivalirudin in PPCI
Beat J. Meyer, MD
A future role for high-cost bivalirudin in primary percutaneous coronary intervention is doubtful.
Previous evidence indicates that bivalirudin provides a moderate benefit over unfractionated heparin (UFH) in patients undergoing primary percutaneous coronary intervention (PPCI). To further compare these agents in this setting, U.K. investigators conducted a single-center, open-label, randomized, controlled trial involving 1829 consecutive patients with acute ST-elevation myocardial infarction scheduled for emergency angiography, of whom 1491 (82%) underwent subsequent PPCI (NCT01519518).
Patients were randomized to UFH (70 U/kg) or bivalirudin (bolus 0.75 mg/kg, infusion 1.75 mg/kg/hr). Additional doses were administered if activated clotting-time values 5 to 15 minutes after the bolus dose or at the end of the procedure were <200 seconds in the UFH group and <225 seconds in the bivalirudin group. The P2Y12 inhibitors prasugrel or ticagrelor were used in about 90% of patients in both groups.
At 28 days, the primary efficacy outcome (a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularization) occurred in more bivalirudin recipients than UFH recipients (8.7% vs. 5.7%; P=0.01), with similar selective use of glycoprotein IIb/IIIa inhibitors (13% and 15%, respectively). Bivalirudin's shortcoming was primarily driven by an increased rate of reinfarction associated with stent thrombosis leading to unplanned target lesion revascularization (3.3% vs. 0.7%; P=0.001). Rates of major bleeding were similar with bivalirudin and UFH (3.5% and 3.1%). Of note, radial access was used in 81% of patients.
Citation(s):
Shahzad A et al. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): An open-label, single centre, randomised controlled trial. Lancet 2014 Jul 5; [e-pub ahead of print].
Shaw D.HEAT-PPCI sheds light on consent in pragmatic trials. Lancet 2014 Jul 5; [e-pub ahead of print].
Berger PB and Blankenship JC.Is the heat on HEAT-PPCI appropriate? Lancet 2014 Jul 5; [e-pub ahead of print].
