Bleeding Complications With Regional Adaptation of a Prolonged Bivalirudin Regimen for ST-Elevation Acute Myocardial Infarction

Bivalirudin (BIV) is superior to a heparin/glycoprotein IIb/IIIa receptor inhibitor (GPI) strategy with respect to net adverse cardiovascular events for ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), albeit with an increased risk of acute stent thrombosis. We hypothesized that a 2-hour BIV infusion after PCI (BIV + 2) could be used without increased bleeding risk as a potential method of mitigating early thrombotic risk. We analyzed a 6-center regional protocol involving routine therapy with aspirin, clopidogrel, and bolus heparin followed by primary PCI for STEMI using BIV. All consecutive patients presenting with STEMI requiring primary PCI were included (2009 to 2011). We compared baseline characteristics and clinical outcomes of the University of Vermont Regional Registry to the historical groups of BIV (BIV terminated at end of PCI) or unfractionated heparin/GPI from the HORIZONS trial and determined independent predictors of bleeding. Of 346 patients undergoing PCI for STEMI, 98% received BIV; 82% of patients received BIV + 2, and 13.3% of all patients receiving BIV received GPI bailout. All-cause mortality was 3.1%. Overall bleeding rates were 50% less than in the HORIZONS GPI arm and similar to the HORIZONS BIV arm. Acute stent thrombosis occurred in <1.0% of patients. Bailout GPI was a potent independent predictor of bleeding complications. In conclusion, BIV + 2 is a feasible regional pharmacologic algorithm for STEMI PCI; BIV + 2 for STEMI PCI is not associated with increased bleeding risk and warrants further study as a mechanism of mitigating very early thrombosis risk.