Giuseppe Tarantini1, Sorin Jakob Brener2, Alberto Barioli3, Andrea Gratta3, Guido Parodi4, Roberta Rossini5, Eliano Pio Navarese6, Giampaolo Niccoli7, Anna Chiara Frigo3, Giuseppe Musumeci5, Sabino Iliceto3, Gregg Whitney Stone8. 1. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com. 2. Weil Cornell Medical College, NY Methodist Hospital, Brooklyn, NY. 3. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. 4. Department of Cardiology, Careggi Hospital, Florence, Italy. 5. Department of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy. 6. Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands. 7. Department of Cardiovascular Medicine, Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy. 8. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY.
Abstract
BACKGROUND: Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding. METHODS: We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (±provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk. RESULTS: A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (±GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum. CONCLUSIONS: Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.
BACKGROUND: Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding. METHODS: We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (±provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk. RESULTS: A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (±GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum. CONCLUSIONS: Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.
Authors: Uwe Zeymer; Arnoud van 't Hof; Jennifer Adgey; Lutz Nibbe; Peter Clemmensen; Claudio Cavallini; Jurrien ten Berg; Pierre Coste; Kurt Huber; Efthymios N Deliargyris; Jonathan Day; Debra Bernstein; Patrick Goldstein; Christian Hamm; Philippe Gabriel Steg Journal: Eur Heart J Date: 2014-05-21 Impact factor: 29.983