PMID- 24576526 OWN - NLM STAT- MEDLINE DCOM- 20140415 LR - 20161125 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 167 IP - 3 DP - 2014 Mar TI - Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: a meta-regression analysis of randomized trials. PG - 401-412.e6 LID - S0002-8703(13)00835-1 [pii] LID - 10.1016/j.ahj.2013.11.013 [doi] AB - 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. CI - (c) 2014. FAU - Tarantini, Giuseppe AU - Tarantini G AD - Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com. FAU - Brener, Sorin Jakob AU - Brener SJ AD - Weil Cornell Medical College, NY Methodist Hospital, Brooklyn, NY. FAU - Barioli, Alberto AU - Barioli A AD - Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. FAU - Gratta, Andrea AU - Gratta A AD - Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. FAU - Parodi, Guido AU - Parodi G AD - Department of Cardiology, Careggi Hospital, Florence, Italy. FAU - Rossini, Roberta AU - Rossini R AD - Department of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy. FAU - Navarese, Eliano Pio AU - Navarese EP AD - Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands. FAU - Niccoli, Giampaolo AU - Niccoli G AD - Department of Cardiovascular Medicine, Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy. FAU - Frigo, Anna Chiara AU - Frigo AC AD - Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. FAU - Musumeci, Giuseppe AU - Musumeci G AD - Department of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy. FAU - Iliceto, Sabino AU - Iliceto S AD - Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. FAU - Stone, Gregg Whitney AU - Stone GW AD - Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY. LA - eng PT - Comparative Study PT - Journal Article PT - Meta-Analysis DEP - 20131219 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Anticoagulants) RN - 0 (Antithrombins) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM MH - *Angioplasty, Balloon, Coronary MH - Anticoagulants/*therapeutic use MH - Antithrombins/*therapeutic use MH - Hemorrhage/chemically induced MH - Heparin/*therapeutic use MH - Hirudins MH - Humans MH - Myocardial Ischemia/*prevention & control MH - Peptide Fragments/*therapeutic use MH - Randomized Controlled Trials as Topic MH - Recombinant Proteins/therapeutic use MH - Regression Analysis MH - Treatment Outcome EDAT- 2014/03/01 06:00 MHDA- 2014/04/16 06:00 CRDT- 2014/03/01 06:00 PHST- 2013/08/24 00:00 [received] PHST- 2013/11/24 00:00 [accepted] PHST- 2014/03/01 06:00 [entrez] PHST- 2014/03/01 06:00 [pubmed] PHST- 2014/04/16 06:00 [medline] AID - S0002-8703(13)00835-1 [pii] AID - 10.1016/j.ahj.2013.11.013 [doi] PST - ppublish SO - Am Heart J. 2014 Mar;167(3):401-412.e6. doi: 10.1016/j.ahj.2013.11.013. Epub 2013 Dec 19.