NDLI: Bivalirudin started during emergency transport for primary PCI.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Van Grunsven, Pierre Bernstein, Debra Clayton, Tim Nef, Holger Prats, Jayne Campo Dell' Orto, Marco Hamm, Christian W. Eggink, Gerrit Jan Pocock, Stuart Clemmensen, Peter Steinmetz, Jacob Nibbe, Lutz Soulat, Louis Huber, Kurt Goldstein, Patrick Coste, Pierre Steg, Philippe Gabriel Zeymer, Uwe Schuette, Diana Lapostolle, Frédéric Deliargyris, Efthymios N. Hamon, Martial Van 't Hof, Arnoud Ten Berg, Jurrien
Description	Author Affiliation: Steg PG ( The authors' affiliations are listed in the Appendix.)
Abstract	BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis. (Funded by the Medicines Company; EUROMAX ClinicalTrials.gov number, NCT01087723.).
ISSN	00284793
Issue Number	23
Volume Number	369
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2013-12-05
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antithrombins Therapeutic Use Emergency Medical Services Myocardial Infarction Drug Therapy Peptide Fragments Percutaneous Coronary Intervention Adult Aged Anticoagulants Adverse Effects Coronary Artery Bypass Coronary Thrombosis Etiology Female Hemorrhage Chemically Induced Prevention & Control Heparin Hirudins Humans Kaplan-Meier Estimate Male Middle Aged Mortality Therapy Recombinant Proteins Stents Transportation Of Patients Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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