Bivalirudin versus unfractionated heparin during percutaneous coronary intervention

Kastrati, Adnan; Neumann, Franz-Josef; Mehilli, Julinda; Byrne, Robert A; Iijima, Raisuke; Büttner, Heinz Joachim; Khattab, Ahmed A; Schulz, Stefanie; Blankenship, James C; Pache, Jürgen; Minners, Jan; Seyfarth, Melchior; Graf, Isolde; Skelding, Kimberly A; Dirschinger, Josef; Richardt, Gert; Berger, Peter B; Schömig, Albert (2008). Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. New England journal of medicine NEJM, 359(7), pp. 688-96. Waltham, Mass.: Massachusetts Medical Society MMS 10.1056/NEJMoa0802944

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BACKGROUND: Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown. METHODS: We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization. RESULTS: The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008). CONCLUSIONS: In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054.)

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Khattab, Ahmed Aziz
ISSN:	0028-4793
ISBN:	18703471
Publisher:	Massachusetts Medical Society MMS
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 15:02
Last Modified:	05 Dec 2022 14:19
Publisher DOI:	10.1056/NEJMoa0802944
PubMed ID:	18703471
Web of Science ID:	000258397900005
URI:	https://boris.unibe.ch/id/eprint/26966 (FactScience: 99311)