title: Bleeding after percutaneous coronary intervention with Bivalirudin or unfractionated Heparin and one-year mortality.
abstract: Compared to unfractionated heparin (UFH), bivalirudin decreases bleeding during percutaneous coronary interventions (PCIs). We sought to investigate the association between periprocedural bleeding and 1-year mortality as a function of antithrombotic therapy with bivalirudin or UFH. This analysis of the association between bleeding with bivalirudin or UFH and 1-year mortality included the 4,570 patients with negative biomarkers enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 3) trial. Major or minor bleeding occurred in 555 patients (12.1%): 225 patients treated with bivalirudin (9.8%) and 330 patients treated with UFH (14.5%, p <0.001). There were 82 deaths (1.8%) within the first year after PCI: 29 deaths occurred in patients who had bled, and 53 deaths occurred in patients who had not bled (Kaplan-Meier estimates of 1-year mortality 5.2% and 1.3%, odds ratio 4.12, 95% confidence interval 2.59 to 6.54, p <0.001). One year after PCI, there were 15 deaths in patients who bled with bivalirudin versus 14 deaths in patients who bled with UFH (Kaplan-Meier estimates of 1-year mortality 6.7% vs 4.2%, odds ratio 1.61, 95% confidence interval 0.76 to 3.40, p = 0.20). Major bleeding occurred in 70 patients (3.0%) treated with bivalirudin and 104 patients treated with UFH (4.5%, p = 0.008). One-year mortality was 11.4% (n = 8) in patients with major bleeding with bivalirudin versus 4.8% (n = 5) in patients with major bleeding with UFH (p = 0.10). In conclusion, these data suggest that in patients with negative biomarkers undergoing PCI, bivalirudin decreases bleeding after PCI compared to UFH, without affecting 1-year mortality in those who had bled.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. ndrepepa@dhm.mhn.de
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Dritan
authors.initials: D
authors.lastname: Keta
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Anette
authors.initials: A
authors.lastname: Birkmeier
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Melchior
authors.initials: M
authors.lastname: Seyfarth
authors.forename: Peter B
authors.initials: PB
authors.lastname: Berger
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000209:etiology* / Q000401:mortality; D011994:Recombinant Proteins / Q000627:therapeutic use; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin