Bleeding after percutaneous coronary intervention with Bivalirudin or unfractionated Heparin and one-year mortality.
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.
Ndrepepa
Gjin
G
Deutsches Herzzentrum, Technische Universität, Munich, Germany. ndrepepa@dhm.mhn.de
Schulz
Stefanie
S
Keta
Dritan
D
Mehilli
Julinda
J
Birkmeier
Anette
A
Massberg
Steffen
S
Laugwitz
Karl-Ludwig
KL
Neumann
Franz-Josef
FJ
Seyfarth
Melchior
M
Berger
Peter B
PB
Schömig
Albert
A
Kastrati
Adnan
A
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
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin