Bivalirudin vs. unfractionated heparin during percutaneous coronary interventions in patients with stable and unstable angina pectoris: 1-year results of the ISAR-REACT 3 trial.
OBJECTIVE
In ISAR-REACT 3, 30-day outcomes in 4570 biomarker negative patients undergoing percutaneous coronary intervention (PCI) > or =2 h after pre-treatment with 600 mg of clopidogrel revealed less bleeding with bivalirudin compared with unfractionated heparin, but no difference in 30-day net clinical benefit. The objective of the present analysis was to assess the impact of bivalirudin vs. heparin on 1-year outcomes in ISAR-REACT 3.


RESULTS
The primary outcome for this analysis was the composite of death, myocardial infarction, or target vessel revascularization 1 year after randomization. The composite of death or myocardial infarction was a secondary outcome. At 1 year, the primary outcome occurred in 17.1% of patients assigned to bivalirudin vs. 17.5% assigned to heparin [hazard ratio (HR), 0.98; 95% confidence interval (CI), 0.86-1.13; P = 0.816]. The combined incidence of death or myocardial infarction was 7.7% in the bivalirudin group vs. 6.7% in the heparin group (HR, 1.15; 95% CI, 0.93-1.43; P = 0.200). The mortality rate was 1.9% in the bivalirudin group and 1.7% in the heparin group (HR, 1.10; 95% CI, 0.71-1.70; P = 0.667). At 1 year, no significant differences in the primary outcome were observed with bivalirudin and heparin in any of the subgroups analysed.


CONCLUSIONS
Bivalirudin and unfractionated heparin during PCI provide comparable outcomes at 1 year in biomarker negative patients undergoing PCI after pre-treatment with 600 mg of clopidogrel.


BACKGROUND
URL www.clinicaltrials.gov; Unique identifier NCT00262054.
Deutsches Herzzentrum, Technische Universität, Munich, Germany. schulzs@dhm.mhn.de
Stefanie
S
Schulz
Julinda
J
Mehilli
Gjin
G
Ndrepepa
Franz-Josef
FJ
Neumann
Katrin A
KA
Birkmeier
Sebastian
S
Kufner
Gert
G
Richardt
Peter B
PB
Berger
Albert
A
Schömig
Adnan
A
Kastrati
D000787:Angina Pectoris / Q000628:therapy*; D017130:Angioplasty / Q000379:methods*; D000925:Anticoagulants / Q000008:administration & dosage*; D016757:Death, Sudden, Cardiac / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization / Q000379:methods; D010446:Peptide Fragments / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin