Bivalirudin versus unfractionated heparin during percutaneous coronary intervention.
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.)
Kastrati
Adnan
A
Deutsches Herzzentrum, Technische Universität, Munich, Germany. kastrati@dhm.mhn.de
Neumann
Franz-Josef
FJ
Mehilli
Julinda
J
Byrne
Robert A
RA
Iijima
Raisuke
R
Büttner
Heinz Joachim
HJ
Khattab
Ahmed A
AA
Schulz
Stefanie
S
Blankenship
James C
JC
Pache
Jürgen
J
Minners
Jan
J
Seyfarth
Melchior
M
Graf
Isolde
I
Skelding
Kimberly A
KA
Dirschinger
Josef
J
Richardt
Gert
G
Berger
Peter B
PB
Schömig
Albert
A
D000368:Aged; D000787:Angina Pectoris / Q000401:mortality / Q000628:therapy*; D000789:Angina, Unstable / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000077144:Clopidogrel; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011292:Premedication; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012306:Risk; D015607:Stents; D013927:Thrombosis; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine; C074619:bivalirudin