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Thromb Res. 2015 Dec;136(6):1087-98. doi: 10.1016/j.thromres.2015.06.001. Epub 2015 Jun 6.

Risk of Stent Thrombosis and Major Bleeding with Bivalirudin Compared with Active Control: A Systematic Review and Meta-analysis of Randomized Trials.

Author information

1
School of Public Health, Yale University, New Haven, CT, United States.
2
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, United States; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, Unites States. Electronic address: Behnood.bikdeli@yale.edu.
3
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, United States; Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut, Unites States; Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, United States.
4
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Abstract

BACKGROUND:

Bivalirudin is commonly used for patients undergoing percutaneous coronary intervention (PCI), but there have been recent concerns that it may be associated with an increased risk of stent thrombosis and provide no benefit regarding major bleeding compared with active control.

METHODS AND RESULTS:

We searched PubMed, clinicaltrials.gov, and conference proceedings for randomized controlled trials of bivalirudin versus active control in patients undergoing PCI. The main outcomes of interest were definite stent thrombosis, myocardial infarction, major bleeding, and mortality. We used random-effects modeling to pool the data. We included 25 trials involving 41,243 patients. Overall, use of bivalirudin compared with active control was associated with an increased risk of definite stent thrombosis (11 trials; 16,864 patients; RR, 1.73; 95% CI, 1.24-2.40; P<0.001; I(2)=0%), similar risk of acute myocardial infarction (22 trials; 40,578 patients; RR, 1.00; 95% CI, 0.87-1.16; P=0.96; I(2)=43%), decreased risk of major bleeding (25 trials; 41,243 patients; RR, 0.59; 95% CI, 0.49-0.72; P<0.001; I(2)=31%) and of cardiac death (6 trials; 6,956 patients; RR, 0.72; 95% CI, 0.53-0.99; P=0.05; I(2)=0%), but no change in all-cause mortality (24 trials; 41,058 patients; RR, 0.96; 95% CI, 0.81-1.15; P=0.69; I(2)=0%). Results were consistent across a wide set of subgroup and sensitivity analyses.

CONCLUSIONS:

Compared with active control, bivalirudin is associated with increased risk of stent thrombosis but lower risk of major bleeding, with no discernible impact on all-cause mortality.

KEYWORDS:

Acute Myocardial Infarction; Bivalirudin; Bleeding; Mortality; Stent

PMID:
26077961
DOI:
10.1016/j.thromres.2015.06.001
[Indexed for MEDLINE]

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