Bivalirudin versus heparin in patients with acute myocardial infarction: A meta-analysis of randomized trials.
BACKGROUND
The aim of this study was to assess the impact of bivalirudin, as compared to unfractionated heparin, on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).


METHODS
A meta-analysis of randomized trials comparing bivalirudin versus heparin in patients with STEMI undergoing primary percutaneous coronary intervention was performed. Three randomised trials enrolling 7,612 patients were included. Analysis was by intention to treat.


RESULTS
At 30 days, bivalirudin, as compared to heparin, was associated with a similar risk of all-cause mortality (3.03% vs. 3.38%, odds ratio (OR) 0.90, 95% confidence intervals (CI) [0.63 to 1.29], P = 0.57). Bivalirudin significantly increased the risk of definite (2.39% vs. 1.06%, OR 2.49, 95% CI [1.30 to 4.76], P = 0.006); definite or probable (2.55% vs. 1.35%, OR 2.26, 95% CI [1.07 to 4.79], P = 0.03), and acute stent thrombosis (1.69% vs. 0.39%, OR 4.34, 95% CI [2.30 to 8.16], P < 0.001); leading to nonsignificantly higher reinfarction rates (2.0% vs. 1.31%, OR 1.72, 95% CI [0.89 to 3.35], P = 0.11), and to a significantly increased risk of ischemia driven revascularization (2.50% vs. 1.52%, OR 1.80, 95% CI [1.02 to 3.18], P = 0.04) at 30 days. No firm evidence for a reduction in major bleeding associated with bivalirudin use was found (3.93% vs. 6.39%, OR 0.63, 95% CI [0.39 to 1.04], P = 0.07).


CONCLUSIONS
In patients with STEMI, bivalirudin, as compared to heparin, increases the risk of stent thrombosis and ischemia driven repeat revascularization at 30 days. There is no strong evidence that bivalirudin significantly reduces major bleeding at 30 days. Bivalirudin does not have an effect on all-cause mortality at 30 days.
Department of Interventional Cardiology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Giuseppe
G
Ferrante
Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Marco
M
Valgimigli
Department of Interventional Cardiology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Paolo
P
Pagnotta
Department of Interventional Cardiology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Patrizia
P
Presbitero
D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D009203:Myocardial Infarction / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
acute myocardial infarction; bivalirudin; primary PCI