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Bivalirudin Versus Heparin in Patients Planned for Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials
Study Questions:
What are the effects of a bivalirudin-based anticoagulation regimen compared with a heparin-based anticoagulation regimen on ischemic and bleeding outcomes in patients undergoing percutaneous coronary intervention (PCI)?
Methods:
The investigators searched Medline, the Cochrane Library, and relevant meeting abstracts (search done on April 9, 2014) for randomized trials that assessed bivalirudin versus heparin in patients planned for PCI. The primary efficacy endpoint was the incidence of major adverse cardiac events (MACE) up to 30 days. Secondary efficacy endpoints were death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis. The primary safety endpoint was major bleeding up to 30 days. The authors calculated pooled risk ratios (RRs) and 95% confidence intervals (CIs) using random-effects models.
Results:
The investigators included data from 16 trials involving 33,958 patients, of whom 2,422 experienced MACE and 1,406 had a major bleed. There was an increase in the risk of MACE with bivalirudin-based regimens compared with heparin-based regimens (RR, 1.09; 95% CI, 1.01-1.17; p = 0.0204), which was largely driven by increases in myocardial infarction (1.12, 1.03-1.23) and seemingly also by ischemia-driven revascularization (1.16, 0.997-1.34) with bivalirudin compared with heparin, with no effect on mortality (0.99, 0.82-1.18). Bivalirudin increased the risk of stent thrombosis (RR, 1.38; 95% CI, 1.09-1.74; p = 0.0074), which was primarily due to an increase in acute cases in ST-segment elevation myocardial infarction (4.27, 2.28-8.00; p < 0.0001). Overall, bivalirudin-based regimens lowered the risk of major bleeding (RR, 0.62; 95% CI, 0.49-0.78; p < 0.0001), but the magnitude of this effect varied greatly (p < 0.0001) depending on whether glycoprotein IIb/IIIa inhibitors were used predominantly in the heparin arm only (0.53, 0.47-0.61; p < 0.0001), provisionally in both arms (0.78, 0.51-1.19; p = 0.25), or planned in both arms (1.07, 0.87-1.31; p = 0.53).
Conclusions:
The authors concluded that compared with a heparin-based regimen, a bivalirudin-based regimen increases the risk of myocardial infarction and stent thrombosis, but decreases the risk of bleeding.
Perspective:
This study reports that in patients undergoing PCI, a bivalirudin-based regimen compared with a heparin-based regimen increased MACE. Conversely, there was a decrease in bleeding, at least when a glycoprotein inhibitor (GPI) was predominantly routinely used with heparin and only provisionally with bivalirudin; this benefit was attenuated when GPI use was provisional in both groups. These findings, which include data from several recent trials, should help clinicians make a more informed decision when selecting an anticoagulant regimen to support PCI in different types of patients by weighing the trade-offs between RRs of thrombotic and bleeding complications. Additional research is indicated to understand better the patient populations at high risk of ischemic events who warrant more intensive antithrombotic therapy versus those patients at high risk of bleeding who might benefit more from less intensive regimens.
Keywords: Odds Ratio, Myocardial Infarction, Heparin, Fibrinolytic Agents, Hirudins, Percutaneous Coronary Intervention, Stents, Thrombosis, Research Personnel, Recombinant Proteins, Peptide Fragments, Confidence Intervals
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