Meta-Analysis Comparing Bivalirudin Versus Heparin Monotherapy on Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention

The American Journal of Cardiology, 08/17/2012

Bertrand OF et al. – In patients undergoing transfemoral Percutaneous Coronary Intervention (PCI), the benefit of bivalirudin over unfractionated heparin (UFH) monotherapy is driven by a significant decrease in major bleeding with similar rates of major adverse cardiovascular events (MACEs). As PCI practice moves toward other bleeding–avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access–site choice.

Methods

  • The authors performed a systematic review and meta–analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin.
  • Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed.
  • Primary outcomes were 30–day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all–cause mortality, MI, major bleeding, and blood transfusion.
  • The authors collected data from 16 studies involving 32,492 patients undergoing PCI.
  • Most observational studies were performed in the United States, whereas all randomized trials were done in Europe.

Results

  • Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08).
  • A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01).
  • MI rate was similar with the 2 anticoagulants.

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