Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris.

Modern antithrombotic strategies for patients undergoing percutaneous coronary interventions (PCIs) must take into account the risk of ischemic and hemorrhagic complications. Bivalirudin decreases the risk of hemorrhagic complications after PCI; however, concerns have been raised about its efficacy in preventing ischemic complications. We evaluated the effectiveness of a prolonged intra- and postprocedural bivalirudin infusion versus a standard regimen in preventing PCI-related myocardial damage. One hundred seventy-eight consecutive patients with stable or unstable angina and complex coronary anatomy were enrolled in this single-center, randomized, single-blinded study. Patients were randomized to bolus plus bivalirudin infusion during PCI (n = 90) or bolus plus bivalirudin infusion during and after PCI (4 hours, n = 88). The primary end point was incidence of periprocedural myocardial damage (creatine kinase-MB increase >or=3 times upper limit of normal). Secondary end points were 30-day and 6-month major adverse cardiovascular events (death, new Q-wave myocardial infarction, target vessel revascularization) and in-hospital bleeding (major/minor). The 2 groups did not differ significantly in baseline and procedural characteristics. The primary end point of the study was significantly less frequent in the prolonged infusion group (6.8% vs 16.7%, p = 0.041). No significant differences for secondary end points were observed. In conclusion, in patients undergoing complex PCI, a prolonged bivalirudin infusion after PCI compared to an intraprocedural-only regimen significantly decreased the incidence of periprocedural myocardial damage.

RCT Entities:   Population Interventions Outcomes