Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention in Patients at High Risk for Bleeding.

The overall rate of bleeding complications during interventional therapeutic procedures for coronary heart disease by the femoral approach is 1.5 to 9%.1 Although bleeding is considered a minor complication related to percutaneous coronary intervention (PCI),2 on rare occasions, it might lead to life-threatening situations that must be treated by intensive medical or surgical approaches.3 These events are multifactorial, involving patient-, physician-, and nursing staff–related prognosis-worsening factors. Patient-related factors include: female gender, age > 70 years, and comorbidities such as diabetes mellitus, obesity, hypertension, and diseases with poor clot formation, such as uremia and thrombocytopenia.4 Physician-related factors include: port of access, mode of arterial puncture (single vs. multiple trials) and anticoagulation regimen.5 Early data using abciximab during high-risk coronary angioplasty (EPIC trial) showed that bleeding complications occur more often in the IIb-/IIIa-treated groups,6 a trend that persisted under low-dose (EPILOG trial), weight-adjusted heparin infusion.7 One of the alternatives to unfractionated heparin (UFH) is bivalirudin (BIV), a direct and reversible thrombin-inhibition oligopeptide with a relatively short half-life. In previous studies of patients at low-to-moderate risk for bleeding, BIV, with or without added IIb/IIIa antagonists, was found to be superior to UFH, with a lower rate of bleeding complications and noninferior clinical outcomes.8 9 10 11 12 However, patients with a high-risk profile for bleeding complications were excluded from these studies. We performed a randomized double-blind prospective trial to compare efficacy and safety of the BIV treatment with the UFH regimen combined with dual antiplatelet therapy during PCI among patients with angina pectoris or non-ST elevation myocardial infarction (NSTEMI) who are at high risk for bleeding.