That conclusion comes from a meta-analysis of relevant randomized trials and observational studies reported in the American Journal of Cardiology online May 14. “Although bivalirudin was associated with a significant decrease in mortality in observational studies, this effect remained inconclusive in randomized trials,” add Dr. Olivier F. Bertrand, at the Quebec Heart-Lung Institute, Canada, and colleagues.
Bivalirudin is superior to UFH plus glycoprotein IIb/IIIa inhibitors in transfemoral PCI, the authors explain in their introduction, but the benefit of bivalirudin versus UHF monotherapy is unclear.
To investigate, they identified 16 studies comparing bivalirudin versus UHF monotherapy in a total of 32,492 patients undergoing PCI. Three studies were randomized trials done in Europe and 13 were observational studies conducted mostly in the US.
Thirty-day rates of MACEs (including death, MI, and urgent revascularization) were not significantly different in the two arms (odds ratio 0.92), but bivalirudin was associated with a significant decrease in major bleeding (odds ratio 0.55), the investigators found.
However, Dr. Bertrand and colleagues comment that it is as yet unclear whether bivalirudin decreases the incidence of major bleeding with the radial approach to PCI. “As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach,” they suggest, “future studies should focus on the interaction between anticoagulant strategy and access-site choice.”
Meanwhile, another paper in the journal focuses on bilvalirudin versus UFH in high-risk PCI patients – ie, patients with diabetes or renal failure or age over 75.
Dr. Giuseppe Patti, at Campus Bio-Medico University of Rome, Italy, and colleagues found that in 401 such patients, 30-day MACE rates were 11.1% with bivalirudin versus 8.9% with UFH – a nonsignificant difference (p=0.56).
Rates of bleeding or access-site complication, however, were significantly different in the two groups, at 1.5% versus 9.9% (p=0.0001).
These authors also comment on the need for further studies in relation to access site. “Most patients in our study underwent PCI using the femoral approach,” they point out, “and with the increasing application of radial access, entry-site complications may be expected to decrease, regardless of the pharmacology used.”
Comparison of Safety and Efficacy of Bivalirudin Versus Unfractionated Heparin in High-Risk Patients Undergoing Percutaneous Coronary Intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty–Bivalirudin vs Heparin Study)