Among elderly patients at high bleeding risk undergoing PCI for chronic total occlusion, bivalirudin was as safe and effective as unfractionated heparin, researchers reported.
The researchers conducted a single-center randomized controlled trial of 123 patients (mean age, 70 years; 46% women) at high bleeding risk as determined by GRACE and CRUSADE scores who were undergoing CTO PCI. Fifty-five patients were assigned unfractionated heparin and 68 were assigned bivalirudin. The heparin group received a glycoprotein IIb/IIIa inhibitor at the discretion of the operator.
The primary efficacy endpoint was MACE, defined as all-cause death, acute MI and target vessel revascularization, in the hospital and at 6 months.
In-hospital MACE occurred in 17.6% of the bivalirudin group and 20% of the heparin group (P = .82), Yong Wang, MD, from the department of cardiology at The People’s Hospital of China Medical University and The People’s Hospital of Liaoning Province in Shenyang, China, and colleagues wrote.
Bleeding Academic Research Consortium (BARC) type 1 and 2 bleeding events were similar between the groups (bivalirudin, 8.8%; heparin, 10.9%; P = .77), and there were no BARC type 3 to 5 bleeding events or severe procedure-related complications in either group, according to the researchers.
MACE at 6-month follow-up occurred in 1.5% of the bivalirudin group and 3.6% of the heparin group (P = .59), and the Kaplan-Meier estimates of MACE-free survival were similar between the groups (P = .43), Wang and colleagues wrote.
At 6 months, there was one case of BARC type 3 to 5 bleeding, a fatal intracranial hemorrhage, in the heparin group.
“This study is the first to confirm that bivalirudin and [unfractionated heparin) have comparable efficacy and safety in elderly patients with a high bleeding risk who are undergoing PCI for CTO lesions,” Wang and colleagues wrote. – by Erik Swain
Disclosures: The authors report no relevant financial disclosures.