Bivalirudin compares favorably to heparin, GPIs in patients with diabetes undergoing PCI
Treatment with bivalirudin yielded similar 30-day ischemic outcomes vs. heparin and glycoprotein inhibitors, with significantly lower rates of major and minor bleeding and 1-year mortality among patients with diabetes undergoing PCI, according to recent findings.
In a meta-analysis of randomized trials, researchers evaluated four randomized controlled trials comparing bivalirudin with unfractionated heparin and glycoprotein IIb/IIIa inhibitors (GPIs) in patients with diabetes undergoing PCI (n = 5,137). They assessed the incidence of major adverse cardiac events, all-cause mortality, MI, urgent revascularization and major and minor bleeding at 30 days, as well as all-cause mortality at 1 year.
Compared with heparin and GPIs, bivalirudin yielded lower 30-day rates of major bleeding (3.7% vs. 6.01%; OR = 0.68; 95% CI, 0.52-0.89) and minor bleeding (9.89% vs. 22.08%; OR = 0.48; 95% CI, 0.41-0.57). Incidence of MACE was comparable between bivalirudin and heparin/GPIs (6.97% vs. 7.97%; OR = 0.87; 95% CI, 0.7-1.08), as was incidence of MI (5.04% vs. 5.73%; OR = 0.87; 95% CI, 0.68-1.1) and urgent revascularization (2.13% vs. 1.95%; OR = 1.12; 95% CI, 0.76-1.65).
All-cause mortality was numerically lower with bivalirudin use at 30 days (1.28% vs. 1.83%; OR = 0.72; 95% CI, 0.46-1.13); this difference became statistically significant at 1 year (3.6% vs. 5.1%; OR = 0.72; 95% CI, 0.52-0.99). In a secondary analysis, the researchers found that the major bleeding benefit associated with bivalirudin may have been attributable to mandated rather than provisional use of GPIs.
“Contrary to other meta-analyses that tended to show trends of higher ischemic complications while markedly reducing bleeding complications, the current data of this analysis suggest both efficacy and safety are maintained or improved with a bivalirudin-alone approach,” the researchers wrote. “Although the use of GPI and heparin in diabetes patients with ACS has long been advised, the results presented in this analysis suggest a superior safety and efficacy profile for bivalirudin in this otherwise high-risk cohort.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.