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Bivalirudin lowers in-hospital adverse event risk vs. heparin for peripheral vascular intervention
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Patients undergoing peripheral vascular interventions who received anticoagulation therapy with bivalirudin exhibited fewer in-hospital adverse events compared with those who received unfractionated heparin, according to results of a recent study.
The observational analysis included data on 23,934 adults with atherosclerosis who underwent lower-extremity peripheral vascular interventions between 2008 and 2012. All patients received bivalirudin (Angiomax, The Medicines Company; n = 4,370) or unfractionated heparin (n = 19,564); propensity score matching resulted in 3,649 matched pairs according to treatment type. Study endpoints included in-hospital incidence of amputation, death, MI, stroke/transient ischemic attack and transfusion, along with MACE and net adverse clinical events.
Within the entire population, all evaluated events were significantly less common among those who received bivalirudin compared with heparin. Analysis of matched pairs indicated significantly lower rates of mortality (OR = 0.4; 95% CI, 0.17-0.86), blood transfusion (OR = 0.74; 95% CI, 0.59-0.93), MACE (OR = 0.64; 95% CI, 0.48-0.87) and net adverse clinical events (OR = 0.72; 95% CI, 0.6-0.87) in the bivalirudin group.
Subgroup analysis of the propensity-matched patients yielded similar results regardless of age, sex, diabetes status, congestive HF, anemia, symptoms at presentation, target vessels and whether patients underwent atherectomy or stent implantation. Sensitivity analyses, one incorporating multivariate logistic regression and another including an additional 645 patients (194 in the bivalirudin group and 454 in the heparin group) treated with a glycoprotein IIb/IIIa inhibitor, also indicated significantly reduced risk for death, amputation, blood transfusion, MACE and net adverse clinical events with bivalirudin compared with heparin.
The researchers wrote that the decreased risk for death and MACE with bivalirudin may be attributable to reductions in bleeding risk from the treatment. They also noted that bivalirudin provides “more predictable and potent thrombin inhibition,” which could be the cause of the improved ischemic protection among these patients.
“When compared with [unfractionated heparin], bivalirudin therapy is associated with significant reductions in important clinical endpoints in patients undergoing [peripheral vascular intervention],” they concluded. “The effects associated with bivalirudin treatment were robust and consistent across clinically relevant subgroups.” – by Adam Taliercio
Disclosure: Some of the researchers report financial relationships with Abbott Vascular, Boston Scientific, Eli Lilly, Gilead Pharmaceuticals, The Medicines Company, Medtronic and WL Gore. The Medicines Company provided funding for the study. Two researchers reported serving as members of the executive committee for the ENDOMAX trial.
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