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Bivalirudin confers fewer complications vs. heparin during peripheral vascular interventions
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In a large, real-world population of patients undergoing subinguinal peripheral vascular intervention, treatment with bivalirudin during hospitalization lowered rates of access-site hematoma, shortened hospital length of stay and improved status at discharge compared with treatment with unfractionated heparin, researchers reported in Catheterization and Cardiovascular Interventions.
Researchers assessed data on 23,732 patients who underwent peripheral vascular intervention using bivalirudin or unfractionated heparin at 131 U.S. and Canadian hospitals participating in the Vascular Quality Initiative between August 2007 and January 2014. The Vascular Quality Initiative is a multicenter registry that encompasses vascular procedures performed by vascular surgeons, cardiologists, radiologists and other specialists at participating sites.
The researcher team used propensity matching to mitigate the effect of the nonrandom selection of anticoagulation agent used in each procedure. A total of 93% (n = 22,110) of participants received unfractionated heparin and 7% (n = 1,622) received bivalirudin. Before matching, patients treated with bivalirudin had a greater likelihood of prior peripheral vascular intervention, history of aspirin or P2Y12 antagonist therapy and to have had peripheral vascular intervention using smaller sheath sizes. Patients treated with unfractionated heparin were more likely to have had subinguinal bypass, assisted access guidance, pharmacologic thrombolysis, and to have been treated with a vascular closure device, according to the findings.
Propensity matching achieved a balanced cohort with 1,524 patients in each treatment group. The primary outcome was access-site complication before hospital discharge. Secondary outcomes included access-site occlusion, distal embolization, discharge to nursing home/rehabilitation center, in-hospital mortality and postprocedural hospital length of stay.
Overall, the researchers found a lower rate of access-site hematomas in the bivalirudin group vs. the heparin group (2.4% vs. 3.9%; P = .018). Additionally, patients treated with bivalirudin had shorter postprocedural hospital length of stay (1 day vs. 1.2 days; P < .001) and lower rates of discharge to a nursing home or rehabilitation facility rather than discharge to home (7.61% vs. 9.73%; P = .034) vs. heparin-treated patients. No significant differences were observed between the treatments in rates of in-hospital access-site occlusion (0.3% vs. 0.3%) distal embolization (1.3% vs. 0.8%) or in-hospital mortality (0.79% vs. 0.33%).
“The benefits of [bivalirudin] found in this and other peripheral endovascular procedure studies should be considered in the context of the lack of randomized trials and [FDA] approval, lack of availability of a reversal agent, a nearly 100-fold increased cost per procedure compared with [unfractionated heparin], and recent findings in PCI showing an increased risk for ischemic events,” the researchers wrote. “The planned ENDOvascular interventions with angioMAX (ENDOMAX) trial may confirm if [bivalirudin] is truly associated with a significant decrease in bleeding complication after [peripheral vascular intervention] compared to [unfractionated heparin] and whether a difference in ischemic complications exists in this population.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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