Bivalirudin Bests Heparin for Lowering Bleeding Risk After CAS

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In patients undergoing carotid artery stenting (CAS), bivalirudin shows an advantage over heparin as a bleeding avoidance strategy, according to a study published online March 26, 2013, ahead of print in Circulation: Cardiovascular Interventions. The newer drug was associated with fewer hemorrhagic complications than heparin, with no increase in in-hospital or 30-day ischemic outcomes.

Researchers led by Siddharth A. Wayangankar, MD, MPH, of the University of Oklahoma Health Sciences Center (Oklahoma City, OK), examined data on 10,560 patients in the CARE Registry who underwent CAS between May 2005 and March 2012 using either bivalirudin or unfractionated heparin as the anticoagulant. Propensity-matched analysis was used to obtain a balanced cohort of 3,555 patients from each anticoagulant group for comparison.

Bivalirudin Associated with Less Bleeding, Transfusions

Patients in the bivalirudin group were less likely to experience bleeding or hematoma requiring blood transfusion compared with those in the heparin group. However, rates of intracerebral hemorrhage as well as ischemic outcomes, including in-hospital all-cause mortality/MI/stroke and its individual components, did not differ between the 2 groups (table 1).

Table 1. In-Hospital Outcomes

Similarly, the composite of all-cause death, MI, or stroke as well as its individual components were equivalent between the 2 groups at 30 days (table 2).

Table 2. Outcomes at 30 Days

Anticoagulant Not Well Studied in CAS

According to the authors, data is lacking on the use of bivalirudin as a bleeding avoidance strategy in patients undergoing CAS or its effect on subsequent adverse outcomes.

Notably, another observational study found not only a decrease in hemorrhagic complications but also lower 30-day stroke and death rates after a single center switched from heparin to bivalirudin for CAS (Lin PH, et al. Am J Surg. 2005;190:850-857). Dr. Wayangankar and colleagues say that while their findings are consistent with this and other studies, they are derived from a database that is considerably larger and more representative.

“Collectively, the evidence base to date suggests that for CAS, bivalirudin is associated with fewer postprocedural hemorrhagic complications than [heparin] without an attendant increase in the risk of ischemic events,” they write.

The authors also point out that, in the current study, the low rates of intracerebral hemorrhage seen in both groups are “important because hemorrhagic conversion of a cerebral infarction can be an important source of morbidity and mortality in patients with symptomatic carotid disease.”

Finally, they note that while bivalirudin is a safe and cost-effective choice for many patients undergoing CAS, it should not be used in those at elevated risk of bleeding since it lacks an antidote, “which could be catastrophic in patients who develop intracranial hemorrhage,” they write.

Study Details

Patients receiving bivalirudin were administered a bolus of 0.75 mg/kg followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure. In patients receiving heparin, the dose was administered per local clinical standards. Prescription of aspirin, clopidogrel, or ticlopidine at discharge was at the discretion of the treating physician.

 

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Source:
Wayangankar SA, Abu-Fadel MS, Aronow HD, et al. Hemorrhagic and ischemic outcomes after bivalirudin versus unfractionated heparin during carotid artery stenting: A propensity score analysis from the NCDR. Circ Cardiovasc Interv. 2013;Epub ahead of print.

 

 

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