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Bleeding risk during CAS lower with bivalirudin vs. heparin
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When used during carotid artery stenting, bivalirudin appears to be linked to a lower risk for periprocedural bleeding complications vs. unfractionated heparin, according to recent findings.
In the meta-analysis, researchers conducted a comprehensive literature search of three electronic databases to identify three observational studies and one randomized clinical trial evaluating ischemic and hemorrhagic outcomes of bivalirudin (Angiomax, The Medicines Company) vs. unfractionated heparin in patients undergoing carotid artery stenting (CAS). A total of 7,784 patients were included in the pooled analysis.
From the data extracted from the studies, the researchers used the inverse variance method to calculate the RR for each study outcome for bivalirudin and unfractionated heparin. The average effects for these outcomes and 95% CIs were determined using a random-effects model. The study’s primary outcomes consisted of hemorrhagic complications such as major/minor bleeding and intracranial hemorrhage, along with ischemic complications such as ischemic stroke, MI and 30-day mortality.
The researchers found that compared with unfractionated heparin, bivalirudin was linked to significantly lower major bleeding events (RR = 0.53; 95% CI, 0.35-0.8; I2 = 0%). Moreover, minor bleeding events were significantly lower in the bivalirudin-treated patients (RR = 0.41; 95% CI, 0.2-0.82; I2 = 0%).
A combined analysis of major and minor bleeding events produced a significantly lower prevalence in the bivalirudin group (RR = 0.52; 95% CI, 0.37-0.73).
In terms of other outcomes, no significant differences were seen between the two agents in the following outcomes: intracranial hemorrhage (RR = 0.73; 95% CI, 0.27-1.98), MI (RR = 1.01; 95% CI, 0.59-1.73) or 30-day mortality (RR = 0.83; 95% CI, 0.47-1.47). For ischemic stroke, there was a numerical trend in favor of bivalirudin but it was not statistically significant (RR = 0.8; 95% CI, 0.6-1.06).
Similar estimates for each of the endpoints were determined in the overall effect calculated by either the random- or fixed-effects models. All findings remained unchanged in an analysis in which individual studies were omitted sequentially.
“Our meta-analysis is limited by having only four studies with the data skewed by one large study from the NCDR-CARE database,” the researchers wrote. “Despite this limitation, we believe the data supports a consistent finding that bivalirudin in CAS was associated with a lower risk of periprocedural bleeding complications, which mirrors the observation made from coronary artery trials.” – by Jennifer Byrne
Disclosure: One researcher reports serving as the chair of the clinical events committee for a trial sponsored by Silk Road Medical and serving on the executive committee for a trial sponsored by The Medicines Company.
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