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Clopidogrel failed to reduce mortality in infants with systemic-to-pulmonary-artery shunts
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Clopidogrel, often administered with aspirin therapy, did not decrease all-cause mortality or shunt-related morbidity in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary-artery shunt, according to recent study results published in TheNew England Journal of Medicine.
In an international, multicenter, double blind, event-driven trial, which included more than 900 infants aged 92 days or younger, researchers compared the efficacy of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) with placebo for the reduction of all-cause mortality and shunt-related morbidity in infants with cyanotic congenital heart disease palliated with systemic-to-pulmonary artery shunts from November 2006 to February 2010.
David L. Wessel
The infants were randomly assigned to clopidogrel 0.2 mg per kilogram of body weight per day (n=467) or placebo (n=439) besides conventional therapy, including aspirin therapy in 87.9% of the cohort. The primary endpoint was a composite of death or heart transplant, shunt thrombosis or cardiac procedure due to an event considered to be thrombotic in nature before age 120 days.
There was no significant difference in the rate of the composite primary endpoint between the clopidogrel group (19.1%) compared with the placebo group (20.5%), with an RR reduction of 11.1% (95% CI, –19.2 to 33.6). The researchers noted no significant differences in the rates of the three components of the composite primary endpoint. Also, no significant benefit was found in any subgroup of patients assigned clopidogrel vs. placebo.
Rates of bleeding were similar between the clopidogrel group and the placebo group (18.8% vs. 20.2%), as were rates of severe bleeding (4.1% vs. 3.4%), according to the study results.
“In conclusion, we found no benefit of clopidogrel, as compared with placebo, in reducing the rate of death for any cause or shunt-related morbidity, particularly shunt thrombosis, among infants with congenital heart disease palliated with a systemic-to-pulmonary-artery shunt,” David L. Wessel, MD, chief medical officer, Children’s National Medical Center, Washington, D.C., and colleagues wrote.
“Once again, pediatric-specific research shows that newborns and infants are not little adults,” Wessel said in a press release. “The take away message for pediatric cardiac care providers is to reconsider use of Plavix in certain cases. In pediatric medicine, the assumption is that smaller doses of a drug that works in adults will work in infants, but our study shows that this is not true for these young patients. For the parents of these fragile newborns, it is important to understand that research informs best practices, and they need to be informed advocates for their children.”
Disclosure: This study was funded by Sanofi-Aventis and Bristol-Myers Squibb. Wessel reports receiving consulting fees or honoraria and support for travel and meetings from Sanofi-Aventis.
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