No reduction in mortality compared with placebo in infants with congenital heart disease
WEDNESDAY, June 19 (HealthDay News) -- In infants less than 3 months old with congenital heart disease and a systemic-to-pulmonary-artery shunt, clopidogrel does not reduce mortality compared with placebo, according to a study published in the June 20 issue of the New England Journal of Medicine.
David L. Wessel, M.D., from the Children's National Medical Center in Washington, D.C., and colleagues randomly assigned 906 infants 92 days of age or younger with cyanotic congenital heart disease and a systemic-to-pulmonary-artery shunt to placebo or clopidogrel (0.2 mg per kg per day). Infants also received conventional treatment, including aspirin in 87.9 percent of infants.
The researchers found that the rate of the primary end point (death or heart transplantation, shunt thrombosis, or performance of a cardiac procedure due to an event considered to be thrombotic in nature before 120 days of age) was similar for the placebo and clopidogrel groups (20.5 and 19.1 percent, respectively). The rates of the three individual components were also similar for both groups. Clopidogrel had no significant benefit for any subgroup, even those based on shunt type. The placebo and clopidogrel groups also had similar rates of overall bleeding (20.2 and 18.8 percent, respectively) and severe bleeding (3.4 and 4.1 percent, respectively).
"Clopidogrel therapy in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary-artery shunt, most of whom received concomitant aspirin therapy, did not reduce either mortality from any cause or shunt-related morbidity," Wessel and colleagues conclude.
The study was funded by Sanofi-Aventis and Bristol-Myers Squibb.
Full Text (subscription or payment may be required) (http://www.nejm.org/doi/full/10.1056/NEJMoa1114588 )