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Clopidogrel in infants with systemic-to-pulmonary-artery shunts

(2013) NEW ENGLAND JOURNAL OF MEDICINE. 368(25). p.2377-2384
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Abstract
Background : Infants with cyanotic congenital heart disease palliated with placement of a systemic-to-pulmonary-artery shunt are at risk for shunt thrombosis and death. We investigated whether the addition of clopidogrel to conventional therapy reduces mortality from any cause and morbidity related to the shunt. Methods : In a multicenter, double-blind, event-driven trial, we randomly assigned infants 92 days of age or younger with cyanotic congenital heart disease and a systemic-to-pulmonary-artery shunt to receive clopidogrel at a dose of 0.2 mg per kilogram of body weight per day (467 infants) or placebo (439 infants), in addition to conventional therapy (including aspirin in 87.9% of infants). The primary efficacy end point was a composite of 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. Results : The rate of the composite primary end point did not differ significantly between the clopidogrel group (19.1%) and the placebo group (20.5%) (absolute risk difference, 1.4 percentage points; relative risk reduction with clopidogrel, 11.1%; 95% confidence interval, -19.2 to 33.6; P = 0.43), nor did the rates of the three components of the composite primary end point. There was no significant benefit of clopidogrel treatment in any subgroup, including subgroups defined by shunt type. Clopidogrel recipients and placebo recipients had similar rates of overall bleeding (18.8% and 20.2%, respectively) and severe bleeding (4.1% and 3.4%, respectively). Conclusions : 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.
Keywords
PERCUTANEOUS CORONARY INTERVENTION, ANTIPLATELET THERAPY, CONGENITAL HEART-DISEASE, CHILDREN, TRIAL

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Citation

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Chicago
Wessel, David L, Felix Berger, Jennifer S Li, Ingo Dahnert, Amit Rakhit, Sylvie Fontecave, Jane W Newburger, the CLARINET Investigators, and Daniël De Wolf. 2013. “Clopidogrel in Infants with Systemic-to-pulmonary-artery Shunts.” New England Journal of Medicine 368 (25): 2377–2384.
APA
Wessel, D. L., Berger, F., Li, J. S., Dahnert, I., Rakhit, A., Fontecave, S., Newburger, J. W., et al. (2013). Clopidogrel in infants with systemic-to-pulmonary-artery shunts. NEW ENGLAND JOURNAL OF MEDICINE, 368(25), 2377–2384.
Vancouver
1.
Wessel DL, Berger F, Li JS, Dahnert I, Rakhit A, Fontecave S, et al. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. NEW ENGLAND JOURNAL OF MEDICINE. 2013;368(25):2377–84.
MLA
Wessel, David L, Felix Berger, Jennifer S Li, et al. “Clopidogrel in Infants with Systemic-to-pulmonary-artery Shunts.” NEW ENGLAND JOURNAL OF MEDICINE 368.25 (2013): 2377–2384. Print.
@article{4120115,
  abstract     = {Background : Infants with cyanotic congenital heart disease palliated with placement of a systemic-to-pulmonary-artery shunt are at risk for shunt thrombosis and death. We investigated whether the addition of clopidogrel to conventional therapy reduces mortality from any cause and morbidity related to the shunt.
Methods : In a multicenter, double-blind, event-driven trial, we randomly assigned infants 92 days of age or younger with cyanotic congenital heart disease and a systemic-to-pulmonary-artery shunt to receive clopidogrel at a dose of 0.2 mg per kilogram of body weight per day (467 infants) or placebo (439 infants), in addition to conventional therapy (including aspirin in 87.9\% of infants). The primary efficacy end point was a composite of 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.
Results : The rate of the composite primary end point did not differ significantly between the clopidogrel group (19.1\%) and the placebo group (20.5\%) (absolute risk difference, 1.4 percentage points; relative risk reduction with clopidogrel, 11.1\%; 95\% confidence interval, -19.2 to 33.6; P = 0.43), nor did the rates of the three components of the composite primary end point. There was no significant benefit of clopidogrel treatment in any subgroup, including subgroups defined by shunt type. Clopidogrel recipients and placebo recipients had similar rates of overall bleeding (18.8\% and 20.2\%, respectively) and severe bleeding (4.1\% and 3.4\%, respectively).
Conclusions : 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.},
  author       = {Wessel, David L and Berger, Felix and Li, Jennifer S and Dahnert, Ingo and Rakhit, Amit and Fontecave, Sylvie and Newburger, Jane W and CLARINET Investigators, the and De Wolf, Dani{\"e}l},
  issn         = {0028-4793},
  journal      = {NEW ENGLAND JOURNAL OF MEDICINE},
  keyword      = {PERCUTANEOUS CORONARY INTERVENTION,ANTIPLATELET THERAPY,CONGENITAL HEART-DISEASE,CHILDREN,TRIAL},
  language     = {eng},
  number       = {25},
  pages        = {2377--2384},
  title        = {Clopidogrel in infants with systemic-to-pulmonary-artery shunts},
  url          = {http://dx.doi.org/10.1056/NEJMoa1114588},
  volume       = {368},
  year         = {2013},
}

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