FDA Mulls Over Results of NEJM Antiplatelet Tx Study

FDA Mulls Over Results of NEJM Antiplatelet Tx Study
FDA Mulls Over Results of NEJM Antiplatelet Tx Study

The recent publication of a study regarding dual antiplatelet therapy after coronary stenting in the New England Journal of Medicine has prompted the Food and Drug Administration (FDA) to issue a response on whether long-term antiplatelet therapy should be continued in these patients.

The Dual Antiplatelet Therapy (DAPT) trial enrolled 9,961 patients who had undergone a coronary stent procedure in which a drug-eluting stent was placed. After 12 months of treatment with a thienopyridine drug (clopidogrel or prasugrel) and aspirin, patients were randomly assigned to continue thienopyridine treatment or placebo for an additional 18 months; all patients continued receiving aspirin. Although the thienopyridine treatment reduced the rates of stent thrombosis and major adverse cardiovascular and cerebrovascular events including myocardial infarction, the all-cause mortality rate in the thienopyridine arm was higher vs. the placebo group after 30 months of treatment.

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The increase in overall mortality was observed in the clopidogrel cohort (2.2% vs. 1.5%, respectively) but not the prasugrel cohort (1.6% vs. 1.6%). It should be noted that in other large clopidogrel trials, increases in risk of non-cardiovascular death have not been observed. Outcomes in patients receiving bare metal stents are still being evaluated.

Presently the FDA believes that the benefits of dual antiplatelet therapy outweigh the potential risks when used for approved uses, and healthcare professionals should not change their prescribing habits. The FDA has not reviewed the trial benefits or reached any conclusions based on the findings from this clinical trial at this time.

For more information visit FDA.gov.

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