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November 17, 2014 — Stent patients who use Plavix plus aspirin for more than 30 months may face an increased risk of death and bleeding, but a 71% lower risk of blood clots and a 29% lower risk of heart attack and stroke, according to a new study.

Anti-platelet drugs, such as Plavix (clopidogrel) and Effient (prasugrel) are used to prevent blood clots. They are often prescribed in combination with aspirin in patients who have had a coronary stent implanted after a heart attack.

Stents are metal-mesh tubes that prop open narrow arteries that supply blood to the heart muscle. Drug-eluting stents have a coating that slowly releases a drug that helps prevent the artery from re-narrowing over time.

In general, drug-eluting stents are preferred over bare metal stents. However, drug-eluting stents require 6-12 months of treatment with anti-platelet drugs, which increases a patient’s risk of bleeding and possibly other side effects.

Although millions of people are implanted with drug-eluting stents every year, the safety of anti-platelet therapy beyond 12 months is poorly understood. So researchers decided to investigate the risk of side effects at 12 months and 30 months.

Surprisingly, researchers found about 2% of patients died after taking anti-platelet drugs for 30 months, compared to 1.5% of patients on a placebo. Prolonged use of anti-platelet drugs also significantly increased the risk of bleeding. About 1 in 1,000 of those bleeds were fatal.

Conclusions were based on data from the Dual Anti-Platelet Therapy (DAPT) study, which enrolled 10,000 patients. The study was published in November 2014 by the New England Journal of Medicine.

In response, the FDA published a Safety Communication to announce that they will review the results, but they have made no conclusions and are not recommending any changes to the way anti-platelet drugs are prescribed.

According to the FDA:

“The higher rate of death was largely explained by an increase in deaths from non-cardiovascular causes, primarily cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not those given prasugrel.”

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