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PRODIGY: Prolonged antiplatelet therapy not safer in 24 months vs. 6 months in coronary disease patients
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European Society of Cardiology Congress 2011
Prolonged antiplatelet therapy in patients with coronary disease is not safer after 24 months vs. 6 months of dual antiplatelet therapy and has a greater risk for hemorrhage, new study results indicated.
In the PRODIGY trial, 2,013 patients scheduled for elective, urgent or emergency coronary angioplasty were randomly assigned in a 1:1:1:1 fashion. First, patients were randomly assigned into everolimus-eluting stent, paclitaxel-eluting stent, zotarolimus-eluting stent or third-generation thin-strut bare metal stent groups. Then, after 30 days, patients in each stent group were randomly assigned to either 6 or 24 months of dual antiplatelet treatment. Results of the trial were presented at the European Society of Cardiology Congress 2011 in Paris.
“The results question the validity of current guideline recommendations — which were based on registry data — that at least 12 months’ dual antiplatelet therapy should be pursued after implantation of the drug-eluting stent,” Marco Valgimigli, MD, of the University Hospital of Ferrara in Italy, said in a press release.
At 2 years, the cumulative risk of the primary outcome was 10.1% with 24-month treatment vs. 10% with 6-month treatment. There was a roughly twofold greater risk of type 5, 3 or 2, as well as type 5 or 3, bleeding events according to the Bleeding Academic Research Consortium classification in patients receiving long-term dual antiplatelet therapy. The 24-month group also had increased risks for thrombolysis in MI-defined major bleeding and red blood cell transfusion. Researchers found that individual risks for death, MI, cerebrovascular accident or stent thrombosis did not differ between 6- and 24-month treatment groups.
“While we cannot exclude the possibility that a smaller than previously anticipated benefit may still exist in prolonging therapy with clopidogrel for several months after coronary stenting, our study clearly shows that the benefit to risk ratio of prolonged therapy has been over-emphasized,” Valgimigli said.
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Disclosure: Dr. Valgimigli has received honoraria for lectures, advisory board, and research grants from Merck, Iroko, Eli Lilly, Medtronic, The Medicines Company, Daiichi Sankyo Inc., St Jude, Abbott Vascular, Cordis, CID, and Terumo, Accumetrics.
Although we are still waiting for the results of larger trials on optimal duration of dual antiplatelet therapy after drug-eluting stents, the PRODIGY trial represents one more victory against the greatest enemy of drug-eluting stents: the wrongly assumed need for endless dual antiplatelet therapy.
Adnan Kastrati, MD
Professor of Cardiolgy,
Deutsches Herzzentrum
Munich, Germany
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