More than 2000 patients scheduled for elective, urgent or emergency coronary angioplasty were randomly assigned in a 1:1:1:1 fashion to one of four stent types: everolimus-eluting stent, paclitaxel-eluting stent, zotarolimus-eluting stent or third-generation thin-strut bare metal stent. Randomisation to the four different types, said Dr Valgimigli, was justified by the different safety profile of each, which was meant to ensure that patients in the two main study groups (six versus 24 month dual antiplatelet therapy) received exactly the same stent types. At 30 days, patients in each stent group were then further randomised to either six or 24 months of dual antiplatelet treatment.
The primary objective of the study was to assess whether 24-month dual antiplatelet treatment, consisting of clopidogrel and aspirin after coronary stenting, was associated with a lower cumulative incidence of all-cause mortality, non-fatal myocardial infarction or cerebrovascular accident (the primary outcome) than six-month dual therapy.
Results showed that the cumulative risk of the primary outcome at two years was 10.1% with the 24-month treatment, and 10.0% with the six-month (HR 0.98; 95% CI 0.74-1.29; P=0.91). The individual risks of death, myocardial infarction, cerebrovascular accident or stent thrombosis did not differ between the two groups.
Among the patients receiving long-term dual antiplatelet therapy, there was a roughly two-fold greater risk of type 5, 3 or 2 bleeding events (HR 2.17, 95% CI 1.44-3.22; p=0.00018) as well as type 5 or 3 bleeding events (HR 1.78, 95% CI 1.02-3.13; p=0.037) according to the Bleeding Academic Research Consortium classification. The risks of TIMI-defined major bleeding and red blood cell transfusion were also increased in the 24-month clopidogrel group.
Commenting on the implications of the results, Dr Valgimigli said: ” While a formal economic analysis will follow, the results of this study have important implications for heathcare expenditure – for this study shows that prolonging therapy with clopidogrel beyond six months is not only associated with no clinical benefit but also with a significant increase in actionable bleeding events requiring re-hospitalisations and multiple diagnostic and therapeutic resources.”
Doctor Valgimigli, Marco (Ferrara, Italy)
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Notes to editor
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Hot Line III – Acute coronary syndromes
PRODIGY: Randomized comparison of six versus twenty-four months clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all comer patients undergoing percutaneous coronary intervention. Results of the PRODIGY trial.
Edited by the ESC from material supplied by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the investigator.