PRODIGY TRIAL
Problem BMS and DES
Format Unblinded, multicenter, 4-by-2 randomized trial
Treatment 6 vs. 24 mo. dual antiplatelet
Control -
Population 2013 patients
Inclusion criteria Any stent indication - stable CAD or ACS
Exclusion criteria Aspirin/clopidogrel allergy
Planned major surgery within 24 months
Major surgery within 15 days
History of bleeding diathesis
Previous stroke in last 6 months
Concomitant oral anticoagulation
Follow-up 2 years
Primary endpoint Composite of death from any cause, myocardial infarction, cerebrovascular accident or stent thrombosis (as per ARC guidelines)
Secondary endpoint(s) Death from any cause
Death from any cause or MI
Death from any cause, MI or CVA


Safety endpoints:
TIMI and Bleedscore
Details Aspirin continued until 24 months

Stenting options (in equal proportions)
-Bare metal stent (no active late loss inhibition)
-Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition)
-Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition)
-Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition)

At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization.
Brief summary: 24 months DAPT appears non-superior to 6 months; possibly underpowered
PAPER: Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial.
Date 24 Apr 2012
Journal Circulation. 2012 Apr 24;125(16):2015-26.
Information 6 vs. 24 months of clopidogrel (alongside aspirin)
-No evidence of benefit in DES or BMS on composite of death/MI/CVA
-No difference with stent types
-Agrees with REAL-LATE and EXCELLENT trials
-Trial may be underpowered, but any benefit is likely to be small
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