http://www.theheart.org/web_slides/1303305.do A randomized trial on Prolonging Dual Antiplatelet Treatment after Grading Stent-induced Intimal Hyperplasia (PRODIGY) to address the ongoing debate of the duration of dual antiplatelet therapy after drug-eluting-sent implantation

1. PRODIGY (Prolonging Dual Antiplatelet
Treatment after Grading Stent-induced
Intimal Hyperplasia Study)

2. PRODIGY (Prolonging Dual Antiplatelet Treatment after
Grading Stent-induced Intimal Hyperplasia Study)
M Valgimigli (University Hospital of Ferrara, Italy)
European Society of Cardiology 2011 Congress
• Purpose:
A randomized trial to address the ongoing debate of the duration of dual
antiplatelet therapy after drug-eluting-stent implantation
• Population and treatment:
2013 patients (74% with ACS and 26% with stable angina) who underwent
stenting
Randomized to six or 24 months of dual antiplatelet treatment:
clopidogrel + aspirin
• Primary outcome:
All-cause mortality, nonfatal MI, or stroke at two years
ACS=acute coronary syndrome

3. PRODIGY: Results
• Primary-end-point outcome was almost identical between the two groups
• Bleeding results showed large differences between the two groups
PRODIGY: Efficacy results
End point 6-mo dual antiplatelet therapy (%) 24-mo dual antiplatelet therapy (%) HR (95% CI)
Death/MI/stroke 10.0 10.1 0.98 (0.74–1.29)
Death 6.6 6.6 1.00 (0.72 –1.40)
Death/MI 9.6 8.9 1.07 (0.80–1.43)
PRODIGY: Bleeding results
End point 6-mo dual antiplatelet therapy (%) 24-mo dual antiplatelet therapy (%) p
Type 2,3 or 5 BARC* bleeding 3.5 7.4 <0.001
TIMI major bleeding 0.6 1.6 0.041
Red blood cell transfusion 1.3 2.6 0.041
*BARC=Bleeding Academic Research Consortium

4. PRODIGY: Commentary*
"We now have three small studies with tantalizingly similar findings. Longer dual
antiplatelet therapy (up to two years) does not appear to be adding much clinical
benefit, and there is a clear signal of increased bleeding."
- Dr Magnus Ohman
"Although we are still waiting for the results of larger trials, PRODIGY represents
one more victory against the greatest enemy of drug-eluting stents—the wrongly
assumed need for endless dual antiplatelet therapy."
- Dr Adnan Kastrati
*All comments from PRODIGY raises questions about longer clopidogrel duration poststenting
(http://www.theheart.org/article/1272023.do)

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