Journal
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
Volume 90, Issue 4, Pages E73-E84Publisher
WILEY
DOI: 10.1002/ccd.26921
Keywords
chronic kidney disease (CKD); clopidogrel; DAPT; cardiovascular events; bleeding
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Funding
- European Association of Percutaneous Cardiovascular Intervention (EAPCI)
- Cardiopath PhD program
- Veronesi Foundation-Cardiovascular research
- Italian Society of Cardiology
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ObjectivesTo assess whether moderate-to-severe CKD is a treatment modifier for benefit or harm in patients randomly allocated to 24-month versus 6-month DAPT. BackgroundIt is still unclear whether chronic kidney disease CKD should impact on the decision-making on optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). Methods and ResultsPRODIGY trial randomized 1970 all-comer patients at 24-month versus 6-month DAPT after PCI. Patients with moderate-to-severe CKD (n=604; 30.7%) were older, more likely to be women, to have hypertension, diabetes, prior MI or PCI, with higher severity of coronary artery disease (CAD), but were less frequently smokers or presenting with stable CAD. After adjustment, the 2-year rates of primary endpoint (composite of death, myocardial infarction and cerebrovascular accident), as well as bleeding and net adverse clinical events were higher in patients with moderate-to-severe CKD. DAPT prolongation at 24-month did not reduce the primary endpoint in both CKD (adj. HR: 0.957; 95% CI 0.652-1.407; P=0.825) and no-CKD (adj. HR: 1.341; 95% CI 0.861-2.086; P=0.194) groups (Pint=0.249), but increased bleeding in both groups (CKD: adj. HR: 1.999; 95% CI 1.100-3.632; P=0.023; no-CKD: adj. HR: 2.880; 95% CI 1.558-5.326; P=0.001; Pint=0.407). ConclusionsModerate-to-severe CKD did not modify the effect of a prolonged or shortened DAPT duration in largely unselected patients undergoing stent implantation. Our analysis suggests that CKD should not be a major driver in the decision-making on the duration of DAPT after stent implantation. This exploratory study is underpowered and should be considered hypothesis-generating only. (c) 2017 Wiley Periodicals, Inc.
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