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Impact of chronic kidney disease on 2‐year clinical outcomes in patients treated with 6‐month or 24‐month DAPT duration: An analysis from the PRODIGY trial
Author(s) -
Gargiulo Giuseppe,
Santucci Andrea,
Piccolo Raffaele,
Franzone Anna,
Ariotti Sara,
Baldo Andrea,
Esposito Giovanni,
Moschovitis Aris,
Windecker Stephan,
Valgimigli Marco
Publication year - 2017
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26921
Subject(s) - medicine , kidney disease , conventional pci , percutaneous coronary intervention , coronary artery disease , clinical endpoint , myocardial infarction , randomized controlled trial , hazard ratio , diabetes mellitus , cardiology , confidence interval , endocrinology
Objectives To 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. Background It 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 Results PRODIGY 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). Conclusions Moderate‐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. © 2017 Wiley Periodicals, Inc.