title: 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.
abstract: OBJECTIVE
  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).
  
  
  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.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.|Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gargiulo
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Santucci
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.|Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Sara
authors.initials: S
authors.lastname: Ariotti
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Baldo
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Aris
authors.initials: A
authors.lastname: Moschovitis
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.|Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003327:Coronary Disease / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D057194:Intention to Treat Analysis; D007558:Italy; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: DAPT; bleeding; cardiovascular events; chronic kidney disease (CKD); clopidogrel