title: The impact of renal impairment on long-term safety and effectiveness of drug-eluting stents.
abstract: BACKGROUND
  Renal impairment (RI) is associated with impaired prognosis in patients with coronary artery disease. Clinical and angiographic outcomes of patients undergoing percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in this patient population are not well established.
  
  
  METHODS
  We pooled individual data for 5,011 patients from 3 trials with the exclusive and unrestricted use of DES (SIRTAX - N = 1,012, LEADERS - N = 1,707, RESOLUTE AC - N = 2,292). Angiographic follow-up was available for 1,544 lesions. Outcomes through 2 years were stratified according to glomerular filtration rate (normal renal function: GFR ≥ 90 ml/min; mild RI: 90<GFR ≥ 60 ml/min; moderate/severe RI GFR<60 ml/min).
  
  
  RESULTS
  Patients with moderate/severe RI had an increased risk of cardiac death or myocardial infarction ([MI], OR 2.14, 95%CI 1.36-3.36), cardiac death (OR 2.21, 95%CI 1.10-4.46), and MI (OR 2.02, 95%CI 1.19-3.43) compared with patients with normal renal function at 2 years follow-up. There was no difference in cardiac death or MI between patients with mild RI compared to those with normal renal function (OR 1.10, 95%CI 0.75-1.61). The risk of target-lesion revascularization was similar for patients with moderate/severe RI (OR 1.17, 95%CI 0.70-1.95) and mild RI (OR 1.16, 95%CI 0.81-1.64) compared with patients with normal renal function. In-stent late loss and in-segment restenosis were not different for patients with moderate/severe RI, mild RI, and normal renal function.
  
  
  CONCLUSIONS
  Renal function does not affect clinical and angiographic effectiveness of DES. However, prognosis remains impaired among patients with moderate/severe RI.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taniwaki
authors.affiliation: Clinical Trials Unit, Bern University Hospital, Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Heart Center at the Isar, Munich, Germany.
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: Clinical Trials Unit, Bern University Hospital, Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland; Clinical Trials Unit, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006801:Humans; D051437:Renal Insufficiency / Q000139:chemically induced / Q000473:pathology*; D012307:Risk Factors; D016896:Treatment Outcome