title: Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials.
abstract: OBJECTIVE
  This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD).
  
  
  BACKGROUND
  The prevalence and effect of CKD in women undergoing PCI with DES is unclear.
  
  
  METHODS
  We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl) <45 ml/min, 45 to 59 ml/min, and ≥60 ml/min. The primary endpoint was the 3-year rate of major adverse cardiovascular events (MACE). Participants for whom baseline creatinine was missing were excluded from the analysis.
  
  
  RESULTS
  Of 4,217 women included in the pooled cohort treated with DES and for whom serum creatinine was available, 603 (14%) had a CrCl <45 ml/min, 811 (19%) had a CrCl 45 to 59 ml/min, and 2,803 (66%) had a CrCl ≥60 ml/min. A significant stepwise gradient in risk for MACE was observed with worsening renal function (26.6% vs. 15.8% vs. 12.9%; p < 0.01). Following multivariable adjustment, CrCl <45 ml/min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction.
  
  
  CONCLUSIONS
  Among women undergoing PCI with DES, CKD is a common comorbidity associated with a strong and independent risk for MACE that is durable over 3 years. The benefits of newer-generation DES are uniform in women with or without CKD.
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Samantha
authors.initials: S
authors.lastname: Sartori
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Melissa
authors.initials: M
authors.lastname: Aquino
authors.affiliation: Division of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.affiliation: Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U698, Paris, France.
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Division of Cardiology, Columbia University Medical Center, New York City, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Department of Cardiology, University of Ferrara, Ferrara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Division of Cardiology, Columbia University Medical Center, New York City, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
authors.affiliation: Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Institut Lorrain du Coeur et des Vaisseaux (ILCV) University Hospital Nancy-Brabois Vandoeuvre-lès-Nancy France.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.affiliation: Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.affiliation: Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David
authors.initials: D
authors.lastname: Kandzari
authors.affiliation: Thoraxcentrum Twente, Enschede, the Netherlands.
authors.forename: Clemens
authors.initials: C
authors.lastname: Von Birgelen
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Mastoris
authors.affiliation: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: Soren
authors.initials: S
authors.lastname: Galatius
authors.affiliation: Department of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Raban V
authors.initials: RV
authors.lastname: Jeger
authors.affiliation: Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom.
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.affiliation: Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California.
authors.forename: Dipti
authors.initials: D
authors.lastname: Itchhaporia
authors.affiliation: Department of Cardiology, Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Laxmi
authors.initials: L
authors.lastname: Mehta
authors.affiliation: Society of Cardiovascular Angiography and Interventions, Washington, DC.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Ortega
authors.affiliation: Department of Cardiology, Seoul National University Main Hospital, Seoul, South Korea.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Herzzentrum, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York. Electronic address: Roxana.Mehran@mountsinai.org.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003404:Creatinine / Q000097:blood; D054855:Drug-Eluting Stents; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000503:physiopathology; D008875:Middle Aged; D015999:Multivariate Analysis; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications* / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D016387:Women's Health
chemical_list: D015415:Biomarkers; D003404:Creatinine
keywords: chronic kidney disease; drug-eluting stents; outcomes; women