Author + information
- Received May 11, 2015
- Revision received August 5, 2015
- Accepted September 10, 2015
- Published online January 11, 2016.
- Usman Baber, MD, MSc∗,
- Gennaro Giustino, MD∗,
- Samantha Sartori, PhD∗,
- Melissa Aquino, MSc∗,
- Giulio G. Stefanini, MD†,
- P. Gabriel Steg, MD‡,
- Stephan Windecker, MD, PhD§,
- Martin B. Leon, MD‖,
- William Wijns, MD, PhD¶,
- Patrick W. Serruys, MD, PhD#,
- Marco Valgimigli, MD, PhD∗∗,
- Gregg W. Stone, MD‖,
- George D. Dangas, MD, PhD∗,
- Marie-Claude Morice, MD††,
- Edoardo Camenzind, MD‡‡,
- Giora Weisz, MD#,
- Pieter C. Smits, MD, PhD§§,
- David Kandzari, MD‖‖,
- Clemens Von Birgelen, MD¶¶,
- Ioannis Mastoris, MD∗,
- Soren Galatius, MD##,
- Raban V. Jeger, MD∗∗∗,
- Takeshi Kimura, MD†††,
- Ghada W. Mikhail, MD‡‡‡,
- Dipti Itchhaporia, MD§§§,
- Laxmi Mehta, MD‖‖‖,
- Rebecca Ortega, MD¶¶¶,
- Hyo-Soo Kim, MD###,
- Adnan Kastrati, MD∗∗∗∗,
- Alaide Chieffo, MD†††† and
- Roxana Mehran, MD∗∗ ()
- ∗The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York
- †Division of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy
- ‡Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U698, Paris, France
- §Department of Cardiology, Bern University Hospital, Bern, Switzerland
- ‖Division of Cardiology, Columbia University Medical Center, New York City, New York
- ¶Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium
- #Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands
- ∗∗Department of Cardiology, University of Ferrara, Ferrara, Italy
- ††Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France
- ‡‡Institut Lorrain du Coeur et des Vaisseaux (ILCV) University Hospital Nancy—Brabois Vandoeuvre-lès-Nancy France
- §§Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands
- ‖‖Piedmont Heart Institute, Atlanta, Georgia
- ¶¶Thoraxcentrum Twente, Enschede, the Netherlands
- ##Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark
- ∗∗∗Department of Cardiology, University Hospital Basel, Basel, Switzerland
- †††Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan
- ‡‡‡Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom
- §§§Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California
- ‖‖‖Department of Cardiology, Ohio State University Medical Center, Columbus, Ohio
- ¶¶¶Society of Cardiovascular Angiography and Interventions, Washington, DC
- ###Department of Cardiology, Seoul National University Main Hospital, Seoul, South Korea
- ∗∗∗∗Herzzentrum, Munich, Germany
- ††††Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- ↵∗Reprint requests and correspondence:
Dr. Roxana Mehran, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives 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.
The Gender Data Forum was sponsored by the Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions. Dr. Stefanini has received speaker fees from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, and The Medicines Company. Dr. Steg has received honorarium from Medtronic as a steering committee member in the PROTECT trial; has received research grants from Sanofi and Servier; has received funding from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo-Lilly, GlaxoSmithKline, Medtronic, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company; and is a stockholder in Aterovax. Dr. Windecker has received research contracts to the institution from Abbott, Biotronik, Boston Scientific, Biosensors, Cordis, Medtronic, and St. Jude; and has received speakers honoraria from AstraZeneca, Eli Lilly, Abbott, Biotronik, Biosensor, Boston Scientific, Medtronic, Edwards Lifesciences, and Bayer. Dr. Wijns has received institutional research grants from Boston, Medtronic, Abbott, Terumo, and Biosensors; is an investigator for sponsored trials by Boston, Medtronic, Abbott, Terumo, and Biosensors; is a nonexecutive board member and shareholder of Argonauts Partners, Cardio3BioSciences, and Genae; and fees or honoraria on his behalf from Boston, Medtronic, Abbott, Terumo, and Biosensors go to the Cardiovascular Center Aalst. Dr. Valgimigli has received honoraria for lectures or advisory board and research grants from Merck, Iroko, Eli Lilly, and Medtronic; honoraria for advisory board and lectures from The Medicines Company, Eli Lilly, Daiichi Sankyo, St. Jude, and Abbott Vascular; and honoraria for lectures from Cordis, Carbostent and Implantable Devices, and Terumo. Dr. Smits has received institutional research grants and speakers fees from Abbott Vascular, St. Jude, and Terumo.
Dr. Kandzari has received research or grant support from Medtronic, Abbott, and Boston Scientific; and has received consulting honoraria from Medtronic, Biotronik, and Boston Scientific. Dr. Von Birgelen is a consultant to and has received lecture fees or travel expenses from Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific, Medtronic, and Merck Sharp and Dohme; and his research department Thoraxcentrum Twente has received educational or research grants from Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific, and Medtronic.
Dr. Galatius has received grant support from St. Jude, Abbott, Terumo, and Biotronik; and has received advisory board honorarium from Eli Lilly and Servier. Dr. Mikhail has received an interventional fellowship from Abbott Vascular; and has received speakers honoraria from AstraZeneca. Dr. Mehran has received institutional research grant support from The Medicines Company, AstraZeneca, Bristol-Myers Squibb, Sanofi, Lilly, and Daiichi Sankyo; has received consulting fees from Abbott Vascular, AstraZeneca, Bayer, Boston Scientific, CSL Behring, Covidien, Janssen Pharmaceuticals, Maya Medical, Merck, Osprey Medical Inc., Regado Biosciences, Watermark Research Partners, and Sanofi; and serves on the scientific advisory board of Abbott Laboratories, Boston Scientific Corporation, Covidien, Janssen Pharmaceuticals, The Medicines Company, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The first 2 authors contributed equally to this work.
- Received May 11, 2015.
- Revision received August 5, 2015.
- Accepted September 10, 2015.
- 2016 American College of Cardiology Foundation