Usman Baber1, Gennaro Giustino1, Samantha Sartori1, Melissa Aquino1, Giulio G Stefanini2, P Gabriel Steg3, Stephan Windecker4, Martin B Leon5, William Wijns6, Patrick W Serruys7, Marco Valgimigli8, Gregg W Stone5, George D Dangas1, Marie-Claude Morice9, Edoardo Camenzind10, Giora Weisz7, Pieter C Smits11, David Kandzari12, Clemens Von Birgelen13, Ioannis Mastoris1, Soren Galatius14, Raban V Jeger15, Takeshi Kimura16, Ghada W Mikhail17, Dipti Itchhaporia18, Laxmi Mehta19, Rebecca Ortega20, Hyo-Soo Kim21, Adnan Kastrati22, Alaide Chieffo23, Roxana Mehran24. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York. 2. Division of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy. 3. Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U698, Paris, France. 4. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 5. Division of Cardiology, Columbia University Medical Center, New York City, New York. 6. Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium. 7. Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. 8. Department of Cardiology, University of Ferrara, Ferrara, Italy. 9. Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France. 10. Institut Lorrain du Coeur et des Vaisseaux (ILCV) University Hospital Nancy-Brabois Vandoeuvre-lès-Nancy France. 11. Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. 12. Piedmont Heart Institute, Atlanta, Georgia. 13. Thoraxcentrum Twente, Enschede, the Netherlands. 14. Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. 15. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 16. Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 17. Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom. 18. Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California. 19. Department of Cardiology, Ohio State University Medical Center, Columbus, Ohio. 20. Society of Cardiovascular Angiography and Interventions, Washington, DC. 21. Department of Cardiology, Seoul National University Main Hospital, Seoul, South Korea. 22. Herzzentrum, Munich, Germany. 23. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 24. 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.
Abstract
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.
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.
Authors: Gennaro Giustino; Rafael Harari; Usman Baber; Samantha Sartori; Gregg W Stone; Martin B Leon; Stephan Windecker; Patrick W Serruys; Adnan Kastrati; Clemens Von Birgelen; Takeshi Kimura; Giulio G Stefanini; George D Dangas; William Wijns; P Gabriel Steg; Marie-Claude Morice; Edoardo Camenzind; Giora Weisz; Pieter C Smits; Sabato Sorrentino; Madhav Sharma; Serdar Farhan; Michela Faggioni; David Kandzari; Soren Galatius; Raban V Jeger; Marco Valgimigli; Dipti Itchhaporia; Laxmi Mehta; Hyo-Soo Kim; Alaide Chieffo; Roxana Mehran Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676
Authors: Gil Moskowitz; Kimberly N Hong; Gennaro Giustino; A Marc Gillinov; Gorav Ailawadi; Joseph J DeRose; Alexander Iribarne; Alan J Moskowitz; Annetine C Gelijns; Natalia N Egorova Journal: J Am Coll Cardiol Date: 2019-11-26 Impact factor: 24.094