TY - JOUR
T1 - Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents A Patient-Level Pooled Analysis of Randomized Controlled Trials
AU - Baber, Usman
AU - Giustino, Gennaro
AU - Sartori, Samantha
AU - Aquino, Melissa
AU - Stefanini, Giulio G.
AU - Steg, P. Gabriel
AU - Windecker, Stephan
AU - Leon, Martin B.
AU - Wijns, William
AU - Serruys, Patrick W.
AU - Valgimigli, Marco
AU - Stone, Gregg W.
AU - Dangas, George D.
AU - Morice, Marie Claude
AU - Camenzind, Edoardo
AU - Weisz, Giora
AU - Smits, Pieter C.
AU - Kandzari, David
AU - Von Birgelen, Clemens
AU - Mastoris, Ioannis
AU - Galatius, Soren
AU - Jeger, Raban V.
AU - Kimura, Takeshi
AU - Mikhail, Ghada W.
AU - Itchhaporia, Dipti
AU - Mehta, Laxmi
AU - Ortega, Rebecca
AU - Kim, Hyo Soo
AU - Kastrati, Adnan
AU - Chieffo, Alaide
AU - Mehran, Roxana
N1 - Publisher Copyright:
© 2016 American College of Cardiology Foundation.
PY - 2016/1/11
Y1 - 2016/1/11
N2 - 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.
AB - 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.
KW - chronic kidney disease
KW - drug-eluting stents
KW - outcomes
KW - women
UR - http://www.scopus.com/inward/record.url?scp=84952944799&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2015.09.023
DO - 10.1016/j.jcin.2015.09.023
M3 - Article
C2 - 26762908
AN - SCOPUS:84952944799
SN - 1936-8798
VL - 9
SP - 28
EP - 38
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 1
ER -