TY - JOUR
T1 - Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents
T2 - 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, 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 E.
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
PY - 2016
Y1 - 2016
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 (DES)
KW - Outcomes
KW - Women
KW - n/a OA procedure
U2 - 10.1016/j.jcin.2015.09.023
DO - 10.1016/j.jcin.2015.09.023
M3 - Article
SN - 1936-8798
VL - 9
SP - 28
EP - 38
JO - JACC : cardiovascular interventions
JF - JACC : cardiovascular interventions
IS - 1
ER -
