Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials

Usman Baber, Gennaro Giustino, Samantha Sartori, Melissa Aquino, Giulio G. Stefanini, Gabriel Steg, Stephan Windecker, Martin B. Leon, William Wijns, Patrick W. Serruys, Marco Valgimigli, Gregg W. Stone, George D. Dangas, Marie-Claude Morice, Edoardo Camenzind, Giora Weisz, Pieter C. Smits, David E. Kandzari, Clemens von Birgelen, Ioannis MastorisSoren Galatius, Raban V. Jeger, Takeshi Kimura, Ghada W. Mikhail, Dipti Itchhaporia, Laxmi Mehta, Rebecca Ortega, Hyo-Soo Kim, Adnan Kastrati, Alaide Chieffo, Roxana Mehran

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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.

Original languageEnglish
Pages (from-to)28-38
JournalJACC : cardiovascular interventions
Volume9
Issue number1
DOIs
Publication statusPublished - 2016

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Chronic Renal Insufficiency
Randomized Controlled Trials
Creatinine
Confidence Intervals
Kidney
Social Adjustment
Cohort Effect
Risk Reduction Behavior
Stents
Comorbidity
Thrombosis
Myocardial Infarction
Safety
Mortality

Keywords

  • Chronic kidney disease
  • Drug-eluting stents (DES)
  • Outcomes
  • Women

Cite this

Baber, Usman ; Giustino, Gennaro ; Sartori, Samantha ; Aquino, Melissa ; Stefanini, Giulio G. ; Steg, Gabriel ; Windecker, Stephan ; Leon, Martin B. ; Wijns, William ; Serruys, Patrick W. ; Valgimigli, Marco ; Stone, Gregg W. ; Dangas, George D. ; Morice, Marie-Claude ; Camenzind, Edoardo ; Weisz, Giora ; Smits, Pieter C. ; Kandzari, David E. ; von Birgelen, Clemens ; Mastoris, Ioannis ; Galatius, Soren ; Jeger, Raban V. ; Kimura, Takeshi ; Mikhail, Ghada W. ; Itchhaporia, Dipti ; Mehta, Laxmi ; Ortega, Rebecca ; Kim, Hyo-Soo ; Kastrati, Adnan ; Chieffo, Alaide ; Mehran, Roxana. / Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents : A Patient-Level Pooled Analysis of Randomized Controlled Trials. In: JACC : cardiovascular interventions. 2016 ; Vol. 9, No. 1. pp. 28-38.
@article{1208d017d4554cafaa286e1de705a264,
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 = "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.",
keywords = "Chronic kidney disease, Drug-eluting stents (DES), Outcomes, Women",
author = "Usman Baber and Gennaro Giustino and Samantha Sartori and Melissa Aquino and Stefanini, {Giulio G.} and Gabriel Steg and Stephan Windecker and Leon, {Martin B.} and William Wijns and Serruys, {Patrick W.} and Marco Valgimigli and Stone, {Gregg W.} and Dangas, {George D.} and Marie-Claude Morice and Edoardo Camenzind and Giora Weisz and Smits, {Pieter C.} and Kandzari, {David E.} and {von Birgelen}, Clemens and Ioannis Mastoris and Soren Galatius and Jeger, {Raban V.} and Takeshi Kimura and Mikhail, {Ghada W.} and Dipti Itchhaporia and Laxmi Mehta and Rebecca Ortega and Hyo-Soo Kim and Adnan Kastrati and Alaide Chieffo and Roxana Mehran",
year = "2016",
doi = "10.1016/j.jcin.2015.09.023",
language = "English",
volume = "9",
pages = "28--38",
journal = "JACC : cardiovascular interventions",
issn = "1936-8798",
publisher = "Elsevier",
number = "1",

}

Baber, U, Giustino, G, Sartori, S, Aquino, M, Stefanini, GG, Steg, G, Windecker, S, Leon, MB, Wijns, W, Serruys, PW, Valgimigli, M, Stone, GW, Dangas, GD, Morice, M-C, Camenzind, E, Weisz, G, Smits, PC, Kandzari, DE, von Birgelen, C, Mastoris, I, Galatius, S, Jeger, RV, Kimura, T, Mikhail, GW, Itchhaporia, D, Mehta, L, Ortega, R, Kim, H-S, Kastrati, A, Chieffo, A & Mehran, R 2016, 'Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials', JACC : cardiovascular interventions, vol. 9, no. 1, pp. 28-38. https://doi.org/10.1016/j.jcin.2015.09.023

Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents : A Patient-Level Pooled Analysis of Randomized Controlled Trials. / Baber, Usman; Giustino, Gennaro; Sartori, Samantha; Aquino, Melissa; Stefanini, Giulio G.; Steg, Gabriel; Windecker, Stephan; Leon, Martin B.; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Stone, Gregg W.; Dangas, George D.; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; von Birgelen, Clemens; Mastoris, Ioannis; Galatius, Soren; Jeger, Raban V.; Kimura, Takeshi; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana.

In: JACC : cardiovascular interventions, Vol. 9, No. 1, 2016, p. 28-38.

Research output: Contribution to journalArticleAcademicpeer-review

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

U2 - 10.1016/j.jcin.2015.09.023

DO - 10.1016/j.jcin.2015.09.023

M3 - Article

VL - 9

SP - 28

EP - 38

JO - JACC : cardiovascular interventions

JF - JACC : cardiovascular interventions

SN - 1936-8798

IS - 1

ER -