Role of stent type and of duration of dual antiplatelet therapy in patients with chronic kidney disease undergoing percutaneous coronary interventions. Is bare metal stent implantation still a justifiable choice? A post-hoc analysis of the all comer PRODIGY trial

Gabriele Crimi, Sergio Leonardi, Francesco Costa, Marianna Adamo, Sara Ariotti, Marco Valgimigli

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13 Citations (Scopus)

Abstract

Aim Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. Methods and results We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60 ml/min/1.73 m2, was found in 373 patients (18.8%). The incidence of ST at 2 years was 5.1% in CKD and 2.1% in non-CKD patients (HR 2.57, 95% confidence interval (CI) 1.46 to 4.52, p <0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: Adjusted HR = 0.288, 95% CI [0.107-0.778, p = 0.014] and HR = 0.394, 95% CI [0.164-0.947, p = 0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4% as compared to BMS 35.1%, ZES-S 33.0%, or PES 35.7% patients, p = 0.551. All-cause death was lowest in ZES-S group 10.6% as compared to BMS 18.1%, PES 25.5% and EES 14.9%, p = 0.040. We found no significant interaction between DAPT duration (6 vs 24 months) and stent type on primary outcome, PINT = 0.47 for BMS, PINT = 0.57 for PES, PINT = 0.41 for ZES-S and PINT = 0.28 for EES. Conclusions In an all-comer population of patients with stable and unstable CAD, CKD at baseline was associated with a double risk of ST and MACE. CKD patients receiving EES had less than half risk of ST 2 years after PCI as compared with BMS and PES. Our analysis suggests that 2nd generation limus-based stent should be favored over paclitaxel-based DES or BMS to reduce ST and MACE in CKD patients.

Original languageEnglish
Pages (from-to)110-117
Number of pages8
JournalInternational Journal of Cardiology
Volume212
DOIs
Publication statusPublished - Jun 1 2016

Fingerprint

Percutaneous Coronary Intervention
Chronic Renal Insufficiency
Stents
Metals
Thrombosis
Therapeutics
Drug-Eluting Stents
Confidence Intervals
Paclitaxel
Cause of Death
Tunica Intima
Population
Kidney Diseases
Everolimus
Glomerular Filtration Rate
Hyperplasia
Coronary Artery Disease
Creatinine

Keywords

  • 2nd generation drug eluting stent
  • Chronic kidney disease
  • Drug eluting stent
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{a39ebbca68a44a2eb0844d82f1d7a2b1,
title = "Role of stent type and of duration of dual antiplatelet therapy in patients with chronic kidney disease undergoing percutaneous coronary interventions. Is bare metal stent implantation still a justifiable choice? A post-hoc analysis of the all comer PRODIGY trial",
abstract = "Aim Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. Methods and results We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60 ml/min/1.73 m2, was found in 373 patients (18.8{\%}). The incidence of ST at 2 years was 5.1{\%} in CKD and 2.1{\%} in non-CKD patients (HR 2.57, 95{\%} confidence interval (CI) 1.46 to 4.52, p <0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: Adjusted HR = 0.288, 95{\%} CI [0.107-0.778, p = 0.014] and HR = 0.394, 95{\%} CI [0.164-0.947, p = 0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4{\%} as compared to BMS 35.1{\%}, ZES-S 33.0{\%}, or PES 35.7{\%} patients, p = 0.551. All-cause death was lowest in ZES-S group 10.6{\%} as compared to BMS 18.1{\%}, PES 25.5{\%} and EES 14.9{\%}, p = 0.040. We found no significant interaction between DAPT duration (6 vs 24 months) and stent type on primary outcome, PINT = 0.47 for BMS, PINT = 0.57 for PES, PINT = 0.41 for ZES-S and PINT = 0.28 for EES. Conclusions In an all-comer population of patients with stable and unstable CAD, CKD at baseline was associated with a double risk of ST and MACE. CKD patients receiving EES had less than half risk of ST 2 years after PCI as compared with BMS and PES. Our analysis suggests that 2nd generation limus-based stent should be favored over paclitaxel-based DES or BMS to reduce ST and MACE in CKD patients.",
keywords = "2nd generation drug eluting stent, Chronic kidney disease, Drug eluting stent, Stent thrombosis",
author = "Gabriele Crimi and Sergio Leonardi and Francesco Costa and Marianna Adamo and Sara Ariotti and Marco Valgimigli",
year = "2016",
month = "6",
day = "1",
doi = "10.1016/j.ijcard.2016.03.033",
language = "English",
volume = "212",
pages = "110--117",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Role of stent type and of duration of dual antiplatelet therapy in patients with chronic kidney disease undergoing percutaneous coronary interventions. Is bare metal stent implantation still a justifiable choice? A post-hoc analysis of the all comer PRODIGY trial

AU - Crimi, Gabriele

AU - Leonardi, Sergio

AU - Costa, Francesco

AU - Adamo, Marianna

AU - Ariotti, Sara

AU - Valgimigli, Marco

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Aim Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. Methods and results We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60 ml/min/1.73 m2, was found in 373 patients (18.8%). The incidence of ST at 2 years was 5.1% in CKD and 2.1% in non-CKD patients (HR 2.57, 95% confidence interval (CI) 1.46 to 4.52, p <0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: Adjusted HR = 0.288, 95% CI [0.107-0.778, p = 0.014] and HR = 0.394, 95% CI [0.164-0.947, p = 0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4% as compared to BMS 35.1%, ZES-S 33.0%, or PES 35.7% patients, p = 0.551. All-cause death was lowest in ZES-S group 10.6% as compared to BMS 18.1%, PES 25.5% and EES 14.9%, p = 0.040. We found no significant interaction between DAPT duration (6 vs 24 months) and stent type on primary outcome, PINT = 0.47 for BMS, PINT = 0.57 for PES, PINT = 0.41 for ZES-S and PINT = 0.28 for EES. Conclusions In an all-comer population of patients with stable and unstable CAD, CKD at baseline was associated with a double risk of ST and MACE. CKD patients receiving EES had less than half risk of ST 2 years after PCI as compared with BMS and PES. Our analysis suggests that 2nd generation limus-based stent should be favored over paclitaxel-based DES or BMS to reduce ST and MACE in CKD patients.

AB - Aim Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. Methods and results We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60 ml/min/1.73 m2, was found in 373 patients (18.8%). The incidence of ST at 2 years was 5.1% in CKD and 2.1% in non-CKD patients (HR 2.57, 95% confidence interval (CI) 1.46 to 4.52, p <0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: Adjusted HR = 0.288, 95% CI [0.107-0.778, p = 0.014] and HR = 0.394, 95% CI [0.164-0.947, p = 0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4% as compared to BMS 35.1%, ZES-S 33.0%, or PES 35.7% patients, p = 0.551. All-cause death was lowest in ZES-S group 10.6% as compared to BMS 18.1%, PES 25.5% and EES 14.9%, p = 0.040. We found no significant interaction between DAPT duration (6 vs 24 months) and stent type on primary outcome, PINT = 0.47 for BMS, PINT = 0.57 for PES, PINT = 0.41 for ZES-S and PINT = 0.28 for EES. Conclusions In an all-comer population of patients with stable and unstable CAD, CKD at baseline was associated with a double risk of ST and MACE. CKD patients receiving EES had less than half risk of ST 2 years after PCI as compared with BMS and PES. Our analysis suggests that 2nd generation limus-based stent should be favored over paclitaxel-based DES or BMS to reduce ST and MACE in CKD patients.

KW - 2nd generation drug eluting stent

KW - Chronic kidney disease

KW - Drug eluting stent

KW - Stent thrombosis

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