Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.

Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.

Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

Original languageEnglish
Article numbere007734
JournalCirculation: Cardiovascular Interventions
Volume12
Issue number7
DOIs
Publication statusPublished - 1 Jul 2019

Fingerprint

Drug-Eluting Stents
Percutaneous Coronary Intervention
Diabetes Mellitus
Stents
Thrombosis
Myocardial Infarction
Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus
Cause of Death
Clinical Trials
Insulin
Safety

Keywords

  • Diabetes mellitus
  • Drug-eluting stents (DES)
  • Myocardial infarction
  • Percutaneous Coronary Intervention (PCI)
  • Women

Cite this

Baber, Usman ; Stefanini, Giulio G. ; Giustino, Gennaro ; Stone, Gregg W. ; Leon, Martin B. ; Sartori, Samantha ; Aquino, Melissa ; Steg, P. Gabriel ; Windecker, Stephan ; Wijns, William ; Serruys, Patrick W. ; Valgimigli, Marco ; Morice, Marie Claude ; Camenzind, Edoardo ; Weisz, Giora ; Smits, Pieter C. ; Kandzari, David E. ; von Birgelen, Clemens ; Dangas, George D. ; 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. / Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents : From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis. In: Circulation: Cardiovascular Interventions. 2019 ; Vol. 12, No. 7.
@article{87dd170b77cf4764ad6cc9925427feec,
title = "Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis",
abstract = "Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5{\%}), adjusted risks (adjusted hazard ratios [95{\%} CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4{\%}) and insulin-dependent DM (n=1053, 10.1{\%}) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.",
keywords = "Diabetes mellitus, Drug-eluting stents (DES), Myocardial infarction, Percutaneous Coronary Intervention (PCI), Women",
author = "Usman Baber and Stefanini, {Giulio G.} and Gennaro Giustino and Stone, {Gregg W.} and Leon, {Martin B.} and Samantha Sartori and Melissa Aquino and Steg, {P. Gabriel} and Stephan Windecker and William Wijns and Serruys, {Patrick W.} and Marco Valgimigli and Morice, {Marie Claude} and Edoardo Camenzind and Giora Weisz and Smits, {Pieter C.} and Kandzari, {David E.} and {von Birgelen}, Clemens and Dangas, {George D.} and Soren Galatius and Jeger, {Raban V.} and Takeshi Kimura and Mikhail, {Ghada W.} and Dipti Itchhaporia and Laxmi Mehta and Rebecca Ortega and Kim, {Hyo Soo} and Adnan Kastrati and Alaide Chieffo and Roxana Mehran",
year = "2019",
month = "7",
day = "1",
doi = "10.1161/CIRCINTERVENTIONS.118.007734",
language = "English",
volume = "12",
journal = "Circulation : cardiovascular interventions",
issn = "1941-7640",
publisher = "Lippincott Williams and Wilkins",
number = "7",

}

Baber, U, Stefanini, GG, Giustino, G, Stone, GW, Leon, MB, Sartori, S, Aquino, M, Steg, PG, Windecker, S, Wijns, W, Serruys, PW, Valgimigli, M, Morice, MC, Camenzind, E, Weisz, G, Smits, PC, Kandzari, DE, von Birgelen, C, Dangas, GD, Galatius, S, Jeger, RV, Kimura, T, Mikhail, GW, Itchhaporia, D, Mehta, L, Ortega, R, Kim, HS, Kastrati, A, Chieffo, A & Mehran, R 2019, 'Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis', Circulation: Cardiovascular Interventions, vol. 12, no. 7, e007734. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007734

Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents : From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis. / Baber, Usman; Stefanini, Giulio G.; Giustino, Gennaro; Stone, Gregg W.; Leon, Martin B.; Sartori, Samantha; Aquino, Melissa; Steg, P. Gabriel; Windecker, Stephan; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Morice, Marie Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; von Birgelen, Clemens; Dangas, George D.; 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: Circulation: Cardiovascular Interventions, Vol. 12, No. 7, e007734, 01.07.2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents

T2 - From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis

AU - Baber, Usman

AU - Stefanini, Giulio G.

AU - Giustino, Gennaro

AU - Stone, Gregg W.

AU - Leon, Martin B.

AU - Sartori, Samantha

AU - Aquino, Melissa

AU - Steg, P. Gabriel

AU - Windecker, Stephan

AU - Wijns, William

AU - Serruys, Patrick W.

AU - Valgimigli, Marco

AU - Morice, Marie Claude

AU - Camenzind, Edoardo

AU - Weisz, Giora

AU - Smits, Pieter C.

AU - Kandzari, David E.

AU - von Birgelen, Clemens

AU - Dangas, George D.

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 - 2019/7/1

Y1 - 2019/7/1

N2 - Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

AB - Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

KW - Diabetes mellitus

KW - Drug-eluting stents (DES)

KW - Myocardial infarction

KW - Percutaneous Coronary Intervention (PCI)

KW - Women

UR - http://www.scopus.com/inward/record.url?scp=85069316631&partnerID=8YFLogxK

U2 - 10.1161/CIRCINTERVENTIONS.118.007734

DO - 10.1161/CIRCINTERVENTIONS.118.007734

M3 - Article

C2 - 31288561

AN - SCOPUS:85069316631

VL - 12

JO - Circulation : cardiovascular interventions

JF - Circulation : cardiovascular interventions

SN - 1941-7640

IS - 7

M1 - e007734

ER -