Association of diabetes with outcomes in patients undergoing contemporary percutaneous coronary intervention: Pre-specified subgroup analysis from the randomized GLOBAL LEADERS study.


Journal

Atherosclerosis
ISSN: 1879-1484
Titre abrégé: Atherosclerosis
Pays: Ireland
ID NLM: 0242543

Informations de publication

Date de publication:
02 2020
Historique:
received: 15 08 2019
revised: 25 11 2019
accepted: 09 01 2020
pubmed: 2 2 2020
medline: 2 1 2021
entrez: 2 2 2020
Statut: ppublish

Résumé

Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status. We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5. A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes. Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.

Sections du résumé

BACKGROUND AND AIMS
Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status.
METHODS
We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5.
RESULTS
A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes.
CONCLUSIONS
Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.

Identifiants

pubmed: 32006758
pii: S0021-9150(20)30017-4
doi: 10.1016/j.atherosclerosis.2020.01.002
pii:
doi:

Substances chimiques

Platelet Aggregation Inhibitors 0

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

45-53

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Dr. Chichareon reports research grant from Biosensors, outside the submitted work. Dr. Modolo reports research grant from Biosensors, outside the submitted work. Dr. Kőszegi have received personal fees from AstraZeneca, Terumo Europe, MSD, Boehringer Ingelheim, Pfizer and Servier outside the submitted work during the last 36 months. Dr. Piek reports non-financial support from Abbott Vascular, personal fees and non-financial support from Philips/Volcano, outside the submitted work. Dr. Hamm reports advisory Board and Speaker fees from AstraZeneca. Dr. Steg reports grants and personal fees from Bayer/Janssen, grants and personal fees from Merck, grants and personal fees from Sanofi, grants and personal fees from Amarin, personal fees from Amgen, personal fees from Bristol Myers Squibb, personal fees from Boehringer-Ingelheim, personal fees from Pfizer, personal fees from Novartis, personal fees from Regeneron, personal fees from Lilly, personal fees from AstraZeneca, grants and personal fees from Servier, outside the submitted work. Dr. Vranckx reports personal fees from Astra Zeneca, personal fees from The Medicines Company, during the conduct of the study; personal fees from Daiichi Sankyo, personal fees from Bayer Health Care, personal fees from CLS Bhering, personal fees from Terumo, outside the submitted work. Dr. Valgimigli reports grants and personal fees from Abbott, personal fees from Chiesi, personal fees from Bayer, personal fees from Daiichi Sankyo, personal fees from Amgen, grants and personal fees from Terumo, personal fees from Alvimedica, grants from Medicure, grants and personal fees from Astrazeneca, personal fees from Biosensors, personal fees from Idorsia, outside the submitted work. Dr. Windecker reported research and institutional grants to the institution from Abbott, Amgen, Bayer, BMS, Boston Scientific, Biotronik, CSL Behring, Edwards, Medtronic, Polares, Sinomed. Dr. Onuma reports being a member of the advisory board of Abbott Vascular. Dr. Serruys reports personal fees from Sino Medical Sciences Technology, personal fees from Philips/Volcano, personal fees from Xeltis, outside the submitted work. All other authors have no disclosures.

Auteurs

Ply Chichareon (P)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.

Rodrigo Modolo (R)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil.

Norihiro Kogame (N)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.

Kuniaki Takahashi (K)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.

Chun-Chin Chang (CC)

Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.

Mariusz Tomaniak (M)

Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

Roberto Botelho (R)

CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil.

Eric Eeckhout (E)

Department of Cardiology, Lausanne University Hospital, Switzerland.

Sjoerd Hofma (S)

The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.

Diana Trendafilova-Lazarova (D)

"St. Ekaterina" University Hospital, Sofia, Bulgaria.

Zsolt Kőszegi (Z)

Jósa András Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital, Nyíregyháza, Hungary.

Andres Iñiguez (A)

Cardiology Department. Hospital Universitario Álvaro Cunqueiro, Vigo, Spain.

Joanna J Wykrzykowska (JJ)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.

Jan J Piek (JJ)

Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.

Scot Garg (S)

East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.

Christian Hamm (C)

Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.

Philippe Gabriel Steg (PG)

Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, FACT (French Alliance for Cardiovascular Trials), Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom.

Peter Jüni (P)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada.

Pascal Vranckx (P)

Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.

Marco Valgimigli (M)

Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

Stephan Windecker (S)

Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

Yoshinobu Onuma (Y)

Department of Cardiology, National University of Ireland Galway, Galway, Ireland.

Patrick W Serruys (PW)

Department of Cardiology, National University of Ireland Galway, Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.

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Classifications MeSH