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Randomized Controlled Trial
. 2020 Feb:295:45-53.
doi: 10.1016/j.atherosclerosis.2020.01.002. Epub 2020 Jan 15.

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

Affiliations
Randomized Controlled Trial

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

Ply Chichareon et al. Atherosclerosis. 2020 Feb.

Abstract

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.

Keywords: Coronary artery disease; Diabetes; Drug-eluting stents; Percutaneous coronary intervention; Ticagrelor.

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Conflict of interest statement

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.

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