External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry.

Abstract

AIMS:

THEMIS is a double-blind, randomized trial of 19,220 patients with diabetes mellitus and stable coronary artery disease (CAD) comparing ticagrelor to placebo, in addition to aspirin. The present study aimed to describe the proportion of patients eligible and reasons for ineligibility for THEMIS within a population of patients with diabetes and CAD included in the Reduction of Atherothrombosis for Continued Health (REACH) registry.

METHODS AND RESULTS:

The THEMIS eligibility criteria were applied to REACH patients. THEMIS included patients ≥50 years with type 2 diabetes and stable CAD as determined by either a history of previous percutaneous coronary intervention, coronary artery bypass grafting, or documentation of angiographic stenosis of ≥50% of at least one coronary artery. Patients with prior myocardial infarction or stroke were excluded. In REACH, 10,156 patients had stable CAD and diabetes. Of these, 6515 (64.1%) patients had at least one exclusion criteria. From the remaining population, 784 patients did not meet inclusion criteria (7.7%) mainly due to absence of aspirin treatment (7.2%), yielding a 'THEMIS-eligible population' of 2857 patients (28.1% of patients with diabetes and stable CAD). The main reasons for exclusion were a history of myocardial infarction (53.1%), use of oral anticoagulation (14.5%), or history of stroke (12.9%). Among the 4208 patients with diabetes and a previous PCI, 1196 patients (28.4%) were eligible for inclusion in the THEMIS-PCI substudy.

CONCLUSIONS:

In a population of patients with diabetes and stable coronary artery disease, a sizeable proportion appear to be 'THEMIS eligible.'

CLINICAL TRIAL REGISTRATION:

http://www.

CLINICALTRIALS:

gov identifier: NCT01991795.

• Authors: Jeremie Abtan, Deepak L Bhatt, Yedid Elbez, Gregory Ducrocq, Shinya Goto, Sidney C Smith Jr, E Magnus Ohman, Kim A Eagle, Kim Fox, Robert A Harrington, Lawrence A Leiter, Shamir R Mehta, Tabassome Simon, Ivo Petrov, Peter R Sinnaeve, Prem Pais, Eli Lev, Héctor Bueno, Peter Wilson, Philippe Gabriel Steg, REACH Registry Investigators
• Journal: International journal of cardiology (Int J Cardiol) Vol. 370 Pg. 51-57 (Jan 01 2023) ISSN: 1874-1754 [Electronic] Netherlands
• PMID: 36270493 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.

Chemical References

• Ticagrelor
• Aspirin
• Platelet Aggregation Inhibitors

Topics

• Humans
• Ticagrelor (therapeutic use)
• Coronary Artery Disease (drug therapy, epidemiology)
• Percutaneous Coronary Intervention
• Diabetes Mellitus, Type 2 (complications, diagnosis, drug therapy)
• Aspirin (therapeutic use)
• Myocardial Infarction (epidemiology)
• Stroke (epidemiology)
• Outcome Assessment, Health Care
• Treatment Outcome
• Platelet Aggregation Inhibitors (therapeutic use)