Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Ticagrelor in Patients with Stable Coronary Disease and Diabetes

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Lipoprotein(a) Reduction in Persons with Cardiovascular Disease

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. A More COMPLETE Picture of Revascularization in STEMI

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Validation of the all-comers design: Results of the TARGET-AC substudy

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Relation of cardiac adipose tissue to coronary calcification and myocardial microvascular function in type 1 and type 2 diabetes

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Evaluation of computed tomography myocardial perfusion in women with angina and no obstructive coronary artery disease

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

BACKGROUND: Patients with stable coronary artery disease and diabetes mellitus who have not had a myocardial infarction or stroke are at high risk for cardiovascular events. Whether adding ticagrelor to aspirin improves outcomes in this population is unclear.

METHODS: In this randomized, double-blind trial, we assigned patients who were 50 years of age or older and who had stable coronary artery disease and type 2 diabetes mellitus to receive either ticagrelor plus aspirin or placebo plus aspirin. Patients with previous myocardial infarction or stroke were excluded. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria.

RESULTS: A total of 19,220 patients underwent randomization. The median follow-up was 39.9 months. Permanent treatment discontinuation was more frequent with ticagrelor than placebo (34.5% vs. 25.4%). The incidence of ischemic cardiovascular events (the primary efficacy outcome) was lower in the ticagrelor group than in the placebo group (7.7% vs. 8.5%; hazard ratio, 0.90; 95% confidence interval [CI], 0.81 to 0.99; P = 0.04), whereas the incidence of TIMI major bleeding was higher (2.2% vs. 1.0%; hazard ratio, 2.32; 95% CI, 1.82 to 2.94; P<0.001), as was the incidence of intracranial hemorrhage (0.7% vs. 0.5%; hazard ratio, 1.71; 95% CI, 1.18 to 2.48; P = 0.005). There was no significant difference in the incidence of fatal bleeding (0.2% vs. 0.1%; hazard ratio, 1.90; 95% CI, 0.87 to 4.15; P = 0.11). The incidence of an exploratory composite outcome of irreversible harm (death from any cause, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage) was similar in the ticagrelor group and the placebo group (10.1% vs. 10.8%; hazard ratio, 0.93; 95% CI, 0.86 to 1.02).

CONCLUSIONS: In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, those who received ticagrelor plus aspirin had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin. (Funded by AstraZeneca; THEMIS ClinicalTrials.gov number, NCT01991795.).

Original languageEnglish
JournalThe New England journal of medicine
Volume381
Issue number14
Pages (from-to)1309-1320
Number of pages12
ISSN0028-4793
DOIs
Publication statusPublished - 3 Oct 2019

    Research areas

  • Aged, Aspirin/adverse effects, Coronary Artery Disease/complications, Diabetes Mellitus, Type 2/complications, Double-Blind Method, Drug Therapy, Combination/adverse effects, Female, Follow-Up Studies, Hemorrhage/chemically induced, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/epidemiology, Platelet Aggregation Inhibitors/adverse effects, Stroke/epidemiology, Ticagrelor/adverse effects, Treatment Outcome

ID: 59126716