Ticagrelor in Patients with Stable Coronary Disease and Diabetes
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
31475798
DOI
10.1056/nejmoa1908077
Knihovny.cz E-resources
- MeSH
- Aspirin adverse effects therapeutic use MeSH
- Stroke epidemiology prevention & control MeSH
- Diabetes Mellitus, Type 2 complications drug therapy mortality MeSH
- Double-Blind Method MeSH
- Incidence MeSH
- Myocardial Infarction epidemiology prevention & control MeSH
- Platelet Aggregation Inhibitors adverse effects therapeutic use MeSH
- Kaplan-Meier Estimate MeSH
- Drug Therapy, Combination adverse effects MeSH
- Hemorrhage chemically induced epidemiology mortality MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Coronary Artery Disease complications drug therapy mortality MeSH
- Aged MeSH
- Ticagrelor adverse effects therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Aspirin MeSH
- Platelet Aggregation Inhibitors MeSH
- Ticagrelor MeSH
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.).
References provided by Crossref.org
Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial
ClinicalTrials.gov
NCT01991795