Abstract | BACKGROUND: METHODS: 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:
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Authors | P Gabriel Steg, Deepak L Bhatt, Tabassome Simon, Kim Fox, Shamir R Mehta, Robert A Harrington, Claes Held, Marielle Andersson, Anders Himmelmann, Wilhelm Ridderstråle, Maria Leonsson-Zachrisson, Yuyin Liu, Grzegorz Opolski, Dmitry Zateyshchikov, Junbo Ge, José C Nicolau, Ramón Corbalán, Jan H Cornel, Petr Widimský, Lawrence A Leiter, THEMIS Steering Committee and Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 381
Issue 14
Pg. 1309-1320
(Oct 03 2019)
ISSN: 1533-4406 [Electronic] United States |
PMID | 31475798
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2019 Massachusetts Medical Society. |
Chemical References |
- Platelet Aggregation Inhibitors
- Ticagrelor
- Aspirin
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Topics |
- Aged
- Aspirin
(adverse effects, therapeutic use)
- Coronary Artery Disease
(complications, drug therapy, mortality)
- Diabetes Mellitus, Type 2
(complications, drug therapy, mortality)
- Double-Blind Method
- Drug Therapy, Combination
(adverse effects)
- Female
- Follow-Up Studies
- Hemorrhage
(chemically induced, epidemiology, mortality)
- Humans
- Incidence
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Myocardial Infarction
(epidemiology, prevention & control)
- Platelet Aggregation Inhibitors
(adverse effects, therapeutic use)
- Stroke
(epidemiology, prevention & control)
- Ticagrelor
(adverse effects, therapeutic use)
- Treatment Outcome
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