Abstract | BACKGROUND: Patients with diabetes appear to be at elevated risk of atherothrombotic events. OBJECTIVES: METHODS: We examined the subgroups of patients with diabetes (n = 6,806) and without diabetes (n = 14,355) from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54), in which 21,162 patients with a history of MI 1 to 3 years prior and with additional risk factors were randomized to ticagrelor (90 or 60 mg twice daily) or placebo. Patients were followed for a median of 33 months. The primary efficacy endpoint was major adverse cardiovascular events ( MACE) (cardiovascular death, MI, stroke) and the primary safety endpoint was TIMI (Thrombolysis In Myocardial Infarction) major bleeding. RESULTS: The relative risk reduction in MACE with ticagrelor was consistent for the pooled doses versus placebo in patients with diabetes (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.72 to 0.99; p = 0.035) and without diabetes (HR: 0.84; 95% CI: 0.74 to 0.96; p = 0.013; p interaction = 0.99). As patients with diabetes were at higher risk of MACE, the absolute risk reduction tended to be greater in patients with versus without diabetes (1.5% vs. 1.1%, with corresponding 3-year number needed to treat of 67 vs. 91). In patients with diabetes requiring pharmacological therapy (n = 5,960), the absolute risk reduction was 1.9% with a 3-year number needed to treat of 53. Additionally, in patients with diabetes, ticagrelor reduced cardiovascular death by 22% and coronary heart disease death by 34%. Similar to patients without diabetes, there was increased TIMI major bleeding in patients with diabetes (HR: 2.56; 95% CI: 1.52 to 4.33; p = 0.0004). CONCLUSIONS: In patients with diabetes with prior MI, adding ticagrelor to aspirin significantly reduces the risk of recurrent ischemic events, including cardiovascular and coronary heart disease death. (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562).
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Authors | Deepak L Bhatt, Marc P Bonaca, Sameer Bansilal, Dominick J Angiolillo, Marc Cohen, Robert F Storey, Kyungah Im, Sabina A Murphy, Peter Held, Eugene Braunwald, Marc S Sabatine, Ph Gabriel Steg |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 67
Issue 23
Pg. 2732-2740
(Jun 14 2016)
ISSN: 1558-3597 [Electronic] United States |
PMID | 27046160
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Purinergic P2Y Receptor Antagonists
- Ticagrelor
- Adenosine
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Topics |
- Adenosine
(administration & dosage, adverse effects, analogs & derivatives)
- Aged
- Coronary Disease
(mortality)
- Diabetes Mellitus
(epidemiology)
- Dose-Response Relationship, Drug
- Female
- Hemorrhage
(chemically induced, epidemiology)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(epidemiology, prevention & control)
- Purinergic P2Y Receptor Antagonists
(administration & dosage, adverse effects)
- Secondary Prevention
- Stroke
(epidemiology, prevention & control)
- Ticagrelor
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