The THEMIS trial: Effect of Ticagrelor on health outcomes in
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The Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study (THEMIS) trial explored whether adding ticagrelor to aspirin would improve, over the long term, cardiovascular outcomes in patients with diabetes, stable CAD, but without a prior acute event such as stroke or myocardial infarction.

Ticagrelor, a reversible P2Y12 receptor antagonist, has been previously tested and found to provide benefit in patients with acute coronary syndromes (compared with clopidogrel in the PLATO trial1) and in high risk post myocardial infarction (MI) patients.

THEMIS found that ticagrelor reduced the primary composite outcome of cardiovascular death, MI, or stroke by 10%.

THEMIS randomized patients with a history of stable CAD (history of percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or ≥50% coronary stenosis treated medically) with type 2 diabetes mellitus to receive either ticagrelor or placebo on top of low-dose aspirin (75 to 150 mg), as well as other evidence-based therapies. A total of 20,108 patients were enrolled, of whom 19,220 were successfully randomized suggesting good generalizability of the findings.

THEMIS found that ticagrelor reduced the primary composite outcome of cardiovascular death, MI, or stroke by 10%. This included reductions in ST-segment elevation MI (STEMI), in ischemic stroke, and in amputations or acute limb ischemia. This benefit was obtained at the expense of increased TIMI major bleeding, which included a modest (0.13%) but statistically significant increase in intracranial hemorrhage (driven by traumatic subdural hematomas).

THEMIS has provided a new option for these patients. Its results suggest that in patients with diabetes and stable CAD and a history of prior coronary stenting who have tolerated dual antiplatelet therapy (DAPT) well in the past without bleeding, continuation of DAPT or re-initiation of DAPT with aspirin and ticagrelor should be considered.

Source: https://www.acc.org/latest-in-cardiology/articles/2020/02/17/10/44/the-effect-of-ticagrelor-on-health-outcomes-in-diabetes-mellitus-patients-intervention-study-themis-trial
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