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La Dra. Silvia Valbuena López subraya en #SECenESC19 las principales conclusiones del estudio presentado en ESC Congress 2019. www.lasectelleva.com

Publicada em: Saúde e medicina
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  1. 1. Silvia Valbuena LópezTHEMIS Study THEMIS: Ticagrelor Added to Aspirin in Patients with Stable Coronary Disease and Diabetes NEJM. September 1, 2019. DOI: 10.1056/NEJMoa1908077
  2. 2. Silvia Valbuena LópezTHEMIS Study BACKGROUND • Patients with CAD and DM2 are a group at particular high risk of CV events • Previous research has shown a benefit of ticagrelor after ACS or in patients with a history of MI • The hypothesis is that DAPT with ticagrelor in addition to aspirin in patients with DM2 and CAD without a history of stroke or MI could benefit these patients
  3. 3. Silvia Valbuena LópezTHEMIS Study TRIAL DESIGN • Multicenter, randomized, double-blind, placebo controlled trial • Ticagrelor vs placebo on top of low-dose aspirin (75-150 mg) • Inclusion criteria  patients >50 years old without prior MI or stroke - DM2 (at least 6 months with oral therapy) - CAD (angiographic stenosis >50% o previous revascularization) • Ticagrelor dose was 90 mg bid initially, but switched to 60 mg bid after data from the PEGASUS trial • Endpoints - Primary efficacy endpoint  composite of CV death, MI or stroke - Secondary efficacy endpoint  CV death, MI, ischaemic stroke and all-cause death - Primary safety endpoint  major bleeding (TIMI)
  4. 4. Silvia Valbuena LópezTHEMIS Study STUDY FLOW
  5. 5. Silvia Valbuena LópezTHEMIS Study BASELINE CHARACTERISTICS
  6. 6. Silvia Valbuena LópezTHEMIS Study PRIMARY ENDPOINT
  7. 7. Silvia Valbuena LópezTHEMIS Study OTHER ENDPOINTS
  8. 8. Silvia Valbuena LópezTHEMIS Study BLEEDING ENDPOINTS
  10. 10. Silvia Valbuena LópezTHEMIS Study LIMITATIONS • Change of ticagrelor dose from 90 mg to 60 mg during the trial • Reduction in ischaemic events at the cost of an increase in major bleeding, including traumatic intracranial bleeding • Higher rate of treatment discontinuation in the ticagrelor group
  11. 11. Silvia Valbuena LópezTHEMIS Study CONCLUSIONS • In patients with stable CAD and DM2, but without a prior history of MI or stroke, adding ticagrelor to aspirin resulted in a reduction of the primary endpoint of CV death, MI or stroke • Higher rates of major bleeding were observed in the ticagrelor group • A long-term DAPT strategy may be beneficial in selected patients at low risk of bleeding but high risk of ischaemic events