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THEMIS Study
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. 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. 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)
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. 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