This is a sub-study of the THEMIS presented during the ESC 2019 scientific sessions in Paris, and simultaneously published in Lancet.
They were all diabetics with stable coronary artery disease, but in this sub-study patients also had prior PCI.
It included over 11000 patients with prior PCI for whom the combination of ticagrelor and aspirin significantly reduced risk of death, infraction or stroke in approximately 15% vs. aspirin plus placebo (7.3% with ticagrelor vs 8.6% with placebo; p=0.01).
Ticagrelor (same as in the main study) significantly increase bleeding risk. We are talking about a two-fold higher compared against placebo as regards major bleeding (HR 2.03; CI 95% 1.48-2.76). However, fatal bleeding risk (BARC 5) or intracranial bleeding were similar between the two.
In terms of net clinical benefit (combination of all-cause death, infarction, stroke, fatal bleeding and intracranial bleeding) outcomes favor ticagrelor in patients with prior PCI (9.3% with ticagrelor vs 11.0% with placebo; p=0.005) but not in patients with no prior PCI.
This difference between the general population (the global THEMIS) and this subgroup with a history of PCI (the THEMIS-PCI) could be explained because patients with prior PCI had already received dual antiplatelet antiaggregation therapy and therefore had passed the bleeding test. Prior PCI basically marks patients with stable coronary angina and lower risk of bleeding; these will indeed benefit from ticagrelor.
Original Title: Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase-3, placebo-controlled, randomized trial.
Reference: Bhatt DL et al. Lancet. 2019; Epub ahead of print.
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