Ticagrelor in diabetic patients reduces CV events but increases major bleeding

Results from the large THEMIS trial demonstrated that the combination ticagrelor/aspirin is associated with a reduction in cardiovascular events in diabetic patients. However, patients on ticagrelor experienced an increase in major bleeding compared with those using only aspirin.

The 10trial –one of the largest studies on diabetes/antithrombotic treatment– evaluated the effects of the antiplatelet ticagrelor + low-dose aspirin (n=9,619) vs placebo + aspirin only (n=9,601) for secondary cardiovascular prevention in patients with type 2 diabetes and stable coronary artery disease [1]. This was defined as a history of percutaneous coronary intervention (PCI), bypass grafting, or angiographic stenosis of 50% or more in at least one coronary artery. Patients with known prior myocardial infarction or stroke were excluded. The trial enrolled 19,220 patients at 1,315 sites across 42 countries in North America, South America, Asia, Africa, Australia, and Europe. Mean patient age was 66 years and 32% was female; follow-up was 39.9 months.

The results showed that the primary efficacy outcome of cardiovascular death, myocardial infarction, or stroke occurred in 7.7% of the ticagrelor/aspirin group vs 8.5% in the placebo/aspirin group (P=0.04). For secondary outcomes, this was 3.8% vs 3.7% for cardiovascular death (P=0.79), 2.8% vs 3.4% for myocardial infarction (P<0.05), and 1.6% vs 2.0% for stroke (P<0.05), respectively. With regard to safety outcomes, thrombolysis in myocardial infarction (TIMI) major bleeding occurred in 2.2% of patients who received ticagrelor/aspirin compared with 1.0% of patients on placebo/aspirin (P<0.001). Also, more patients in the ticagrelor/aspirin group discontinued study medication due to bleeding or dyspnoea compared with those in the placebo/aspirin group.

Dr Deepak Bhatt (Harvard Medical School, USA), who presented the results on behalf of the THEMIS Steering Committee and Investigators, concluded that the combination ticagrelor/aspirin does not appear to have a favourable risk/benefit ratio among patients with stable ischaemic heart disease and type 2 diabetes. He added that the TWILIGHT trial is currently evaluating a strategy of ticagrelor alone compared with aspirin alone in a similar population.

1. Deepak B, et al. THEMIS - Main Results of the Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study. FP Number 2097. ESC Congress 2019, 31 Aug-4 Sept, Paris, France.

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Posted on 10 October, 2019