The use of ticagrelor in patients with stable coronary artery disease significantly reduces the rate of major cardiovascular events when compared against aspirin, according to this study presented on Sunday at ESC 2019 simultaneously published in NEJM, though the cost in terms of major bleeding seems unacceptable.
Primary end point rate (composite of cardiovascular death, infarction and stroke) occurred in 7.7% of patients receiving ticagrelor and aspirin vs. 8.5% receiving placebo and aspirin (p=0.04).
The cost of this benefit was to double the risk of major bleeding in patients receiving ticagrelor on top of significantly increasing the risk of intracranial bleeding.
Unless the risk of thrombotic events were high and at the same time the risk of bleeding were low, this study shows the net clinical benefit is not in favor of ticagrelor.
The THEMIS included 19271 patients with stable CAD and diabetes randomized to aspirin plus 60 mg of ticagrelor every 12 hrs. (the dose was lowered from 90 mg to 60 mg after the PEGASUS-TIMI 54 outcomes) vs. aspirin plus placebo.
Patients with prior MI or stroke were excluded. It is worth mentioning that 58% of both arms had a history of PCI (which facilitated the THEMIS-PCI). More than half of patients presented angina and 62% had multivessel disease with a long history of diabetes (mean 10 years).
Primary end point reduction was driven by MI (16% less) and stroke (20% less) but cardiovascular death or all-cause death did not see any changes.
Bleeding cost was superior to the benefit above mentioned, which is why dual APT (ticagrelor and aspirin) in these patients seems not a good idea, which is similar to what we had observed years ago with clopidogrel in the CHARISMA study.
Original Title: Ticagrelor in patients with stable coronary disease and diabetes.
Reference: Steg PG et al. N Engl J Med. 2019; Epub ahead of print.
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