At the European Society of Cardiology Congress 2019, researchers from Brigham and Women's Hospital and Greater Paris University Hospitals - AP-HP/Université de Paris, have presented the results from The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study ( THEMIS ), a clinical trial that has evaluated whether adding Ticagrelor ( Brilique ) to Aspirin ( Acetylsalicylic acid ) improves outcomes for patients with stable coronary artery disease and diabetes mellitus but without a history of myocardial infarction or stroke.
Taking Ticagrelor in addition to Aspirin has reduced the risk of a composite of cardiovascular death, myocardial infarction, or stroke.
Patients on this dual-antiplatelet therapy also experienced greater risk of major bleeding.
In THEMIS-PCI, a study that specifically looked at THEMIS patients with a history of previous percutaneous coronary intervention ( PCI ) that includes stenting, versus the overall THEMIS population, researchers found even more favorable results for patients taking Ticagrelor plus Aspirin.
Results of THEMIS are published simultaneously in The New England Journal of Medicine and results from THEMIS-PCI are published simultaneously in The Lancet.
In THEMIS, the largest trial of patients with diabetes to date, more than 19,000 patients with stable coronary artery disease and diabetes were randomized to receive either Ticagrelor plus Aspirin or a placebo plus Aspirin.
Patients were followed for an average of more than three years.
During that time, 736 of 9,619 patients ( 7.7% ) taking Ticagrelor plus Aspirin experienced cardiovascular death, myocardial infarction, or stroke versus 818 of 9,601 patients ( 8.5% ) taking placebo plus Aspirin ( 10% reduction ).
As seen with other anti-platelet medications, Ticagrelor has increased the risk of major bleeding ( 206 patients versus 100 patients ) and intracranial hemorrhage ( 70 patients versus 46 patients ) compared with placebo.
The difference in intracranial hemorrhages was driven by an increased number of traumatic bleeds, most of them subdural, and not by spontaneous or procedural bleeding.
Among participants with a history of previous PCI, the risk reductions outweighed the increased bleeding risks.
Patients who had received PCI, which commonly uses devices known as stents to widen a coronary blood vessel and keep blood flowing, accounted for the majority ( 58% ) of the total THEMIS population.
Among these patients in THEMIS-PCI, 404 of 5,558 ( 7.3% ) participants taking Ticagrelor plus Aspirin experienced cardiovascular death, myocardial infarction, or stroke, versus 480 of 5,596 ( 8.6% ) participants taking placebo plus Aspirin ( 15% reduction ).
Major bleeding occurred in 111 of 5,536 ( 2.0% ) patients receiving Ticagrelor and 62 of 5,564 ( 1.1% ) patients receiving placebo.
The risk for intracranial bleeding was similar between Ticagrelor and placebo ( 33 patients versus 31 patients, respectively ).
Ticagrelor have provided a very favorable balance of benefit versus risk, more than in patients without a history of PCI. ( Xagena )
Source: European Society of Cardiology ( ESC ) Congress 2019