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A post hoc analysis of the TWILIGHT trial suggests the effects of ticagrelor monotherapy observed in the overall trial were consistent, irrespective of diabetes and chronic kidney disease status.
A new analysis of the TWILIGHT trial examining the effects of ticagrelor in patients with concomitant diabetes and chronic kidney disease indicates ticagrelor monotherapy reduced risk of clinically relevant and major bleeding with no significant increase in ischemic events compared to ticagrelor plus aspirin.
Presented at the European Society of Cardiology (ESC) Congress 2021, the study outlines the increased risk of bleeding and ischemic outcomes in this patient population as well as the association of ticagrelor monotherapy with a more favorable net benefit than ticagrelor plus aspirin among patients in the trial.
With increasing rates of diabetes and chronic kidney disease in recent years, developing an understanding of best practices in anticoagulation among this patient population has the potential to reduce event rates and improve patient outcomes for a large patient population. With this in mind, TWILIGHT CKD-DM was designed to assess whether a short dual antiplatelet therapy course reduced BARC 2, 3, or 5 bleeding without increasing death, myocardial infarction, or stroke among patients in the trial with concomitant diabetes and chronic kidney disease.
Of the 7119 patients randomized in the TWILIGHT trial, 499 (8.0%) had concomitant diabetes and chronic kidney disease. For the purpose of analysis, patients were stratified according to diabetes status and presence of chronic kidney disease. These groups included 561 patients with chronic kidney disease but without diabetes, 1822 patients with diabetes but without chronic kidney disease, and 3391 patients without either diagnosis.
Upon analysis, results suggested ticagrelor monotherapy was associated with significant. Reductions in BARC 2, 3 or 5 and BARC 3 or 5 bleeding events, irrespective of diabetes and chronic kidney disease status. Investigators pointed out the results of this post hoc analysis are intended to be hypothesis-generating and larger studies are needed to confirm these findings.
For more on the results of this study, Practical Cardiology reached out to study investigator Davide Cao, MD, an interventional cardiology at Icahn School of Medicine at Mount Sinai, and that conversation is the subject of this ESC Congress 2021 House Call.
This study, “Ticagrelor monotherapy after percutaneous coronary intervention in patients with concomitant diabetes mellitus and chronic kidney disease: a TWILIGHT substudy,” was presented at ESC Congress 2021.