Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease: TWILIGHT DM-CKD.

Abstract

AIMS:

We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI).

METHODS AND RESULTS:

In the TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM-/CKD-), 1822 (29.0%) had DM only (DM+/CKD-), 561 (8.9%) had CKD only (DM-/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (P-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (P-trend < 0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (P-trend < 0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2-5 [4.5% vs. 8.7%; hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.24-1.01] as well as BARC 3-5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03-0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups.

CONCLUSION:

Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events compared with ticagrelor plus aspirin.

• Authors: Payam Dehghani, Davide Cao, Usman Baber, Johny Nicolas, Samantha Sartori, Carlo A Pivato, Zhongjie Zhang, George Dangas, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, Dariusz Dudek, Michael Gibson, Robert Gil, Kurt Huber, Upendra Kaul, Ran Kornowski, Mitchell W Krucoff, Vijay Kunadian, Shamir Mehta, David J Moliterno, E Magnus Ohman, Javier Escaned, Gennaro Sardella, Samin K Sharma, Richard Shlofmitz, Giora Weisz, Bernhard Witzenbichler, Stuart Pocock, Roxana Mehran
• Journal: European heart journal. Cardiovascular pharmacotherapy (Eur Heart J Cardiovasc Pharmacother) Vol. 8 Issue 7 Pg. 707-716 (Sep 29 2022) ISSN: 2055-6845 [Electronic] England
• PMID: 35325085 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

Chemical References

• Platelet Aggregation Inhibitors
• Ticagrelor
• Aspirin

Topics

• Aspirin (adverse effects)
• Diabetes Mellitus (drug therapy)
• Drug Therapy, Combination
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Myocardial Infarction (epidemiology)
• Percutaneous Coronary Intervention (adverse effects, methods)
• Platelet Aggregation Inhibitors (adverse effects)
• Renal Insufficiency, Chronic (complications, diagnosis, therapy)
• Stroke (epidemiology)
• Ticagrelor (adverse effects)