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Ticagrelor monotherapy in patients with chronic kidney disease undergoing percutaneous coronary intervention:
Giulio G Stefanini1,2, Carlo Briguori3, Davide Cao4
1Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan 20090, Italy.
Insights
Ticagrelor monotherapy in chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) significantly reduced bleeding events compared to dual therapy. This approach did not increase ischemic event rates, offering a safer option for CKD patients.
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- Chronic kidney disease (CKD) is prevalent in patients undergoing percutaneous coronary intervention (PCI).
- Optimal antiplatelet therapy in CKD patients post-PCI remains a critical clinical question.
Purpose of the Study:
- To evaluate the safety and efficacy of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with and without CKD undergoing PCI.
- To assess the impact of renal function on treatment outcomes in the TWILIGHT trial.
Main Methods:
- Prespecified subanalysis of the TWILIGHT trial, including patients with drug-eluting stent implantation and high-risk criteria.
- Patients received ticagrelor plus aspirin for 3 months, then were randomized to ticagrelor monotherapy or ticagrelor plus aspirin for 12 months.
- CKD defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
Main Results:
- Ticagrelor monotherapy significantly reduced major bleeding (BARC types 2, 3, or 5) in both CKD (4.6% vs. 9.0%) and non-CKD (4.0% vs. 6.7%) patients, with a greater absolute risk reduction in CKD patients.
- No significant differences in rates of death, myocardial infarction, or stroke were observed between the groups, regardless of CKD status.
- P-interaction for bleeding was 0.508 and for ischemic events was 0.111, indicating no significant differential treatment effect based on CKD presence.
Conclusions:
- Ticagrelor monotherapy is a safe and effective strategy for CKD patients undergoing PCI, reducing bleeding risk without compromising ischemic protection.
- The findings support a tailored antiplatelet approach considering renal function in high-risk PCI patients.
Aims:
The aim of this study was to assess the impact of chronic kidney disease (CKD) on the safety and efficacy of ticagrelor monotherapy among patients undergoing percutaneous coronary intervention (PCI).
Methods And Results:
In this prespecified subanalysis of the TWILIGHT trial, we evaluated the treatment effects of ticagrelor with or without aspirin according to renal function. The trial enrolled patients undergoing drug-eluting stent implantation who fulfilled at least one clinical and one angiographic high-risk criterion. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, was a clinical study entry criterion. Following a 3-month period of ticagrelor plus aspirin, event-free patients were randomly assigned to aspirin or placebo on top of ticagrelor for an additional 12 months. Of the 6835 patients randomized and with available eGFR at baseline, 1111 (16.3%) had CKD. Ticagrelor plus placebo reduced the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding as compared with ticagrelor plus aspirin in both patients with [4.6% vs. 9.0%; hazard ratio (HR) 0.50, 95% confidence interval (CI) 0.31-0.80] and without (4.0% vs. 6.7%; HR 0.59, 95% CI 0.47-0.75; Pinteraction = 0.508) CKD, but the absolute risk reduction was greater in the former group. Rates of death, myocardial infarction, or stroke were not significantly different between the two randomized groups irrespective of the presence (7.9% vs. 5.7%; HR 1.40, 95% CI 0.88-2.22) or absence of (3.2% vs. 3.6%; HR 0.90, 95% CI 0.68-1.20; Pinteraction = 0.111) CKD.
Conclusion:
Among CKD patients undergoing PCI, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events as compared with ticagrelor plus aspirin.
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