Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial
Authors' conclusion
Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events.
Study context
- Population
- Patients at high ischemic or bleeding risk undergoing percutaneous coronary intervention (PCI), with or without PAD489 (7%) with PAD
- Participants
- 7,119 patients
- Comparison
- Ticagrelor monotherapy vs Ticagrelor plus aspirin
- Primary endpoint
- Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding
- Follow-up
- 12 months after randomization
Methodological detailspost-hoc subgroup analysis, placebo-controlled, open-label ticagrelor
- Post-hoc subgroup analysis
- Placebo-controlled
- Open-label ticagrelor
Primary result
As reported in the abstract
BARC 2, 3, or 5 bleeding, by PAD (subgroups) · 12 months
Ticagrelor monotherapy vs Ticagrelor plus aspirinHazard ratio (95% CI)
PAD: 4.6% vs 8.7%
0.52(0.25–1.07)
No PAD: 4.0% vs 7.0%
0.56(0.45–0.69)
Secondary outcomes
All-cause death, myocardial infarction (MI), or stroke, by PAD (key secondary) · 12 months
- Similar risk of death, MI, or stroke with ticagrelor monotherapy in PAD and no-PAD
- Interaction P-value .446
Original publication
Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial. Am Heart J. Published 6 March 2024. doi:10. 1016/ j. ahj. 2024. 03. 002
Summarised from the published abstract; every number is checked against it