Key result
Ticagrelor monotherapy significantly reduced the total number of BARC 2, 3, or 5 bleeding events compared with ticagrelor plus aspirin (148 vs 278 events; P<0.001).
Why the study?
It was unknown whether the benefits of ticagrelor monotherapy versus ticagrelor plus aspirin after PCI are preserved when recurrent bleeding and ischaemic events are considered.
Does ticagrelor monotherapy reduce total and recurrent bleeding events without increasing ischemic events compared to ticagrelor plus aspirin in high-risk patients post-PCI?
RCT (n=7,119)
Does ticagrelor monotherapy reduce total and recurrent bleeding events without increasing ischemic events compared to ticagrelor plus aspirin in high-risk patients post-PCI?
p-value: p=<0.001
In high-risk patients post-PCI, dropping aspirin after 3 months and continuing ticagrelor monotherapy significantly reduces total and recurrent bleeding events without increasing ischemic risk.
Ticagrelor monotherapy after early aspirin discontinuation reduces total bleeding without excess ischaemia post-PCI; extends TWILIGHT time-to-first findings to recurrent events.
AIMS: In standard time-to-first event analysis, early aspirin discontinuation followed by ticagrelor monotherapy has been shown to reduce bleeding without increasing ischaemic complications compared with ticagrelor plus aspirin after percutaneous coronary intervention (PCI). We evaluated whether these treatment effects are preserved when recurrent events are considered. METHODS AND RESULTS: In this TWILIGHT trial post-hoc analysis, we assessed the effects of ticagrelor monotherapy on the total number of events that occurred over the 12-month follow-up among 7119 high-risk patients randomized to aspirin or placebo in addition to ticagrelor at 3 months post-PCI if event-free and adherent to treatment. There were 391 patients with at least one Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (primary endpoint). Of those, 28 (7.2%) had a recurrent event. The total number of BARC 2, 3, or 5 bleeding events was 148 in the ticagrelor monotherapy arm compared with 278 with ticagrelor plus aspirin arm (P < 0.001). Among 272 patients with at least one key secondary ischaemic endpoint (all-cause death, myocardial infarction, or stroke), 37 (13.6%) sustained a recurrent event. Total ischaemic events were similar (155 vs. 159) in the two groups. CONCLUSION: Among selected high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy followed by ticagrelor with or without aspirin, recurrent bleeding was less common than recurrent ischaemic events over 12 months. Analysis of total events indicates that ticagrelor monotherapy continues to be more effective than ticagrelor plus aspirin in reducing bleeding without a signal of ischaemic harm.
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Baber et al. (2024) conducted an RCT in High-risk patients after percutaneous coronary intervention (n=7,119). Ticagrelor monotherapy vs. Ticagrelor plus aspirin was evaluated on Total number of BARC type 2, 3, or 5 bleeding events (p=<0.001). Ticagrelor monotherapy significantly reduced the total number of BARC 2, 3, or 5 bleeding events compared with ticagrelor plus aspirin (148 vs 278 events; P<0.001).
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