Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial
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Why the study?
To determine whether ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy improves outcomes after PCI compared with standard antiplatelet regimens.
Does ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy for 23 months reduce all-cause mortality or new Q-wave myocardial infarction in patients undergoing percutaneous coronary intervention compared to standard dual antiplatelet therapy?
Comparison
1-month DAPT then 23-month ticagrelor monotherapy vs 12-month standard DAPT then 12-month aspirin monotherapy
Design
Multicentre, open-label, randomised superiority trial
Follow-up
2 years
Key result
Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by aspirin alone in preventing all-cause mortality or new Q-wave myocardial infarction (RR 0.87, p=0.073).
Authors
Discussion
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Overview
Does not support ticagrelor monotherapy after 1-month DAPT post-PCI; fails to confirm superiority hypothesis in broad populations.
Key Points
- To determine if 1 month of ticagrelor plus aspirin followed by 23 months of ticagrelor monotherapy improves outcomes over standard antiplatelet therapy after drug-eluting stent implantation.
- Multicentre, open-label randomised superiority trial (GLOBAL LEADERS, NCT01813435) conducted across 130 sites in 18 countries involving 15,968 participants undergoing percutaneous coronary intervention with biolimus A9-eluting stents.
- Participants were randomly assigned (1:1) to aspirin plus ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy (n=7,980) or standard dual antiplatelet therapy for 12 months followed by 12 months of aspirin monotherapy (n=7,988).
- The primary endpoint of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction occurred in 304 participants (3.81%) in the experimental group vs 349 (4.37%) in the control group (rate ratio 0.87 [95% CI 0.75-1.01]; p=0.073 for superiority).
- BARC grade 3 or 5 bleeding occurred in 163 participants (2.04%) in the experimental group and 169 (2.12%) in the control group (rate ratio 0.97 [95% CI 0.78-1.20]; p=0.77).
Study Design
Type
RCT (n=15,968)
Blinding
Open-label
Randomization
1:1, concealed, stratified by centre and clinical presentation, blocked
Multicenter
Yes
Structured PICO
Does ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy for 23 months reduce all-cause mortality or new Q-wave myocardial infarction in patients undergoing percutaneous coronary intervention compared to standard dual antiplatelet therapy?
P
Population
15,968 patients with stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention with a biolimus A9-eluting stent, followed for 2 years.
I
Intervention
75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy.
C
Comparator
Standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months.
O
Outcome
Composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction at 2 years.composite
Main Result
Relative Risk: 0.87 (95% CI 0.75–1.01)
Absolute Event Rate: 3.81% vs 4.37%
p-value: p=0.073
Ticagrelor monotherapy after 1 month of dual antiplatelet therapy was not superior to standard 12-month dual antiplatelet therapy followed by aspirin in reducing mortality or new Q-wave myocardial infarction at 2 years after percutaneous coronary intervention.
Limitations
- Open-label trial design
- Investigator reporting used without central adjudication for secondary outcomes
- Lower than expected event rate limiting the power of the trial
- Higher than anticipated proportion of unanalyzable ECGs
Cite This Study
Vranckx et al. (2018) conducted an RCT in Stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention (n=15,968). Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy vs. 75-100 mg aspirin daily plus either 75 mg clopidogrel daily or 90 mg ticagrelor twice daily for 12 months, followed by aspirin monotherapy for 12 months was evaluated on Composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction (RR 0.87, 95% CI 0.75-1.01, p=0.073). Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by aspirin alone in preventing all-cause mortality or new Q-wave myocardial infarction (RR 0.87, p=0.073).
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