Characterizing high-risk enrollment criteria and impact on clinical outcomes in a large randomized clinical trial: Insights from the TWILIGHT trial
Authors' conclusion
In the TWILIGHT trial, the high-risk features correlated more strongly with ischemic than with bleeding risk. Nonetheless, the benefits of ticagrelor compared with ticagrelor plus aspirin were consistent, irrespective of the number of high-risk features. These findings are only applicable to patients who are event-free at 3 months after PCI.
Study context
- Population
- High-risk patients who underwent percutaneous coronary intervention (PCI) and were event-free at 3 months, enrolled in the TWILIGHT trialpatients analysed by number of high-risk criteria
- Participants
- 7,119 patients
- Comparison
- Ticagrelor monotherapy vs ticagrelor plus aspirin
- Outcome
- Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, by number of risk factors
Main finding
As reported in the abstract
ticagrelor monotherapy vs ticagrelor plus aspirinHazard ratio (95% CI)
≤ 3-RF: 3.5% vs 5.8%
0.59(0.38–0.93)
4-RF: 3.7% vs 6.4%
0.57(0.37–0.86)
5-RF: 3.8% vs 8.6%
0.44(0.29–0.66)
≥ 6-RF: 5.3% vs 7.9%
0.65(0.44–0.96)
Secondary outcomes
| Outcome | Ticagrelor monotherapy | Ticagrelor plus aspirin | HR (95% CI) | |
|---|---|---|---|---|
| Composite of death, myocardial infarction, or stroke (key secondary), by number of risk factors · within 1 year after randomization≤ 3-RF | 1.6% | 2.1% | 0.75 (0.38–1.50) | |
| Composite of death, myocardial infarction, or stroke (key secondary), by number of risk factors · within 1 year after randomization4-RF | 3.5% | 2.2% | 1.58 (0.91–2.75) | |
| Composite of death, myocardial infarction, or stroke (key secondary), by number of risk factors · within 1 year after randomization5-RF | 4.1% | 5.0% | 0.80 (0.51–1.24) | |
| Composite of death, myocardial infarction, or stroke (key secondary), by number of risk factors · within 1 year after randomization≥ 6-RF | 6.7% | 6.9% | 0.98 (0.67–1.43) | |
| 0.20.5125Hazard ratio (log scale) |
- Composite of death, myocardial infarction, or stroke (key secondary), by number of risk factors: p-interaction = .22
Proportion of patients fulfilling ≤ 3, 4, 5, or ≥ 6 risk factors
- ≤ 3 risk factors
- 21.5%
- 4 risk factors
- 32.7%
- 5 risk factors
- 27.4%
- ≥ 6 risk factors
- 18.4%
Most prevalent enrollment criteria
- Troponin-positive acute coronary syndrome (ACS), most prevalent clinical criterion
- 64.9%
- Multivessel disease (MVD), most prevalent angiographic criterion
- 66.5%
- Most frequent intersection: troponin-positive ACS, atherosclerotic vascular disease, MVD, left main or proximal anterior descending lesion, and stent length > 30 mm
Ischemic and bleeding risk by number of high-risk criteria
- Stepwise increase in ischemic but not in bleeding risk with an increasing number of high-risk criteria
Original publication
Characterizing high-risk enrollment criteria and impact on clinical outcomes in a large randomized clinical trial: Insights from the TWILIGHT trial. Am Heart J. Published 30 January 2025. doi:10.
Summarised from the published abstract; every number is checked against it