- Question
- Can a stepwise de-escalation of antiplatelet therapy, less intense than 12 months of DAPT, be non-inferior in patients with acute coronary syndrome treated exclusively with drug-coated balloons?
- Design
- Multicentre, randomised 1:1, open-label, assessor-blind non-inferiority trial conducted in 41 hospitals in China between November 2021 and January 2023, including 1948 patients.
- Population
- Adults aged 18 to 80 years with acute coronary syndrome treated exclusively with paclitaxel-coated balloons. Most treated lesions were in small vessels and a portion were in-stent restenosis.
- Intervention
- Stepwise de-escalation (n=975): aspirin plus ticagrelor for one month, then five months of ticagrelor monotherapy, followed by six months of aspirin monotherapy.
- Control
- Standard DAPT (n=973): aspirin plus ticagrelor for 12 months.
- Primary outcome
- Net adverse clinical events at 12 months (all-cause death, stroke, myocardial infarction, revascularisation and BARC type 3 or 5 bleeding) in the intention-to-treat population. Non-inferiority required the upper limit of the one-sided 95% CI of the absolute risk difference to be below 3.2%.
- Results
- The primary endpoint occurred in 87 patients (8.9%) with de-escalation and 84 (8.6%) with standard DAPT (difference 0.36%; upper limit of one-sided 95% CI 2.47%; P for non-inferiority=0.013). BARC type 3 or 5 bleeding was lower with de-escalation (0.4% vs 1.6%; difference -1.19%, 95% CI -2.07% to -0.31%; P=0.008).
- Safety
- Major bleeding (BARC type 3 or 5) was significantly less frequent with de-escalation (four vs 16 patients). The composite of death, stroke, myocardial infarction and revascularisation was 8.6% vs 7.6% (difference 1.05%, 95% CI -1.37% to 3.47%; P=0.396).
- Conclusion
- In patients with acute coronary syndrome treated exclusively with drug-coated balloons, stepwise DAPT de-escalation was non-inferior to 12-month DAPT for net adverse clinical events.
- Why it matters
- Supports a shorter, less intense antiplatelet regimen after drug-coated balloon angioplasty with less bleeding, although in a Chinese population and with an open-label design.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026