Coronary disease & ACSRandomised controlled trial
Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial
- Randomised controlled trial
- multicentre
- open label
- assessor blind
- non-inferiority
Authors' conclusion
Among participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.
Study context
- Population
- Adults (18–80 years) with ACS treated exclusively with paclitaxel-coated balloons, 41 hospitals in China, 2021–2023
- Participants
- 1,948 adults
- Comparison
- Stepwise dual antiplatelet therapy (DAPT) de-escalation vs standard 12-month DAPT
- Stepwise de-escalationn = 975
- Standard DAPTn = 973reference
- Primary endpoint
- Net adverse clinical events (all cause death, stroke, MI, revascularisation, Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Difference
0.36%
P = 0.013 for non-inferiority
Events by treatment group
Further findings
| Outcome | Stepwise de-escalation | Standard DAPT | difference (95% CI) | P value | |
|---|---|---|---|---|---|
| All cause death, stroke, MI and revascularisation | 8.6% | 7.6% | 1.05% (−1.37% to 3.47%) | P = 0.396 | |
| −2024Difference (linear scale) |
Wins
| Outcome | Stepwise de-escalation | Standard DAPT | win ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Hierarchical composite (death, stroke, MI, BARC 3 bleeding, revascularisation, BARC 2 bleeding), win ratio | 14.4% | 10.1% | 1.43 (1.12–1.83) | P = 0.004 | |
| 0.512Win ratio (log scale) |
Safety
| Outcome | Stepwise de-escalation | Standard DAPT | difference (95% CI) | P value | |
|---|---|---|---|---|---|
| BARC type 3 or 5 bleeding | 0.4% | 1.6% | −1.19% (−2.07% to −0.31%) | P = 0.008 | |
| −3−2−101Difference (linear scale) |
Original publication
Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. Published 31 March 2025. doi:10.1136/bmj-2024-082945
Summarised from the published abstract; every number is checked against it