Coronary disease & ACSRandomised controlled trial
Randomized Trial of Biolimus Drug-coated Balloon (DCB) for In-Stent Restenosis
- Randomised controlled trial
- multicentre
- assessor-blinded
- non-inferiority
- 2:1 randomisation
Authors' conclusion
In patients with ISR, the REFORM study failed to demonstrate noninferiority of the investigational biolimus DCB compared with the standard paclitaxel DCB.
Study context
- Population
- Patients with coronary in-stent restenosis
- Participants
- 202 patients · 20 centres · 6 countries
- Comparison
- Biolimus A9-coated balloon vs paclitaxel-coated balloon
- BCBn = 135
- Paclitaxel-coated balloon (PCB)n = 67reference
- Primary endpoint
- In-segment percentage diameter stenosis
- Follow-up
- 6 months
Primary result
As reported in the abstract
95% CI 4.9%–18.8%; P = 0.48
Secondary outcomes
| Outcome | BCB | PCB | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Target lesion failure · 1 year | 23.7% | 17.1% | 1.44 (0.72–2.88) | P = 0.28 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Randomized Trial of Biolimus DCB for In-Stent Restenosis. JACC Cardiovasc Interv. Published 5 February 2025. doi:10.1016/j.jcin.2024.11.026
Summarised from the published abstract; every number is checked against it