Randomized Trial of Biolimus Drug-coated Balloon (DCB) for In-Stent Restenosis: The Primary Results of the REFORM Study
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 patients20 centres6 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
Methodological detailsmulticentre, assessor-blinded, non-inferiority, 2:1 randomisation
- Multicentre
- Assessor-blinded
- Non-inferiority
- 2:1 randomisation
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: The Primary Results of the REFORM Study. JACC Cardiovasc Interv. Published 5 February 2025. doi:10.
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