Coronary disease & ACSRandomised controlled trial
A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels
- Randomised controlled trial
- multicentre
- non-inferiority
- prospective
Authors' conclusion
The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.
Study context
- Population
- Patients with de novo coronary small vessel disease; balloon sizing by optical coherence tomography109 completed angiographic follow-up
- Participants
- 121 patients
- Comparison
- Sirolimus-coated balloon vs paclitaxel-coated balloon
- Primary endpoint
- Non-inferiority for angiographic net lumen gain
- Follow-up
- 6 months
Primary result
Angiographic net lumen gain
Absolute difference
−0.23 mm
95% CI −0.37 to −0.09
P = 0.173 for non-inferiority
By group
SCB vs PCB
absolute difference −0.23 mm (95% CI −0.37 to −0.09); P for non-inferiority = 0.173
Non-inferiority margin 0.3 as printed, not drawn
As reported in the abstract
Further findings
Late lumen loss · smaller late loss with PCB
P < 0.001
| Outcome | SCB | PCB | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Late lumen enlargement | 30.0% | 53.7% | 2.60 (1.22–5.67) | P = 0.014 | |
| Binary restenosis | 32.8% | 12.5% | 3.41 (1.36–9.44) | P = 0.012 | |
| 0.10.31310Odds ratio (log scale) |
| Outcome | SCB | PCB | Estimate | P value |
|---|---|---|---|---|
| Angiography-derived fractional flow ratio · follow-up | mean 0.86 (SD 0.15) | mean 0.91 (SD 0.09) | P = 0.026 | |
| Vessels with ratio ≤0.80 | 13 | 5 |
Original publication
A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels. JACC Cardiovasc Interv. Published 23 October 2023. doi:10.1016/j.jcin.2023.09.026
Summarised from the published abstract; every number is checked against it