Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in Percutaneous Coronary Intervention (PCI): The SORT OUT XI Randomized Trial
Authors' conclusion
BES was noninferior to DTS at 1-year follow-up regarding the primary endpoint of TLF. However, BES was associated with significantly increased risk of definite stent thrombosis.
Study context
- Population
- All-comer patients undergoing PCI at 3 Western Danish heart centres
- Participants
- 3,136 patients
- Comparison
- BES vs DTS
- BESn = 1,566
- DTSn = 1,570reference
- Primary endpoint
- Target lesion failure (TLF) (cardiac death, target lesion MI or target lesion revascularization)
- Follow-up
- 1 year
Methodological detailsnon-inferiority, multicentre
- Non-inferiority
- Multicentre
Primary result
As reported in the abstract
TLF
BES vs DTSRisk difference (1-sided 90% CI)P value
Non-inferiority margin 2.1%; noninferior
−1.07%(upper limit 0.21%)
P = 0.00002for non-inferiorityBES vs DTSIncidence rate ratio (95% one-sided CI)P value
TLF
0.79(0.57–1.09)
P = 0.15Non-inferiority margin 2.1 as printed, not drawn
Further findings
| Outcome | BES | DTS | IRR (95% CI) | P value | |
|---|---|---|---|---|---|
| Cardiac death · 1 year | 1.1% | 1.9% | 0.60 (0.33–1.07) | P = 0.08 | |
| Target lesion MI · 1 year | 2.3% | 2.1% | 1.09 (0.68–1.75) | P = 0.73 | |
| 0.20.5125Incidence rate ratio (log scale) |
Safety
| Outcome | BES | DTS | IRR (95% CI) | P value | |
|---|---|---|---|---|---|
| Definite stent thrombosis · 1 year | 1.3% | 0.6% | 2.33 (1.07–5.11) | P = 0.034 | |
| 0.20.5125Incidence rate ratio (log scale) |
Original publication
Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial. J Am Coll Cardiol. Published 21 May 2025. doi:10.
Summarised from the published abstract; every number is checked against it