Coronary disease & ACSRandomised controlled trial
5-Year Outcomes With a Novel Coronary Sirolimus-Eluting Bioresorbable Scaffold
- Randomised controlled trial
- 1:1 randomisation
Authors' conclusion
At 5-year follow-up, target lesion failure and stent thrombosis rates were comparable after NeoVas BRS and CoCr EES implantation in noncomplex lesions.
Study context
- Population
- Patients with single de novo native coronary lesions (reference vessel diameter 2.5–3.75 mm, lesion length ≤20 mm)
- Participants
- 560 patients
- Comparison
- NeoVas bioresorbable scaffolds (BRS) vs CoCr everolimus-eluting stents (EES)
- Primary endpoint
- Target lesion failure
- Follow-up
- 5 years
Primary result
As reported in the abstract
Hazard ratio
1.33
95% CI 0.74–2.38
P = 0.33
By group
NeoVas vs CoCr EES
HR 1.33 (95% CI 0.74–2.38); P = 0.33
Further findings
| Outcome | NeoVas | CoCr EES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Device thrombosis · 5 years | 1.5% | 0.7% | 2.05 (0.37–11.16) | P = 0.45 | |
| 0.050.21520Hazard ratio (log scale) |
- Scaffold absorption by OCT (NeoVas, subset) · 3 years
- 72.3% · ± 13.2%
Fractional flow reserve (prespecified subgroup) · postprocedure and 3 years
- FFR not significantly different between the 2 groups postprocedure or at 3 years (0.89 ± 0.07 vs 0.90 ± 0.05)
- P = 0.11
Safety
| Outcome | NeoVas | CoCr EES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Device thrombosis · 5 years | 1.5% | 0.7% | 2.05 (0.37–11.16) | P = 0.45 | |
| 0.050.21520Hazard ratio (log scale) |
Original publication
5-Year Outcomes With a Novel Coronary Sirolimus-Eluting Bioresorbable Scaffold. JACC Cardiovasc Interv. Published 8 September 2025. doi:10.1016/j.jcin.2025.06.036
Summarised from the published abstract; every number is checked against it