Coronary disease & ACSRandomised controlled trial
Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES
- Randomised controlled trial
- prospective
- multicentre
- single-blind
- non-inferiority
Authors' conclusion
The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year.
Study context
- Population
- Patients undergoing PCI for chronic or acute coronary syndromes, North America and Europe
- Participants
- 1,720 patients · 2,159 lesions
- Comparison
- Biodegradable polymer sirolimus-eluting stent (BP-SES) vs second-generation DES
- BP-SESn = 860
- Controln = 860reference
- Primary endpoint
- Target lesion failure (TLF) (cardiac death, target vessel-related MI or ischemia-driven target lesion revascularization)
- Follow-up
- 12 months
Primary result
TLF
Absolute risk difference
0.13%
97.5% CI upper bound 2.03
P < 0.0001 for non-inferiority
By group
As reported in the abstract
Secondary outcomes
Mean, mm
| Outcome | BP-SES | Control | least squares mean difference (90% CI) | P value | |
|---|---|---|---|---|---|
| In-stent late lumen loss (angiography substudy) · 13 months | 0.149 (SD 0.263) | 0.327 (SD 0.463) | −0.178 (−0.2943 to −0.0632) | P for non-inferiority < 0.0001 | |
| −0.4−0.200.2Difference (linear scale) |
- In-stent late lumen loss (angiography substudy): 104 patients (97.2%), 128 (94.1%) lesions with angiographic follow-up
Mean neointimal hyperplasia thickness (OCT substudy, 37 patients, 42 lesions) · 13 months
- No difference between groups
- P for non-inferiority = 0.01
Cardiac death, MI, stent thrombosis
- Rates similar between groups
Original publication
Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES. J Am Coll Cardiol. Published 30 October 2024. doi:10.1016/j.jacc.2024.10.074
Summarised from the published abstract; every number is checked against it