A Randomized Comparison of Bioheart Sirolimus-Eluting Bioresorbable Scaffold and Everolimus-Eluting Stents: The BIOHEART-II Trial
Authors' conclusion
In this multicenter randomized trial, the Bioheart BRS was noninferior to the CoCr-EES for 1-year in-segment late loss, and resulted in a comparable 3-year clinical outcome.
Study context
- Population
- Patients with CAD, 22 Chinese sites
- Participants
- 434 patients
- Comparison
- Bioheart sirolimus-eluting bioresorbable scaffolds (BRS) vs cobalt-chromium everolimus-eluting stent (CoCr-EES)
- Bioheart BRSn = 218
- CoCr-EESn = 216reference
- Primary endpoint
- In-segment late loss
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, non-inferiority
- Prospective
- Multicentre
- Non-inferiority
Primary result
As reported in the abstract
1 year
P for non-inferiority < 0.0001
Secondary outcomes
| Outcome | Bioheart BRS | CoCr-EES | Difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| Proportion of covered struts on optical coherence tomography (key secondary) · 12 months · P for superiority = 0.91 | 97.9% | 98.5% | 0.02 (−0.3% to 0.26%) | P for non-inferiority < 0.0001 | |
| −0.4−0.200.20.4Difference, % (linear scale) |
Target lesion failure · 3 years
P = 0.84
Target lesion failure · 3 years
- Clinical outcomes at 3 years similar in the 2 groups
Original publication
A Randomized Comparison of Bioheart Sirolimus-Eluting Bioresorbable Scaffold and Everolimus-Eluting Stents: The BIOHEART-II Trial. JACC Cardiovasc Interv. Published 13 January 2025. doi:10.
Summarised from the published abstract; every number is checked against it