One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry
Authors' conclusion
The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.
Study context
- Population
- Patients with CAD treated with a resorbable magnesium scaffold, >100 centres in Europe, Asia and Asia-Pacific
- Participants
- 2,066 patients2,154 lesions
- Outcome
- Target lesion failure (TLF)
- Follow-up
- 24 months
Methodological detailsinternational, multicentre
- International
- Multicentre
Main finding
As reported in the abstract
TLF
Target lesion failure (TLF) rate
6.8%
Clinically driven target lesion revascularisation
6.0%
Observational data: associations, not effects.
Further findings
| Outcome | P value |
|---|---|
| TLF, NSTEMI vs no NSTEMI (subgroup) · 24 months9.3% vs 6.2% | P = 0.025 |
Device and procedure success
- Device success
- 97.5%
- Procedure success
- 99.1%
TLF, DM and type B2/C lesion subgroups · 24 months
- DM: no significant difference
- 7.0%
- Type B2/C lesions: no significant difference
- 7.9%
Safety
Definite or probable scaffold thrombosis · 24 months
- Scaffold thrombosis rate
- 0.8%
- Half occurred after premature discontinuation of antiplatelet/anticoagulation therapy; only one beyond 6 months (day 391)
Original publication
One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry. EuroIntervention. Published 19 June 2023. doi:10.
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