Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial
Authors' conclusion
Lesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon.
Study context
- Population
- Patients with stable angina undergoing implantation of a Magmaris bioresorbable scaffolds (BRS)6-month follow-up with OCT and IVUS available in 74 patients
- Participants
- 82 patients
- Comparison
- Lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS
- Primary endpoint
- minimal lumen area
- Follow-up
- 6-month follow-up
Methodological details1:1 ratio
- 1:1 ratio
Primary result
As reported in the abstract
Scoring balloon
4.7±1.4
mm²
Standard noncompliant balloon
3.9±1.9
mm²
P = 0.04
Further findings
| Outcome | Scoring balloon | Standard noncompliant balloon | P value |
|---|---|---|---|
| Post-implantation minimal lumen area, mean scaffold area, mean lumen area · Following Magmaris BRS implantationDid not differ significantly | |||
| Minimal lumen area | 6.4±1.6 | 6.3±1.5 | |
| Mean scaffold area | 7.8±1.5 | 7.5±1.7 | |
| Mean lumen area | 8.0±1.6 | 7.7±2.1 | |
| Mean lumen area · 6 monthsDid not differ significantly | 7.2±1.4 mm² | 6.8±2.2 mm² | P = 0.35 |
| IVUS mean vessel area at lesion site, baseline to follow-up · baseline to 6-month follow-up | 16.8±2.9 versus 17.0±3.6 mm² | 17.1±4.4 versus 15.7±4.9 mm² |
- Post-implantation minimal lumen area, mean scaffold area, mean lumen area: minimal lumen area P =0.65
- Post-implantation minimal lumen area, mean scaffold area, mean lumen area: mean scaffold area P =0.37
- Post-implantation minimal lumen area, mean scaffold area, mean lumen area: mean lumen area P =0.41
- IVUS mean vessel area at lesion site, baseline to follow-up: scoring balloon: no difference, P =0.62
- IVUS mean vessel area at lesion site, baseline to follow-up: standard noncompliant balloon: smaller due to negative remodeling, P <0.001
Original publication
Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial. Circ Cardiovasc Interv. Published 21 January 2025. doi:10.
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