Optimal lesion preparation before implantation of a Magmaris bioresorbable scaffold in patients with coronary artery stenosis: Rationale, design and methodology of the OPTIMIS study

Kirstine Nørregaard Hansen*, Akiko Maehara, Manijeh Noori, Jens Trøan, Christian Oliver Fallesen, Mikkel Hougaard, Julia Ellert-Gregersen, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

12 Downloads (Pure)

Abstract

Introduction: Percutaneous coronary intervention with implantation of a bioresorbable scaffold (BRS) provide the vessel support for a limited period allowing the vessel to restore normal vasomotion after degradation of the BRS, opposed to treatment with drug-eluting stents where the metal persist in the vessel wall. Late lumen loss and reduction in lumen area after implantation have been reported. The purpose of this study was to investigate whether intense pre-dilatation before BRS implantation resulted in less reduction of minimal lumen area at 6- and 12-month follow-up after implantation of a Magmaris BRS (MgBRS). Coronary imaging with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) was assessed to track changes in lumen and vessel dimensions. Methods: The prospective Optimal lesion PreparaTion before Implantation of the Magmaris bioresorbable scaffold In patients with coronary artery Stenosis (OPTIMIS) study randomly assigned eighty-two patients with chronic coronary syndrome to two pre-dilatation treatment strategies. Patients were randomized in a 1:1 ratio to pre-dilatation with either a non-compliant scoring balloon or a standard non-compliant balloon prior to implantation of a MgBRS. The treated segment was evaluated with OCT and IVUS at baseline, after 6 and 12 months to assess changes in lumen and vessel dimensions. The hypothesis was that more intense pre-dilatation with a non-compliant scoring balloon before MgBRS implantation can reduce the risk of late lumen reduction compared to standard pre-dilatation. The power calculation used expected MLA after 6 months (6.22 mm2 for the scoring balloon and 5.01 mm2 for the standard non-compliant balloon), power of 80 %, significance level of 0.05 and expected drop-out rate of 15 %, requiring 82 patients to be enrolled. Results: Eighty-two patients were included in the study. Enrollment was from December 2020 to September 2023. Conclusion: The hypothesis was that more intense pre-dilatation with a non-compliant scoring balloon before MgBRS implantation can reduce the risk of late lumen reduction compared to standard pre-dilatation.

Original languageEnglish
Article number101260
JournalContemporary Clinical Trials Communications
Volume38
Number of pages9
ISSN2451-8654
DOIs
Publication statusPublished - Apr 2024

Keywords

  • Bioresorbable scaffolds
  • Intravascular imaging
  • Intravascular ultrasound
  • Optical coherence tomography

Fingerprint

Dive into the research topics of 'Optimal lesion preparation before implantation of a Magmaris bioresorbable scaffold in patients with coronary artery stenosis: Rationale, design and methodology of the OPTIMIS study'. Together they form a unique fingerprint.

Cite this