Mechanistic insights into lumen reduction after implantation of a drug-eluting bioresorbable metallic scaffold assessed with serial intracoronary imaging: from the OPTIMIS trial.

Authors

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

Published in

Coronary artery disease. Aug 20, 2025. Epub Aug 20, 2025.

Abstract

The mechanisms behind lumen reduction after percutaneous coronary intervention with a sirolimus-eluting Magmaris bioresorbable scaffold (MgBRS) are unclear.
To identify mechanisms and risk factors for lumen reduction after MgBRS implantation.
In the OPTIMIS-trial, patients were randomized to predilatation with a scoring balloon or a standard noncompliant balloon before MgBRS implantation. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed. Patients were divided into two groups according to minimal lumen area (MLA) at 6-month follow-up: MLA less than or equal to 4 mm2 and MLA greater than 4 mm2 assessed with OCT. Matched-framed analysis identified MLA at the lesion site and corresponding sites postprocedure and at follow-up. Vessel injury was defined as an intrascaffold dissection flap greater than or equal to 200 µm. Logistic regression predicted MLA less than or equal to 4 mm2.
Preprocedural, postprocedural, and 6-month follow-up IVUS and OCT were analyzable in 73 lesions (MLA ≤ 4 mm2, n = 28, and MLA > 4 mm2, n=45). In the MLA less than or equal to 4 mm2 group, lumen area (7.7 ± 1.8-6.4 ± 2.6 mm2, P = 0.002) and vessel area (15.5 ± 3.8-14.1 ± 4.4 mm2; P = 0.03) were reduced from postprocedure to follow-up, whereas lumen and vessel area did not differ significantly in the MLA less than or equal to 4 mm2 group. Vessel injury [odds ratio (OR): 5.1, 95% confidence interval (CI): 1.4-18.8] and predilatation with a standard noncompliant balloon (OR: 4.0, 95% CI: 1.1-14.4) were independent predictors of MLA less than or equal to 4 mm2.
Vessel shrinkage was associated with lumen reduction at the lesion site. Vessel injury and lesion preparation with a standard noncompliant balloon were associated with MLA less than or equal to 4 mm2.

PMID:
40832681
Bibliographic data and abstract were imported from PubMed on 20 Aug 2025.

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