Dataset Information

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

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.

SUBMITTER: Hansen KN

PROVIDER: S-EPMC10879808 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Hansen Kirstine Nørregaard KN Maehara Akiko A Noori Manijeh M Trøan Jens J Fallesen Christian Oliver CO Hougaard Mikkel M Ellert-Gregersen Julia J Veien Karsten Tange KT Junker Anders A Hansen Henrik Steen HS Lassen Jens Flensted JF Jensen Lisette Okkels LO

Contemporary clinical trials communications 20240207

<h4>Introduction</h4>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 impla ...[more]

PMID: 38384894

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Project description:BackgroundBioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound.MethodsEighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up.ResultsFollowing Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm2; P=0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm2; P=0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm2; P=0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm2; P=0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm2; P=0.35) did not differ significantly. Intravascular ultrasound findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8±2.9 versus 17.0±3.6 mm2; P=0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm2; P<0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling.ConclusionsLesion 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.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.

Dataset Information

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

Introduction

Methods

Results

Conclusion

Publications

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

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