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Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold.

ABSTRACT: OBJECTIVES:To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points. BACKGROUND:Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points. METHODS:A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points. RESULTS:At a median of 8?months (range 4-12?months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59?±?0.39?mm, a percentage diameter stenosis of 39.65?±?15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44?±?28.62 and 38.20?±?25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5?months. CONCLUSIONS:Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA.

SUBMITTER: Tovar Forero MN

PROVIDER: S-EPMC7027819 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold.

Tovar Forero Maria Natalia MN van Zandvoort Laurens L Masdjedi Kaneshka K Diletti Roberto R Wilschut Jeroen J de Jaegere Peter P PP Zijlstra Felix F Van Mieghem Nicolas M NM Daemen Joost J

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20190429 2

<h4>Objectives</h4>To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points.<h4>Background</h4>Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.<h4>Method ...[more]

PMID: 31033171

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Project description:ImportanceBioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown.ObjectiveTo examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals.Data sourcesWe searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies.Study selectionEligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria.Data extraction and synthesisIndividual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed.Main outcomes and measuresThe major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years.ResultsMean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis.Conclusions and relevanceThe period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease.Trial registrationClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Dataset Information

Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold.

Publications

Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold.

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