ArticleCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025
The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months.
Article in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04157153 (BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System), which is not on this map. Not yet cited in PubMed.
What it found
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The trial behind it
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BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
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10 authors.
Funding
Abstract
backgroundThird-generation resorbable magnesium scaffold (RMS) was developed with stronger mechanical properties and thinner struts compared to its predecessor. This study aimed to assess the influence of the OCT-derived underlying plaque characteristics on in-scaffold late lumen loss (LLL) in patients treated with RMS up to 12-months.
methodsPatients enrolled in the BIOMAG-I trial and who underwent OCT imaging before and after the index procedure were included in the current analysis. The acquired intravascular imaging data were evaluated to assess the presence of fibrous, calcific, or lipidic lesions. We calculated the proportions of each plaque feature per pullback and assessed their correlation with LLL obtained at 6- and 12-months follow-up. In addition, we investigated the potential impact of scaffold edge dissection and strut malapposition on in-scaffold LLL.
resultsEighty-four patients and 84 lesions were evaluated in the current analysis. There was no significant correlation between the underlying plaque characteristic and in-scaffold LLL at 6-months (p = 0.79 for fibrous, p = 0.88 for calcific, p = 0.67 for lipid lesions). This trend was similar at 12 months follow-up (p = 0.56 for fibrous, p = 0.75 for calcific, p = 0.69 for lipid lesions). The presence or absence of edge dissection did not influence the degree of in-scaffold - (p = 0.51 at 6-months, p = 0.68 at 12-months follow-up) or in-segment LLL (p = 0.88 at 6-months, p = 0.70 at 12-months follow-up).
conclusionThe underlying plaque characteristics, edge dissection or strut malapposition had no significant impact on in-scaffold LLL following DREAMS 3 G implantation up to 12 months. This suggests better device performance irrespective of the underlying plaque characteristics.
trial registrationClinicalTrials.gov ID: NCT04157153.
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