Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen
{"title":"镁基生物可吸收支架植入前最佳病变准备的效果：OPTIMIS研究的12个月结果","authors":"Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen","doi":"10.1016/j.carrev.2025.03.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.</p><p><strong>Method: </strong>In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.</p><p><strong>Results: </strong>Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm<sup>2</sup> vs. standard 3.6 ± 0.5 mm<sup>2</sup>, p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm<sup>2</sup>-5.1 ± 1.7 mm<sup>2</sup>-5.0 ± 1.9 mm<sup>2</sup>, p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm<sup>2</sup>-5.2 ± 1.5 mm<sup>2</sup>-5.3 ± 2.0 mm<sup>2</sup>, p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.</p><p><strong>Conclusion: </strong>In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of optimal lesion preparation prior to implantation of a magnesium-based bioresorbable scaffold: 12-month results of the OPTIMIS study.\",\"authors\":\"Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen\",\"doi\":\"10.1016/j.carrev.2025.03.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.</p><p><strong>Method: </strong>In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.</p><p><strong>Results: </strong>Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm<sup>2</sup> vs. standard 3.6 ± 0.5 mm<sup>2</sup>, p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm<sup>2</sup>-5.1 ± 1.7 mm<sup>2</sup>-5.0 ± 1.9 mm<sup>2</sup>, p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm<sup>2</sup>-5.2 ± 1.5 mm<sup>2</sup>-5.3 ± 2.0 mm<sup>2</sup>, p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.</p><p><strong>Conclusion: </strong>In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.</p>\",\"PeriodicalId\":47657,\"journal\":{\"name\":\"Cardiovascular Revascularization Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2025-03-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cardiovascular Revascularization Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.carrev.2025.03.003\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Revascularization Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.carrev.2025.03.003","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Effect of optimal lesion preparation prior to implantation of a magnesium-based bioresorbable scaffold: 12-month results of the OPTIMIS study.
Background: Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.
Method: In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.
Results: Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm2 vs. standard 3.6 ± 0.5 mm2, p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm2-5.1 ± 1.7 mm2-5.0 ± 1.9 mm2, p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm2-5.2 ± 1.5 mm2-5.3 ± 2.0 mm2, p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.
Conclusion: In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.
期刊介绍：
Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.
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