Kirstine Nørregaard Hansen, Jens Trøan, Akiko Maehara, Manijeh Noori, Mikkel Hougaard, Julia Ellert-Gregersen, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen
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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.</p><p><strong>Methods: </strong>Eighty-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.</p><p><strong>Results: </strong>Following Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm<sup>2</sup>; <i>P</i>=0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm<sup>2</sup>; <i>P</i>=0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm<sup>2</sup>; <i>P</i>=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 mm<sup>2</sup>; <i>P</i>=0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm<sup>2</sup>; <i>P</i>=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 mm<sup>2</sup>; <i>P</i>=0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm<sup>2</sup>; <i>P</i><0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling.</p><p><strong>Conclusions: </strong>Lesion 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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"18 1","pages":"e014665"},"PeriodicalIF":6.1000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748912/pdf/","citationCount":"0","resultStr":"{\"title\":\"Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial.\",\"authors\":\"Kirstine Nørregaard Hansen, Jens Trøan, Akiko Maehara, Manijeh Noori, Mikkel Hougaard, Julia Ellert-Gregersen, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen\",\"doi\":\"10.1161/CIRCINTERVENTIONS.124.014665\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bioresorbable 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. 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引用次数: 0
摘要
背景：生物可吸收支架（BRS）的开发是为了克服药物洗脱支架晚期支架失效的局限性，但有报道称，BRS植入后随着时间的推移，管腔减少。本研究旨在探讨在Magmaris BRS植入后，与标准的不合规球囊相比，使用评分球囊进行病变准备是否能最大限度地减少管腔缩小，并进行光学相干断层扫描和血管内超声评估。方法：在植入Magmaris BRS之前，82例稳定型心绞痛患者按1:1的比例随机分配，分别使用评分球囊和标准不合规球囊进行病变准备。6个月随访时，主要终点为最小管腔面积。结果：Magmaris BRS植入后，最小管腔面积（6.4±1.6 vs 6.3±1.5 mm2）；P=0.65)，平均支架面积（7.8±1.5 vs 7.5±1.7 mm2）；P=0.37)，平均管腔面积(8.0±1.6 vs 7.7±2.1 mm2；P=0.41)，分别在用评分法和标准不合规球囊准备病变的患者中没有显著差异。通过光学相干断层扫描和血管内超声对74例患者进行了6个月的血管造影随访。主要终点，6个月最小管腔面积，与标准不合规球囊相比，使用评分球囊准备的病变明显更大(4.7±1.4 vs 3.9±1.9 mm2；P=0.04)，而平均管腔面积(7.2±1.4 vs 6.8±2.2 mm2；P=0.35)，差异无统计学意义。血管内超声结果显示，评分球囊组病变部位的平均血管面积从基线到随访无差异(16.8±2.9 vs 17.0±3.6 mm2；P=0.62)，而平均血管面积(17.1±4.4 vs 15.7±4.9 mm2；结论：在植入Magmaris BRS前使用评分球囊进行病变准备，与使用标准不合规球囊进行病变准备相比，6个月后由于较少的负性重塑，病变准备的最小管腔面积明显更大。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04666584。
Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial.
Background: Bioresorbable 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.
Methods: Eighty-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.
Results: Following 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.
Conclusions: Lesion 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.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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