Department of Cardiology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Department of Cardiology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Cardiovasc Revasc Med. 2022 Oct;43:28-35. doi: 10.1016/j.carrev.2022.05.028. Epub 2022 May 26.
Magmaris® (Biotronik AG, Switzerland) is the first RMS and early experience has shown promising results in stable coronary artery disease. Acute coronary syndromes have been hypothesized as a potential target group for bioresorbable scaffolds, but the efficacy and safety of RMS has not been extensively studied in ST-segment elevation myocardial infarction (STEMI). BEST-MAG is a prospective multicenter trial designed to evaluate optical coherence tomography (OCT-)guided implantation of resorbable magnesium scaffold (RMS) in STEMI. Consecutive STEMI patients fulfilling inclusion/exclusion criteria were treated with RMS following a standardized OCT-based implantation technique including systematic pre- and post-dilatation, and baseline plus final OCT imaging. The primary endpoint was a device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) within 12 months. Clinical outcomes were compared after propensity score matching (PSM) to the results of the randomized controlled BIOSTEMI trial comparing biodegradable polymer sirolimus eluting (BP-SES) and durable polymer everolimus eluting stents (DP-EES) in STEMI. Between 15th February 2019 and 25th May 2020, 30 patients were included in 5 centers. Procedural success was achieved in all cases based on OCT control with final scaffold expansion of 82 ± 11%. At twelve-months, DOCE rate was 13.3% (n = 4), including 4 cases of TLR (13.3%) and one case of TV-MI (3.3%). No cardiac death occurred, and no scaffold thrombosis (ScT) was observed. Using PSM, DOCE rates in BP-SES and DP-EES groups were 10% and 6% respectively and TLR rates were 3.3% and 0.0%. In this study, OCT-guided RMS implantation in selected STEMI patients appeared feasible but was associated with numerically higher rates of TLR as compared with conventional drug-eluting stents, although the limited number of patients included in this analysis does not allow drawing statistically significant conclusions.
玛格瑞斯®（Biotronik AG，瑞士）是首款雷帕霉素药物洗脱可降解支架（RMS），早期经验表明其在稳定型冠状动脉疾病中具有良好的疗效。生物可吸收支架被认为是急性冠脉综合征的潜在治疗靶点，但在 ST 段抬高型心肌梗死（STEMI）中，RMS 的疗效和安全性尚未得到广泛研究。BEST-MAG 是一项前瞻性多中心研究，旨在评估光学相干断层扫描（OCT）指导下雷帕霉素药物洗脱可降解支架（RMS）在 STEMI 中的应用。连续入选符合纳入/排除标准的 STEMI 患者，按照基于 OCT 的标准化植入技术进行治疗，包括系统的预扩张和后扩张，以及基线和最终 OCT 成像。主要终点是一个器械导向的复合终点（DOCE），包括 12 个月内心脏性死亡、靶血管心肌梗死（TV-MI）和靶病变血运重建（TLR）。在进行倾向评分匹配（PSM）后，将临床结果与随机对照 BIOSTEMI 试验的结果进行比较，该试验比较了在 STEMI 中使用生物可降解聚合物西罗莫司洗脱（BP-SES）和持久聚合物依维莫司洗脱支架（DP-EES）的效果。2019 年 2 月 15 日至 2020 年 5 月 25 日，5 个中心共纳入 30 例患者。所有病例均根据 OCT 进行了控制性操作，最终支架扩张率为 82±11%。12 个月时，DOCE 发生率为 13.3%（n=4），包括 4 例 TLR（13.3%）和 1 例 TV-MI（3.3%）。无心脏性死亡发生，无支架血栓形成（ScT）。使用 PSM，BP-SES 和 DP-EES 组的 DOCE 发生率分别为 10%和 6%，TLR 发生率分别为 3.3%和 0.0%。在这项研究中，OCT 指导下的 RMS 植入术在选择的 STEMI 患者中似乎是可行的，但与传统药物洗脱支架相比，TLR 的发生率较高，尽管这项分析纳入的患者数量有限，无法得出统计学意义上的结论。
