Bossard Matthias, Madanchi Mehdi, Avdijaj Dardan, Attinger-Toller Adrian, Cioffi Giacomo Maria, Seiler Thomas, Tersalvi Gregorio, Kobza Richard, Schüpfer Guido, Cuculi Florim
Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.
Faculty of Medicine, University of Zurich, Luzern, Switzerland.
Front Cardiovasc Med. 2022 Apr 14;9:856930. doi: 10.3389/fcvm.2022.856930. eCollection 2022.
The magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce.
We analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years.
In total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61-64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling.
In contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.
镁基西罗莫司洗脱生物可吸收支架（Mg-BRS）Magmaris™在部分研究患者中显示出良好的临床结果，包括低靶病变失败率（TLF）和支架内血栓形成率（ScT）。然而，关于所有患者人群长期（>2年）结果的见解仍然很少。
我们分析了来自单中心注册研究的数据，包括接受使用Mg-BRS进行经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）和慢性冠状动脉综合征（CCS）患者。主要结局包括以器械为导向的复合终点（DoCE），代表长达5年的心源性死亡、ScT、靶血管心肌梗死（TV-MI）和临床驱动的靶病变血运重建（TLR）的分层复合终点。
2016年6月至2017年3月期间，共有84例患者[平均年龄62±11岁，63例（75%）为男性]接受了Mg-BRS器械治疗。总体而言，101处病变成功接受了Mg-BRS器械治疗，每处病变使用1.2±0.4个器械。所有病例中分别有101例（100%）和98例（97%）使用专用器械进行了预扩张和后扩张。中位随访时间为62（61-64）个月后，14例（18%）患者出现了DoCE，而4例（4.9%）患者发生了ScT[3例为早期ScT（<30天）和2例致命病例]。在4例（29%）DoCE病例中，光学相干断层扫描证实了Mg-BRS塌陷和不受控制的降解。
与早期研究相反，我们在接受Mg-BRS治疗的所有患者队列中遇到了相对较高的DoCE发生率。我们甚至观察到支架塌陷和不受控制的降解。这意味着这种金属基BRS需要进一步研究，可能仅适用于经过严格筛选的病例。
