Long‐term clinical, angiographic, and optical coherence tomography findings of Mg‐based bioresorbable scaffold in patients with acute coronary syndrome

Abstract

Background: This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months. Methods:Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%).Results: At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001).At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse.Conclusions: At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

Optimal lesion preparation before implantation of a Magmaris bioresorbable scaffold in patients with coronary artery stenosis: Rationale, design and methodology of the OPTIMIS study

“…Nakatani et al [ 15 ] express the need for a different methodological approach when analyzing BRS compared to permanent stents and highlight that only flow area based on lumen contour is assessable at long-term follow-up. Other studies have invented new terminology with different healing states or stages to describe the OCT quantitative findings at follow-up [ 9 , 41 , 43 ] based on the discernibility of the remained struts. However, the quantitative OCT findings are usually limited to lumen measurements in the scaffold treated area.…”

Treatment of in-stent restenosis with sirolimus-eluting magnesium bioresorbable scaffolds: optical coherence tomography insights

“…Recent data suggest the safety and efficacy of MgS up to 3 years even in complex clinical and anatomic scenarios [16]. However, some reports still suggest controversial results compared with new-generation DES [17]. For patients with ISR, no recovery of vessel motility is expected due to the presence of previous underlying metal layers; moreover, the current strut thickness (150 µm) of MgS would also pose a significant obstacle in the vessel lumen [18].…”

Moving research direction in the field of metallic bioresorbable stents-A mini-review

“…In 2021, Gutiérrez-Barriose et al [ 7 ] valuated the clinical outcomes of 90 patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aimed to investigate the Mg BRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months.…”