Al Nooryani Arif, Aboushokka Wael, AlBaba Bassam, Kerfes Jalal, Abudaqa Loai, Bhatia Amit, Mansoor Anoop, Nageeb Ruwaide, Aleksandric Srdjan, Beleslin Branko
Al Qassimi Hospital, Sharjah 3500, United Arab Emirates.
Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia.
J Clin Med. 2022 Jun 28;11(13):3726. doi: 10.3390/jcm11133726.
: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients' population. We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE-cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE-all cause death, any myocardial infarction, any revascularization). Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21-24.456; = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419-28.855; = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216-24.613; = 0.001). The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome.
需要阐明生物可吸收血管支架(BVS),包括玛格丽丝(Magmaris)在现实世界临床实践中的长期疗效和安全性,以便更好地了解这项新兴且不断发展的技术的性能。本研究的目的是评估药物洗脱生物可吸收金属支架玛格丽丝在所有患者群体中的长期性能。我们将首批54例接受玛格丽丝治疗且随访至少30个月的患者纳入了这个前瞻性注册研究。患者年龄为54±11岁,其中男性46例。分别有33例(61%)和30例(56%)患者患有糖尿病和急性冠状动脉综合征。在中位随访47个月期间,对患者进行了针对器械和患者的心脏事件随访(器械相关心脏事件 - 心源性死亡、靶血管心肌梗死和靶病变血运重建;患者相关心脏事件 - 全因死亡、任何心肌梗死、任何血运重建)。器械相关心脏事件和患者相关心脏事件的无事件生存率分别为86.8%和79.2%。器械相关心脏事件发生率为7/54(13%),其中包括2例(4%)患者发生靶血管心肌梗死,6例(11%)患者发生靶病变血运重建,无心脏死亡病例。患者相关心脏事件发生率为11/54(21%),其中包括3例(6%)患者发生任何心肌梗死,11例(20%)患者发生任何血运重建,无死亡病例。2例患者(3.7%)发生明确的玛格丽丝支架内血栓形成,5例患者(9.3%)发生支架内再狭窄。与器械相关心脏事件相关的变量为植入≥2个玛格丽丝BVS(HR:5.4;95%CI:1.21 - 24.456;P = 0.027)以及玛格丽丝BVS总长度≥40 mm(HR:6.4;95%CI:1.419 - 28.855;P = 0.016),而既往PCI是患者相关心脏事件的唯一独立预测因素(HR:7.4;95%CI:2.216 - 24.613;P = 0.001)。在具有复杂临床和血管造影特征的患者中植入玛格丽丝后的长期临床结果是可接受且有前景的。病变处植入多个BVS以及更长的多个BVS的患者临床结果较差。