■已广泛研究了第一代较厚的支柱耐用的基于聚合物的药物洗脱支架(DES)的短期临床结果。然而,缺乏对DES长期使用的定性研究来评估冠状动脉疾病的更薄的可生物降解支架。因此,我们试图研究在有症状的缺血性心脏病的现实世界患者中,基于生物可降解聚合物的薄支柱BioMime西罗莫司洗脱冠状动脉支架系统的长期安全性和性能.
■这是一个回顾,观察,单中心,上市后临床随访研究。主要终点是主要不良心脏事件(MACE)的发生率,定义为心脏死亡的复合物,心肌梗死(MI)归因于靶血管血运重建(TVR),和靶病变血运重建(TLR)在1-,2-,3年和4年随访。次要终点是心脏死亡,MI,TLR,TVR,设备和程序成功率,支架内血栓形成(ST)。
■总之,1,188名连续患者入选,1,565个病变中的1,333个(1,257个从头和76个支架内再狭窄病变)接受了研究装置治疗。患者的平均年龄为53.26±10.31岁,男性占86.2%。定量冠状动脉造影得出的平均病变长度和直径分别为29.62±9.62mm和3.01±0.29mm,分别。植入的研究设备的平均长度和直径为30.89±6.31mm和3.17±0.25mm,分别。MACE的累积发生率在1,2-,3-,4年为0.61%,1.47%,2.08%,和3.40%,分别,心脏原因导致的累计死亡为0.61%,1.13%,1.22%,和1.83%,分别。随访1年无TLR或TVR病例。TLR在2-,3-,4年是0.35%,0.87%,和1.57%,分别,而TVR的比例为0.61%,1.47%,和2.35%,分别。在6个月的随访中发生了3例(0.3%)可能的ST;没有新病例的报道。在亚组分析中,通过4年的随访,长支架组和短支架组的MACE具有可比性。
■这项长期研究证明了超薄BioMime西罗莫司洗脱支架的安全性和性能,在有症状的缺血性心脏病患者的实际情况下具有令人满意的临床结果。
UNASSIGNED: The short-term clinical outcomes of first-generation thicker-strut durable polymer-based drug-eluting stents (DES) have been widely examined. However, there is a scarcity on qualitative research on the long-term usage of DES that evaluated the thinner strut biodegradable stents for coronary artery disease. Hence, we sought to investigate the long-term safety and performance of thinner strut biodegradable polymer-based BioMime sirolimus-eluting coronary stent system in real-world patients with symptomatic ischemic heart disease.
UNASSIGNED: This was a retrospective, observational, single-center, post-marketing clinical follow-up
study. The primary endpoints were the incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel revascularization (TVR), and target lesion revascularization (TLR) at 1-, 2-, 3- and 4-year follow-ups. The secondary endpoints were cardiac death, MI, TLR, TVR, device and procedural success rates, and stent thrombosis (ST).
UNASSIGNED: In all, 1,188 consecutive patients were enrolled, and 1,333 (1,257 de novo and 76 in-stent restenotic lesions) out of 1,565 lesions were treated with the
study device. The mean age of patients was 53.26 ± 10.31 years and 86.2% were male. The quantitative coronary angiographic derived mean lesion length and diameter were 29.62 ± 9.62 mm and 3.01 ± 0.29 mm, respectively. The average length and diameter of the
study device implanted were 30.89 ± 6.31 mm and 3.17 ± 0.25 mm, respectively. The cumulative incidence of MACE at 1-, 2-, 3-, and 4 years was 0.61%, 1.47%, 2.08%, and 3.40%, respectively, and cumulative deaths due to cardiac causes were 0.61%, 1.13%, 1.22%, and 1.83%, respectively. There were no cases of TLR or TVR at 1-year follow-up. The cumulative rate of TLR at 2-, 3-, and 4 years was 0.35%, 0.87%, and 1.57%, respectively, while that of TVR was 0.61%, 1.47%, and 2.35%, respectively. Three (0.3%) incidences of probable ST occurred during the 6-month follow-up; no new cases were reported further. In subgroup analysis, MACEs were comparable across the long- and short-length stent groups through 4-year follow-up.
UNASSIGNED: This long-term
study demonstrates the safety and performance of the ultra-thin BioMime sirolimus-eluting stent with satisfactory clinical outcomes in patients with symptomatic ischemic heart disease in real-world scenario.