Meennahalli Palleda Girish, Gupta Mohit, Bansal Ankit, Batra Vishal, Tyagi Sanjay, Kunal Shekhar
Department of Cardiology, Gobind Ballabh Pant Hospital, New Delhi, India.
These authors contributed equally to this work.
Cardiol Res. 2023 Oct;14(5):360-369. doi: 10.14740/cr1515. Epub 2023 Oct 21.
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.
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).
In all, 1,188 consecutive patients were enrolled, and 1,333 (1,257 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.
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.
第一代厚支撑耐用聚合物基药物洗脱支架（DES）的短期临床结果已得到广泛研究。然而，关于评估用于冠状动脉疾病的薄支撑可生物降解支架长期使用情况的定性研究却很匮乏。因此，我们试图在有症状的缺血性心脏病真实世界患者中研究薄支撑可生物降解聚合物基BioMime西罗莫司洗脱冠状动脉支架系统的长期安全性和性能。
这是一项回顾性、观察性、单中心、上市后临床随访研究。主要终点是1年、2年、3年和4年随访时的主要不良心脏事件（MACE）发生率，MACE定义为心脏死亡、归因于靶血管血运重建（TVR）的心肌梗死（MI）和靶病变血运重建（TLR）的复合事件。次要终点是心脏死亡、MI、TLR、TVR、器械和手术成功率以及支架血栓形成（ST）。
总共纳入了1188例连续患者，1565个病变中的1333个（1257个原发病变和76个支架内再狭窄病变）使用该研究器械进行了治疗。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。植入的研究器械的平均长度和直径分别为30.89±6.31mm和3.17±0.25mm。1年、2年、3年和4年时MACE的累积发生率分别为0.61%、1.47%、2.08%和3.40%，心脏原因导致的累积死亡率分别为0.61%、1.13%、1.22%和1.83%。1年随访时无TLR或TVR病例。2年、3年和4年时TLR的累积发生率分别为0.35%、0.87%和1.57%，而TVR的累积发生率分别为0.61%、1.47%和2.35%。在6个月随访期间发生了3例（0.3%）可能的ST；之后未再报告新病例。在亚组分析中，通过4年随访，长支架组和短支架组的MACE情况相当。
这项长期研究证明了超薄BioMime西罗莫司洗脱支架在有症状的缺血性心脏病真实世界患者中的安全性和性能，临床结果令人满意。
