超薄（60μm）、超长（≥40mm）西罗莫司洗脱支架：真实世界患者临床和安全性特征研究。
Ultrathin (60 μm), ultralong (≥40 mm) sirolimus-eluting stent: study of clinical and safety profiles among real-world patients.
机构信息
Department of Cardiology, LPS Institute of Cardiology, Kanpur, India.
Department of Cardiology, Dr. Ram Manohar Lohia Institute of Cardiology; New Delhi-India.
出版信息
Anatol J Cardiol. 2021 Feb;25(2):111-119. doi: 10.14744/AnatolJCardiol.2020.40909.
OBJECTIVE
Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (≥40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (≥40 mm) and ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions.
METHODS
The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure.
RESULTS
The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively.
CONCLUSION
Ultralong (≥40 mm), ultrathin (60 μm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions.
目的
尽管具有更灵活设计的薄壁药物洗脱支架（DES）更容易获得，但关于使用超长（≥40mm）DES 治疗长冠状动脉病变的文献数据有限。因此，本研究评估了具有独特长双 Z 链接（LDZ-link）设计的超长（≥40mm）和超薄（60μm）可生物降解聚合物涂层西罗莫司洗脱支架（SES）Supralimus Grace 在长冠状动脉病变的真实世界患者中的安全性和疗效。
方法
共对 684 例患者植入指定支架。主要终点是靶病变失败（TLF），它是心血管死亡、靶血管心肌梗死（MI）和靶病变血运重建（TLR）的综合指标，而围手术期次要终点包括器械失败（支架输送失败、支架更换和支架断裂）和患者导向的复合终点（POCE），它是所有死亡、任何 MI 和任何血运重建以及支架血栓形成（ST）的综合指标。这些结果在一年随访时和手术期间进行分析。
结果
患者平均年龄为 52.7±15.9 岁，537 例（78.5%）为男性。626 例（91.5%）患者患有急性冠状动脉综合征，58 例（8.5%）患者患有慢性冠状动脉综合征（CSS）。共处理 989 个病变。每个患者的平均病变和支架植入数量分别为 1.3±0.2mm 和 1.4±0.3mm。42 例（6.1%）患者因心脏死亡、靶血管 MI 和 TLR 而发生 TLF，9 例（1.3%）、20 例（2.9%）和 13 例（1.9%）患者分别发生 TLR。131 例（19.1%）患者在一年随访时发生 POCE，主要是 63 例（9.2%）患者因任何血运重建而发生。21 例（3.1%）患者因输送失败（2.2%）、边缘夹层（0.8%）和断裂（0.1%）而发生支架失败。确定和可能的 ST 在 8 例（1.1%）和 9 例（1.3%）患者中分别观察到。
结论
超长（≥40mm）、超薄（60μm）Supralimus Grace 支架可安全植入长且多病变的血管。
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