Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Meguro-ku, Japan.
Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
JACC Cardiovasc Interv. 2022 Jul 11;15(13):1324-1334. doi: 10.1016/j.jcin.2022.05.028.
Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention.
The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance.
CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan. Percutaneous coronary intervention patients were assigned (1:1) to an ultrathin, biodegradable-polymer sirolimus-eluting stent (BP-SES) or a thin, durable-polymer everolimus-eluting stent (DP-EES). The primary endpoint was TLF, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year follow-up.
Between May 2019 and March 2020, 1,440 patients were randomly assigned to BP-SES (n = 722) or DP-EES (n = 718). TLF occurred in 6.0% and 5.7% of patients, respectively. Noninferiority (P = 0.040) was met because the upper limit (2.67%) of the 1-sided 95% CI between the groups was lower than the prespecified noninferiority margin (3.3%). No significant interactions were observed in the relative rates of TLF between prespecified subgroups.
The BP-SES was noninferior to the DP-EES regarding 1-year TLF. This demonstrates that strut thickness differences among DES have little impact on clinical outcomes when implanted with intravascular imaging guidance.
先前的试验表明，在经皮冠状动脉介入治疗（PCI）后 1 年，超薄支架药物洗脱支架（DES）在靶病变失败（TLF）方面优于薄壁支架 DES。
本研究旨在比较超薄和薄壁 DES（CASTLE [随机比较全患者研究超薄支架和薄壁药物洗脱支架]；jRCTs032180084）的临床结局，采用血管造影和血管内超声或光相干断层扫描指导下植入支架。
CASTLE 是一项在日本 65 家机构进行的多中心、前瞻性、非劣效性研究。将经皮冠状动脉介入治疗患者按 1:1 比例分配至超薄、生物可降解聚合物西罗莫司洗脱支架（BP-SES）或薄、耐用聚合物依维莫司洗脱支架（DP-EES）。主要终点为 1 年随访时的 TLF，定义为心脏死亡、靶血管相关心肌梗死和临床驱动的靶病变血运重建的复合终点。
2019 年 5 月至 2020 年 3 月，1440 例患者被随机分配至 BP-SES（n=722）或 DP-EES（n=718）组。分别有 6.0%和 5.7%的患者发生 TLF。由于组间差异的单侧 95%CI 的上限（2.67%）低于预设的非劣效性边界（3.3%），因此满足非劣效性（P=0.040）。在预先指定的亚组中，TLF 的相对发生率没有观察到显著的交互作用。
BP-SES 在 1 年 TLF 方面不劣于 DP-EES。这表明在血管内成像指导下植入时，DES 的支架厚度差异对临床结局影响不大。
