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前瞻性多中心注册研究:应用依维莫司洗脱金属支架的杂交冠状动脉血运重建术联合非隐静脉旁路移植术和经皮冠状动脉介入治疗(PRIDE-METAL 研究)。

Prospective multicenter registry of hybrid coronary artery revascularization combined with non-saphenous vein graft surgical bypass and percutaneous coronary intervention using everolimus eluting metallic stents (PRIDE-METAL study).

机构信息

Department of Cardiology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan.

Department of Cardiovascular Medicine, Sapporo Cardiovascular Clinic, Sapporo Heart Center, Sapporo, Japan.

出版信息

Cardiovasc Interv Ther. 2022 Apr;37(2):304-311. doi: 10.1007/s12928-021-00784-5. Epub 2021 May 18.

Abstract

The concept of hybrid coronary revascularization (HCR) combines the advantages of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) to improve the treatment of patients with complex multivessel disease. This study aimed to investigate a 1-year clinical follow-up of a prospective multicenter registry of HCR combined with non-saphenous vein graft surgical bypass and PCI using everolimus-eluting metallic stents (the PRIDE-METAL study). From June 2016 to June 2018, a total of 54 patients with multivessel coronary disease from six Japanese institutes were enrolled in this study. The primary endpoint of the study was the occurrence of major adverse cardiovascular event (MACE; all-cause death, myocardial infarction, stroke, and repeat revascularization) at 1 year. Three patients declined before complete HCR, and two patients were lost by the 1-year follow-up. All-cause mortality at 30 days and at 1 year was 0% and 4.1%, respectively. The rates of myocardial infarction, repeat revascularization, stroke, and MACE were 0% at 30 days, and 0%, 2.0%, 2.0%, and 8.2% at 1-year follow-up, respectively. No occlusion of arterial bypass graft at the 30-day follow-up was observed, and was observed in 1.7% at the 1-year follow-up. HCR was safe and feasible and associated with a low risk of MACE at the 1-year follow-up. Further validation in multicenter and randomized studies is needed.

摘要

杂交血运重建(HCR)的概念结合了冠状动脉旁路移植术(CABG)和经皮冠状动脉介入治疗(PCI)的优势,以改善复杂多血管疾病患者的治疗效果。本研究旨在调查一项前瞻性多中心注册研究的 1 年临床随访结果,该研究将 HCR 与非隐静脉桥接旁路手术和使用依维莫司洗脱金属支架的 PCI 相结合(PRIDE-METAL 研究)。2016 年 6 月至 2018 年 6 月,来自日本六家机构的 54 名多血管病变患者纳入本研究。研究的主要终点是 1 年内主要不良心血管事件(MACE;全因死亡、心肌梗死、卒中和再次血运重建)的发生情况。3 名患者在完全 HCR 之前拒绝治疗,2 名患者在 1 年随访时失访。30 天和 1 年的全因死亡率分别为 0%和 4.1%。30 天的心肌梗死、再次血运重建、卒中和 MACE 发生率分别为 0%,1 年随访时分别为 0%、2.0%、2.0%和 8.2%。在 30 天的随访中未观察到动脉旁路移植术闭塞,在 1 年的随访中观察到 1.7%。HCR 是安全可行的,在 1 年随访时 MACE 的风险较低。需要多中心和随机研究进一步验证。

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