医学
血管内超声
经皮冠状动脉介入治疗
随机对照试验
光学相干层析成像
心肌梗塞
血运重建
放射科
不稳定型心绞痛
临床终点
心脏病学
传统PCI
内科学
作者
Do‐Yoon Kang,Jung‐Min Ahn,Hanbit Park,Pil Hyung Lee,Myung Ho Jeong,Seung‐Whan Lee,Young‐Hak Kim,Seong‐Wook Park,Sang‐Wook Kim,Seung‐Ho Hur,Yun‐Kyeong Cho,Cheol Hyun Lee,Soon Jun Hong,Young Joon Hong,Young Won Yoon,Soo–Joong Kim,Jang‐Ho Bae,Jun‐Hyok Oh,Duk‐Woo Park,Seung‐Jung Park
标识
DOI:10.1016/j.ahj.2020.08.003
摘要
The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown.The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023.This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.
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