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Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial

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Author(s)
Do-Yoon KangJung-Min AhnHanbit ParkPil Hyung LeeSoo-Jin KangSeung-Whan LeeYoung-Hak KimSeong-Wook ParkSang-Wook KimSeung-Ho HurYun-Kyeong ChoCheol Hyun LeeSoon Jun HongYoung Joon HongYoung Won YoonSoo-Joong KimJang-Ho BaeJun-Hyok OhDuk-Woo ParkSeung-Jung Park
Keimyung Author(s)
Hur, Seung HoCho, Yun KyeongLee, Cheol Hyun
Department
Dept. of Internal Medicine (내과학)
Journal Title
American Heart Journal
Issued Date
2020
Volume
228
Abstract
Background:
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.

Methods and design:
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.

Results:
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.

Conclusion:
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.
Keimyung Author(s)(Kor)
허승호
조윤경
이철현
Publisher
School of Medicine (의과대학)
Citation
Do-Yoon Kang et al. (2020). Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. American Heart Journal, 228, 72–80. doi: 10.1016/j.ahj.2020.08.003
Type
Article
ISSN
1097-6744
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S000287032030226
DOI
10.1016/j.ahj.2020.08.003
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42942
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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