Comparison of optical coherence tomography–guided versus intravascular ultrasound–guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial - 17/09/20

Doi : 10.1016/j.ahj.2020.08.003

Do-Yoon Kang, MD ^a, Jung-Min Ahn, MD ^a, Hanbit Park, MD ^a, Pil Hyung Lee, MD ^a, Soo-Jin Kang, MD ^a, Seung-Whan Lee, MD ^a, Young-Hak Kim, MD ^a, Seong-Wook Park, MD ^a, Sang-Wook Kim, MD ^b, Seung-Ho Hur, MD ^c, Yun-Kyeong Cho, MD ^c, Cheol Hyun Lee, MD ^c, Soon Jun Hong, MD ^d, Young Joon Hong, MD ^e, Young Won Yoon, MD ^f, Soo-Joong Kim, MD ^g, Jang-Ho Bae, MD ^h, Jun-Hyok Oh, MD ⁱ, Duk-Woo Park, MD ^a,^{^⁎} , Seung-Jung Park, MD ^a,^{^⁎}
^a Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
^b Division of Cardiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea
^c Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea
^d Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea
^e Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea
^f Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
^g Department of Cardiology, Kyunghee University College of Medicine, Seoul, Republic of Korea
^h Department of Cardiology, Konyang University Hospital, Daejeon, Republic of Korea
ⁱ Department of Cardiology, Pusan National University Hospital, Busan, Republic of Korea

^⁎Reprint requests: Dr Duk-Woo Park and Dr Seung-Jung Park, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-gu, Seoul 138-736, Republic of Korea.Division of CardiologyAsan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-guSeoul138-736Republic of Korea

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.

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Plan

Methods

Study objective

Trial design

Study population and randomization

Imaging modality and imaging-guided PCI optimization

Study end points and clinical follow-up

Statistical methods

Organization and sources of funding

Results

Discussion

Study limitations

Summary and significance

Clinical trial registration: URL: www.clinicaltrials.gov. Unique identifier: NCT03394079.

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Vol 228

P. 72-80 - octobre 2020 Retour au numéro

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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 - 17/09/20

Abstract

Background

Methods and design

Results

Conclusion

Plan

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