OCTIVUS Trial

Future Perspective on Ongoing Trials from AMC


Do-Yoon Kang, MD
Asan Medical Center, Korea (Republic of)
The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is widely acknowledged. Although optical coherence tomography (OCT) and intravascular ultrasound (IVUS) are the most commonly used intravascular imaging methods for guiding and optimizing PCI in daily clinical practice, there are limited data on head-to-head comparison between OCT-guided and IVUS-guided PCI concerning clinical endpoints. Prior studies (ILUMIEN-3, OPINION, etc.) which compared the two imaging modalities might have been hampered by the use of surrogate imaging endpoints, limited patient numbers, and strict inclusion criteria including relatively simple lesions. Future clinical trials should focus on a large, unselected patient population that is more representative of routine clinical practice.

The OCTIVUS trial is an investigator-initiated, multicenter, open-label, pragmatic randomized controlled trial comparing the efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in an all-comers population with minimal exclusion criteria (Figure 1). Due to the lack of stringent exclusion criteria, a large proportion of patients with acute coronary syndrome, multivessel disease, or complex lesions, such as left main, bifurcation, long, or restenotic lesions, the patients who represented those undergoing PCI in contemporary clinical practice, could be enrolled in this trial. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary endpoint was target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year, which was tested for both noninferiority and superiority.

Figure 1. The study design of the OCTIVUS trial.

From April 2018 through January 2022, a total of 2,000 patients were enrolled. This year, the primary results will be available. It is anticipated to provide valuable clinical evidence regarding the comparative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI.

Clinical Science

Future Perspective on Ongoing Trials from AMC

Monday, May 08, 11:00 AM - 12:20 AM
Presentation Theater 1, Vista 3, B2

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Edited by

Do-Yoon Kang
Do-Yoon Kang, MD

Asan Medical Center, Korea (Republic of)

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