Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI (FLASH Trial)

초록

BACKGROUND: Recently developed artificial intelligence-based coronary angiography (AI-QCA, fully automated) provides real-time, objective, and reproducible quantitative analysis of coronary angiography without requiring additional time or labor. OBJECTIVE: This study aimed to evaluate the efficacy of AI-QCA-assisted percutaneous coronary intervention (PCI) compared to optical coherence tomography (OCT)-guided PCI in terms of post-PCI results. METHODS: This trial enrolled 400 patients with significant coronary artery disease undergoing PCI from 13 participating centers in South Korea. Patients were randomized in a 1:1 ratio to either AI-QCA-assisted or OCT-guided PCI. The primary endpoint was the post-PCI minimal stent area (MSA) assessed by OCT. The noninferiority of AI-QCA-assisted PCI to OCT-guided PCI regarding the post-PCI MSA was tested with a noninferiority margin of 0.8&#xa0;mm2. RESULTS: A total of 395 patients (199 in the AI-QCA group and 196 in the OCT group) were included in the primary endpoint analysis. The post-PCI MSA was 6.3 &#xb1; 2.2&#xa0;mm2 in the AI-QCA group and 6.2 &#xb1; 2.2&#xa0;mm2 in the OCT group (difference,&#xa0;-0.16; 95%&#xa0;CI:&#xa0;-0.59 to 0.28; P for noninferiority&#xa0;<&#xa0;0.001). Other OCT-defined endpoints, such as stent underexpansion (50.8% [101/199] vs 54.6% [107/196]; P&#xa0;=&#xa0;0.48), dissection (15.6% [31/199] vs 12.8% [25/196]; P&#xa0;=&#xa0;0.42), and untreated reference segment disease (15.1% [30/199] vs 13.3% [26/196]; P&#xa0;=&#xa0;0.61), were not significantly different between groups, except for a higher incidence of stent malapposition in the AI-QCA group (13.6% [27/199] vs 5.6 [11/196]; P&#xa0;=&#xa0;0.007). CONCLUSIONS: This study demonstrated the noninferiority of AI-QCA-assisted PCI to OCT-guided PCI in achieving MSA with comparable OCT-defined endpoints. (Fully Automated Quantitative Coronary Angiography Versus Optical Coherence Tomography Guidance for Coronary Stent Implantation [FLASH]; NCT05388357). Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

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