한빛사논문
- 조회447
Do-Yoon Kang 1, Jung-Min Ahn 1, Sung-Cheol Yun 2, Seung Ho Hur 3, Yun-Kyeong Cho 3, Cheol Hyun Lee 3, Soon Jun Hong 4, Subin Lim 4, Sang-Wook Kim 5, Hoyoun Won 6, Jun-Hyok Oh 7, Jeong Cheon Choe 7, Young Joon Hong 8, Yong-Hoon Yoon 9, Hoyun Kim 1, Yeonwoo Choi 1, Jinho Lee 1, Young Won Yoon 10, Soo-Joong Kim 11, Jang Ho Bae 12, Duk-Woo Park 1, Seung-Jung Park 1; OCTIVUS Investigators
1Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
2Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
3Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea.
4Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
5Division of Cardiology, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University College of Medicine, Gwangmyeong-si, Korea.
6Division of Cardiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.
7Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan, Korea.
8Department of Cardiology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
9Division of Cardiology, Chungnam National University Sejong Hospital, Sejong, Korea.
10Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
11Department of Cardiology, College of Medicine, Kyung Hee University, Seoul, Korea.
12Department of Cardiology, Konyang University Hospital, Daejeon, Korea.
* Corresponding Author : Duk-Woo Park
Abstract
Background: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared to angiography-guided PCI. However, comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown.
Methods: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary-artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group as compared with the IVUS group. Safety outcomes were also assessed.
Results: At 1 year, primary end-point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% confidence interval, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group vs. 15 patients [1.5%] in the IVUS group, P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] vs. 37 [3.7%], P=0.047), although imaging procedure-related complications were not observed.
Conclusions: In patients with significant coronary-artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower than expected event rates should be considered in interpreting the trial.
논문정보
- Research article
- 2023년 08월 (BRIC 등록일 2023-09-05)
- 국내 연구진
- 의약학 > 응용의학
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