Optical Coherence Tomography–Guided or Intravascular Ultrasound–Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial

医学 血管内超声 经皮冠状动脉介入治疗 传统PCI 血运重建 心肌梗塞 临床终点 光学相干层析成像 心脏病学 内科学 放射科 冠状动脉疾病 随机对照试验
作者
Do‐Yoon Kang,Jung‐Min Ahn,Sung‐Cheol Yun,Seung‐Ho Hur,Yun‐Kyeong Cho,Cheol Hyun Lee,Soon Jun Hong,Subin Lim,Sang‐Wook Kim,Hoyoun Won,Jun‐Hyok Oh,Jeong Cheon Choe,Young Joon Hong,Yong‐Hoon Yoon,Hoyun Kim,Yeonwoo Choi,Jinho Lee,Young Won Yoon,Soo–Joong Kim,Jang–Ho Bae,Duk‐Woo Park,Seung‐Jung Park
出处
期刊:Circulation [Ovid Technologies (Wolters Kluwer)]
卷期号:148 (16): 1195-1206 被引量:76
标识
DOI:10.1161/circulationaha.123.066429
摘要

Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown.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 compared with the IVUS group. Safety outcomes were also assessed.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% CI, 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 versus 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%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed.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.URL: https://www.gov; Unique number: NCT03394079.
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