光学相干断层成像引导或血管内超声引导经皮冠状动脉介入治疗：OCTIVUS 随机临床试验。
Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.
机构信息
Division of Cardiology (D.-Y.K., J.-M.A., H.K., Y.C., J.L., D.-W.P., S.-J.P.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Division of Biostatistics (S.-C.Y.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
出版信息
Circulation. 2023 Oct 17;148(16):1195-1206. doi: 10.1161/CIRCULATIONAHA.123.066429. Epub 2023 Aug 27.
BACKGROUND
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.
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 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% CI, 0.97 percentage points; <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; =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%]; =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.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique number: NCT03394079.
背景
血管内超声（IVUS）或光相干断层扫描（OCT）指导的经皮冠状动脉介入治疗（PCI）与血管造影指导的 PCI 相比，具有更优的临床结局。然而，OCT 指导的 PCI 与 IVUS 指导的 PCI 在临床结局方面的比较效果尚不清楚。
方法
在这项前瞻性、多中心、开放性、实用临床试验中，我们以 1:1 的比例随机分配 2008 例接受 PCI 的有明显冠状动脉病变的患者，分别进行 OCT 指导的 PCI 或 IVUS 指导的 PCI。主要终点是 1 年时由心脏原因引起的死亡、靶血管相关心肌梗死或缺血驱动的靶血管血运重建组成的复合终点，该试验旨在证明 OCT 组与 IVUS 组相比非劣效性。还评估了安全性结局。
结果
在 1 年时，OCT 组 1005 例患者中有 25 例（Kaplan-Meier 估计值，2.5%）和 IVUS 组 1003 例患者中有 31 例（Kaplan-Meier 估计值，3.1%）发生主要终点事件（绝对差异，-0.6 个百分点；单侧 97.5%CI 的上限，0.97 个百分点；<0.001，非劣效性）。造影剂肾病的发生率相似（OCT 组 14 例[1.4%]，IVUS 组 15 例[1.5%]；=0.85）。OCT 组的主要手术并发症发生率低于 IVUS 组（22 例[2.2%]比 37 例[3.7%]；=0.047），尽管没有观察到与成像程序相关的并发症。
结论
在有明显冠状动脉病变的患者中，与 IVUS 指导的 PCI 相比，OCT 指导的 PCI 在 1 年时的心脏原因引起的死亡、靶血管相关心肌梗死或缺血驱动的靶血管血运重建复合发生率方面非劣效。在解释该试验时，应考虑到所选的研究人群和低于预期的事件发生率。
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