血管内影像学指导或血管造影指导下的复杂 PCI。
Intravascular Imaging-Guided or Angiography-Guided Complex PCI.
机构信息
From Samsung Medical Center (J.M.L., K.H.C., Y.B.S., D.H., T.K.P., J.H.Y., S.-H.C., H.-C.G., J.-Y.H.) and Kangbuk Samsung Hospital (J.-Y.L., S.-J.L.), Sungkyunkwan University School of Medicine, the Catholic University of Korea, Uijeongbu St. Mary's Hospital (C.J.K., H.-S.A.), Chung-Ang University College of Medicine, Chung-Ang University Hospital (W.S.L.), the Catholic University of Korea, Incheon St. Mary's Hospital (K.Y.L.), Hanyang University Seoul Hospital, College of Medicine, Hanyang University (Y.-H.L.), Kyung Hee University Hospital at Gangdong (J.-M.C.), and Ewha Womans University College of Medicine (W.J.J.), Seoul, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju (S.Y.L., S.M.K.), Chung-Ang University College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong (S.Y.L.), Wonkwang University Hospital, Iksan (K.H.Y., J.Y.C.), Keimyung University Dongsan Hospital, Daegu (C.-W.N., H.-J.Y.), Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon (Y.H.P.), Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon (J.-O.J., P.S.S.), Inje University Ilsan-Paik hospital, Goyang (J.-H.D.), the Cardiovascular Center, Hallym University Sacred Heart Hospital, Anyang (S.-H.J.), Seoul National University Bundang Hospital, Seongnam-si (C.-H.Y.), Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju (M.G.K., J.-S.K.), Hanyang University Myongji Hospital, Goyang (Y.-H.C.), and Pusan National University Yangsan Hospital, Yangsan (K.-J.C.) - all in South Korea.
出版信息
N Engl J Med. 2023 May 4;388(18):1668-1679. doi: 10.1056/NEJMoa2216607. Epub 2023 Mar 5.
BACKGROUND
Data regarding clinical outcomes after intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited.
METHODS
In this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators' discretion. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed.
RESULTS
A total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging-guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel-related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events.
CONCLUSIONS
Among patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).
背景
血管内影像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，其复杂冠状动脉病变患者的临床结局数据有限。
方法
在韩国进行的这项前瞻性、多中心、开放标签试验中，我们将复杂冠状动脉病变患者按 2:1 的比例随机分为血管内影像指导 PCI 组或血管造影指导 PCI 组。在血管内影像组中，血管内超声和光相干断层扫描的选择由术者决定。主要终点是心源性死亡、靶血管相关心肌梗死或临床驱动的靶血管血运重建的复合终点。还评估了安全性。
结果
共有 1639 名患者接受了随机分组，其中 1092 名患者接受血管内影像指导 PCI，547 名患者接受血管造影指导 PCI。中位随访 2.1 年（四分位距 1.4 至 3.0），血管内影像组有 76 例（累积发生率 7.7%）和血管造影组有 60 例（累积发生率 12.3%）发生主要终点事件（风险比 0.64；95%置信区间 0.45 至 0.89；P=0.008）。血管内影像组有 16 例（累积发生率 1.7%）和血管造影组有 17 例（累积发生率 3.8%）死于心源性原因；靶血管相关心肌梗死分别为 38 例（累积发生率 3.7%）和 30 例（累积发生率 5.6%）；临床驱动的靶血管血运重建分别为 32 例（累积发生率 3.4%）和 25 例（累积发生率 5.5%）。两组间与操作相关的安全性事件发生率无明显差异。
结论
在复杂冠状动脉病变患者中，血管内影像指导的 PCI 可降低心源性死亡、靶血管相关心肌梗死或临床驱动的靶血管血运重建的复合风险，优于血管造影指导的 PCI。（由 Abbott Vascular 和 Boston Scientific 支持；RENOVATE-COMPLEX-PCI ClinicalTrials.gov 编号，NCT03381872）。
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