OCT 或血管造影指导复杂分叉病变的 PCI
OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.
机构信息
From the Department of Cardiology, Aarhus University Hospital, Aarhus (N.R.H., L.N.A., O.N., S.-H.B.R., L.J.H.M., M.S.L., E.H.C.), the Department of Cardiology, Gentofte Hospital, Gentofte (N.T.O., A.T.K.), the Department of Cardiology, Zealand University Hospital, Roskilde (O.H.), the Department of Cardiology, Rigshospitalet, Copenhagen (J.L.), the Department of Cardiology, Odense University Hospital, Odense (L.O.J.), and the Department of Cardiology, Aalborg University Hospital, Aalborg (A.E.) - all in Denmark; the Department of Cardiology, North Estonia Medical Center, Tallinn, Estonia (P.L.); Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia (I.K.); the Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven (J.B.), and the Department of Cardiology, Ziekenhuis Oost-Limburg, Genk (J.D.) - both in Belgium; the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (J.O.), the Department of Cardiology, Karolinska University Hospital (L.H.), and the Department of Clinical Science and Education, Karolinska Institute, Unit of Cardiology, Södersjukhuset (N.W., I.S.-P.), Stockholm, and the Department of Cardiology, Örebro University Hospital, Örebro (F.C.) - all in Sweden; the Department of Cardiology, Oslo University Hospital, Ullevål (P.H.), the Department of Cardiology, Trondheim University Hospital, Trondheim (M.H.), the Department of Cardiology, Oslo University Hospital, Oslo (C.E.), and the Department of Cardiology, Sørlandet Sykehus Arendal, Arendal (S. Calic) - all in Norway; the Department of Cardiology, Manchester Academic Health Science Centre, Wythenshawe Hospital, Manchester (S. Chowdhary), the Department of Cardiology, Royal Bournemouth Hospital, Bournemouth (P.O.), the Department of Cardiology, Golden Jubilee Hospital, Glasgow (S.W.), the Department of Cardiology, Sussex Cardiac Centre, Brighton (J.C.), the Department of Cardiology, Belfast Health and Social Care Trust, Belfast (A.M.), and Cardiology Care Group, St. George's University Hospitals NHS Foundation Trust and Cardiovascular Clinical Academic Group, St. George's University of London, London (J.C.S.) - all in the United Kingdom; the Department of Cardiology, St. Antonius Ziekenhaus, Nieuwegein (J.P.V.K.), the Department of Cardiology, Amsterdam UMC, Amsterdam (P.K.), and the Department of Cardiology, Northwest Hospital Alkmaar, Alkmaar (T.H.) - all in the Netherlands; Azienda Ospedaliero-Universitaria di Ferrara, Cardiology Unit, Ferrara (S.B.), and the Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome (F.B.) - both in Italy; the Department of Cardiology, University Hospital Galway, Galway, Ireland (D.M.); 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland (L.K.); Tampere Heart Hospital, Tampere University Hospital, Tampere, Finland (O.A.K.); and Vivantes Klinikum im Friedrichshain, Berlin (S.K.).
出版信息
N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
BACKGROUND
Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.
METHODS
We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.
RESULTS
We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.
CONCLUSIONS
Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
背景
与血管造影引导下的经皮冠状动脉介入治疗（PCI）相比，影像学引导下的 PCI 与更好的临床结局相关。在涉及冠状动脉分支点（分叉）的病变 PCI 中，与血管造影引导相比，常规光学相干断层扫描（OCT）指导是否能改善临床结局尚不确定。
方法
我们在欧洲的 38 个中心进行了一项多中心、随机、开放标签试验。根据冠状动脉造影，有临床指征行 PCI 且存在复杂分叉病变的患者以 1:1 的比例随机分配至 OCT 指导下的 PCI 或血管造影指导下的 PCI。主要终点是主要不良心脏事件（MACE）的复合终点，定义为心源性死亡、靶病变心肌梗死或缺血驱动的靶病变血运重建，中位随访 2 年。
结果
我们将 1201 例患者分配至 OCT 指导下的 PCI（600 例）或血管造影指导下的 PCI（601 例）。在 OCT 指导下的 PCI 组中，共有 111 例（18.5%）患者和血管造影指导下的 PCI 组中有 116 例（19.3%）患者存在左主干冠状动脉分叉病变。在 2 年时，OCT 指导下的 PCI 组中有 59 例（10.1%）患者和血管造影指导下的 PCI 组中有 83 例（14.1%）患者发生主要终点事件（风险比，0.70；95%置信区间，0.50 至 0.98；P=0.035）。在 OCT 指导下的 PCI 组中，有 41 例（6.8%）患者发生了与手术相关的并发症，血管造影指导下的 PCI 组中有 34 例（5.7%）患者发生了与手术相关的并发症。
结论
在复杂的冠状动脉分叉病变患者中，与血管造影指导下的 PCI 相比，OCT 指导下的 PCI 可降低 2 年时的 MACE 发生率。（由 Abbott Vascular 等资助；OCTOBER ClinicalTrials.gov 编号，NCT03171311。）
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