In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18–85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with , . Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2–72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6–72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55–1·11, p=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] nine [1·2%]; HR 1·56, 95% CI 0·68–3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22–0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients 31 [4·2%] patients; HR 0·61, 95% CI 0·39–0·95, p=0·030). In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation. Erasmus University Medical Center and Biotronik.

中文翻译：

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急性冠脉综合征和多支冠状动脉疾病 (BIOVASC) 患者的立即血运重建与分期完全血运重建：一项前瞻性、开放标签、非劣效性、随机试验

在患有急性冠状动脉综合征和多支冠状动脉疾病的患者中，通过经皮冠状动脉介入治疗（PCI）进行完全血运重建与改善临床结果相关。我们的目的是调查是否应在初次手术期间或分期尝试对非肇事病变进行 PCI。这项前瞻性、开放标签、非劣效性随机试验在比利时、意大利、荷兰和西班牙的 29 家医院进行。我们纳入了年龄为 18-85 岁、患有 ST 段抬高型心肌梗死或非 ST 段抬高型急性冠状动脉综合征和多支血管（即，两条或更多冠状动脉直径为 2·5 毫米或以上且≥70%）的患者。基于视觉估计或阳性冠状动脉生理学测试的狭窄）具有明显可识别的罪魁祸首病变的冠状动脉疾病。基于网络的随机化模块用于随机分配患者（1:1），随机块大小为 4 至 8，按研究中心分层，立即进行完全血运重建（首先对罪魁祸首病变进行 PCI，然后是其他非- 操作者在初次手术期间认为有临床意义的罪魁祸首病变）或分期完全血运重建（在初次手术期间仅对罪魁祸首病变进行 PCI，并在 6 周内对操作者认为有临床意义的所有非罪魁祸首病变进行 PCI）在索引过程之后）。主要结局是指数手术后 1 年的全因死亡率、心肌梗塞、任何计划外的缺血驱动的血运重建或脑血管事件的综合结果。次要结局包括全因死亡率、心肌梗死和初次手术后 1 年内计划外的缺血驱动的血运重建。根据意向治疗对所有随机分配的患者进行主要和次要结局评估。如果主要结局的风险比 (HR) 的 95% CI 上限不超过 1·39，则认为满足立即与分期完全血运重建的非劣效性。该试验已在 , 注册。2018年6月26日至2021年10月21日期间，764名患者（中位年龄65·7岁[IQR 57·2–72·9]和598名[78·3%]男性）被随机分配到立即完全血运重建组761 名患者（中位年龄 65·3 岁 [58·6–72·9] 和 589 名男性 [77·4%]）被随机分配到分期完全血运重建组，并纳入意向治疗人群。1 年时的主要结局发生在立即完全血运重建组 764 名患者中的 57 名 (7·6%) 和分期完全血运重建组 761 名患者中的 71 名 (9·4%) (HR 0·78, 95%) CI 0·55–1·11，p=0·0011）。立即和分期完全血运重建组之间的全因死亡没有差异（14 [1·9%] 9 [1·2%]；HR 1·56，95% CI 0·68–3·61，p =0·30）。立即完全血运重建组有 14 名患者（1·9%）发生心肌梗死，分期完全血运重建组有 34 名患者（4·5%）发生心肌梗死（HR 0·41，95% CI 0·22–0·76） ，p=0·0045）。分期完全血运重建组比立即完全血运重建组进行更多计划外缺血驱动的血运重建（50 [6·7%] 例患者 31 [4·2%] 例患者；HR 0·61，95% CI 0·39 –0·95，p=0·030）。在患有急性冠状动脉综合征和多支血管疾病的患者中，对于主要复合结局，立即完全血运重建并不劣于分期完全血运重建，并且与心肌梗死和计划外缺血驱动的血运重建的减少相关。伊拉斯姆斯大学医学中心和 Biotronik。