Abstract Aims To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39–0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11–0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37–0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27–1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10–4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07–0.97, P = 0.045). Conclusion At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier NCT02015832

中文翻译：

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新发三支血管疾病患者最先进的经皮冠状动脉血运重建的临床结果：SYNTAX II 研究的 1 年结果

Abstract Aims To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. 方法和结果 SYNTAX II 研究是一项多中心、所有受试者、开放标签、单臂研究，在来自四个欧洲国家的 22 个中心调查了当代 PCI 策略对 3VD 患者临床结果的影响。SYNTAX-II 策略包括：利用 SYNTAX Score II（一种结合解剖学和临床因素的临床工具）进行心脏团队决策、冠状动脉生理学引导的血运重建、植入薄支柱生物可吸收聚合物药物洗脱支架、血管内超声 (IVUS)引导支架植入术，当代慢性完全闭塞血运重建技术和指南指导的药物治疗。将一年内主要不良心脑血管事件（MACCE [全因死亡、脑血管事件、任何心肌梗塞和任何血运重建的组合]）的发生率与在 SYNTAX-I 试验中选择的原始 SYNTAX-I 试验中预先确定的 PCI 队列进行比较。 CABG 和 PCI 之间 4 年死亡率的平衡基础。作为探索性终点，与原始 SYNTAX-I 试验的历史 CABG 队列进行了比较。总共有 708 名患者在心脏团队内进行了筛查和讨论；454 名患者被认为适合接受 PCI。一年时，SYNTAX-II 策略优于均衡衍生的 SYNTAX-I PCI 队列（MACCE SYNTAX-II 10.6% 与 SYNTAX-I 17.4%；HR 0.58，95% CI 0.39–0.85，P = 0.006） . 这种差异是由 MI（HR 0.27，95% CI 0.11-0.70，P = 0.007）和血运重建（HR 0.57，95% CI 0.37-0.9，P = 0.015）发生率显着降低所致。全因死亡率（HR 0.69，95% CI 0.27-1.73，P = 0.43）和卒中（HR 0.69，95% CI 0.10-4.89，P = 0.71）相似。SYNTAX-II 中明确的支架血栓形成率显着降低（HR 0.26，95% CI 0.07–0.97，P = 0.045）。结论 一年后，与在最初 SYNTAX-I 试验的可比患者中进行的 PCI 相比，SYNTAX-II 策略的临床结果与改善的临床结果相关。需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 11–0.70，P = 0.007）和血运重建（HR 0.57，95% CI 0.37–0.9，P = 0.015）。全因死亡率（HR 0.69，95% CI 0.27-1.73，P = 0.43）和卒中（HR 0.69，95% CI 0.10-4.89，P = 0.71）相似。SYNTAX-II 中明确的支架血栓形成率显着降低（HR 0.26，95% CI 0.07–0.97，P = 0.045）。结论 一年后，与最初 SYNTAX-I 试验的可比患者中进行的 PCI 相比，SYNTAX-II 策略的临床结果与改善的临床结果相关。需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 11–0.70，P = 0.007）和血运重建（HR 0.57，95% CI 0.37–0.9，P = 0.015）。全因死亡率（HR 0.69，95% CI 0.27-1.73，P = 0.43）和卒中（HR 0.69，95% CI 0.10-4.89，P = 0.71）相似。SYNTAX-II 中明确的支架血栓形成率显着降低（HR 0.26，95% CI 0.07–0.97，P = 0.045）。结论 一年后，与在最初 SYNTAX-I 试验的可比患者中进行的 PCI 相比，SYNTAX-II 策略的临床结果与改善的临床结果相关。需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 71) 相似。SYNTAX-II 中明确的支架血栓形成率显着降低（HR 0.26，95% CI 0.07–0.97，P = 0.045）。结论 一年后，与在最初 SYNTAX-I 试验的可比患者中进行的 PCI 相比，SYNTAX-II 策略的临床结果与改善的临床结果相关。需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 71) 相似。SYNTAX-II 中明确的支架血栓形成率显着降低（HR 0.26，95% CI 0.07–0.97，P = 0.045）。结论 一年后，与在最初 SYNTAX-I 试验的可比患者中进行的 PCI 相比，SYNTAX-II 策略的临床结果与改善的临床结果相关。需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832 需要进行更长期的随访，并有必要对当代 CABG 进行随机临床试验。ClinicalTrials.gov 标识符 NCT02015832