Background

The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results.

Methods

The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with , .

Findings

From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1·17 [95% CI 0·97–1·41], p=0·092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1·41 [95% CI 1·10–1·80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·90 [0·68–1·20], p _interaction=0·019). There was no treatment-by-subgroup interaction with diabetes (p _interaction=0·66) and no linear trend across SYNTAX score tertiles (p _trend=0·30).

Interpretation

At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease.

Funding

German Foundation of Heart Research (SYNTAXES study, 5–10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0–5-year follow-up).

中文翻译：

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三支血管或左主干冠状动脉疾病患者的经皮冠状动脉介入治疗与冠状动脉旁路移植术：多中心随机对照SYNTAX试验的10年随访

背景

PCI与紫杉类和心脏外科手术之间的协同作用（SYNTAX）试验是一项非劣效性试验，该试验比较了三期新发患者中使用第一代紫杉醇洗脱支架与冠状动脉搭桥术（CABG）进行的经皮冠状动脉介入治疗（PCI） -血管和左主冠状动脉疾病，并报告了长达5年的结果。现在，我们报告10年全因死亡结果。

方法

SYNTAX延长生存期（SYNTAXES）研究是一项由研究人员驱动，扩展了在18个北美和欧洲国家/地区的85家医院进行的多中心，随机对照试验的随访。患有新血管三支血管病变和左主冠状动脉疾病的患者被随机分配（1：1）入PCI组或CABG组。有PCI或CABG病史，急性心肌梗塞或有心脏手术指征的患者被排除在外。SYNTAXES研究的主要终点是10年全因死亡，这是根据意向治疗原则进行评估的。根据左主冠状动脉疾病和糖尿病的存在与否，以及根据核心实验室SYNTAX评分三分位数定义的冠脉复杂性，进行预先指定的亚组分析。

发现

从2005年3月到2007年4月，将1800例患者随机分为PCI组（n = 903）或CABG组（n = 897）。PCI组的841名患者（93％）和CABG组的848名（95％）患者在10年时的生命状态信息完整。在10年时，244例（27％）患者在PCI后死亡，211例（24％）在CABG术后死亡（危险比1·17 [95％CI 0·97-1·41]，p = 0·092）。在三支血管疾病患者中，546例中有151人死于PCI后死亡，而549例中CABG后有113人（21％）死亡（危险比1·41 [95％CI 1·10-1·80]），并且在左主冠状动脉疾病患者中，PCI后死亡的有93例（26％），而CABG术后死亡的有348例中的98％（28％）（0·90 [0·68-1·20]，p_相互作用= 0·019） ）。没有与糖尿病的亚组间交互作用（p_交互作用= 0·66），并且整个SYNTAX得分三分位数均无线性趋势（p_趋势= 0·30）。

解释

在第10年时，使用第一代紫杉醇洗脱支架的PCI与CABG的全因死亡之间无显着差异。但是，CABG在三支血管疾病患者中提供了显着的生存获益，但在左主冠状动脉疾病患者中却没有。

资金

德国心脏研究基金会（SYNTAXES研究，为5至10年的随访）和波士顿科学公司（SYNTAX研究，为0至5年的随访）。