荷兰伊拉斯姆斯大学Daniel J F M Thuijs研究组与合作者，比较了第一代紫杉醇洗脱支架PCI与冠状动脉旁路移植术治疗冠脉病变的全因死亡率之间的差异。相关论文2019年9月2日在线发表于《柳叶刀》。

SYNTAX试验是一项非劣效性试验，比较了第一代紫杉醇洗脱支架经皮冠状动脉介入治疗（PCI）与冠状动脉旁路移植术（CABG）治疗冠脉三支病变和左主干病变患者的效果，报告随访长达5年。研究组现将其扩展至10年。

SYNTAXES研究是一项研究者驱动、多中心、随机对照的随访扩展试验，在北美和欧洲18个国家的85家医院进行。2005年3月至2007年4月，1800名冠状动脉三支病变和左主干病变的患者按1：1随机分配到PCI组（903名）或CABG组（897名）。

随访10年后，PCI组中有244名患者（27%）死亡，CABG组为211例（24%），风险比为1.17。PCI组546例冠脉三支病变的患者中有151例（28%）死亡，CABG组549例患者中有113例（21%），风险比1.41；PCI组357例冠脉左主干病变的患者中有93例（26%）死亡，CABG组348例患者中有98例（28%），风险比为0.90。

手术10年后，第一代紫杉醇洗脱支架PCI与CABG的全因死亡率无显著差异。但CABG显著提高了冠脉三支病变患者的生存率。

附：英文原文

Title: Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial

Author: Daniel J F M Thuijs, MD.Prof A Pieter Kappetein, PhD,Prof Patrick W Serruys, PhD,Prof Friedrich-Wilhelm Mohr, PhD,Marie-Claude Morice, PhD,Michael J Mack, PhD,David R Holmes Jr, MD,Prof Nick Curzen, PhD,Piroze Davierwala, MD,Thilo Noack, MD,Milan Milojevic, PhD,Keith D Dawkins, MD,Bruno R da Costa, PhD,Prof Peter Jüni, MD,Stuart J Head, PhD,for the SYNTAX Extended Survival Investigators

Issue&Volume: September 2, 2019

Summary：

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 ClinicalTrials.gov, NCT03417050.

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.