Abstract
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], pinteraction=0·019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0·66) and no linear trend across SYNTAX score tertiles (ptrend=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).
| Original language | English |
|---|---|
| Journal | The Lancet |
| Volume | 394 |
| Issue number | 10206 |
| Pages (from-to) | 1325-1334 |
| Number of pages | 10 |
| ISSN | 0140-6736 |
| DOIs | |
| Publication status | Published - 12.10.2019 |
Funding
APK is Chief Medical Officer, Vice President at Medtronic. PWS reports personal consultancy fees from Abbott Laboratories, Biosensors, Cardialysis, Medtronic, Micell, Sino Medical Sciences Technology, Philips/Volcano, Xeltis, and Heartflow. MJM reports non-financial support from Edwards Lifesciences, Medtronic, and Abbott, outside the submitted work. NC reports grants from Boston Scientific Corporation, Haemonetics, and HeartFlow; personal fees from Boston Scientific Corporation, Abbott, Haemonetics, and Heartflow; education grant from Volcano Phillips; and non-financial support from Haemonetics, Heartflow, Biosensors, and Edwards, outside the submitted work. KDD is the chief medical officer of Shockwave Medical Inc and 4Tech Cardio Ireland, and is also on the Board of Directors of Avicena LLC, JenaValve Technology Inc, and InnovHeart srl, and is a senior adviser to Conformal Medical Inc. PJ reports grants from Canadian Institutes of Health Research, AstraZeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company, outside the submitted work; reports honoraria to the institution for participation in advisory boards from Amgen unrelated to the submitted work, but has not received personal payments by any pharmaceutical company or device manufacturer; serves as unpaid member of the steering group of trials funded by AstraZeneca, Biotronik, Biosensors, St Jude Medical, and The Medicines Company; and is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases funded by the Canadian Institutes of Health Research. SJH is Global Clinical Evidence Director at Medtronic. All other authors declare no competing interests. The SYNTAX trial was supported by Boston Scientific Corporation (Marlborough, MA, USA) during the first 5-years of follow-up. The SYNTAX Extended Survival study was funded by the German Heart Research Foundation (Frankfurt am Main, Germany) for 5–10 years of follow-up. We thank all research coordinators, cardiothoracic surgeons, and cardiologists at participating hospitals who contributed to the SYNTAX Extended Survival study.
