SYNTAXES
Research type
Research Study
Full title
Synergy between PCI with TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES)
IRAS ID
237300
Contact name
Daniel J.F.M. Thuijs
Contact email
Sponsor organisation
Erasmus Medical Center
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT03417050, ClinicalTrials.gov
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The SYNTAX trial was the first large-scale randomized trial that randomly assigned patients with coronary artery disease (CAD) to undergo Coronary Artery Bypass Grafting (CABG) versus Percutaneous Coronary Intervention (PCI) with drug-eluting stents. It is currently considered to be the most important trial of CABG versus PCI. Follow-up to 5 years demonstrated that Kaplan Meier curves continued to diverge between PCI and CABG, with significantly lower rates of cardiac death, myocardial infarction and repeat revascularization in favour of CABG. Findings from subgroup analyses have been crucial in determining the most appropriate treatment strategy according to baseline characteristics of patients with CAD. Outcomes showed to differ substantially between patients with three vessel disease (3VD) or left-main (LM) disease; those with LM disease had similar outcomes with PCI and CABG, while those with 3VD had significantly better outcomes with CABG. In addition, the SYNTAX score, an angiographically based risk model, proved to be a useful tool to stratify which patients should undergo PCI or CABG, with CABG being the preferred strategy especially in patients with more complex lesions. Unfortunately, the SYNTAX trial completed at the 5 year follow-up. Therefore, numerous questions on the debate of whether CABG or PCI provide better outcomes remain unanswered. Particularly subgroup analyses, which have more limited statistical power because of smaller groups and/or events, could significantly benefit from an extended follow-up.
The primary endpoint for The SYNTAXES study is all cause death at 10-years.
Since follow-up completed after 5-years, a retrospective, non-interventional review of mortality will be performed. All 8 participating UK hospitals will provide NHS details on all SYNTAXES patients in order to collect survival status from the NHS database (dead or alive, exact date of death).REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0258
Date of REC Opinion
6 Nov 2018
REC opinion
Further Information Favourable Opinion