SYNTAX II - Study purpose


The anatomical-based SYNTAX Score, designed and implemented in the landmark SYNTAX trial, has established itself as a tool to aid the Heart Team consensus in determining the optimal revascularization modality in patients with unprotected left main coronary artery disease or de novo three-vessel disease (3VD).Since publication of the SYNTAX trial, the anatomical-based SYNTAX Score, has been validated in multiple studies, and has been advocated in both the US and European revascularization guidelines.

Dedicated studies in the post SYNTAX Trial era investigating 3VD remain scarce. As of present, current revascularization guidelines recommend that a low SYNTAX Score (0-22) may offer similar clinical outcomes between percutaneous coronary intervention (PCI) with drug eluting stents (DES) and coronary artery bypass graft (CABG) surgery.

The purpose of the SYNTAX II trial is to investigate the management of de-novo 3VD in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between CABG and PCI, using contemporary PCI practice.

In SYNTAX II the effectiveness of a contemporary stent (the new generation SYNERGY™ and/or SYNERGY II™ DES) will be compared against PCI practice in the original SYNTAX trial, using pressure wire assessment of lesions (iFR/FFR) to allow for ischemia-driven revascularisation and IVUS guidance to optimise stent deployment. If present, chronic total occlusion (CTO) lesions will be treated with contemporary techniques.

The SYNTAX II will involve the SYNTAX Score II to prospectively recruit subjects on the grounds of patient safety.