The SYNERGY II Everolimus elutiNg stent In patients Older than 75 years undergoing coronary Revascularisation associated with a short dual antiplatelet therapy (SENIOR) trial: rationale and design of a large-scale randomised multicentre study.

Abstract

In the elderly population, bare metal stents (BMS) are often preferred over drug-eluting stents (DES) because of the longer duration of dual antiplatelet therapy (DAPT) associated with the latter. The SENIOR trial is designed to determine whether one of the latest generation of DES can reduce major cardiovascular events compared to BMS, despite a similar short DAPT duration. The SENIOR trial is a multicentre, single-blind, prospective, randomised trial comparing the latest generation DES (SYNERGY™ II; Boston Scientific, Marlborough, MA, USA) to BMS (Rebel™; Boston Scientific) in 1,200 patients ≥75 years old. DAPT will be given for one or six months according to clinical presentation, irrespective of stent type. The primary outcome is the composite of all-cause mortality, non-fatal myocardial infarction, stroke or ischaemia-driven target lesion revascularisation at one year. Secondary endpoints include the rate of major bleedings and the rate of stent thrombosis at one year. This trial is designed to evaluate a new revascularisation strategy combining DES and short duration DAPT in elderly patients. It has the potential to decrease the need for target lesion revascularisation without a significant DAPT-related increase in bleeding compared to BMS.