Non-invasive vessel fractional flow reserve versus fractional flow reserve guidance to revascularize intermediate coronary stenosis (LIPSIA-STRATEGY) trial: study protocol for a randomized controlled trial

BACKGROUND: Current guidelines on coronary revascularization support the use of wire-based coronary physiology measurements to guide decision making in patients with coronary artery stenoses. Nevertheless, the use of these techniques in clinical practice is variable and its application worldwide remains limited by its requirement for the use of an intracoronary pressure wire and prolonged procedure time. Recently, angiography-based wire-free techniques to estimate fractional flow reserve (FFR) values have been introduced. These developments may translate towards more physiology-guided intervention bearing the potential to improve clinical outcomes in patients with stable coronary artery disease (CAD). METHODS: The LIPSIA-STRATEGY trial is a randomized controlled, investigator-initiated, multicenter, open-label study. A total of 1054 eligible patients will be randomized 1:1 to coronary revascularization based on angiography-derived vessel fractional flow reserve (vFFR) or revascularization based on FFR obtained by pressure wire measurements. The major inclusion criterion is the presence of visually assessed intermediate coronary artery stenoses in one or more native major epicardial coronary arteries in the setting of stable angina or an acute coronary syndrome (ACS). In patients with an ACS, only non-culprit vessels will be considered for inclusion. The primary endpoint is the occurrence of major adverse cardiovascular events (MACE) during the first year after randomization. DISCUSSION: The LIPSIA-STRATEGY trial will be the first to compare angiography-derived vFFR with invasive FFR with respect to clinical outcomes in patients with intermediate coronary lesions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03497637. Registered 2018-04-13.