Research Article: Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patients with coronary artery disease: a randomised controlled trial (FLAVOUR II)
Abstract:
Introduction Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear. Method and analysis The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR?0.8?and minimal lumen area (MLA)?3?mm 2 or 3 mm 2
Introduction:
Intravascular ultrasound (IVUS) is an adjunctive technique that can improve procedural quality and provide a better percutaneous coronary intervention (PCI) result by optimising revascularisation in the catheter laboratory. 1 Several clinical studies and meta-analyses have shown that an IVUS-guided PCI strategy could reduce the incidence of major clinical events after stent implantation. 2–5 Nevertheless, with a lack of flow-relevant information, IVUS cannot accurately define ischaemia-causing stenoses. In…
Read more