Ongoing randomised controlled trials of early intervention in asymptomatic severe aortic stenosis
| Trial | Start year and region | N | Definition of severity | Other key criteria | Intervention | Primary outcome |
| Aortic valve replacement vs conservative treatment in asymptomatic severe aortic stenosis (AVATAR)68
NCT02436655 | 2015 Europe | ~312 (event-driven) | Vmax ≥4.0 m/s or MG ≥40 mm Hg and AVA ≤1.0 cm2 or AVAi ≤0.6 cm2/m2 | ≥18 years STS score <8% LVEF >50% | SAVR | Composite: all-cause death, acute myocardial infarction, cerebrovascular insult and unplanned hospitalisation for heart failure requiring intravenous treatment. |
| Danish national randomized study on early aortic valve replacement in patients with asymptomatic severe aortic stenosis (DANAVR) NCT03972644 | 2020 Denmark | 1700 | Vmax ≥3.5m/s and AVA ≤1.0 cm2 and other echo/CT measures as required | ≤85 years Increased LV filling pressures LVEF ≥50% | TAVI/SAVR | All-cause mortality |
| Evaluation of transcatheter aortic valve replacement compared with surveillance for patients with asymptomatic severe aortic stenosis (EARLY-TAVR) NCT03042104 | 2017 USA | 1109 | Severe aortic stenosis | ≥65 years Favourable iliofemoral anatomy Tricuspid aortic valve | Transfemoral TAVI | Composite: all-cause death, stroke and unplanned cardiovascular hospitalisation. |
| Early valve replacement guided by biomarkers of left ventricular decompensation in asymptomatic patients with severe aortic stenosis (EVOLVED)69
NCT03094143 | 2017 UK | ~400 (event-driven) | Vmax ≥4.0 m/s or Vmax ≥3.5 m/s and AVAi <0.6 cm2/m2 | >18 years Presence of mid-wall late gadolinium enhancement on cardiac magnetic resonance LVEF >50% | TAVI/SAVR | Composite: all-cause mortality and unplanned aortic stenosis-related hospitalisation. |
| Early surgery for patients with asymptomatic aortic stenosis (ESTIMATE) NCT02627391 | 2016 France | 360 | Vmax >4.0 m/s and/or MG >40 mm Hg | 18–80 years EuroSCORE II ≤5% LVEF >50% No symptoms/fall in BP during exercise test | SAVR | Composite: overall mortality and cardiac morbidity, including cardiac event requiring hospitalisation. |
| Early valve replacement in severe asymptomatic aortic stenosis study (EASY-AS) NCT04204915 | 2019 UK Australia New Zealand | 2844 | Vmax ≥4.0 m/s or MG ≥40 mm Hg and AVA ≤1.0 cm2 or AVAi ≤0.6 cm2/m2 | >18 years LVEF >50% | TAVI/SAVR | Composite: cardiovascular death and hospitalisation for heart failure |
AVA, aortic valve area; AVAi, indexed aortic valve area; LVEF, left ventricular ejection fraction; MG, mean gradient; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgery; TAVI, transcatheter aortic valve replacement; Vmax, peak aortic valve velocity.