Table 1

Main characteristics of the two randomised controlled trials

AVATARRECOVERY
Trial designMultinational, randomised, controlled, parallel-group, event-drivenMulticentre, randomised, controlled, parallel-group, open-label
Recruitment sitesNine medical centres, seven European Union countriesFour medical centres, one country
Recruitment periodJune 2015–September 2020July 2010–April 2015
Follow-up period (median)32 months73 months
Inclusion criteria
  • Asymptomatic patients.

  • Severe AS (AVA <1 cm2, Vmax >4 m/s or MG >40 mm Hg).

  • Negative exercise tolerance test.

  • Asymptomatic patients.

  • Very severe AS (AVA <0.75 cm2, Vmax >4.5 m/s or MG >50 mm Hg).

Exercise testing was selectively performed to evaluate patients with non-specific symptoms (24 patients) and those with a positive exercise test were excluded (3 patients).
Main exclusion criteria
  • Symptoms (exertional dyspnoea, syncope, presyncope or angina).

  • LVEF <50%.

  • Very severe AS (>5.5 m/s at rest).

  • Clinically significant aortic regurgitation or mitral valve disease.

  • Significant aortic root and/or ascending aorta dilatation requiring surgery.

  • Previous cardiac surgery.

  • Symptoms (exertional dyspnoea, syncope, presyncope or angina).

  • LVEF <50%.

  • Clinically significant aortic regurgitation or mitral valve disease.

  • Previous cardiac surgery.

Aetiology of aortic stenosis
  • Degenerative valvular disease: 133 patients (84.7%).

  • Bicuspid aortic valve: 22 patients (14.0%).

  • Rheumatic valvular disease: 2 patients (1.3%).

  • Degenerative valvular disease: 48 (33%).

  • Bicuspid aortic valve: 88 patients (61%).

  • Rheumatic valvular disease: 9 patients (6%).

Primary endpoints
  • All-cause mortality or major adverse cardiovascular events comprised all-cause death, acute myocardial infarction, stroke and unplanned heart failure hospitalisation needing intravenous treatment with diuretics or inotropes.

  • Operative mortality (death during or within 30 days after surgery) or death from cardiovascular causes during the entire follow-up period.

  • Data are presented as available by the relevant published studies.

  • AS, aortic stenosis; AVA, aortic valve area; AVATAR, Aortic Valve Replacement versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis; LVEF, left ventricular ejection fraction; MG, mean gradient; RECOVERY, Randomized Comparison of Early Surgery versus Conventional Treatment in Very Severe Aortic Stenosis; Vmax, maximal velocity across the aortic valve.