RECOVERY

https://www.ncbi.nlm.nih.gov/pubmed/?term=10.1056%2FNEJMoa1912846

RECOVERY

Clinical Question

In patients with asymptomatic severe aortic stenosis, does early surgery as compared to conservative management improve clinical outcomes?

Bottom Line

For patients with asymptomatic very severe aortic stenosis, early surgical management compared to guideline-recommended conservative management decreased the composite primary endpoint of operative mortality and death from cardiovascular causes.

Major Points

Current guidelines for the management of asymptomatic severe aortic stenosis recommend monitoring for the development of symptoms prior to intervention; however, the optimal timing of intervention remains unclear.

Guidelines

No guidelines reflect the results of this trial as of October 2018.

Design

• Randomized, open-label, parallel assignment, multicenter trial
• N=145
  • Early surgery (SAVR) (n=73)
  • Conservative care (n=72)
• Setting: 4 centers in South Korea
• Enrollment: July 2010 to April 2015
• Follow-up: Median 6.2 years (interquartile range, 5.0 to 7.4
• Analysis: Intention-to-treat
• Primary end point: operative mortality or death from cardiovascular cause
• Secondary end points: death from any cause; clinical thromboembolic event; repeat aortic valve surgery; hospitalization for heart failure

Population

Inclusion Criteria

• Age 20-80 years old
• Very severe aortic stenosis (aortic valve area 0.75 cm2 with either peak aortic jet velocity 4.5 m/s or mean transaortic gradient 50mmHg)

Exclusion Criteria

• Exertional dyspnea, syncope, presyncope, angina
• Positive exercise stress test
• Left ventricular ejection fraction <50%
• Clinically significant aortic regurgitation or mitral valve disease
• Prior cardiac surgery
• Medical contraindication to surgery such as cancer

Baseline Characteristics

From the early surgery group.

• Mean age: 65.07.8 years
• Male sex: 51%
• BMI: 24.73.4
• Medical history
  • Hypertension: 55%
  • Diabetes mellitus: 18%
  • Hypercholesterolemia: 56%
  • Atrial fibrillation: 4%
  • CAD: 7%
  • Previous PCI: 4%
  • Previous stroke: 4%
  • Peripheral vascular disease: 1%
  • Serum creatinine: 0.840.23
  • EuroSCORE II score: 0.90.3
• Medications
  • ACEi: 5%
  • ARB: 33%
  • Calcium antagonist: 26%
  • Beta-blocker: 18%
  • Diuretic: 18%
  • Statin: 47%
• Echocardiographic findings
  • Bicuspid aortic valve: 67%
  • Degenerative valvular disease: 30%
  • Rheumatic valvular disease: 3%
  • Peak aortic jet velocity: 5.140.52
  • Transaortic pressure gradient, peak: 106.921.9
  • Transaortic pressure gradient, mean: 64.314.4
  • Aortic valve area: 0.630.09
  • Aortic valve area index: 0.380.06
  • Left ventricular mass index: 135.638.2
  • Left ventricular ejection fraction: 64.85.2

Interventions

• Randomized to early surgery (within 2 months of randomization) or conservative care (per ACC/AHA guidelines)

Outcomes

Comparisons are early surgery vs. conservative care.

Primary Outcome

Operative mortality or death from cardiovascular cause

1% vs. 15% (HR 0.09; 95% CI 0.01 to 0.67)

Secondary Outcomes

Death from any cause

7% vs. 21% (HR 0.33; 95% CI 0.12 to 0.90)

Clinical thromboembolic event

1% vs. 6% (HR 0.30; 95% CI 0.04 to 2.31)

Repeat aortic valve surgery

0% vs. 3% (95% CI 0.10 to 8.00)

Hospitalization for heart failure

0% vs. 11% (95% CI 0.00 to 1.05)

Subgroup Analysis

No subgroup analyses were performed.

Adverse Events

No adverse events other than the outcomes listed above were reported.

Criticisms

• Lack of generalizability to all patients with severe aortic stenosis
• Trial was not blinded
• Exercise testing was not performed in all patients, so it is possible that some patients were symptomatic
• Relatively small number of patients
• Patients had low operative risk due to younger age

Funding

The study was funded by the Korean Institute of Medicine.

Further Reading

Kang DH et al. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N. Engl. J. Med. 2020. 382:.</ref>