Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis (RECOVERY)

Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Procedure: Early surgery

Detailed Description

Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated AV replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College of Cardiology/American Heart Association guidelines recommend surgery as a class IIb indication only in patients with extremely severe AS and who are at low operative risk. Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and asymptomatic patients with very severe AS are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe AS, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe AS is associated with an improved long-term survival in a prospective, observational study. However, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe AS. We sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.

According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.

Exclusion Criteria:

• Exertional dyspnea
• Angina
• Syncope
• Left ventricular ejection fraction < 50%
• Significant aortic regurgitation
• Significant mitral valve disease
• Pregnancy
• Age < 20 years or > 80 years
• Coexisting malignancies
• Positive exercise test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conventional treatment; In the conventional treatment group, indications for aortic valve replacement surgery are development of symptoms, reduced left ventricular systolic function and an increase in aortic jet velocity > 0.5 m/sec during follow-up.
ACTIVE_COMPARATOR: Early Surgery; Early surgery is performed within 2 months of randomization.	Procedure: Early surgery; Early surgery is performed within 2 months of randomization.; Other Names: Early aortic valve replacement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac mortality	defined as death from complications of myocardial infarction, heart failure, shock, complications of cardiac surgery or intervention, other cardiovascular diseases including sudden cardiac death	Entire follow-up ( a minimum of 4 years)
Operative mortality	Operative mortality is defined as death within 30 days of surgery.	up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death		Entire follow-up (a minimum of 4 years)
Repeat aortic valve surgery		Entire follow-up (a minimum of 4 years)
Clinical thromboembolic events	Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.	Entire follow-up (a minimum of 4 years)
Hospitalization due to congestive heart failure	A hospitalization due to congestive heart failure is defined as an unplanned, urgent admission for the management of congestive heart failure.	Entire follow-up (a minimum of 4 years)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Korea Institute of Medicine
• Investigators: Principal Investigator: Duk-Hyun Kang, M.D., Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine

Publications and helpful links

General Publications

• Kang DH, Park SJ, Rim JH, Yun SC, Kim DH, Song JM, Choo SJ, Park SW, Song JK, Lee JW, Park PW. Early surgery versus conventional treatment in asymptomatic very severe aortic stenosis. Circulation. 2010 Apr 6;121(13):1502-9. doi: 10.1161/CIRCULATIONAHA.109.909903. Epub 2010 Mar 22.
• Park SJ, Lee S, Lee SA, Kim DH, Kim HK, Hong GR, Song JM, Chung CH, Park SW, Kang DH. Impact of Early Surgery and Staging Classification on Survival in Asymptomatic Very Severe Aortic Stenosis. J Am Coll Cardiol. 2021 Feb 2;77(4):506-508. doi: 10.1016/j.jacc.2020.11.045. No abstract available.
• Kang DH, Park SJ, Lee SA, Lee S, Kim DH, Kim HK, Yun SC, Hong GR, Song JM, Chung CH, Song JK, Lee JW, Park SW. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med. 2020 Jan 9;382(2):111-119. doi: 10.1056/NEJMoa1912846. Epub 2019 Nov 16.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2010
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (ESTIMATE): July 14, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: aortic stenosis; surgery, survival
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2010-0065