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

• ClinicalTrials.gov Identifier: NCT01161732
• Recruitment Status: Completed
• First Posted: July 14, 2010
• Last Update Posted: May 3, 2019
• Sponsor: Asan Medical Center
• Collaborator: Korea Institute of Medicine
• Information provided by (Responsible Party): Duk-Hyun Kang, Asan Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Aortic Stenosis	Procedure: Early surgery	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 145 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: early aortic valve replacement
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
• Actual Study Start Date: July 2010
• Actual Primary Completion Date: April 30, 2019
• Actual Study Completion Date: April 30, 2019

Arms and Interventions

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 Name: Early aortic valve replacement surgery

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Asan Medical Center

Seoul, Korea, Republic of, 138-736

Seoul National University Hospital

Seoul, Korea, Republic of

Yonsei University Medical Center

Seoul, Korea, Republic of

Sponsors and Collaborators

Asan Medical Center

Korea Institute of Medicine

Investigators

• Principal Investigator: Duk-Hyun Kang, M.D.; Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duk-Hyun Kang, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT01161732
• Other Study ID Numbers: 2010-0065
• First Posted: July 14, 2010
• Last Update Posted: May 3, 2019
• Last Verified: May 2019

Keywords provided by Duk-Hyun Kang, Asan Medical Center:

aortic stenosis; surgery, survival

Additional relevant MeSH terms:

Aortic Valve Stenosis; Constriction, Pathologic; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction