Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

Aortic Stenosis Clinical Trial

— RECOVERY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161732
• Other study ID #: 2010-0065
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Early surgery
Early surgery is performed within 2 months of randomization.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korean Institute of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Operative mortality	Operative mortality is defined as death within 30 days of surgery.	up to 30 days after surgery
Secondary	All-cause death		Entire follow-up (a minimum of 4 years)
Secondary	Repeat aortic valve surgery		Entire follow-up (a minimum of 4 years)
Secondary	Clinical thromboembolic events	Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.	Entire follow-up (a minimum of 4 years)
Secondary	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)