Brief Title
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
Official Title
Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
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.
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
Primary Outcome
Cardiac mortality
Secondary Outcome
All-cause death
Condition
Aortic Stenosis
Intervention
Early surgery
Study Arms / Comparison Groups
Conventional treatment
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
145
Start Date
July 2010
Completion Date
April 30, 2019
Primary Completion Date
April 30, 2019
Eligibility 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
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Duk-Hyun Kang, M.D., ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01161732
Organization ID
2010-0065
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Korea Institute of Medicine
Study Sponsor
Duk-Hyun Kang, M.D., Principal Investigator, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine
Verification Date
May 2019