Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

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

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