Clinical trial NCT01161732: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: aortic stenosis
surgery, survival
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Institute of Medicine
First posted: 2010-07-14
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: early aortic valve replacement
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cardiac mortality
timeFrame: Entire follow-up ( a minimum of 4 years)
measure: Operative mortality
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: All-cause death
timeFrame: Entire follow-up (a minimum of 4 years)
measure: Repeat aortic valve surgery
timeFrame: Entire follow-up (a minimum of 4 years)
measure: Clinical thromboembolic events
timeFrame: Entire follow-up (a minimum of 4 years)
measure: Hospitalization due to congestive heart failure
timeFrame: Entire follow-up (a minimum of 4 years)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center
Study officials:
affiliation: Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine
name: Duk-Hyun Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.