NCT01161732

Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
PROCEDURE	Early surgery	Early surgery is performed within 2 months of randomization.

Timeline

• Start date: 2010-07-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2010-07-14
• Last updated: 2025-06-26

Locations

4 sites across 1 country: South Korea