Early Surgery Versus Conventional Treatment in Infective Endocarditis

Endocarditis Clinical Trial

— EASE  

Official title:

A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750373
• Other study ID #: 2006-0257
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: April 6, 2015
• Start date: September 2006
• Est. completion date: September 2011

Study information

• Verified date: April 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.

Description:

Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased.

To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:

• severe mitral or aortic regurgitation

• vegetation length > 10 mm on mitral or aortic valve

Exclusion Criteria:

• Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis

• Prosthetic valve endocarditis

• Patient without vegetations on echocardiography

• Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission

• Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis

• Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies

• Patients who did not consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial

Intervention

Procedure:
• Valve surgery with removal of vegetations
Early valve repair or replacement with removal of vegetations within 48 hours of randomization

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With In-hospital Death or Clinical Embolic Events	The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.	within 6 weeks from the randomization	No
Secondary	All-cause Death		up to 6 month after enrollment	No
Secondary	Recurrences of Infective Endocarditis		up to 6 months after enrollment	No
Secondary	All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies		up to 6 months after enrollment	No
Secondary	Readmission Due to Development of Congestive Heart Failure		up to 6 months after enrollment	No