Early Surgery Versus Conventional Treatment in Infective Endocarditis

NCT ID: NCT00750373

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-09-30

Brief 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.

Detailed 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.

Conditions

Endocarditis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional

Conventional Treatment based on current guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgery

Early surgery within 48 hours of randomization

Group Type: ACTIVE_COMPARATOR

Valve surgery with removal of vegetations

Intervention Type: PROCEDURE

Early valve repair or replacement with removal of vegetations within 48 hours of randomization

Interventions

Valve surgery with removal of vegetations

Early valve repair or replacement with removal of vegetations within 48 hours of randomization

Intervention Type: PROCEDURE

Other Intervention Names

early surgery

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Duk-Hyun Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duk-Hyun Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Kang DH, Lee S, Kim YJ, Kim SH, Kim DH, Yun SC, Song JM, Chung CH, Song JK, Lee JW. Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial. Korean Circ J. 2016 Nov;46(6):846-850. doi: 10.4070/kcj.2016.46.6.846. Epub 2016 Oct 20.

Reference Type: DERIVED

PMID: 27826345 (View on PubMed)

Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.

Reference Type: DERIVED

PMID: 22738096 (View on PubMed)

Other Identifiers

2006-0257

Identifier Type: -

Identifier Source: org_study_id