Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00750373
First received: September 8, 2008
Last updated: August 8, 2012
Last verified: August 2012

September 8, 2008
August 8, 2012
September 2006
April 2011   (final data collection date for primary outcome measure)
Number of Participants With In-hospital Death or Clinical Embolic Events [ Time Frame: within 6 weeks from the randomization ] [ Designated as safety issue: No ]
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.
The composite of in-hospital death and clinical embolic events confirmed by imaging studies [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00750373 on ClinicalTrials.gov Archive Site
  • All-cause Death [ Time Frame: up to 6 month after enrollment ] [ Designated as safety issue: No ]
  • Recurrences of Infective Endocarditis [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]
  • All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]
  • Readmission Due to Development of Congestive Heart Failure [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]
  • All-cause death [ Time Frame: 6 month after enrollment ] [ Designated as safety issue: No ]
  • Recurrences of infective endocarditis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • All embolic events including symptomatic and asymptomatic embolization documented by imaging studies [ Time Frame: In-hospital, 6 months after enrollment ] [ Designated as safety issue: No ]
  • Readmission due to development of congestive heart failure [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Early Surgery Versus Conventional Treatment in Infective Endocarditis
A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endocarditis
Procedure: Valve surgery with removal of vegetations
Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Other Name: early surgery
  • No Intervention: Conventional
    Conventional Treatment based on current guidelines
  • Active Comparator: Surgery
    Early surgery within 48 hours of randomization
    Intervention: Procedure: Valve surgery with removal of vegetations
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
September 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00750373
2006-0257
No
Duk-Hyun Kang, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Duk-Hyun Kang, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP