Clinical trial NCT00750373: Early Surgery Versus Conventional Treatment in Infective Endocarditis
Official title: A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endocarditis
Keywords: Endocarditis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 76
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With In-hospital Death or Clinical Embolic Events
timeFrame: within 6 weeks from the randomization
Secondary outcomes:
measure: All-cause Death
timeFrame: up to 6 month after enrollment
measure: Recurrences of Infective Endocarditis
timeFrame: up to 6 months after enrollment
measure: All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
timeFrame: up to 6 months after enrollment
measure: Readmission Due to Development of Congestive Heart Failure
timeFrame: up to 6 months after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Duk-Hyun Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.