"Early Surgery versus Conventional Treatment for Infective Endocarditis".The New England Journal of Medicine. ClinicalTrials.gov number, NCT00750373.
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Does early surgery in patients with infective endocarditis and large vegetations decrease the risk of death or embolic events compared to conventional treatment?
Early surgery in patients with infective endocarditis and large vegetations significantly reduced the risk of systemic embolism and the composite end point of death from any cause or embolic events compared to conventional therapy, without increasing operative mortality or recurrence of infective endocarditis.
Embolic events are a common and serious complication of infective endocarditis, particularly within the first week after diagnosis. Although surgical intervention is expanding in the treatment of infective endocarditis, the timing and indications for this intervention to prevent systemic embolism remain controversial. The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial was conducted to compare clinical outcomes between early surgery and conventional treatment.
The trial found that early surgery within 48 hours after diagnosis of infective endocarditis significantly reduced the risk of embolic events and the composite primary end point of in-hospital death or embolic events within 6 weeks of randomization. In-hospital and 6-month mortality rates were also substantially lower than previously reported, possibly due to more aggressive surgical approaches and rapid diagnosis and initiation of treatment.
Guidelines advocate surgical management for complicated left-sided infective endocarditis, with early surgery strongly indicated for patients with infective endocarditis and congestive heart failure. However, surgical indications for infective endocarditis with a high risk of embolism remain to be defined.
Prospective, randomized trial comparing clinical outcomes of early surgery within 48 hours after diagnosis with conventional treatment in patients with left-sided infective endocarditis and large vegetations.
- Patients 18 years of age or older with left-sided, native-valve infective endocarditis, severe valve disease, and large vegetations (diameter >10 mm). - Exclusion: Moderate-to-severe congestive heart failure, heart block, annular or aortic abscess, destructive lesions, fungal endocarditis, age >80, major embolic stroke risk, serious coexisting conditions, prosthetic valve involvement, right-sided or small vegetations.
- Early surgery group: Surgery within 48 hours after randomization. - Conventional treatment group: Treatment according to AHA guidelines, with surgery for complications during medical treatment or persistent symptoms after completion of antibiotic therapy.
- Primary Outcome: Composite of in-hospital death and clinical embolic events within 6 weeks of randomization. - Secondary Outcomes at 6 months: All-cause mortality, embolic events, recurrence of infective endocarditis, repeat hospitalization due to congestive heart failure.
- Limited scope: Only patients with severe valvular disease and large vegetations were included, excluding those with major stroke or prosthetic valve endocarditis. - Applicability: Results may not apply to centers with low surgical volumes or patients with high operative risk. - Study population and frequency of causative microorganisms may not reflect previous studies.
Not reported.
The New England Journal of Medicine article and supplementary material at NEJM.org.