Randomized Trial of Early Surgery Versus Conventional Treatment for Infective Endocarditis - EASE
The goal of the trial was to compare early surgery with conventional treatment among patients with infective endocarditis.
Early surgery will improve clinical outcomes.
- Patients 15-80 years of age, with severe aortic or mitral valve infective endocarditis (vegetation >10 mm)
Number of screened applicants: 134
Number of enrollees: 76
Duration of follow-up: 6 months
Mean patient age: 46 years
Percentage female: 35%
Ejection fraction: 62%
- Urgent indication for surgery (congestive heart failure, complete heart block, annular or aortic abscess, penetrating lesions, or fungal endocarditis)
- Not candidate for early surgery (age >80 years, major embolic stroke, or poor medical status)
- Prosthetic valve endocarditis
- Right-sided endocarditis
- Small vegetation (≤10 mm)
- In-hospital mortality or embolic event at 6 weeks
- All-cause mortality, recurrent endocarditis, embolic events, or repeat hospitalization at 6 months
Asian patients with definite infective endocarditis were randomized to early surgery within 48 hours (n = 37) versus conventional treatment (n = 39).
Overall, 76 patients were randomized. The mean age was 46 years, 35% were women, 22% had diabetes, serum creatinine was 1.3 mg/dl, 51% had an embolism on admission (38% spleen, 30% brain, 16% kidney), mean left ventricular ejection fraction was 62%, and mean vegetation diameter was 14 mm. The mitral valve was most commonly involved (59%), followed by aortic valve (30%), and mitral/aortic valve (11%). The most common organism was streptococcus in 57%, and cultures remained negative in 27%.
The primary outcome, in-hospital mortality or embolic event at 6 weeks, occurred in 3% of the early surgery group versus 23% of the conventional therapy group (p = 0.014). In-hospital death: 3% versus 3% (p > 0.99), embolic event: 0 versus 21% (p = 0.005), respectively.
Composite clinical events at 6 months occurred in 3% versus 28% (p = 0.003), respectively. Mortality: 3% versus 5% (p > 0.99), embolic events: 0 versus 21% (p = 0.005), recurrent endocarditis: 0 versus 3% (p > 0.99), respectively.
Among patients with a large vegetation of the aortic or mitral valve, early surgery was beneficial at reducing clinical events at 6 weeks. This was due to a significant reduction in recurrent embolic events in the early surgery group. A primary concern of early surgery with infective endocarditis is development of prosthetic valve endocarditis. While these results appear promising, larger studies with long-term follow-up (beyond 6 months) are necessary.
Presented by Dr. Duk-Hyun Kang at the American Heart Association Scientific Sessions, Orlando, FL, November 16, 2011.
Keywords: Spleen, Hospital Mortality, Streptococcus, Stroke Volume, Embolism, Creatinine, Endocarditis, Bacterial, Mitral Valve, Diabetes Mellitus, Brain
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