Key result
Early surgery significantly reduced the composite end point of death, embolic events, or recurrence of infective endocarditis at 4 years compared to conventional treatment (8.1% vs 30.8%, HR 0.22).
Why the study?
Does early surgery reduce death, embolic events, or recurrence of IE compared to conventional treatment in patients with left-sided infective endocarditis, severe valve disease, and large vegetations?
RCT (n=76)
Open-label
1:1 using an interactive web response system
Yes
Does early surgery reduce death, embolic events, or recurrence of IE compared to conventional treatment in patients with left-sided infective endocarditis, severe valve disease, and large vegetations?
Hazard Ratio: 0.22 (95% CI 0.06–0.78)
Absolute Event Rate: 8.1% vs 30.8%
p-value: p=0.02
Early surgery provides sustained long-term benefits up to 7 years by significantly reducing the composite of death, embolic events, or IE recurrence in patients with left-sided infective endocarditis and large vegetations.
Early surgery sustains composite benefit to 7 years in IE with large vegetations; extends short-term RCT findings with durable event reduction.
BACKGROUND AND OBJECTIVES: Compared with conventional treatment, early surgery significantly reduced the composite end point of all-cause death and embolic events during hospitalization, but long-term data in this area are lacking. This study sought to compare long-term outcomes of early surgery with a conventional treatment strategy in patients with infective endocarditis (IE) and large vegetations. SUBJECTS AND METHODS: The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial randomly assigned patients with left-sided IE, severe valve disease and large vegetation to early surgery (37 patients) or conventional treatment groups (39 patients). The pre-specified end points were all-cause death, embolic events, recurrence of IE and repeat hospitalizations due to the development of congestive heart failure occurring during follow-up. RESULTS: There were no significant differences between the early surgery and the conventional treatment group in all-cause mortality at 4 years (8.1% and 7.7%, respectively; hazard ratio [HR] 1.04; 95% CI, 0.21 to 5.15; p=0.96). The rate of the composite end point of death from any cause, embolic events or recurrence of IE at 4 years was 8.1% in the early surgery group and 30.8% in the conventional treatment group (HR, 0.22; 95% CI, 0.06-0.78; p=0.02). The estimated actuarial rate of end points at 7 years was significantly lower in the early surgery group than in the conventional treatment group (log-rank p=0.007). CONCLUSION: There was a substantial benefit in having early surgery for patients with IE and large vegetations whose health was sustained up to 7 years, and late clinical outcome after surgery was excellent in survivors of IE. (EASE clinicaltrials.gov identifier: NCT00750373).
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Kang et al. (2016) conducted an RCT in Infective endocarditis with large vegetations (n=76). Early surgery vs. Conventional treatment was evaluated on Composite of death from any cause, embolic events, or recurrence of infective endocarditis at 4 years (HR 0.22, 95% CI 0.06-0.78, p=0.02). Early surgery significantly reduced the composite end point of death, embolic events, or recurrence of infective endocarditis at 4 years compared to conventional treatment (8.1% vs 30.8%, HR 0.22).
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