Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial

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)