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).