In a clinical trial (EASE Trial: ClinicalTrials.gov number, NCT00750373) recently reported in the New England Journal of Medicine, clinical outcomes of early surgery versus conventional treatment for infective endocarditis are compared. (1)
In this study, patients with left-sided infective endocarditis, severe valve disease, and large vegetations were randomly assigned to early surgery (37 patients) or conventional treatment (39 patients). The primary end point was a composite of in-hospital death and embolic events that occurred within 6 weeks after randomization.
All the patients assigned to the early-surgery group underwent valve surgery within 48 hours after randomization, whereas 30 patients (77%) in the conventional-treatment group underwent surgery during the initial hospitalization (27 patients) or during follow-up (3 patients). The primary end point occurred in 1 patient (3%) in the early-surgery group as compared with 9 (23%) in the conventional-treatment group (hazard ratio 0.10; 95% confidence interval [CI], 0.01 to 0.82; P = 0.03). There was no significant difference in all-cause mortality at 6 months in the early-surgery and conventional-treatment groups (3% and 5%, respectively; hazard ratio 0.51; 95% CI, 0.05 to 5.66; P = 0.59). The rate of the composite end point of death from any cause, embolic events, or recurrence of infective endocarditis at 6 months was 3% in the early-surgery group and 28% in the conventional-treatment group (hazard ratio 0.08; 95% CI, 0.01 to 0.65; P=0.02).
The authors conclude that early surgery in patients with infective endocarditis and large vegetations significantly reduced the composite end point of death from any cause and embolic events by effectively decreasing the risk of systemic embolism.
An accompanying editorial discusses strength and limitations of the study. (2) Despite the relatively small size and other limitations, the authors of the editorial state that “the implication of this study for early surgery is profound and raises the bar for the treatment of patients who do not have urgent indications but do have valve dysfunction and vegetations" and that "the study by Kang and colleagues provides the stimulus for designing randomized trials that will further refine the indications for and timing of surgery".
1. Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73.
2. Gordon SM, Pettersson GB. Native-valve infective endocarditis--when does it require surgery? N Engl J Med. 2012 Jun 28;366(26):2519-21. No abstract available.