Division of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.
The timing and indications for surgical intervention to prevent systemic embolism in infective endocarditis remain controversial. We conducted a trial to compare clinical outcomes of early surgery and conventional treatment in patients with infective endocarditis.
We randomly assigned patients with left-sided infective endocarditis, severe valve disease, and large vegetations to early surgery (37 patients) or conventional treatment (39). 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). 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).
As compared with conventional treatment, 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. (EASE ClinicalTrials.gov number, NCT00750373.).
在感染性心内膜炎中，预防全身栓塞的手术时机和适应证仍存在争议。我们进行了一项试验，比较了感染性心内膜炎患者早期手术与常规治疗的临床结局。
我们将左侧感染性心内膜炎、严重瓣膜病和大赘生物的患者随机分为早期手术（37 例）或常规治疗（39 例）。主要终点是随机分组后 6 周内住院死亡和栓塞事件的复合终点。
所有随机分至早期手术组的患者均在随机分组后 48 小时内接受了瓣膜手术，而常规治疗组中有 30 例（77%）患者在初始住院期间（27 例）或随访期间（3 例）接受了手术。早期手术组的主要终点事件发生在 1 例患者（3%）中，而常规治疗组则发生在 9 例患者（23%）中（风险比，0.10；95%置信区间 [CI]，0.01 至 0.82；P=0.03）。早期手术组和常规治疗组在 6 个月时的全因死亡率分别为 3%和 5%（风险比，0.51；95%CI，0.05 至 5.66；P=0.59）。早期手术组和常规治疗组在 6 个月时的复合终点事件（任何原因导致的死亡、栓塞事件或感染性心内膜炎复发）发生率分别为 3%和 28%（风险比，0.08；95%CI，0.01 至 0.65；P=0.02）。
与常规治疗相比，对于感染性心内膜炎合并大赘生物的患者，早期手术可显著降低任何原因导致的死亡和栓塞事件的复合终点事件发生率，通过有效降低全身栓塞的风险而获益。[注册号：EASE ClinicalTrials.gov，NCT00750373。]
