NEJM：早期手术与常规治疗对感染性心内膜炎的疗效比较

　　背景在感染性心内膜炎的治疗中，手术干预以预防全身栓塞的时机和指征尚存在争议。我们在感染性心内膜炎患者中进行了一项试验，以比较早期手术和常规治疗的临床转归。

　　方法我们将有左侧感染性心内膜炎、严重瓣膜病、并有巨大赘生物的患者随机分配接受早期手术（37例）或常规治疗（39例）。主要终点是发生在随机分组后6周内的院内死亡以及栓塞事件的复合终点。

　　结果在随机分组后48 小时内，所有被分配至早期手术组的患者接受了瓣膜手术，而常规治疗组有30 例（77%）患者在首次住院（27例）或随访期间（3例）接受了手术。早期手术组中有1例（3%）患者发生主要终点事件，相比之下，常规治疗组有9 例（23%）患者发生主要终点事件[风险比为0.10，95%可信区间（CI）为0.01～0.82，P=0.03]。6 个月时，早期手术组和常规治疗组的全因死亡率无显著差异（分别为3%和5%，风险比为0.51，95%CI 为0.05～5.66，P=0.59）。6个月时任何原因死亡、栓塞事件或感染性心内膜炎复发的复合终点发生率在早期手术组为3%，相比之下，在传统治疗组为28%（风险比为0.08，95% CI 为0.01～0.65，P=0.02）。

　　结论对于感染性心内膜炎且有巨大赘生物的患者，与常规治疗相比，早期手术可通过有效降低全身栓塞危险来显著减少任何原因的死亡和栓塞事件的复合终点。

Early Surgery versus Conventional Treatment for Infective Endocarditis

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.)