Department of Cardiology, The Heart Centre, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Department of Emergency Medicine, Copenhagen University Hospital-Herlev and Gentofte Hospital, Herlev, Denmark.
Eur Heart J. 2023 Dec 21;44(48):5095-5106. doi: 10.1093/eurheartj/ehad715.
In the Partial Oral Treatment of Endocarditis (POET) trial, stabilized patients with left-sided infective endocarditis (IE) were randomized to oral step-down antibiotic therapy (PO) or conventional continued intravenous antibiotic treatment (IV), showing non-inferiority after 6 months. In this study, the first guideline-driven clinical implementation of the oral step-down POET regimen was examined.
Patients with IE, caused by Staphylococcus aureus, Enterococcus faecalis, Streptococcus spp. or coagulase-negative staphylococci diagnosed between May 2019 and December 2020 were possible candidates for initiation of oral step-down antibiotic therapy, at the discretion of the treating physician. The composite primary outcome in patients finalizing antibiotic treatment consisted of embolic events, unplanned cardiac surgery, relapse of bacteraemia and all-cause mortality within 6 months.
A total of 562 patients [median age 74 years (IQR, interquartile range, 65-80), 70% males] with IE were possible candidates; PO was given to 240 (43%) patients and IV to 322 (57%) patients. More patients in the IV group had IE caused by S. aureus, or had an intra-cardiac abscess, or a pacemaker and more were surgically treated. The primary outcome occurred in 30 (13%) patients in the PO group and in 59 (18%) patients in the IV group (P = .051); in the PO group, 20 (8%) patients died vs. 46 (14%) patients in the IV group (P = .024). PO-treated patients had a shorter median length of stay [PO 24 days (IQR 17-36) vs. IV 43 days (IQR 32-51), P < .001].
After clinical implementation of the POET regimen almost half of the possible candidates with IE received oral step-down antibiotic therapy. Patients in the IV group had more serious risk factors for negative outcomes. At 6-month follow-up, there was a numerically but not statistically significant difference towards a lower incidence of the primary outcome, a lower incidence of all-cause mortality and a reduced length of stay in the PO group. Due to the observational design of the study, the lower mortality may to some extent reflect selection bias and unmeasured confounding. Clinical implementation of PO regimens seemed feasible and safe.
在部分口服治疗心内膜炎（POET）试验中，稳定的左侧感染性心内膜炎（IE）患者被随机分配至口服降级抗生素治疗（PO）或常规持续静脉内抗生素治疗（IV），6 个月后显示非劣效性。在这项研究中，首次根据指南实施了口服降级 POET 方案。
2019 年 5 月至 2020 年 12 月期间，可能符合开始口服降级抗生素治疗的 IE 患者，由金黄色葡萄球菌、粪肠球菌、链球菌或凝固酶阴性葡萄球菌引起，由主治医生决定。接受抗生素治疗的患者的复合主要结局包括栓塞事件、计划外心脏手术、菌血症复发和 6 个月内全因死亡率。
共有 562 例 IE 患者（中位数年龄 74 岁[IQR，四分位距（65-80）]，70%为男性）可能为候选患者；240 例（43%）患者接受 PO 治疗，322 例（57%）患者接受 IV 治疗。IV 组中更多的患者患有金黄色葡萄球菌引起的 IE、心内脓肿、起搏器或接受手术治疗。PO 组中有 30 例（13%）患者发生主要结局，IV 组中有 59 例（18%）患者发生（P =.051）；PO 组中有 20 例（8%）患者死亡，IV 组中有 46 例（14%）患者死亡（P =.024）。PO 治疗组的中位住院时间较短[PO 24 天（IQR 17-36）vs. IV 43 天（IQR 32-51），P <.001]。
POET 方案实施后，近一半可能的 IE 候选患者接受了口服降级抗生素治疗。IV 组患者有更多导致不良结局的严重危险因素。在 6 个月随访时，PO 组的主要结局发生率较低，全因死亡率较低，住院时间较短，但无统计学意义。由于研究的观察设计，较低的死亡率在一定程度上可能反映了选择偏倚和未测量的混杂因素。PO 方案的临床实施似乎是可行和安全的。
