Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism: a Randomized Superiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Complications and deaths in all included patient
研究概览
简要总结
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%). Leading causes of mortality are heart failure (HF) resulting from valve dysfunction, and stroke caused by vegetation embolization. The rate of symptomatic embolic events occurring after antibiotic initiation is around 15%. Valve surgery benefit has been clearly demonstrated in patients with periannular complications and moderate to severe HF resulting from acute valve regurgitation. The timing of surgery to prevent embolism is critical since the risk of new embolic event is highest during the first weeks of antibiotic treatment.
The primary objective is to compare clinical outcomes of Early Valve Surgery (as soon as possible within 72 hours of randomization) with those of a conventional management based on current guidelines in patients with native left-sided IE and high risk of embolism.
208 patients (104 patients per arm) will be included in a national multicenter (21 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.
详细描述
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%). Leading causes of mortality are heart failure (HF) resulting from valve dysfunction, and stroke caused by vegetation embolization. The rate of symptomatic embolic events occurring after antibiotic initiation is around 15%. Valve surgery benefit has been clearly demonstrated in patients with periannular complications and moderate to severe HF resulting from acute valve regurgitation. Indications of valve surgery for prevention of embolic complications are less clearly defined. Potential complications of valve surgery and of implanted permanent prosthetic valve are to be balanced against their potential benefits in terms of prevented embolism and improved survival. The timing of surgery to prevent embolism is critical since the risk of new embolic event is highest during the first weeks of antibiotic treatment. The points in favor of early valve surgery (EVS) in patients with high embolic risk include the following 1) patients with high risk of embolism are identified by transesophageal echocardiography (TOE); 2) advances in surgical management of IE dramatically lowered postoperative mortality; 3) 2015 European ESC IE guidelines state that valve surgery should be performed in IE with vegetation above 10 mm AND an embolic event occurring while patients are receiving antibiotic (grade I/B) and should be considered in IE with vegetation above 30 mm (Grade IIaB ) and may be above 10 mm and severe valve regurgitation.
The primary objective is to compare clinical outcomes of EVS (as soon as possible within 72 hours of randomization) with those of a conventional management based on current 2015 European ESC guidelines in patients with native left-sided IE and high risk of embolism.
The primary assessment criterion is a composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
208 patients (104 patients per arm) will be included in a national multicenter (21 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Definite or possible IE based on the modified Duke criteria (ESC 2015)
- •Length of vegetation on native aortic and/or mitral valve, as assessed by TOE * :
- •between 10 and 15 mm AND (severe regurgitation OR previous symptomatic or asymptomatic embolic events)
- •OR above or equal to 15 mm
- •Initiation of specific IE active antibiotic less than 5 days (≤120 hours) before inclusion
- •For non-menopause women: negative blood or urinary β-HCG test. *If the patient has several vegetations, only one vegetation with these criterions, is enough to included patient.
排除标准
- •Patient with "emergent" indication of surgery based on 2015 European Guidelines
- •Prosthetic valve endocarditis
- •Patient who is not candidate for surgery due to high risk post-surgery mortality including for example coexisting major embolic stroke with a high risk of hemorrhagic transformation, symptomatic hemorrhagic stroke; poor medical status, such as coexisting malignancies...
- •No written informed consent from the patient or a legal representative if appropriate
- •Patient with no national health or universal plan affiliation coverage
- •Patient under guardianship or curatorship
结局指标
主要结局
Complications and deaths in all included patient
时间窗: Week 6
A composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
次要结局
- Complications and deaths in patient with definite IE(Week 6)
- Complications and deaths(Months 6 and 12)
- Intensive care scale(Week 6 , Months 3, 6 and 12)
- Infective EI relapse(Months 6 and 12)
- Infective EI recurrences(Months 6 and 12)
- Rehospitalization(Week 6, Months 6 and 12)
- Deaths(Months 6 and 12)
- Symptomatic embolic events(Months 6 and 12)
- Rehospitalization for valve surgery(Months 6 and 12)
- Quality of life scale 1(Months 6 and 12)
- Quality of life scale 2(Months 6 and 12)
- Delay between randomization and surgery(Months 12)
- Thrombosis and ischemia(Months 6 and 12)