Trial Outcomes & Findings for Early Surgery Versus Conventional Treatment in Infective Endocarditis (NCT NCT00750373)

Results Overview

The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

76 participants

Primary outcome timeframe

within 6 weeks from the randomization

Results posted on

2015-04-23

Participant Flow

Patients were eligible for enrollment if they were diagnosed as definite infective endocarditis and had both severe mitral or aortic valve disease and vegetation length \> 10 mm. Between September 2006 and March 2011, a total of 76 patients were enrolled at the Asan Medical Center (n=71) and Seoul National University Hospital (n=5) in Korea.

The exclusion criteria were defined as patients with moderate to severe CHF; heart block; annular or aortic abscess; fungal endocarditis; and those who were not candidates for early surgery on the basis of age \> 80 years, coexisting major embolic stroke with a risk of hemorrhagic transformation and/or poor medical status.

Participant milestones

Participant milestones
Measure	Conventional Conventional Treatment based on current guidelines	Surgery Early surgery within 48 hours of randomization
Overall Study STARTED	39	37
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Surgery Versus Conventional Treatment in Infective Endocarditis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional n=39 Participants Conventional Treatment based on current guidelines	Surgery n=37 Participants Early surgery within 48 hours of randomization	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 17 • n=5 Participants	46 years STANDARD_DEVIATION 15 • n=7 Participants	47 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Korea, Republic of	39 participants n=5 Participants	37 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: within 6 weeks from the randomization

Population: intention to treat analysis

The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.

Outcome measures

Outcome measures
Measure	Conventional n=39 Participants Conventional Treatment based on current guidelines	Surgery n=37 Participants Early surgery within 48 hours of randomization
Number of Participants With In-hospital Death or Clinical Embolic Events	9 participants	1 participants

SECONDARY outcome

Timeframe: up to 6 month after enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months after enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months after enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months after enrollment

Outcome measures

Outcome data not reported

Adverse Events

Conventional

Serious events: 9 serious events

Other events: 1 other events

Deaths: 0 deaths

Surgery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Conventional n=39 participants at risk Conventional Treatment based on current guidelines	Surgery n=37 participants at risk Early surgery within 48 hours of randomization
Cardiac disorders Cardiac death	5.1% 2/39 • Number of events 2 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.	0.00% 0/37 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.
Vascular disorders embolism	20.5% 8/39 • Number of events 8 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.	0.00% 0/37 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.
Infections and infestations In-hospital noncardiac death	0.00% 0/39 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.	2.7% 1/37 • Number of events 1 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.

Other adverse events

Other adverse events
Measure	Conventional n=39 participants at risk Conventional Treatment based on current guidelines	Surgery n=37 participants at risk Early surgery within 48 hours of randomization
Infections and infestations recurrence of infective endocarditis	2.6% 1/39 • Number of events 1 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.	0.00% 0/37 • All patients underwent complete follow-up that began in September 2006 and ended in September 2011.

Additional Information

Dr. Duk-Hyun Kang

Asan Medical Center

Phone: 82-2-3010-3149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place