Trial Outcomes & Findings for Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results? (NCT NCT04002648)

NCT ID: NCT04002648

Last Updated: 2020-08-07

Results Overview

The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk

• Recruitment status: COMPLETED
• Target enrollment: 208 participants
• Primary outcome timeframe: 12 years
• Results posted on: 2020-08-07

Participant Flow

Participant milestones

Measure	MT-Right Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy Sternotomy: Longitudinal resection of the sternum
Overall Study STARTED	104	104
Overall Study COMPLETED	102	104
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	MT-Right Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy Sternotomy: Longitudinal resection of the sternum
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

2 patients lost to follow-up

Baseline characteristics by cohort

Measure	MT-Right n=104 Participants Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy n=104 Participants Sternotomy: Longitudinal resection of the sternum	Total n=208 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 8 • n=104 Participants	51 years STANDARD_DEVIATION 13 • n=104 Participants	43.5 years STANDARD_DEVIATION 10.5 • n=208 Participants
Sex: Female, Male Female	68 Participants n=102 Participants • 2 patients lost to follow-up	38 Participants n=104 Participants • 2 patients lost to follow-up	106 Participants n=206 Participants • 2 patients lost to follow-up
Sex: Female, Male Male	34 Participants n=102 Participants • 2 patients lost to follow-up	66 Participants n=104 Participants • 2 patients lost to follow-up	100 Participants n=206 Participants • 2 patients lost to follow-up
Region of Enrollment Italy	102 participants n=102 Participants • 2 patients lost to follow-up	104 participants n=104 Participants • 2 patients lost to follow-up	206 participants n=206 Participants • 2 patients lost to follow-up

PRIMARY outcome

Timeframe: 12 years

The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk

Outcome measures

Measure	MT-Right n=102 Participants Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy n=104 Participants Sternotomy: Longitudinal resection of the sternum
Cardiac Death	3.9 percentage of participants with event Interval 0.6 to 13.3	3.8 percentage of participants with event Interval 1.3 to 8.8

PRIMARY outcome

Timeframe: 12 years

The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk

Outcome measures

Measure	MT-Right n=102 Participants Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy n=104 Participants Sternotomy: Longitudinal resection of the sternum
Severe MR	5.8 percentage of participants with event Interval 1.8 to 13.4	11.4 percentage of participants with event Interval 5.9 to 18.8

Adverse Events

MT-Right

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Sternotomy

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	MT-Right n=102 participants at risk Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy n=104 participants at risk Sternotomy: Longitudinal resection of the sternum
Surgical and medical procedures Reoperation	10.8% 11/102 • Number of events 11	9.6% 10/104 • Number of events 10

Other adverse events

Adverse event data not reported

Additional Information

Prof. Michele De Bonis

IRCCSSRaffaele

Phone: +390226437102

Email: debonis.michele@hsr.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place