Trial Outcomes & Findings for Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM) (NCT NCT00086450)

NCT ID: NCT00086450

Last Updated: 2017-02-06

Results Overview

median 3.8 years of follow-up

• Recruitment status: UNKNOWN
• Study phase: PHASE3
• Target enrollment: 1900 participants
• Primary outcome timeframe: Measured at Year 5
• Results posted on: 2017-02-06

Participant Flow

All trial-eligible patients must have multivessel disease suitable for either approach as determined by both an interventional cardiologist and a surgical investigator. The interventionalist and surgeon at each site will document their intentions of which vessels are targets for revascularization.

Participant milestones

Measure	Percutaneous Coronary Intervention Percutaneous Coronary Intervention	Coronary Artery Bypass Graft Coronary Artery Bypass Graft
Overall Study STARTED	953	947
Overall Study COMPLETED	953	947
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)

Baseline characteristics by cohort

Measure	Percutaneous Coronary Intervention n=953 Participants Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 Participants Coronary Artery Bypass Graft	Total n=1900 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 8.9 • n=5 Participants	63.1 years STANDARD_DEVIATION 9.2 • n=7 Participants	63.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Gender Female	255 Participants n=5 Participants	289 Participants n=7 Participants	544 Participants n=5 Participants
Gender Male	698 Participants n=5 Participants	658 Participants n=7 Participants	1356 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Year 5

median 3.8 years of follow-up

Outcome measures

Measure	Percutaneous Coronary Intervention n=953 Participants Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 Participants Coronary Artery Bypass Graft
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke	26.6 percentage of participants	18.7 percentage of participants

SECONDARY outcome

Timeframe: Measured at Year 1

Outcome measures

Measure	Percutaneous Coronary Intervention n=953 Participants Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 Participants Coronary Artery Bypass Graft
Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization	16.8 percentage of participants	11.8 percentage of participants

SECONDARY outcome

Timeframe: Measured at Year 5

Outcome measures

Measure	Percutaneous Coronary Intervention n=953 Participants Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 Participants Coronary Artery Bypass Graft
All-cause Mortality	16.3 percentage of participants	10.9 percentage of participants

SECONDARY outcome

Timeframe: Measured at Day 30

Major adverse cardiovascular and cerebrovascular events

Outcome measures

Measure	Percutaneous Coronary Intervention n=953 Participants Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 Participants Coronary Artery Bypass Graft
Rates of Individual MACCE Endpoints	4.8 percentage of participants	5.2 percentage of participants

Adverse Events

Percutaneous Coronary Intervention

Serious events: 24 serious events

Other events: 44 other events

Deaths: 0 deaths

Coronary Artery Bypass Graft

Serious events: 42 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Percutaneous Coronary Intervention n=953 participants at risk Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 participants at risk Coronary Artery Bypass Graft
Blood and lymphatic system disorders Major bleeding	2.4% 23/953 • Number of events 23	3.6% 34/947 • Number of events 34
Renal and urinary disorders Acute Renal Failure	0.10% 1/953 • Number of events 1	0.84% 8/947 • Number of events 8

Other adverse events

Measure	Percutaneous Coronary Intervention n=953 participants at risk Percutaneous Coronary Intervention	Coronary Artery Bypass Graft n=947 participants at risk Coronary Artery Bypass Graft
Renal and urinary disorders Renal insufficiency	4.6% 44/953 • Number of events 44	3.9% 37/947 • Number of events 37

Additional Information

Dr. Valentin Fuster, M.D., Ph.D.

Icahn School of Medicine at Mount Sinai

Phone: 212-860-1056

Email: valentin.fuster@mssm.edu

Results disclosure agreements

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