Trial Outcomes & Findings for Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery (NCT NCT01334866)

Results Overview

For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

91 participants

Primary outcome timeframe

At time of procedure (day 1)

Results posted on

2013-11-26

Participant Flow

A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.

Participant milestones

Participant milestones
Measure	Minimally Invasive Coronary Artery Bypass Grafting 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
Overall Study STARTED	91
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Minimally Invasive Coronary Artery Bypass Grafting 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
Overall Study Withdrawal by Subject	10
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	3
Overall Study medically necessary prior to procedure	2
Overall Study medically necessary post-procedure	1

Baseline Characteristics

Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Completion Cohort n=91 Participants 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
Age Continuous	64.1 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Region of Enrollment Canada	46 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of procedure (day 1)

For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.

Outcome measures

Outcome measures
Measure	Minimally Invasive Coronary Artery Bypass Grafting n=208 Grafts 89 Subjects received study treatment
Technical Success (Graft Patency) in a MICS Approach	100 percentage of grafts

PRIMARY outcome

Timeframe: At time of procedure (day 1)

A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.

Outcome measures

Outcome measures
Measure	Minimally Invasive Coronary Artery Bypass Grafting n=89 Participants 89 Subjects received study treatment
Procedural Success in a MICS Approach	100 percentage of subjects

PRIMARY outcome

Timeframe: 6 months post-procedure

For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results. The FitzGibbon Scoring system is as follows: A:Excellent graft with unimpaired runoff (\< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to \<50% of the grafted coronary artery. O:Occluded (100% stenosed)

Outcome measures

Outcome measures
Measure	Minimally Invasive Coronary Artery Bypass Grafting n=165 Grafts 89 Subjects received study treatment
Patency of the Index Graft at 6 Months Grade A	90.9 percentage of grafts
Patency of the Index Graft at 6 Months Grade B	0.6 percentage of grafts
Patency of the Index Graft at 6 Months Grade O	8.5 percentage of grafts

PRIMARY outcome

Timeframe: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)

During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include: * Major hemorrhage/bleeding requiring surgical intervention * Aortic complications * Graft vessel revision (GVR) * Transient ischemic attacks (TIA) * Cerebrovascular accidents (CVA)/stroke * Myocardial infarction (MI) * Death

Outcome measures

Outcome measures
Measure	Minimally Invasive Coronary Artery Bypass Grafting n=89 Participants 89 Subjects received study treatment
Composite Major Adverse Event Rate (Early)	2.2 percentage of subjects Interval 0.0 to 6.9

SECONDARY outcome

Timeframe: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation

Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include: * Major hemorrhage/bleeding requiring surgical intervention * Aortic complications * Graft vessel revision (GVR) * Transient ischemic attacks (TIA) * Cerebrovascular accidents (CVA)/stroke * Myocardial infarction (MI) * Death

Outcome measures

Outcome measures
Measure	Minimally Invasive Coronary Artery Bypass Grafting n=89 Participants 89 Subjects received study treatment
Composite Major Adverse Event Rate (Late)	0 percentage of subjects

Adverse Events

Study Procedure Cohort

Serious events: 14 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Procedure Cohort n=89 participants at risk 89 Subjects received study treatment
Cardiac disorders Angina	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Blood and lymphatic system disorders Anemia and blood loss	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Blood and lymphatic system disorders Bleeding	3.4% 3/89 • Number of events 3 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Gastrointestinal disorders Bowel Obstruction	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Blood and lymphatic system disorders Coagulopathy	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Vascular disorders Hypotension	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Cardiac disorders Low Cardiac Index	3.4% 3/89 • Number of events 3 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Surgical and medical procedures Surgical Blood Loss	1.1% 1/89 • Number of events 1 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.

Other adverse events

Other adverse events
Measure	Study Procedure Cohort n=89 participants at risk 89 Subjects received study treatment
Blood and lymphatic system disorders Anemia	5.6% 5/89 • Number of events 5 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Atelectasis	12.4% 11/89 • Number of events 11 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Cardiac disorders Atrial Fibrillation	16.9% 15/89 • Number of events 15 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Vascular disorders Hypertension	10.1% 9/89 • Number of events 9 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Vascular disorders Hypotension	14.6% 13/89 • Number of events 13 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	15.7% 14/89 • Number of events 14 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.7% 6/89 • Number of events 6 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Subcutaneous Emphysema	6.7% 6/89 • Number of events 6 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.
Respiratory, thoracic and mediastinal disorders Atelectasis and Pleural Effusion	12.4% 11/89 • Number of events 11 • Adverse events reported from treatment through 6-month follow-up. Adverse events were classified as serious by the PI following ISO 14155 standards.

Additional Information

Kristin Lawman

Medtronic, Inc.

Phone: 763-514-9809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60