Trial Outcomes & Findings for Hybrid Revascularization Observational Study (NCT NCT01121263)

NCT ID: NCT01121263

Last Updated: 2014-03-14

Results Overview

For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components: * Death * Stroke * Myocardial Infarction * Repeat Revascularization

• Recruitment status: COMPLETED
• Target enrollment: 298 participants
• Primary outcome timeframe: Month 12
• Results posted on: 2014-03-14

Participant Flow

Study Recruitment started in May 2010 and completed in November 2011 across 11 US medical centers that included adult patients with multivessel coronary artery disease and clinical indication for revascularization, who were candidates for both Hybrid Coronary Revascularization (HCR) and Percutaneous Coronary Intervention (PCI) with DES

Participant milestones

Measure	Cohort 2: Intervention Cohort - HCR Group (N=200) Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG	Cohort 2: Intervention Cohort - PCI Group (N=98) Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
Overall Study STARTED	200	98
Overall Study COMPLETED	175	83
Overall Study NOT COMPLETED	25	15

Reasons for withdrawal

Measure	Cohort 2: Intervention Cohort - HCR Group (N=200) Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG	Cohort 2: Intervention Cohort - PCI Group (N=98) Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
Overall Study Death	3	2
Overall Study Lost to Follow-up	22	12
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Hybrid Revascularization Observational Study

Baseline characteristics by cohort

Measure	Cohort 2: Intervention Cohort - HCR Group (N=200) n=200 Participants Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG	Cohort 2: Intervention Cohort - PCI Group (N=98) n=98 Participants Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)	Total n=298 Participants Total of all reporting groups
Age, Continuous Age	64.41 years STANDARD_DEVIATION 11.78 • n=5 Participants	63.91 years STANDARD_DEVIATION 10.82 • n=7 Participants	64.24 years STANDARD_DEVIATION 11.46 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	28 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	70 Participants n=7 Participants	222 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	183 Participants n=5 Participants	83 Participants n=7 Participants	266 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	11 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	161 Participants n=5 Participants	83 Participants n=7 Participants	244 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants	98 participants n=7 Participants	298 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:

• Death
• Stroke
• Myocardial Infarction
• Repeat Revascularization

Outcome measures

Measure	HCR Group (N=200) n=200 Participants Primary Outcome in Cohort 2: Intervention Cohort - HCR Group	PCI Group (N=98) n=98 Participants Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Myocardial Infarction	4 participants Interval 0.666 to 1.697	3 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Stroke	5 participants Interval 0.666 to 1.697	0 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Any MACCE	23 participants Interval 0.666 to 1.697	10 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Death	3 participants Interval 0.666 to 1.697	1 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Revascularization	14 participants Interval 0.666 to 1.697	8 participants

SECONDARY outcome

Timeframe: Occurence of MACCE through the end of study up to two years

For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:

• Death
• Stroke
• Myocardial infarction
• Repeat revascularization

Outcome measures

Measure	HCR Group (N=200) n=200 Participants Primary Outcome in Cohort 2: Intervention Cohort - HCR Group	PCI Group (N=98) n=98 Participants Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Any MACCE	23 participants	12 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Death	3 participants	2 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Myocardial Infarction	4 participants	3 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Stroke	5 participants	0 participants
Major Adverse Cardiac and Cerebrovascular Event (MACCE) Revascularization	14 participants	10 participants

Adverse Events

HCR Group (N=200)

Serious events: 39 serious events

Other events: 5 other events

Deaths: 0 deaths

PCI Group (N=98)

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HCR Group (N=200) n=200 participants at risk Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group	PCI Group (N=98) n=98 participants at risk Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
Cardiac disorders Cardiac Arrhythmias	3.0% 6/200 • Number of events 6 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Congestive Heart Failure	0.50% 1/200 • Number of events 2 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Cardiogenic Shock	0.00% 0/200 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Diastolic Heart Failure	0.00% 0/200 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Dresseler's Syndrome	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Hypertension Resulting in Dizziness	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders IABP placed after becoming hypotensive	0.00% 0/200 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Myocardial Infarction	1.5% 3/200 • Number of events 4 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	3.1% 3/98 • Number of events 4 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Revascularization	6.5% 13/200 • Number of events 14 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	10.2% 10/98 • Number of events 12 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Gastrointestinal disorders Acute viral gastroenteritis	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Gastrointestinal disorders GI Bleed	1.0% 2/200 • Number of events 2 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
General disorders Allergic reaction to antihypertensive drug	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
General disorders Atypical Chest Pain	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	5.1% 5/98 • Number of events 5 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
General disorders Bleeding	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
General disorders Weakness and dizziness	0.00% 0/200 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Infections and infestations Major Infection	3.0% 6/200 • Number of events 6 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Nervous system disorders Stroke	2.0% 4/200 • Number of events 4 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Nervous system disorders Transient Ischemic Attack (TIA)	1.0% 2/200 • Number of events 2 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Psychiatric disorders Post op deliriums/psychosis	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Renal and urinary disorders Benign prostatic hyperplasia with bladder obstruction	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.5% 3/200 • Number of events 3 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.5% 3/200 • Number of events 3 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	1.0% 1/98 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Vascular disorders Percutaneous transluminal angioplasty of superficial femoral artery	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.

Other adverse events

Measure	HCR Group (N=200) n=200 participants at risk Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group	PCI Group (N=98) n=98 participants at risk Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
Cardiac disorders Cardiac Arrhythmias	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Myocardial Infarction	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Cardiac disorders Revascularization	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Infections and infestations Major Infection	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.
Nervous system disorders Stroke	0.50% 1/200 • Number of events 1 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.	0.00% 0/98 • Adverse events were reported throughout the period of trial participation for each study participant. Adverse events were documented and reported by staff at the study sites as they occurred per the protocol definitions.

Additional Information

Deborah Ascheim, MD

Icahn School of Medicine at Mount Sinai

Phone: 212-659-9567

Email: deborah.ascheim@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee MSSM and sites shall cooperate in the submission of manuscript(s) for publication of the study results and sites shall not submit manuscripts for publication without express written permission of the Operations Committee. After dissolution of the Operations committee or one year after the completion of the agreement, whichever occurs first, no such permission shall be required.
• Publication restrictions are in place

Restriction type: OTHER