Hybrid Coronary Revascularization Trial | NCT03089398

ID	Type	Description	Link
1U01HL125506-01A1	U.S. NIH Grant/Contract		View source
1U01HL125488-01A1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

Detailed Description

The increasing prevalence of coronary artery disease (CAD), advances in coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and concomitant medical therapy, and the costs of revascularization have resulted in rising interest regarding the appropriate indications and alternatives for coronary revascularization.

Hybrid coronary revascularization is the intended combination of CABG and PCI. The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) and PCI of non-LAD coronary stenoses. Essentially, stents are substituted for saphenous vein grafts (SVG) for non-LAD lesions, and the surgical LIMA to LAD bypass is performed, ideally through a limited access, minimally traumatic approach.

Unfortunately, the published data to date on HCR must be considered limited and hypothesis generating. Clinicians, payers, and patients are interested in the specific benefits of revascularization alternatives. HCR as a scientifically validated approach would have a major healthcare impact. The ability to deliver a new therapy for CAD that provides durability, but without the obligatory trauma and prolonged recovery time characteristic of conventional CABG would be a major advance in the field of cardiovascular medicine. The NHLBI-funded Hybrid Observational Study demonstrated that equipoise exists between the two coronary revascularization paradigms; however, a rigorously designed randomized clinical trial is now needed to provide sufficient evidence to guide clinical decision making for this important patient population.

This trial is a prospective, multi-center randomized comparative effectiveness trial of HCR compared to multi-vessel PCI in patients with multi-vessel CAD involving the LAD or left main (LM) territories. The trial is designed as a "large, simple" trial, and some baseline, procedure-related and short-term outcomes data collection will be extracted from existing registry data (Society of Thoracic Surgeons [STS] Data Registry). The overall objective of this trial is to evaluate the effectiveness and safety of Hybrid Coronary Revascularization (HCR) compared to multi-vessel PCI with drug-eluting stents (DES) in patients with multi-vessel coronary artery disease involving the Left Main and/or Left Anterior Descending arteries.

The primary objective the trial is to determine whether hybrid coronary revascularization is associated with a reduction in Major Adverse Cardiac and Cerebrovascular Events (MACCE) compared to PCI with DES.

The secondary objectives are to determine the impact of HCR compared to PCI on health status and quality of life.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hybrid Coronary Revascularization Group	Active Comparator	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target.	Procedure: Hybrid Coronary Revascularization (isolated LIMA-LAD) Device: Hybrid Coronary Revascularization (PCI)
Percutaneous Coronary Intervention	Active Comparator	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol.	Device: Percutaneous Coronary Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hybrid Coronary Revascularization (isolated LIMA-LAD)	Procedure	sternal-sparing, off-pump, isolated LIMA-LAD revascularization	Hybrid Coronary Revascularization Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Coronary and Cerebrovascular Events (MACCE)	The current sample size of 200 patients will not provide sufficient power to test the original null hypothesis of the trial. However, it will allow for an estimate of the MACCE rate in the two groups. A 2-year follow-up will be used to capture and understand the difference in MACCE between the two procedures. This reasoning is based on the NHLBI-funded Hybrid Revascularization Observational Study (ClinicalTrials.gov Identifier NCT01121263), which enrolled 200 HCR and 98 multi-vessel PCI with drug-eluting stent (DES) patients, and demonstrated similar risk-adjusted MACCE rates over the first 12 months following the intervention but divergence by approximately 18 months of followup. Therefore, it is important to continue the follow-up of the 200 randomized patients to at least 24 months. Of note, some patients who were enrolled early in the trial will have up to 3 years of follow-up data collected by the time the final patient randomized completes the 2-year time point.	Up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin Levels	For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.	Up to 90 days post-randomization
Creatinine Levels	For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation (US sites)
Age ≥ 18 years
Clinical indication for coronary revascularization
Coronary anatomy requiring revascularization as follows(2)
- Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment (LCX or RCA), OR
- Single vessel disease involving the LAD and a major diagonal, with both requiring independent revascularization with at least one stent if randomized to HCR and stents for both the LAD and diagonal if randomized to multivessel PCI Note: If the patient qualifies based only on a LM lesion, then there must be involvement of the distal bifurcation (Medina 1,1,1) intended for treatment with a 2-stent approach (separate stents into the LAD and LCX) if randomized to PCI. However, if the patient also has non-LM disease in the RCA and/or non-ostial LAD and/or non-ostial LCX that requires separate treatment, any LM lesion is a valid criterion for enrollment, whether LM ostial, shaft or distal bifurcation disease, and any strategy of treating the LM may be employed, including not treating the ostial LCX, a provisional approach or a planned 2-stent strategy as appropriate. Similarly, if the patient qualifies based only on LAD-Dg disease, whether a bifurcation lesion or separate lesions in the LAD and Dg, without RCA or LCX disease, then both the LAD and Dg must be true lesions intended for stents (planned 2-stent approach). However, if the patient has LAD-Dg disease and a lesion in the RCA or LCX that also requires treatment, the LAD-Dg disease can then be treated in any fashion (2-stents, a provisional approach, or the Dg not even dilated if it is small), according to operator preference
Suitable candidate for both PCI with metallic DES and HCR as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
Ability to tolerate and no plans to interrupt dual anti-platelet therapy for ≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation with biomarker positive acute coronary syndrome (ACS)
Willing to comply with all protocol required follow-up

Exclusion Criteria:

Previous cardiac surgery of any kind, including CABG
Previous thoracic surgery involving the left pleural space
Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b) within 1 cm of a qualifying lesion
Previous PCI of the LM and/or LAD within 12 months prior to randomization
PCI with bare metal stent (BMS) within 12 months prior to randomization
Any complication or unsuccessful revascularization with PCI within 30 days prior to randomization.

Note: A patient may be considered eligible for enrollment if PCI with DES in non-LM and non-LAD territory was performed within 30 days prior to randomization, as long as revascularization was successful and uncomplicated, or has been performed more than 30 days prior even if unsuccessful or complicated

Planned treatment with bioresorbable vascular scaffold(s) after randomization
Total occlusion (TIMI 0 or 1 flow) of the LM, LAD or LCX.
Cardiogenic shock at time of screening
STEMI within 72 hours prior to randomization
Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
Indication for chronic oral anticoagulation therapy at the time of randomization
Any prior lung resection
End-Stage Renal Disease (ESRD) on dialysis
Patients who could not be switched from prasugrel or ticagrelor to clopidogrel, should that be needed prior to a CABG, during reverse HCR
Extra-cardiac illness that is expected to limit survival to less than 5 years
Allergy or hypersensitivity to any of the study drugs or devices used in the trial
Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
Pregnant at time of screening or unwilling to use effective birth control measures while dual antiplatelet therapy is required.

Name	Affiliation	Role
Emilia Bagiella, PhD	Icahn School of Medicine at Mount Sinai	Principal Investigator
Alan Moskowitz, MD	Ichan School of Medicine at Mount Sinai	Principal Investigator
John Puskas, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator
Gregg Stone, MD	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Long Beach Memorial Medical Center		Long Beach	California	90806	United States
University of Southern California

PubMed Identifier	Type	Citation	Retractions
34016423	Derived	Ganyukov VI, Kochergin NA, Shilov AA, Tarasov RS, Skupien J, Kozyrin KA, Barbarash OL, Musialek P. Randomized Clinical Trial of Surgical Versus Percutaneous Versus Hybrid Multivessel Coronary Revascularization: 3 Years' Follow-Up. JACC Cardiovasc Interv. 2021 May 24;14(10):1163-1165. doi: 10.1016/j.jcin.2021.02.037. No abstract available.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Hybrid Coronary Revascularization Group	Hybrid Coronary Revascularization (HCR) is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 25, 2017

Arm/Group Information

ID	Title	Description
BG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
BG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.130(0.080 to 0.211) OG0010.111(0.073 to 0.167)

Secondary

Hemoglobin Levels

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).

Posted

Median

Inter-Quartile Range

g/dL

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Creatinine Levels

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Posted

Median

Inter-Quartile Range

mg/dL

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

CK-MB Levels (ng/dL)

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Posted

Median

Inter-Quartile Range

ng/dL

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

CK-MB Levels (IU/L)

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Posted

Median

Inter-Quartile Range

IU/L

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Troponin Levels

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Posted

Median

Inter-Quartile Range

ng/mL

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Number of Participants Requiring Medications

For HCR patients, medications are prior/during/after CABG. For PCI patients, medications are prior/during/after the last PCI. Number of participants requiring medications at any time 24 Hours Prior to, During, and Within 24 Hours of the Procedure. Procedures can occur up to 90 days after randomization.

Posted

Count of Participants

Participants

24 Hours Prior to, During, and Within 24 Hours of the Procedure

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention

Secondary

Number of Participants Requiring Transfusion

Number of participants requiring transfusion during procedure and after procedure

The overall analysis population represents the number of patients who contributed to at least one of the intra/post measurements. Patients with at least one post-randomization procedure are included. Additional patients are missing data on transfusions.

Posted

Count of Participants

Participants

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Length of Stay

Length of stay for all study procedures combined, beginning at date of procedure

Patients with at least one post-randomization procedure are included. Additional patients are missing data on length of stay.

Posted

Median

Inter-Quartile Range

days

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Discharge Disposition

Discharge disposition is for the last study procedure

Patients with at least one post-randomization procedure are included. Additional patients are missing data on discharge disposition.

Posted

Count of Participants

Participants

Up to 90 days post-randomization

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Cost-Effectiveness

Health Status as measured by cost-effectiveness. Cost-effectiveness will be evaluated using a micro-simulation model, which will predict the accrued health care costs and quality-adjusted life expectancy for each subject at the end of the trial follow-up period and in addition over a lifetime horizon.

While quality of life data was collected, they are not usable in a cost-effectiveness analysis due to the reduced sample size and reduced follow-up. In addition, since the trial was halted prematurely, cost data was not collected. Therefore, a cost-effectiveness analysis is not feasible.

Posted

Up to 24 months

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Secondary

Feasibility of Incorporating Registry Data in a Randomized Clinical Trial

For the HCR group, partial data will be extracted and transferred from the STS registry. Thus, this study will also allow evaluation of the process of data transfer, assessment of the data quality, and eventually determination of the feasibility to conduct a clinical trial with data linked to a registry.

HCR: Obtaining data from the STS registry was not straightforward and was related to difficulty in obtaining the data and linking all clinical trial patients with their STS data. In general, more work needs to be done before registry data can be incorporated into clinical trials.

PCI: Researchers were unable to obtain data from CATH-PCI registry. At the time of trial start-up, the registry was being restructured and moved to a different platform. Linkage to clinical trial data was not possible.

Posted

Up to 24 months

ID	Title	Description
OG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target
OG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Hybrid Coronary Revascularization Group	HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target. Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target	4	88	20	88	18	88
EG001	Percutaneous Coronary Intervention	PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol. Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.	9	112	11	112	9	112

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bleeding	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 affected88 at risk EG0013 affected112 at risk
Post-Pericardiotomy Syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk
Stent Thrombosis	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected88 at risk EG0012 affected112 at risk
Graft Stenosis or Occlusion	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Infection Requiring Antibiotics	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 affected88 at risk EG0011 affected112 at risk
Ischemic Stroke	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Other Bleeding	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Renal Failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk
Renal and Urinary Bleeding	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Unplanned Repeat Revascularization	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 affected88 at risk EG0018 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bleeding	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected88 at risk EG0012 affected112 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 affected88 at risk EG0010 affected112 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0012 affected112 at risk
Post-Pericardiotomy Syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 affected88 at risk EG0010 affected112 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 affected88 at risk EG0011 affected112 at risk
Ischemic Stroke	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Unknown Etiology Stroke	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0010 affected112 at risk
Renal Failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0011 affected112 at risk
Renal and Urinary Bleeding	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected88 at risk EG0011 affected112 at risk
Mediastinal Bleeding	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk
Unplanned Repeat Revascularization	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 affected88 at risk EG0013 affected112 at risk
Vascular Bleeding	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected88 at risk EG0010 affected112 at risk

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures