Trial Outcomes & Findings for Hybrid Coronary Revascularization Trial (NCT NCT03089398)

Last Updated: 2025-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2025-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	88	112
Overall Study COMPLETED	61	71
Overall Study NOT COMPLETED	27	41

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Death	4	9
Overall Study Lost to Follow-up	21	30
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

NYHA denominators differ from the overall study population due to missing data.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 24 months

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=88 Participants 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	Percutaneous Coronary Intervention n=112 Participants 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.
Major Adverse Coronary and Cerebrovascular Events (MACCE)	0.130 MACCE Event Rate per Person-Year Interval 0.08 to 0.211	0.111 MACCE Event Rate per Person-Year Interval 0.073 to 0.167

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

Population: 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).

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=70 Participants 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	Percutaneous Coronary Intervention n=89 Participants 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.
Hemoglobin Levels Pre-Procedure	13.95 g/dL Interval 12.8 to 15.2	13.40 g/dL Interval 12.2 to 14.7
Hemoglobin Levels Post-Procedure	10.95 g/dL Interval 9.9 to 12.3	12.90 g/dL Interval 11.8 to 14.1

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=70 Participants 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	Percutaneous Coronary Intervention n=89 Participants 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.
Creatinine Levels Pre-Procedure	0.95 mg/dL Interval 0.82 to 1.14	0.95 mg/dL Interval 0.81 to 1.11
Creatinine Levels Post-Procedure	1.03 mg/dL Interval 0.89 to 1.22	0.93 mg/dL Interval 0.8 to 1.17

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=17 Participants 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	Percutaneous Coronary Intervention n=23 Participants 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.
CK-MB Levels (ng/dL) Pre-Procedure	0.90 ng/dL Interval 0.5 to 1.2	1.80 ng/dL Interval 1.15 to 3.15
CK-MB Levels (ng/dL) Post-Procedure	2.79 ng/dL Interval 2.2 to 4.9	3.75 ng/dL Interval 2.6 to 8.3

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=7 Participants 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	Percutaneous Coronary Intervention n=4 Participants 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.
CK-MB Levels (IU/L) Pre-Procedure	72.00 IU/L Interval 39.0 to 118.0	62.00 IU/L Interval 33.0 to 96.5
CK-MB Levels (IU/L) Post-Procedure	311.00 IU/L Interval 62.55 to 1045.0	77.00 IU/L Interval 44.0 to 119.5

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=45 Participants 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	Percutaneous Coronary Intervention n=69 Participants 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.
Troponin Levels Pre-Procedure Troponin I	0.03 ng/mL Interval 0.01 to 0.18	0.03 ng/mL Interval 0.01 to 0.12
Troponin Levels Post-Procedure Troponin I	0.30 ng/mL Interval 0.13 to 0.97	0.17 ng/mL Interval 0.03 to 0.81
Troponin Levels Pre-Procedure Troponin T	0.03 ng/mL Interval 0.02 to 0.31	0.01 ng/mL Interval 0.01 to 0.03
Troponin Levels Post-Procedure Troponin T	0.05 ng/mL Interval 0.01 to 0.34	0.01 ng/mL Interval 0.01 to 0.35

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=85 Participants 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	Percutaneous Coronary Intervention n=103 Participants 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.
Number of Participants Requiring Medications Antiplatelets	74 Participants	101 Participants
Number of Participants Requiring Medications Anticoagulants	53 Participants	66 Participants
Number of Participants Requiring Medications Beta Blockers	73 Participants	65 Participants
Number of Participants Requiring Medications ACE Inhibitors or ARBs	22 Participants	37 Participants
Number of Participants Requiring Medications Diuretics	25 Participants	18 Participants
Number of Participants Requiring Medications Statins	71 Participants	79 Participants

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

Population: 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.

Number of participants requiring transfusion during procedure and after procedure

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=69 Participants 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	Percutaneous Coronary Intervention n=109 Participants 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.
Number of Participants Requiring Transfusion Transfusion Intra-Procedure	3 Participants	1 Participants
Number of Participants Requiring Transfusion Transfusion Post-Procedure	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

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

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=72 Participants 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	Percutaneous Coronary Intervention n=109 Participants 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.
Length of Stay	7.00 days Interval 6.0 to 9.0	2.00 days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Up to 90 days post-randomization

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

Discharge disposition is for the last study procedure

Outcome measures

Outcome measures
Measure	Hybrid Coronary Revascularization Group n=83 Participants 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	Percutaneous Coronary Intervention n=109 Participants 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.
Discharge Disposition Home	76 Participants	105 Participants
Discharge Disposition Extended Care/Transitional Care Unit/Rehab	5 Participants	3 Participants
Discharge Disposition Other Acute Care Hospital	0 Participants	1 Participants
Discharge Disposition Nursing Home	1 Participants	0 Participants
Discharge Disposition Other	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Hybrid Coronary Revascularization Group

Serious events: 20 serious events

Other events: 18 other events

Deaths: 4 deaths

Percutaneous Coronary Intervention

Serious events: 11 serious events

Other events: 9 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Hybrid Coronary Revascularization Group n=88 participants at risk 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	Percutaneous Coronary Intervention n=112 participants at risk 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.
Blood and lymphatic system disorders Bleeding	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Atrial Fibrillation	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Myocardial Infarction	3.4% 3/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	2.7% 3/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Post-Pericardiotomy Syndrome	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Stent Thrombosis	0.00% 0/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	1.8% 2/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Graft Stenosis or Occlusion	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Gastrointestinal disorders Gastrointestinal Bleeding	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Infections and infestations Infection Requiring Antibiotics	5.7% 5/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.89% 1/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Nervous system disorders Ischemic Stroke	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Nervous system disorders Other Bleeding	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Renal and urinary disorders Renal Failure	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Renal and urinary disorders Renal and Urinary Bleeding	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Surgical and medical procedures Unplanned Repeat Revascularization	9.1% 8/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	7.1% 8/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.

Other adverse events

Other adverse events
Measure	Hybrid Coronary Revascularization Group n=88 participants at risk 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	Percutaneous Coronary Intervention n=112 participants at risk 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.
Blood and lymphatic system disorders Bleeding	0.00% 0/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	1.8% 2/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Atrial Fibrillation	6.8% 6/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Myocardial Infarction	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	1.8% 2/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Cardiac disorders Post-Pericardiotomy Syndrome	4.5% 4/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Gastrointestinal disorders Gastrointestinal Bleeding	3.4% 3/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.89% 1/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Nervous system disorders Ischemic Stroke	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Nervous system disorders Unknown Etiology Stroke	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Renal and urinary disorders Renal Failure	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.89% 1/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Renal and urinary disorders Renal and Urinary Bleeding	1.1% 1/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.89% 1/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Respiratory, thoracic and mediastinal disorders Mediastinal Bleeding	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Surgical and medical procedures Unplanned Repeat Revascularization	4.5% 4/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	2.7% 3/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.
Vascular disorders Vascular Bleeding	2.3% 2/88 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.	0.00% 0/112 • 24 months Serious adverse events include components of the primary endpoint, which, according to the protocol, will be analyzed on an intent-to-treat (ITT) basis.

Additional Information

Dr. Emilia Bagiella

Icahn School of Medicine at Mount Sinai

Phone: 212-659-9580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Hybrid Coronary Revascularization Group n=88 Participants 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	Percutaneous Coronary Intervention n=112 Participants 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.	Total n=200 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 8.8 • n=88 Participants	66.8 years STANDARD_DEVIATION 9.2 • n=112 Participants	65.3 years STANDARD_DEVIATION 9.2 • n=200 Participants
Sex: Female, Male Female	25 Participants n=88 Participants	36 Participants n=112 Participants	61 Participants n=200 Participants
Sex: Female, Male Male	63 Participants n=88 Participants	76 Participants n=112 Participants	139 Participants n=200 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=88 Participants	22 Participants n=112 Participants	44 Participants n=200 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=88 Participants	84 Participants n=112 Participants	150 Participants n=200 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=88 Participants	6 Participants n=112 Participants	6 Participants n=200 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=88 Participants	0 Participants n=112 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Asian	4 Participants n=88 Participants	6 Participants n=112 Participants	10 Participants n=200 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=88 Participants	1 Participants n=112 Participants	1 Participants n=200 Participants
Race (NIH/OMB) Black or African American	12 Participants n=88 Participants	15 Participants n=112 Participants	27 Participants n=200 Participants
Race (NIH/OMB) White	67 Participants n=88 Participants	78 Participants n=112 Participants	145 Participants n=200 Participants
Race (NIH/OMB) More than one race	0 Participants n=88 Participants	0 Participants n=112 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=88 Participants	12 Participants n=112 Participants	17 Participants n=200 Participants
New York Heart Association (NYHA) Classification No Heart Failure	38 Participants n=86 Participants • NYHA denominators differ from the overall study population due to missing data.	41 Participants n=110 Participants • NYHA denominators differ from the overall study population due to missing data.	79 Participants n=196 Participants • NYHA denominators differ from the overall study population due to missing data.
New York Heart Association (NYHA) Classification Class I	18 Participants n=86 Participants • NYHA denominators differ from the overall study population due to missing data.	23 Participants n=110 Participants • NYHA denominators differ from the overall study population due to missing data.	41 Participants n=196 Participants • NYHA denominators differ from the overall study population due to missing data.
New York Heart Association (NYHA) Classification Class II	20 Participants n=86 Participants • NYHA denominators differ from the overall study population due to missing data.	28 Participants n=110 Participants • NYHA denominators differ from the overall study population due to missing data.	48 Participants n=196 Participants • NYHA denominators differ from the overall study population due to missing data.
New York Heart Association (NYHA) Classification Class III	5 Participants n=86 Participants • NYHA denominators differ from the overall study population due to missing data.	13 Participants n=110 Participants • NYHA denominators differ from the overall study population due to missing data.	18 Participants n=196 Participants • NYHA denominators differ from the overall study population due to missing data.
New York Heart Association (NYHA) Classification Class IV	5 Participants n=86 Participants • NYHA denominators differ from the overall study population due to missing data.	5 Participants n=110 Participants • NYHA denominators differ from the overall study population due to missing data.	10 Participants n=196 Participants • NYHA denominators differ from the overall study population due to missing data.
Angina Class - CCSC No Angina	26 Participants n=88 Participants • CCSC denominators differ from the overall study population due to missing data.	27 Participants n=110 Participants • CCSC denominators differ from the overall study population due to missing data.	53 Participants n=198 Participants • CCSC denominators differ from the overall study population due to missing data.
Angina Class - CCSC Grade I	11 Participants n=88 Participants • CCSC denominators differ from the overall study population due to missing data.	17 Participants n=110 Participants • CCSC denominators differ from the overall study population due to missing data.	28 Participants n=198 Participants • CCSC denominators differ from the overall study population due to missing data.
Angina Class - CCSC Grade II	19 Participants n=88 Participants • CCSC denominators differ from the overall study population due to missing data.	22 Participants n=110 Participants • CCSC denominators differ from the overall study population due to missing data.	41 Participants n=198 Participants • CCSC denominators differ from the overall study population due to missing data.
Angina Class - CCSC Grade III	27 Participants n=88 Participants • CCSC denominators differ from the overall study population due to missing data.	30 Participants n=110 Participants • CCSC denominators differ from the overall study population due to missing data.	57 Participants n=198 Participants • CCSC denominators differ from the overall study population due to missing data.
Angina Class - CCSC Grade IV	5 Participants n=88 Participants • CCSC denominators differ from the overall study population due to missing data.	16 Participants n=110 Participants • CCSC denominators differ from the overall study population due to missing data.	21 Participants n=198 Participants • CCSC denominators differ from the overall study population due to missing data.
SF-12 Score Physical Health Composite Score	41.5 units on a scale n=86 Participants • SF-12 denominators differ from the overall study population due to missing data.	42.4 units on a scale n=111 Participants • SF-12 denominators differ from the overall study population due to missing data.	41.7 units on a scale n=197 Participants • SF-12 denominators differ from the overall study population due to missing data.
SF-12 Score Mental Health Composite Score	53.6 units on a scale n=86 Participants • SF-12 denominators differ from the overall study population due to missing data.	54.0 units on a scale n=111 Participants • SF-12 denominators differ from the overall study population due to missing data.	53.9 units on a scale n=197 Participants • SF-12 denominators differ from the overall study population due to missing data.
Euroqol Health Rating	75.0 units on a scale n=86 Participants • Euroqol denominators differ from the overall study population due to missing data.	75.0 units on a scale n=112 Participants • Euroqol denominators differ from the overall study population due to missing data.	75.0 units on a scale n=198 Participants • Euroqol denominators differ from the overall study population due to missing data.
Risk Factors Diabetes	50 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	54 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	104 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Dyslipidemia	77 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	88 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	165 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Hypertension	72 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	99 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	171 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Dialysis	1 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	2 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	3 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Tobacco Use	19 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	10 Participants n=108 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	29 Participants n=195 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Lung Disease	13 Participants n=85 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	12 Participants n=107 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	25 Participants n=192 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Liver Disease	5 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	2 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	7 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Immunocompromise Present	5 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	3 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	8 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Peripheral Artery Disease	4 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	5 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	9 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Cerebrovascular Disease	11 Participants n=85 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	5 Participants n=109 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	16 Participants n=194 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Previous PCI	37 Participants n=87 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	44 Participants n=111 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	81 Participants n=198 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Previous MI	34 Participants n=81 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	42 Participants n=108 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	76 Participants n=189 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Heart Failure	10 Participants n=83 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	25 Participants n=109 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	35 Participants n=192 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.
Risk Factors Arrhythmia	7 Participants n=83 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	6 Participants n=110 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.	13 Participants n=193 Participants • Measure Analysis Population Description: Risk factor denominators differ from the overall study population due to missing data.