Coronary Artery DiseaseNCT03089398
Hybrid Coronary Revascularization Trial
A study testing Hybrid Coronary Revascularization (isolated LIMA-LAD), Hybrid Coronary Revascularization (PCI) and Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Emilia Bagiella at 46 sites in 2 countries.
Trial summary
The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hybrid Coronary Revascularization (isolated LIMA-LAD), Hybrid Coronary Revascularization (PCI) and Percutaneous Coronary Intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 9 Oct 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States39 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Buffalo General Medical Center/Gates Vascular Institute
Buffalo, New York, 14203
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
Erlanger Health System
Chattanooga, Tennessee, 37403
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Maryland
College Park, Maryland, 20742
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
HealthPark Lee Memorial Health Systems
Fort Myers, Florida, 33908
Pinnacle Health Cardiovascular System
Harrisburg, Pennsylvania, 17104
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Gundersen Health System
La Crosse, Wisconsin, 54601
Long Beach Memorial Medical Center
Long Beach, California, 90806
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53706
Universty of Minnesota
Minneapolis, Minnesota, 55455
Yale University
New Haven, Connecticut, 06510
Mount Sinai Beth Israel
New York, New York, 10003
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
Orlando Health Heart Institute
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Baylor Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, 75093
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
Stanford University
Stanford, California, 94305
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
Montefiore - Einstein
The Bronx, New York, 10461
University of Toledo Medical Center
Toledo, Ohio, 43614
The Reading Health System
West Reading, Pennsylvania, 19611
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Canada7 sites
University of Alberta
Edmonton, Alberta, T6G 2R3
London Health Sciences Centre
London, Ontario
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Centre Intégré Universitaire/Sacre Coeur
Montreal
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention
The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary Revascularization [HCR] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention [PCI] (catheter procedures alone to open up clogged heart arteries). There are no new or "experimental" procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Hybrid Coronary Revascularization (isolated LIMA-LAD), Hybrid Coronary Revascularization (PCI), Percutaneous Coronary Intervention
- Keywords
- Hybrid Coronary Revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Coronary Revascularization (isolated LIMA-LAD)Procedure or surgery
Also called Left Internal Mammary Artery (LIMA) to LAD
sternal-sparing, off-pump, isolated LIMA-LAD revascularization
Hybrid Coronary Revascularization (PCI)Device
Also called PCI with metallic DES of non-LAD vessel(s)
percutaneous revascularization of at least one non-LAD target
Percutaneous Coronary InterventionDevice
Also called PCI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (11)
Hemoglobin Levels
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Measured: 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.
Measured: Up to 90 days post-randomization
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.
Measured: Up to 90 days post-randomization
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.
Measured: Up to 90 days post-randomization
Troponin Levels
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Measured: Up to 90 days post-randomization
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.
Measured: 24 Hours Prior to, During, and Within 24 Hours of the Procedure
Number of Participants Requiring Transfusion
Number of participants requiring transfusion during procedure and after procedure
Measured: Up to 90 days post-randomization
Length of Stay
Length of stay for all study procedures combined, beginning at date of procedure
Measured: Up to 90 days post-randomization
Discharge Disposition
Discharge disposition is for the last study procedure
Measured: Up to 90 days post-randomization
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start9 Oct 2017
- Primary completion31 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a prospective, multi-center randomized comparative effectiveness trial of HCR compared to multi-vessel PCI with metallic DES in patients with multi-vessel CAD involving the LAD or LM territories.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilia Bagiella
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Emilia Bagiella, Icahn School of Medicine at Mount Sinai
- Investigators
- Emilia Bagiella, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiAlan Moskowitz, MD, Principal investigator, Ichan School of Medicine at Mount SinaiJohn Puskas, MD, Principal investigator, Icahn School of Medicine at Mount SinaiGregg Stone, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089398
- Sponsor's protocol ID
- GCO 14-0250
- Other IDs
- 1U01HL125506-01A1, 1U01HL125488-01A1
- Status last verified
- May 2025
- First submitted
- 20 Mar 2017
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34016423
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03089398
- Acronym / sponsor ID
- GCO 14-0250
- Conditions
- Coronary Artery Disease
- Keywords
- Hybrid Coronary Revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Emilia BagiellaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary Revascularization [HCR] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention [PCI] (catheter procedures alone to open up clogged heart arteries). There are no new or "experimental" procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a prospective, multi-center randomized comparative effectiveness trial of HCR compared to multi-vessel PCI with metallic DES in patients with multi-vessel CAD involving the LAD or LM territories.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Coronary Revascularization Group | Active comparator | Procedure: Hybrid Coronary Revascularization (isolated LIMA-LAD), Device: Hybrid Coronary Revascularization (PCI)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. |
| Percutaneous Coronary Intervention | Active comparator | Device: Percutaneous Coronary InterventionPCI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Coronary Revascularization (isolated LIMA-LAD)Also: Left Internal Mammary Artery (LIMA) to LADsternal-sparing, off-pump, isolated LIMA-LAD revascularization | Procedure or surgery | Hybrid Coronary Revascularization Group |
| Hybrid Coronary Revascularization (PCI)Also: PCI with metallic DES of non-LAD vessel(s)percutaneous revascularization of at least one non-LAD target | Device | Hybrid Coronary Revascularization Group |
| Percutaneous Coronary InterventionAlso: PCIMulti-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. | Device | Percutaneous Coronary Intervention |
Primary outcome
Major Adverse Coronary and Cerebrovascular Events (MACCE)
Time frame: Up to 24 months
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.
11 secondary outcomes
Hemoglobin Levels
Time frame: Up to 90 days post-randomization
Creatinine Levels
Time frame: Up to 90 days post-randomization
CK-MB Levels (ng/dL)
Time frame: Up to 90 days post-randomization
CK-MB Levels (IU/L)
Time frame: Up to 90 days post-randomization
Troponin Levels
Time frame: Up to 90 days post-randomization
Number of Participants Requiring Medications
Time frame: 24 Hours Prior to, During, and Within 24 Hours of the Procedure
Number of Participants Requiring Transfusion
Time frame: Up to 90 days post-randomization
Length of Stay
Time frame: Up to 90 days post-randomization
Discharge Disposition
Time frame: Up to 90 days post-randomization
Cost-Effectiveness
Time frame: Up to 24 months
Feasibility of Incorporating Registry Data in a Randomized Clinical Trial
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34016423Ganyukov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Bagiella, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Alan Moskowitz, MD principal investigator
Ichan School of Medicine at Mount Sinai
John Puskas, MD principal investigator
Icahn School of Medicine at Mount Sinai
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Coronary Revascularization (isolated LIMA-LAD), Hybrid Coronary Revascularization (PCI) and Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Emilia Bagiella at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Coronary and Cerebrovascular Events (MACCE) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.