Hybrid Coronary Revascularization Trial

NCT ID: NCT03089398

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2021-09-30

Brief 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). 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hybrid Coronary Revascularization (isolated LIMA-LAD)

Intervention Type: PROCEDURE

sternal-sparing, off-pump, isolated LIMA-LAD revascularization

Hybrid Coronary Revascularization (PCI)

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type: DEVICE

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.

Interventions

Hybrid Coronary Revascularization (isolated LIMA-LAD)

sternal-sparing, off-pump, isolated LIMA-LAD revascularization

Intervention Type: PROCEDURE

Hybrid Coronary Revascularization (PCI)

percutaneous revascularization of at least one non-LAD target

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Left Internal Mammary Artery (LIMA) to LAD; PCI with metallic DES of non-LAD vessel(s); PCI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Emilia Bagiella

OTHER

Sponsor Role: lead

Responsible Party

Emilia Bagiella

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emilia Bagiella, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Alan Moskowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Ichan School of Medicine at Mount Sinai

John Puskas, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Gregg Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

University of Southern California

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

HealthPark Lee Memorial Health Systems

Fort Myers, Florida, United States

Orlando Health Heart Institute

Orlando, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Maryland

College Park, Maryland, United States

Universty of Minnesota

Minneapolis, Minnesota, United States

Our Lady of Lourdes Medical Center

Camden, New Jersey, United States

Buffalo General Medical Center/Gates Vascular Institute

Buffalo, New York, United States

Mount Sinai Beth Israel

New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Montefiore - Einstein

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

WakeMed Health and Hospitals

Raleigh, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

Pinnacle Health Cardiovascular System

Harrisburg, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

The Reading Health System

West Reading, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Houston Methodist Hospital

Houston, Texas, United States

Baylor Research Institute at The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Gundersen Health System

La Crosse, Wisconsin, United States

University of Wisconsin

Madison, Wisconsin, United States

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Intégré Universitaire/Sacre Coeur

Montreal, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 34016423 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U01HL125506-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1U01HL125488-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 14-0250

Identifier Type: -

Identifier Source: org_study_id