Hybrid Coronary Revascularization Trial

NCT03089398 | Completed Results DMC FDA Device

• 3 other identifiers: GCO 14-02501U01HL125506-01A11U01HL125488-01A1
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 46

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.

Conditions

Coronary Artery Disease

Keywords

Hybrid Coronary Revascularization; Coronary Artery Bypass Grafting; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Major Adverse Coronary and Cerebrovascular Events (MACCE)

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

  Up to 24 months

Secondary Outcomes (11)

• Hemoglobin Levels

  Up to 90 days post-randomization

• Creatinine Levels

  Up to 90 days post-randomization

• CK-MB Levels (ng/dL)

  Up to 90 days post-randomization

• CK-MB Levels (IU/L)

  Up to 90 days post-randomization

• Troponin Levels

  Up to 90 days post-randomization

Study Arms (2)

Hybrid Coronary Revascularization Group

ACTIVE COMPARATOR

HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target.

Procedure: Hybrid Coronary Revascularization (isolated LIMA-LAD); Device: Hybrid Coronary Revascularization (PCI)

Percutaneous Coronary Intervention

ACTIVE COMPARATOR

PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol.

Device: Percutaneous Coronary Intervention

Interventions

Hybrid Coronary Revascularization (isolated LIMA-LAD) PROCEDURE

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

Also known as: Left Internal Mammary Artery (LIMA) to LAD

Hybrid Coronary Revascularization Group

Hybrid Coronary Revascularization (PCI) DEVICE

percutaneous revascularization of at least one non-LAD target

Also known as: PCI with metallic DES of non-LAD vessel(s)

Hybrid Coronary Revascularization Group

Percutaneous Coronary Intervention 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.

Also known as: PCI

Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emilia Bagiella: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (46)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

HealthPark Lee Memorial Health Systems

Fort Myers, Florida, 33908, United States

Location

Orlando Health Heart Institute

Orlando, Florida, 32806, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

Universty of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Our Lady of Lourdes Medical Center

Camden, New Jersey, 08103, United States

Location

Buffalo General Medical Center/Gates Vascular Institute

Buffalo, New York, 14203, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

Montefiore - Einstein

The Bronx, New York, 10461, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Pinnacle Health Cardiovascular System

Harrisburg, Pennsylvania, 17104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

The Reading Health System

West Reading, Pennsylvania, 19611, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Baylor Research Institute at The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Intégré Universitaire/Sacre Coeur

Montreal, Canada

Location

Related Publications (1)

• 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.

  PMID: 34016423 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Emilia Bagiella
• Organization: Icahn School of Medicine at Mount Sinai

emilia.bagiella@mountsinai.org

212-659-9580

Study Officials

• Emilia Bagiella, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Alan Moskowitz, MD

  Ichan School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• John Puskas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Gregg Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The DCC Research Coordinator will be blinded to treatment assignment during follow-up telephone calls and will be blinded to aggregate outcomes data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: October 9, 2017
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (39); CA (7)