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Hybrid Coronary Revascularization Trial

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ClinicalTrials.gov Identifier: NCT03089398
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Emilia Bagiella, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Hybrid Coronary Revascularization Device: Hybrid Coronary Revascularization Device: Percutaneous Coronary Intervention Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The DCC Research Nurse will be blinded to treatment assignment during follow-up telephone calls and will be blinded to aggregate outcomes data.
Primary Purpose: Treatment
Official Title: Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Procedure: Hybrid Coronary Revascularization
sternal-sparing, off-pump, isolated LIMA-LAD revascularization
Other Name: Left Internal Mammary Artery (LIMA) to LAD

Device: Hybrid Coronary Revascularization
percutaneous revascularization of at least one non-LAD target
Other Name: PCI with metallic DES of non-LAD vessel(s)

Active Comparator: 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.
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.
Other Name: PCI




Primary Outcome Measures :
  1. Major Adverse Coronary and Cerebrovascular Events (MACCE) [ Time Frame: over a minimum of 5 years follow-up after randomization ]
    defined as all-cause mortality, myocardial infarction (MI), stroke, or unplanned revascularization


Secondary Outcome Measures :
  1. Cardiovascular Events [ Time Frame: 60 months ]
    MACCE, individual components of MACCE (all-cause mortality, myocardial infarction (MI), stroke, or unplanned revascularization), Ischemia-driven Revascularization, Cardiovascular Mortality and Non-Cardiovascular Mortality, Stent thrombosis, Symptomatic graft stenosis or occlusion

  2. Hospitalizations [ Time Frame: 60 months ]
    Re-hospitalization will be assessed and classified as all-cause or cardiovascular (further subdivided as due to cardiac arrest, acute MI, heart failure or cardiogenic shock, other cardiovascular causes, or bleeding), as adjudicated by the CEC

  3. Bleeding Academic Research Consortium (BARC) Scale [ Time Frame: 60 months ]
    Site assessed bleeding complications will be reported using the Bleeding Academic Research Consortium (BARC) Scale. Range from Type 0: No bleeding to Type 5: Fatal bleeding

  4. Angina Score [ Time Frame: 60 months ]
    Angina Score as measured by Canadian Cardiovascular Society Classification (CCSC), Grade I (No limitation of ordinary activity) to Grade IV (Unable to carry on any physical activity without discomfort)

  5. SF-12 [ Time Frame: 60 months ]
    Health Status as measured by SF-12. 12-item scale with total score from 0 (lower health status) to 100 (higher health status).

  6. EuroQoL [ Time Frame: 60 months ]
    Health Status as measured by EuroQoL. The EuroQoL 5-D is a standardized instrument for measuring health-related quality of life. This questionnaire provides a simple descriptive profile that consists of 5 dimensions. The 5 domains are anxiety/depression, pain/discomfort, usual activities, self-care, and mobility. The instrument also has a self-assessment of health status. Patients are asked to draw a line from a box indicating their current health state to whichever point on the scale indicates how good or bad their current health state is.

  7. Cost Effectiveness [ Time Frame: 60 months ]
    Health Status as measured by Cost Effectiveness. Cost-effectiveness will be evaluated using a microsimulation 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089398


  Show 46 Study Locations
Sponsors and Collaborators
Emilia Bagiella
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: 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

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Responsible Party: Emilia Bagiella, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03089398     History of Changes
Other Study ID Numbers: GCO 14-0250
1U01HL125506-01A1 ( U.S. NIH Grant/Contract )
1U01HL125488-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Emilia Bagiella, Icahn School of Medicine at Mount Sinai:
Hybrid Coronary Revascularization
Coronary Artery Bypass Grafting
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases