Hybrid Coronary Revascularization Trial
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|ClinicalTrials.gov Identifier: NCT03089398|
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Hybrid Coronary Revascularization Device: Hybrid Coronary Revascularization Device: Percutaneous Coronary Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2354 participants|
|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.|
|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|
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
- 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
- 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
- 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
- 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
- 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)
- 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).
- 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.
- 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.
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
|Contact: Susan Comninel, BSN, MPHfirstname.lastname@example.org|
|Contact: Ellen Moquete, RN, BSNemail@example.com|
Show 46 Study Locations
|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|