Hybrid Coronary Revascularization Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03089398|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Hybrid Coronary Revascularization (isolated LIMA-LAD) Device: Hybrid Coronary Revascularization (PCI) 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)|
|Actual Enrollment :||200 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 Coordinator 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 2021|
|Estimated Study Completion Date :||March 2021|
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 (isolated LIMA-LAD)
sternal-sparing, off-pump, isolated LIMA-LAD revascularization
Other Name: Left Internal Mammary Artery (LIMA) to LAD
Device: Hybrid Coronary Revascularization (PCI)
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: 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.
- Safety Evaluation [ Time Frame: up to 24 months ]We will compare pre- and post-revascularization values between the two groups: Hemoglobin (g/dL), Creatinine (mg/dL), CK-MB (IU/L) and/or Troponin I or T (ng/mL) (some data from the STS Registry). Antiplatelets and anticoagulants, beta-blockers, ACE inhibitors, ARBs, aldosterone antagonists and statins used prior to, during and within 24 hours of the procedure will be analyzed. Data on intra- and peri-procedural AEs in the PCI and HCR groups, including bleeding, will also be available. Information about the index procedure(s) and hospitalization for patients receiving HCR will be extracted from STS, including LOS, transfusions, repeat procedures, and discharge disposition. Data on MACCE events that occur during study-procedure related hospitalizations will be extracted from STS. The Imaging Core Laboratory will analyze the pre and post procedural angiograms. Patients randomized to the HCR procedure and received CABG first will also have data on the patency of the LIMA to LAD graft.
- Feasibility of Incorporating Registry Data in a Randomized Clinical Trial [ Time Frame: up to 24 months ]
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.
- Cost Effectiveness [ Time Frame: up to 24 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
|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|