Hybrid Revascularization Observational Study

This study has been completed.
Sponsor:
Collaborators:
International Center for Health Outcomes and Innovation Research
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01121263
First received: May 10, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries). Participation in the study will last up to 21 months after a patient's heart procedure(s). The study collects information about the medical care patients receive during their planned procedure(s) and how well they do following the procedure(s). No new testing or procedures will be done. Patients will receive only the tests or procedures their doctor already has planned for them. The information collected should help to plan the design of a pivotal comparative effectiveness study of hybrid revascularization.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hybrid Revascularization Observational Study

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Event (MACCE) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

    For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:

    • Death
    • Stroke
    • Myocardial Infarction
    • Repeat Revascularization


Secondary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Event (MACCE) [ Time Frame: Occurence of MACCE through the end of study up to two years ] [ Designated as safety issue: No ]

    For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:

    • Death
    • Stroke
    • Myocardial infarction
    • Repeat revascularization


Enrollment: 298
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Angiogram Review Group
All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period
Therapeutic Intervention Group
  • Cohort 2 Therapeutic Intervention Group - HCR Patients (including those from the angiogram review group) who undergo Hybrid coronary revascularization (HCR) with minimally invasive LIMA-LAD CABG, OR
  • Cohort 2 Therapeutic Intervention Group - PCI Patients (including those from the angiogram review group) who meet the proposed anatomic and clinical eligibility criteria and undergo multivessel Percutaneous Coronary Intervention with Drug Eluting Stents

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 for coronary revascularization. For patients with 3-vessel disease, revascularization by CABG has recently been rated as appropriate while revascularization by PCI has been rated uncertain. Ideally, physicians would like to offer their multi-vessel CAD patients what they truly seek: a solution which provides a safe, minimally invasive treatment that does not compromise long term durability and survival. Integrating the positive features of both PCI and CABG has been the fundamental rationale of "hybrid" coronary revascularization.

Hybrid Coronary Revascularization (HCR) (the intended combination of CABG and PCI) 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. Candidates in whom HCR would be particularly advantageous would be several subgroups of CAD patients that are increasing in numbers: the elderly, patients with a high predicted risk of mortality and/or morbidity for CABG, deconditioned patients or patients with significant disabilities and patients in whom treatment durability is important, but a significantly invasive approach is not an option. Moreover, HCR is likely to bridge the divide in treatment philosophies and approaches that exist between cardiologists and cardiac surgeons. Collaboration rather than competition between these specialties will ultimately benefit patients, hospitals, payers and healthcare providers. The Hybrid Revascularization Observational Study is a multi-center observational study planning grant which will explore target populations for Hybrid Coronary Revascularization (HCR), their outcomes, and variations in specific ways these patients are managed, in order to inform the design of a pivotal comparative effectiveness trial of this emerging therapeutic strategy.

Given the observational nature of the study, the HCR and PCI groups' baseline characteristics and event rates are not directly comparable; rather, the results were intended to inform the design of a larger, randomized pivotal trial. The study was designed in two phases: Cohort 1, which captured demographic, angiographic, and practice patterns data for 6,669 consecutively screened patients; and Cohort 2 which captured demographic, angiographic, practice patterns, and outcome data for 298 patients who underwent either HCR or PCI with DES (90 of whom were also part of Cohort 1).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort 1 (Angiogram Review Group): All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period.

Cohort 2 (Therapeutic Intervention Group): All patients (including those from cohort 1) who meet either of the following: (a) undergo HCR with minimally invasive LIMA-LAD CABG (HCR Group) OR (b) meet the proposed anatomic and clinical eligibility criteria defined below and undergo multivessel PCI with DES (PCI Group).

Criteria

The following criteria apply to Cohort 2 PCI patients only:

Inclusion Criteria:

  • Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
  • Age 18 years or older
  • Clinical indication for revascularization
  • LAD and at least one additional vessel coronary disease (> 70% stenosis) confirmed by angiogram
  • Clinical characteristics and multi-vessel disease amenable to both PCI with DES and Hybrid as adjudicated by one interventional cardiologist and one cardiac surgeon
  • Ability to tolerate and no plans to interrupt double platelet therapy for ≥ 12 months
  • Ability to tolerate to single lung ventilation in the judgment of the investigator
  • Willing to comply with all protocol required follow-up

Exclusion Criteria:

  • Previous coronary stent within:

    • 1 month prior to enrollment for bare metal stent (BMS) or
    • 6 months prior to enrollment for DES
  • Evidence of in stent restenosis of a DES or BMS
  • Previous cardiac surgery of any kind
  • Chronic total occlusion (CTO) in LAD or ≥ 2 CTOs in major coronary territories that are considered targets for revascularization
  • Left main disease ≥ 50% stenosis
  • Presence of fresh coronary thrombus
  • Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysm, carotid endarterectomy or stenting, etc)
  • Previous STEMI within 30 days prior to randomization
  • Previous stroke within 6 months prior to randomization
  • Previous thoracic surgery involving the left pleural space
  • Acute decompensated heart failure within 30 days prior to randomization
  • Ejection fraction < 30%
  • Creatinine clearance ≤ 50 ml/min within 24 hours prior to randomization
  • Hemodynamic instability at time of screening
  • Body mass index > 40
  • Extra-cardiac illness that is expected to limit survival to less than 3 years
  • Participation or planned participation in another investigational intervention study within 60 days prior to randomization
  • Unable to give informed consent or potential for noncompliance with the study protocol due to psychiatric illness, organic brain disease, dementia, current alcohol abuse, mental retardation, language barrier, or geographical inaccessibility;
  • Pregnancy at time of screening or intention to become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121263

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia Health Systems
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Mount Sinai School of Medicine
International Center for Health Outcomes and Innovation Research
Investigators
Principal Investigator: John Puskas, MD, MSc, FACS, FACC Emory University
Principal Investigator: Deborah Ascheim, MD Icahn School of Medicine at Mount Sinai (Data Coordinating Center)
Principal Investigator: Joseph J DeRose, MD, FACS Montefiore Medical Center
Principal Investigator: Michael Argenziano, MD, FACS Columbia University
Principal Investigator: Mathew Williams, MD Columbia University
Principal Investigator: John G. Byrne, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01121263     History of Changes
Other Study ID Numbers: GCO 09-0657, 1RC1HL100951
Study First Received: May 10, 2010
Results First Received: November 25, 2013
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
coronary arteriosclerosis
coronary heart disease
coronary artery bypass
coronary artery bypass, off-pump
coronary angiography
drug-eluting stents

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

ClinicalTrials.gov processed this record on September 22, 2014