Hybrid Revascularization Observational Study

NCT ID: NCT01121263

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 298 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

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).

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Angiogram Review Group

All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Center for Health Outcomes and Innovation Research

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Puskas, MD, MSc, FACS, FACC

Role: PRINCIPAL_INVESTIGATOR

Emory University

Deborah Ascheim, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai (Data Coordinating Center)

Joseph J DeRose, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Michael Argenziano, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Mathew Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

John G. Byrne, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Emory University

Atlanta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Virginia Health Systems

Charlottesville, Virginia, United States

Countries

United States

References

Puskas JD, Halkos ME, DeRose JJ, Bagiella E, Miller MA, Overbey J, Bonatti J, Srinivas VS, Vesely M, Sutter F, Lynch J, Kirkwood K, Shapiro TA, Boudoulas KD, Crestanello J, Gehrig T, Smith P, Ragosta M, Hoff SJ, Zhao D, Gelijns AC, Szeto WY, Weisz G, Argenziano M, Vassiliades T, Liberman H, Matthai W, Ascheim DD. Hybrid Coronary Revascularization for the Treatment of Multivessel Coronary Artery Disease: A Multicenter Observational Study. J Am Coll Cardiol. 2016 Jul 26;68(4):356-65. doi: 10.1016/j.jacc.2016.05.032.

Reference Type: DERIVED

PMID: 27443431 (View on PubMed)

Other Identifiers

1RC1HL100951

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 09-0657

Identifier Type: -

Identifier Source: org_study_id