Hybrid Revascularization Observational Study
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| ClinicalTrials.gov Identifier: NCT01121263 |
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Recruitment Status :
Completed
First Posted : May 12, 2010
Results First Posted : January 13, 2014
Last Update Posted : March 14, 2014
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| Condition or disease |
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| Coronary Artery Disease |
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).
| Study Type : | Observational |
| Actual Enrollment : | 298 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Hybrid Revascularization Observational Study |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | August 2013 |
| Group/Cohort |
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Angiogram Review Group
All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period
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Therapeutic Intervention Group
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- Major Adverse Cardiac and Cerebrovascular Event (MACCE) [ Time Frame: Month 12 ]
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
- Major Adverse Cardiac and Cerebrovascular Event (MACCE) [ Time Frame: Occurence of MACCE through the end of study up to two years ]
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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
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:
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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
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): NCT01121263
| 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 | |
| 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 Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT01121263 History of Changes |
| Other Study ID Numbers: |
GCO 09-0657 1RC1HL100951 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 12, 2010 Key Record Dates |
| Results First Posted: | January 13, 2014 |
| Last Update Posted: | March 14, 2014 |
| Last Verified: | February 2014 |
Keywords provided by Icahn School of Medicine at Mount Sinai:
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coronary arteriosclerosis coronary heart disease coronary artery bypass |
coronary artery bypass, off-pump coronary angiography drug-eluting stents |
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 |