Hybrid Revascularization Observational Study

Completed

Conditions: Coronary Artery Disease

Registration Number: NCT01121263

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 298

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Event (MACCE)	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

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Event (MACCE)	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

Trial Locations

Locations (11): Columbia University Medical Center
🇺🇸
New York, New York, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Lankenau Hospital
🇺🇸
Wynnewood, Pennsylvania, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
University of Virginia Health Systems
🇺🇸
Charlottesville, Virginia, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States