Hybrid Revascularization Observational Study
Hybrid Revascularization Observational Study
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.
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).
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