Hybrid Revascularization Observational Study

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.

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