Clinical trial NCT01121263: Hybrid Revascularization Observational Study
Official title: Hybrid Revascularization Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary arteriosclerosis
coronary heart disease
coronary artery bypass
coronary artery bypass, off-pump
coronary angiography
drug-eluting stents
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: International Center for Health Outcomes and Innovation Research
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-05-12
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Event (MACCE)
timeFrame: Month 12
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Event (MACCE)
timeFrame: Occurence of MACCE through the end of study up to two years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
Study officials:
affiliation: Emory University
name: John Puskas, MD, MSc, FACS, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai (Data Coordinating Center)
name: Deborah Ascheim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Joseph J DeRose, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Michael Argenziano, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Mathew Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: John G. Byrne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.