Hybrid Revascularization Observational Study

NCT01121263 | Completed Results DMC

• 2 other identifiers: GCO 09-06571RC1HL100951
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 11

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.

Conditions

Coronary Artery Disease

Keywords

coronary arteriosclerosis; coronary heart disease; coronary artery bypass; coronary artery bypass, off-pump; coronary angiography; drug-eluting stents

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac and Cerebrovascular Event (MACCE)

  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

  Month 12

Secondary Outcomes (1)

• Major Adverse Cardiac and Cerebrovascular Event (MACCE)

  Occurence of MACCE through the end of study up to two years

Study Arms (2)

Angiogram Review Group

All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period

Therapeutic Intervention Group

* Cohort 2 Therapeutic Intervention Group - HCR Patients (including those from the angiogram review group) who undergo Hybrid coronary revascularization (HCR) with minimally invasive LIMA-LAD CABG, OR * Cohort 2 Therapeutic Intervention Group - PCI Patients (including those from the angiogram review group) who meet the proposed anatomic and clinical eligibility criteria and undergo multivessel Percutaneous Coronary Intervention with Drug Eluting Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Previous coronary stent within:
• month prior to enrollment for bare metal stent (BMS) or
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• International Center for Health Outcomes and Innovation Research: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (11)

Emory University

Atlanta, Georgia, 30308, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 27443431 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Deborah Ascheim, MD
• Organization: Icahn School of Medicine at Mount Sinai

deborah.ascheim@mssm.edu

212-659-9567

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: March 14, 2014
• Results First Posted: January 13, 2014

Record last verified: 2014-02

Locations

US (11)