OPTIMUM: Outcomes of Surgically Ineligible Patients With Multivessel CAD

Sponsor
Saint Luke's Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02996877
Collaborator
Piedmont Heart Institute, Inc., Atlanta, GA (Industry)
750
21
78
35.7
0.5

Study Details

Study Description

Brief Summary

The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort design to follow patients who have multivessel or left main coronary artery disease ("surgical anatomy" according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be selected to participate in the registry from a national network of leading centers across the United States with recognized expertise in both complex PCI and coronary artery bypass surgery. We will invite leading cardiac centers, as defined by US News and World reports rankings for heart care. Additional sites may be added to meet the target enrollment goal.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objectives 1. Compare 30-day mortality and the composite of mortality and morbidity following high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons (STS) survival and morbidity in patients with severe multivessel or left main coronary artery disease (CAD).

    1. Compare the 12-month health status and clinical outcomes of surgically ineligible multivessel or left main CAD patients treated with PCI compared to those treated with a medical therapy alone.

    2. Understand the association between completeness of revascularization and long-term health status and clinical outcomes among patients with multivessel or left main CAD treated with PCI deemed ineligible for surgery.

    3. Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival (ASCERT risk model)

    4. Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease (CAD).

    5. Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD.

    6. Describe the frequency and predictors of complete revascularization in this population.

    7. Describe the costs and costs per quality adjusted life year (QALY) gained of the strategy of management of multivessel or left main CAD with PCI versus medical therapy among surgically ineligible patients.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry
    Study Start Date :
    Dec 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2020
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Guideline Directed Medical Therapy

    Patients who have an initial treatment strategy of using guideline-directed medical therapy only.

    Percutaneous Coronary Intervention

    Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy.

    Outcome Measures

    Primary Outcome Measures

    1. 30 day survival following high risk percutaneous coronary revascularization who are at high risk. [30 days]

      Patients will be followed with phone calls at 30 days.

    Secondary Outcome Measures

    1. 12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only. [12 months]

      Patients will be called at 12 months time by the centralized follow up center.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participant Selection Inclusion Criteria
    1. Participant undergoes coronary angiography revealing unprotected left main stenosis of

    50%, 3 vessel disease with stenoses > 70% or 2 vessel coronary disease (>70%) with one lesion involving the proximal LAD. Patients will also be included if there is FFR evidence of flow limiting stenosis (FFR ≤ 0.80) in the setting of > 40% angiographic stenosis the left main, 3 epicardial coronaries or 2 vessels including the proximal LAD. Patients with prior bypass surgery will be included if they have ≥ 2 epicardial vascular distributions subtended by a severe native coronary stenosis with either no bypass graft supplying the vessel, a severely diseased (>70% stenosis) bypass graft supplying the affected vessel or an occluded bypass graft to the affected vessel.

    1. Patient considered high risk for coronary artery bypass surgery and declared ineligible for surgery by the heart team.

    2. Patient is experiencing clinical symptoms consistent with obstructive coronary artery disease or with evidence of coronary ischemia on non-invasive/invasive (FFR) functional testing.

    3. Subject is ≥ 18 years of age at the time of consent and is willing to sign an informed consent document approved by the enrolling hospital's Institutional Review Board and follow-up for 12-months following enrollment in the study

    4. Patient is able to speak English.

    Exclusion Criteria:
    • Exclusion Criteria
    1. Established iodine allergy that cannot be managed medically, allergy to everolimus, or absolute contraindication to aspirin, P2Y12 antagonist therapy with either clopidogrel, prasgurel, ticagrelor or ticlopidine or absolute contraindication to bivalirudin and heparin precluding procedural anticoagulation.

    2. Emergent revascularization required for ST-elevation myocardial infarction or cardiac arrest, or severe sustained hemodynamic instability.

    3. Patients presenting late after STEMI (> 12 hours after symptom onset) for "salvage" PCI.

    4. Too hard of hearing to do follow-up by telephone.

    5. Currently incarcerated.

    6. Dementia.

    7. Subjects with no way to be contacted by telephone for follow-up, including those who live outside of the U.S. or spend significant time outside of the U.S.

    8. Patients with conditions such as cancer, mental illness, or other pathology which, in the opinion of the local investigator, might put the patient at risk, preclude follow-up or confound the results of the study.

    9. Patients who refuse.

    10. Female subjects with a positive quantitative or qualitative pregnancy test will not be enrolled.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center Phoenix Arizona United States 85006
    2 Unifersity of California San Diego Medical Center San Diego California United States 92037
    3 Washington Hospital Center Washington District of Columbia United States 20010
    4 Emory University Hospital Midtown Atlanta Georgia United States 30308
    5 Piedmont Heart Institute Atlanta Georgia United States 30606
    6 University of Kansas Medical Center Kansas City Kansas United States 66160
    7 Massachusetts General Hospital Boston Massachusetts United States 02114
    8 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    9 Henry Ford Hospital Detroit Michigan United States 48202
    10 Mayo Clinic Rochester Minnesota United States 55905
    11 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    12 Washington University in Saint Louis Saint Louis Missouri United States 63110
    13 Northwell Health System Manhasset New York United States 11030
    14 Columiba University Medical Center New York New York United States 10032
    15 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    16 Cleveland Clinic Cleveland Ohio United States 44195
    17 Geisinger Health System Danville Pennsylvania United States 17822
    18 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    19 University of Virginia Medical Center Charlottesville Virginia United States 22908
    20 University of Washington Medical Center Seattle Washington United States 98195
    21 Charleston Area Medical Center Charleston West Virginia United States 25304

    Sponsors and Collaborators

    • Saint Luke's Health System
    • Piedmont Heart Institute, Inc., Atlanta, GA

    Investigators

    • Principal Investigator: Adam C Salisbury, MD MSc, Saint Luke's Health System
    • Principal Investigator: David E Kandzari, MD, Piedmont Heart and Vascular Institute
    • Principal Investigator: James A Grantham, MD, Saint Luke's Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saint Luke's Health System
    ClinicalTrials.gov Identifier:
    NCT02996877
    Other Study ID Numbers:
    • ISROTH10299
    First Posted:
    Dec 19, 2016
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Oct 13, 2021