Outcomes of Surgically Ineligible Patients With Multivessel CAD

Coronary Artery Disease Clinical Trial

— OPTIMUM  

Official title:

Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02996877
• Other study ID #: ISROTH10299
• Status: Active, not recruiting
• Start date: December 15, 2016
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

2. 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.

3. 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.

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

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

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

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

8. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: June 2025
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

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

4. 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

5. 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Geisinger Health System	Danville	Pennsylvania
United States	Henry Ford Hospital	Detroit	Michigan
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Northwell Health System	Manhasset	New York
United States	Columiba University Medical Center	New York	New York
United States	Banner University Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University in Saint Louis	Saint Louis	Missouri
United States	Unifersity of California San Diego Medical Center	San Diego	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Piedmont Heart Institute, Inc., Atlanta, GA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day survival following high risk percutaneous coronary revascularization who are at high risk.	Patients will be followed with phone calls at 30 days.	30 days
Secondary	12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.	Patients will be called at 12 months time by the centralized follow up center.	12 months