Outcomes of Surgically Ineligible Patients With Multivessel CAD



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:December 2016
End Date:June 2020
Contact:Adam C Salisbury, MD
Email:asalisbury@saint-lukes.org
Phone:816-932-5634

Use our guide to learn which trials are right for you!

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

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.

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.

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.
We found this trial at
17
sites
Charleston, West Virginia 25304
Principal Investigator: Aravinda Nanjundappa, MD
?
mi
from
Charleston, WV
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Farouc Jaffer, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Robert Yeh, MD
Phone: 617-632-8956
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Phone: 404-605-3118
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Charlottesville, Virginia 22908
Principal Investigator: Michael Ragosta, MD
Phone: 434-982-1058
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cleveland, Ohio 44012
Principal Investigator: Hiram Bezerra, MD
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Danville, Pennsylvania 17822
Principal Investigator: James Blankenship, MD
?
mi
from
Danville, PA
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Khaldoon Alaswad, MD
Phone: 313-916-1879
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Mark Wiley, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-5634
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Ajay Kirtane, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85006
Principal Investigator: Ashish Pershad, MD
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Catalin Toma, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Rajv Gulati, MD
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: William Lombardi, MD
Phone: 206-221-5758
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Ron Waksman, MD
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
?
mi
from
Washington,
Click here to add this to my saved trials