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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

  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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Gulati, M.D., Ph.D.

Closed for enrollment

Contact information:

Makinzee Kazeck

(507)538-3561

Kazeck.Makinzee@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20338654

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