دورية أكاديمية
The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease (OPTIMUM) Registry: Rationale and Design.
| العنوان: | The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease (OPTIMUM) Registry: Rationale and Design. |
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| المؤلفون: | Salisbury AC; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America. Electronic address: asalisbury@saint-lukes.org., Kirtane AJ; Columbia University and New York Presbyterian Hospital, New York, NY, United States of America., Ali ZA; Columbia University and New York Presbyterian Hospital, New York, NY, United States of America., Grantham JA; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America., Lombardi WL; University of Washington, Seattle, WA, United States of America., Yeh RW; Beth Israel Deaconess Medical Center, Boston, United States of America., Genereux P; Morristown Medical Center, Morristown, NJ, United States of America., Allen KB; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America., Brown WM; Piedmont Heart Institute, Atlanta, GA, United States of America., Nugent K; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America., Gosch KL; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America., Karmpaliotis D; Columbia University and New York Presbyterian Hospital, New York, NY, United States of America., Spertus JA; Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America., Kandzari DE; Piedmont Heart Institute, Atlanta, GA, United States of America. |
| مؤلفون مشاركون: | OPTIMUM Study Investigators |
| المصدر: | Cardiovascular revascularization medicine : including molecular interventions [Cardiovasc Revasc Med] 2022 Aug; Vol. 41, pp. 83-91. Date of Electronic Publication: 2022 Jan 31. |
| نوع المنشور: | Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101238551 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-0938 (Electronic) Linking ISSN: 18780938 NLM ISO Abbreviation: Cardiovasc Revasc Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Elsevier, c2005- |
| مواضيع طبية MeSH: | Coronary Artery Disease*/diagnostic imaging , Coronary Artery Disease*/surgery , Percutaneous Coronary Intervention*/adverse effects, Coronary Artery Bypass/adverse effects ; Humans ; Registries ; Risk Factors ; Treatment Outcome |
| مستخلص: | Background: Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD. Methods: We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated. Results: Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality. Conclusions: OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population. Competing Interests: Declaration of competing interest Dr. Salisbury reports consulting and advisory board fees from Medtronic and institutional grant support from Boston Scientific. Dr. Grantham reports speaking fees, honoraria and travel expense reimbursement from Asahi, Boston Scientific, Abbott and Corindus. Consulting fees and advisory board fees for Corindus and Boston Scientific. Institutional research grants Boston Scientific and Asahi. Dr. Kirtane reports Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, Neurotronic. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: Consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., Medtronic, Orbus Neich and Teleflex, and personal consulting honoraria from Biotronik, Cardiovascular Systems, Inc., and Medtronic. All remaining authors report no conflicts of interest. Dr. Ali reports institutional research/grant support from Abbott Vascular, Boston Scientific, Philips Volcano, Cardiovascular Systems, Inc., Medtronic, Acist Medical, Opsens, and personal consulting honoraria from Amgen, Astra Zeneca and Boston Scientific, and equity in Shockwave Medical. All remaining authors report no conflicts of interest. (Copyright © 2022 Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Cardiovascular surgery; Coronary artery disease; Quality of life; Revascularization |
| تواريخ الأحداث: | Date Created: 20220205 Date Completed: 20220719 Latest Revision: 20220811 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.carrev.2022.01.008 |
| PMID: | 35120846 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1878-0938 |
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| DOI: | 10.1016/j.carrev.2022.01.008 |