Eileen M Handberg1, C Noel Bairey Merz2, Rhonda M Cooper-Dehoff3, Janet Wei2, Michael Conlon4, Margaret C Lo5, William Boden6, Susan M Frayne7, Todd Villines8, John A Spertus9, William Weintraub10, Patrick O'Malley11, Bernard Chaitman12, Leslee J Shaw13, Matthew Budoff14, Andre Rogatko15, Carl J Pepine16. 1. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL. Electronic address: eileen.handberg@medicine.ufl.edu. 2. Barbra Streisand Women's Heart Center, Cedars Sinai Smidt Heart Institute, Los Angeles, CA. 3. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL. 4. Clinical and Translational Science Institute, University of Florida, Gainesville, FL. 5. Division of Internal Medicine, Department of Medicine, University of Florida, Gainesville, FL. 6. Clinical Trials Network, MAVERIC Center, VA Boston Healthcare System, Boston, MA. 7. VA Women's Health Practice-Based Research Network, VA Palo Alto Health Care System, Palo Alto, CA; Division of Primary Care and Population Health, Stanford University, VA Palo Alto Health Care System, Menlo Park, CA. 8. Cardiovascular Imaging Center, University of Virginia Health System and School of Medicine, Charlottesville, VA. 9. Department of Biomedical and Health Informatics, Internal Medicine, UMKC and Saint Luke's Mid America Heart Institute, Kansas City, MO. 10. Heart and Vascular Institute, Medstar Research Institute, Washington, D.C. 11. General Internal Medicine, Uniformed Services University of Health Sciences, Bethesda, MD. 12. Cardiovascular Department, St. Louis University School of Medicine, St. Louis, MO. 13. Division of Cardiology, Emory University School of Medicine, Atlanta, GA. 14. Division of Cardiology, Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA. 15. Biostatistics and Bioinformatics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA. 16. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL.
Abstract
BACKGROUND: Approximately half of all women with anginal symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA) referred for coronary angiography have elevated risk for major adverse cardiac events (MACE), poor quality of life and resource consumption. Yet, guidelines focus on symptom management while clinical practice typically advocates only reassurance. Pilot studies of INOCA subjects suggest benefit with intensive medical therapy (IMT) that includes high-intensity statins and angiotensin converting enzyme inhibitors (ACE-I) or receptor blockers (ARB) to provide the rationale for a randomized pragmatic trial to limit MACE. METHODS: The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) in 4,422 symptomatic women with INOCA (NCT03417388) in approximately 70 United States sites. The hypothesis is that IMT will reduce the primary outcome of first occurrence of MACE by 20% vs. UC at ∼2.5 year followup. Secondary outcomes include quality of life, time to return to "duty"/work, healthcare utilization, angina, cardiovascular death and individual primary outcome components over 3 years follow-up. The study utilizes web-based data capture, e-consents, single IRB and centralized pharmacy distribution of strategy medications directly to patients' homes to reduce site and patient burden. A biorepository will collect blood samples to assess potential mechanisms. CONCLUSIONS: The results of this trial will provide important data necessary to inform guidelines regarding how best to manage this growing and challenging population of women with INOCA.
RCT Entities:
BACKGROUND: Approximately half of all women with anginal symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA) referred for coronary angiography have elevated risk for major adverse cardiac events (MACE), poor quality of life and resource consumption. Yet, guidelines focus on symptom management while clinical practice typically advocates only reassurance. Pilot studies of INOCA subjects suggest benefit with intensive medical therapy (IMT) that includes high-intensity statins and angiotensin converting enzyme inhibitors (ACE-I) or receptor blockers (ARB) to provide the rationale for a randomized pragmatic trial to limit MACE. METHODS: The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) in 4,422 symptomatic women with INOCA (NCT03417388) in approximately 70 United States sites. The hypothesis is that IMT will reduce the primary outcome of first occurrence of MACE by 20% vs. UC at ∼2.5 year followup. Secondary outcomes include quality of life, time to return to "duty"/work, healthcare utilization, angina, cardiovascular death and individual primary outcome components over 3 years follow-up. The study utilizes web-based data capture, e-consents, single IRB and centralized pharmacy distribution of strategy medications directly to patients' homes to reduce site and patient burden. A biorepository will collect blood samples to assess potential mechanisms. CONCLUSIONS: The results of this trial will provide important data necessary to inform guidelines regarding how best to manage this growing and challenging population of women with INOCA.
Authors: Keva Garg; Toral R Patel; Arjun Kanwal; Todd C Villines; Niti R Aggarwal; Khurram Nasir; Roger S Blumenthal; Michael J Blaha; Pamela S Douglas; Leslee J Shaw; Garima Sharma Journal: J Cardiovasc Comput Tomogr Date: 2021-10-08
Authors: Patricia F Rodriguez Lozano; Elona Rrapo Kaso; Jamieson M Bourque; Mohamed Morsy; Angela M Taylor; Todd C Villines; Christopher M Kramer; Michael Salerno Journal: JACC Cardiovasc Imaging Date: 2022-03-16
Authors: Ellen C Keeley; Han J Li; Christopher R Cogle; Eileen M Handberg; C Noel Bairey Merz; Carl J Pepine Journal: Am J Cardiol Date: 2021-10-30 Impact factor: 3.133