Trial DesignInternational Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design
Section snippets
Methods
Funding from National Institutes of Health grants U01HL117904 and U01HL117905 was used to support the research and creation of this paper. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Discussion
Patients with SIHD and advanced CKD are underrepresented in contemporary clinical trials comparing optimal coronary revascularization and medical therapy versus OMT alone, providing very limited data on management of these challenging patients. We considered including patients with advanced CKD in the ISCHEMIA trial, that is, having no eGFR exclusion criterion. The COURAGE trial was designed without a creatinine cutoff for trial entry, yet only 16 patients with advanced CKD were enrolled in
Disclosures
Dr Sripal Bangalore: ad hoc consultant/speaker: Abbott Vascular, Pfizer, Daiichi Sankyo, Merck, Medicines Company, Astra Zeneca; research grant: Abbott Vascular, NHLBI; travel grant: Boston Scientific, Medtronic.
Dr John Spertus: ad hoc consultant: United Healthcare, Novartis, Bayer, Janssen, AstraZeneca; research grant: Abbott Vascular; intellectual property: copyright to Seattle Angina Questionnaire; equity: Health Outcomes Sciences.
Dr Glenn M. Chertow: member, Board of Directors: Satellite
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2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
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Michelle O'Shaughnessy, MD, served as guest editor for this article.
RCT# NCT01985360.
Funding source: The study was funded by the National Heart, Lung, and Blood Institute (U01HL117904, U01HL117905).
Disclaimer: The content of this manuscript is solely the responsibility of the authors and does not necessarily reflect the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the United States Department of Health and Human Services.