Author + information
- Received February 19, 2018
- Revision received November 7, 2018
- Accepted November 26, 2018
- Published online February 25, 2019.
- Abhinav Sharma, MDa,b,c,
- Adrian Coles, PhDa,
- Nishant K. Sekaran, MDa,
- Neha J. Pagidipati, MD, MPHa,
- Michael T. Lu, MD, MPHd,
- Daniel B. Mark, MD, MPHa,
- Kerry L. Lee, PhDa,
- Hussein R. Al-Khalidi, PhDa,
- Udo Hoffmann, MDd and
- Pamela S. Douglas, MDa,∗ (, )@pamelasdouglas@dukemedschool
- aDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- bMazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada
- cDivision of Cardiology, Stanford University, Palo Alto, California
- dMassachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Pamela S. Douglas, Duke University School of Medicine, 200 Morris Street, Room 7710, DUMC, P.O. Box 17969, Durham, North Carolina 27715.
Background The optimal noninvasive test (NIT) for patients with diabetes and stable symptoms of coronary artery disease (CAD) is unknown.
Objectives The purpose of this study was to assess whether a diagnostic strategy based on coronary computed tomographic angiography (CTA) is superior to functional stress testing in reducing adverse cardiovascular (CV) outcomes (CV death or myocardial infarction [MI]) among symptomatic patients with diabetes.
Methods PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) was a randomized trial evaluating an initial strategy of CTA versus functional testing in stable outpatients with symptoms suggestive of CAD. The study compared CV outcomes in patients with diabetes (n = 1,908 [21%]) and without diabetes (n = 7,058 [79%]) based on their randomization to CTA or functional testing.
Results Patients with diabetes (vs. without) were similar in age (median 61 years vs. 60 years) and sex (female 54% vs. 52%) but had a greater burden of CV comorbidities. Patients with diabetes who underwent CTA had a lower risk of CV death/MI compared with functional stress testing (CTA: 1.1% [10 of 936] vs. stress testing: 2.6% [25 of 972]; adjusted hazard ratio: 0.38; 95% confidence interval: 0.18 to 0.79; p = 0.01). There was no significant difference in nondiabetic patients (CTA: 1.4% [50 of 3,564] vs. stress testing: 1.3% [45 of 3,494]; adjusted hazard ratio: 1.03; 95% confidence interval: 0.69 to 1.54; p = 0.887; interaction term for diabetes p value = 0.02).
Conclusions In diabetic patients presenting with stable chest pain, a CTA strategy resulted in fewer adverse CV outcomes than a functional testing strategy. CTA may be considered as the initial diagnostic strategy in this subgroup. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550)
Dr. Sekaran is now at the Intermountain Heart Institute, Salt Lake City, Utah. Dr. Sharma is now at the Division of Cardiology, McGill University, Montreal, Quebec, Canada. This project was supported by grants R01HL098237, R01HL098236, R01HL98305, and R01HL098235 from the National Heart, Lung, and Blood Institute (NHLBI). 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. This paper does not necessarily represent the official views of the NHLBI. Dr. Sharma has received support from the Bayer-Canadian Cardiovascular Society, Alberta Innovates Health Solution, Roche Diagnostics, Bristol-Myers Squibb-Pfizer, Bayer, and Takeda. Dr. Pagidipati has ownership in Freedom Health, Inc., Physician Partners, RXAdvance, and Florida Medical Associates; and has received research funding from Regeneron, Sanofi, Verily, Novartis, and Alexion. Dr. Lu has received support from the American Roentgen Ray Society Scholarship; has served as a consultant for PQBypass; and has received research support from NVIDIA. Dr. Mark has received grants from the National Institutes of Health, Eli Lilly and Company, Bristol-Myers Squibb, Gilead Sciences, AGA Medical Corporation, Merck, Oxygen Therapeutics, and AstraZeneca; and has received personal fees from CardioDx, Medtronic, and St. Jude Medical. Dr. Lee has received grants from the National Institutes of Health. Dr. Hoffmann has received grants from HeartFlow and Kowa Pharmaceuticals. Dr. Douglas has received grant support from HeartFlow; and has served on a data and safety monitoring board for GE HealthCare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received February 19, 2018.
- Revision received November 7, 2018.
- Accepted November 26, 2018.
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