Changes in Medical Therapy and Lifestyle After Anatomical Versus Functional Testing for Coronary Artery Disease: The PROMISE Trial (PROspective Multicenter Imaging Study for Evaluation of Chest Pain)
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2015-11-10
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Abstract
Introduction: Diagnostic testing may represent a “teachable moment” for patients newly presenting with symptoms suggestive of CAD and requiring further evaluation, and may influence risk factor management, independent of test results. However, little is known about changes in medications and lifestyle after anatomical versus functional testing.
Hypothesis: Patients assigned to coronary CTA will report greater use of preventive medications and lifestyle practices.
Methods: We randomly assigned 10,003 symptomatic patients (53% women; mean age 61 yrs) to anatomical testing with CTA or functional testing (exercise ECG, nuclear stress, or stress echocardiography). We assessed use of preventive medications (aspirin, statin, beta blocker, and ACEi/ARB) and lifestyle practices (heart healthy diet, regular exercise, smoking, and obese/overweight status [BMI>25]) at 60 days. Chi-square tests assessed between-group changes (initiation or discontinuation). Multivariable logistic regression models assessed the association between testing strategy and prevalence of medication use or lifestyle practices.
Results: There were no differences in medications or lifestyle practices at baseline. At 60 days, the CTA strategy was associated with a higher proportion of patients newly initiating aspirin (11.6% vs 7.6%), statin (12.7% vs 6.2%), and beta blockers (8.2% vs 5.4%), compared to functional testing (p<0.0001 for each). The CTA strategy was also associated with a higher incidence of weight loss among obese/overweight patients (2.8% vs 2.4%), but the difference was not significant (p=0.051). Overall prevalences of aspirin (aOR=1.55), statin (aOR=2.04), and beta blocker (aOR=1.32) use were higher after CTA (p<0.001 for each). Eating a healthy diet (54.7% vs 50.8%) was increased after CTA (aOR=1.13 p=0.004), whereas obese/overweight status was reduced (aOR=0.79 p=0.047). Exercise and smoking cessation increased similarly in both arms. Benefits of CTA for statin use and weight loss persisted after adjusting for test results.
Conclusions: Among patients with suspected CAD, anatomical testing is associated with greater favorable changes in preventive medical and lifestyle practices. This may represent a long term benefit of a CTA testing strategy.
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Scholars@Duke
Kerry L. Lee
As a faculty-level biostatistician, my research activities are focused on the statistical and data coordination aspects of several large multicenter clinical trials, and on statistical issues in the design and analysis of collaborative clinical research projects associated with the Duke University Cardiovascular Disease Database. I am currently the principal investigator of the statistical and data coordinating center for two NIH-sponsored multicenter randomized clinical trials, namely (1) the Pacemaker Mode Selection Trial, a 2000 patient study of dual chamber versus single chamber pacing in patients with sinus node dysfunction, and (2) the Sudden Cardiac Death in heart Failure Trial a 2,500 patient, three-arm randomized trial of implantable defibrillator therapy or amiodarone versus conventional therapy in patients with class II or III congestive heart failure. During the past year my colleagues and I have completed a third trial sponsored by the NIH for which I was the principal investigator of the data coordinating center. This trial assessed the efficiency of electrophy siologic-guided antiarrhythmic therapy in patients at risk for sudden cardiac death. I also serve as the statistical director and principal statistician for the following major clinical trials:
(1) Symphony II, a 7,000 patient randomized trial of long-term oral platelet inhibition therapy in patients following an acute coronary syndrome, sponsored by Hoffman-LaRoche.
(2) PARAGON B, a 5,200 patient trial of platelet inhibition therapy in patients with unstable angina, also sponsored by Hoffman-LaRoche.
Methodologically, my research activities are focused on the analytic and design issues associated with clinical trials, on regression modeling strategies for risk assessment with logistic and proportional hazards regression models, and on methods for validating prognostic models and assessing probabilistic predictions.
Rowena Joy Dolor
Rowena J. Dolor, MD, MHS did her medical training and internal medicine residency at Duke University Medical Center. She completed the Ambulatory Care/Health Services Research fellowship at the Durham VA Medical Center in 1996 and obtained her Masters in Health Sciences degree in Biometry (renamed MHS in Clinical Research) from the Duke University School of Medicine in 1998. Dr. Dolor was a staff physician in the Ambulatory Care Service at the Durham VA Medical Center and Research Associate at the Center for Health Services Research in Primary Care at the Durham VAMC from 1995-2012. She is currently an investigator of several federally-funded projects conducted in the community-based setting. Dr. Dolor served as a member of the AHRQ PBRN Resource Center Steering Committee and co-chaired the NAPCRG PBRN conference from 2012-2016.
Since 1996, Dr. Dolor has been the director of the Primary Care Research Consortium (PCRC), a network of primary care practices in the Duke University Health System and outlying communities. The PCRC has participated in over 100 industry- and investigator-initiated studies on hypertension, hyperlipidemia, asthma, otitis, obesity, diabetes, depression, anticoagulation, and vaccines. In 2002, the Duke PCRC received grant funding from the Agency for Healthcare Research and Quality (AHRQ) for Primary Care Practice-based Research Networks (PBRNs). The focus of her research pertains to primary care clinical and outcomes research. She has helped lead a number of comparative effectiveness studies and large, pragmatic trials in the primary care setting. In addition, Dr. Dolor has led or co-led networks in otolaryngology and integrative medicine.
Dr. Dolor has contributed to the development and methodology of Practice-based Research Networks (PBRNs). She has served as a co-investigator on three online resources to help researchers conduct multi-center research in the primary care practice-based setting – (1) A toolkit for building and sustaining health research partnership with practices and communities, http://www.researchtoolkit.org/index.php (2) Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice Based Research Networks, http://www.dartnet.info/ClinicalTrialsPBRNToolkit.htm ; and (3) PBRN Research Good Practices (PRGP), http://www.napcrg.org/PBRNResearchGoodPractice
From July 2009-June 2012, she served as the Associate Director for the Duke EPC. She worked closely with the Director, Gillian Sanders PhD, in overseeing the day-to-day functioning of EPC projects and supervising EPC personnel. The Duke EPC was awarded a contract entitled “American Recovery and Reinvestment Act of 2009: Comprehensive EPC Comparative Effectiveness Reviews for Effective Health Care” to serve within a core group of EPCs to focus on a comprehensive approach to comparative effectiveness review (CER) and evidence synthesis. The Duke EPC area of concentration was cardiovascular and pulmonary disorders.
She previously served as the principal investigator for the systematic literature review for the AHA Scientific Statement: Evidence-based guidelines for cardiovascular disease prevention in women published in 2004 and updated in 2007. She was the PI of four CER projects on “Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women” and “Treatment Strategies for Women with CAD”, “PAD”, and “UA/NSTEMI” as well as upcoming CER topics on pulmonary arterial hypertension, peripheral artery disease and unstable angina/non-ST elevation myocardial infarction.
Within the Duke Clinical and Translational Institute (CTSI), Dr. Dolor directs the collaboration with CTSI researchers on community-based PBRN projects. From 2011- 2014, she was co-chair of the CTSA PBRN Collaboration Workgroup, and a member of the Community Engagement Key Function Committee, the CTSA Strategic Goal 4 Combined Networking Group committee, and the CTSA Comparative Effectiveness Research Key Function Committee (CER KFC). Since September 2016, she serves as a Co-chair of the Dissemination, Implementation and Knowledge Transfer Workgroup within the Collaboration Engagement Domain Task Force.
In the fall of 2014, Dr. Dolor joined Vanderbilt part-time as a Consultant/Adjunct Associate Professor of Medicine within the Division of General Internal Medicine. Her role is to assist in the formation of the Meharry-Vanderbilt Clinical Research Network, a PBRN in the mid-Tennessee region. In addition, she is a co-investigator on the Mid-South Clinical Data Research Network, a PCORnet awardee, to build the partnership with the community practices for comparative effectiveness studies that will utilize the electronic health records/information system infrastructure of the CDRN.
Harry Wells Severance
Site Principle Investigator: PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) prospective, randomized, multi-center clinical trial:
Principle Investigator - Duke E.D. Site - "Speed" Study. Pilot phase of Gusto IV. Investigating Abciximab (a GP IIb-IIIa inhibitor) in combination with rapid access to cardiac cath. Funded through Duke Clinical Research Institute. Multi-center trial.
Principle Investigator - Project: proposed mechanisms for afferent pain transmission from myocardial cells to pain centers. Purpose is to identify potential biochemical markers for early anginal presentations. Funded: grants received from Merck & Co. and Roche-Boehringer-Mannheim. Pilot phase paper - in preparation.
Other Interest Areas:
Blasts/Ballistics
Wounding and medical management of penetrating injuries derived from firearms and blast-related injuries.
Impact of Observation/short-stay strategies on clinical care and inpatient/outpatient systems.
Impact of Emerging Viral Threats on clinical management and social/economic/political systems,
Acute Cardiology - Chest Pain Presentations
Evolving Technology and AI in improving clinical care/management
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