Dr. Lewis is a board-certified, fellowship-trained specialist in cardiovascular medicine. He is the chief of the Division of Cardiovascular Medicine and a professor of cardiovascular medicine.
Dr. Lewis is an esteemed clinician-scientist who specializes in the care of patients with advanced heart failure. He is an internationally recognized expert on heart failure, heart transplant, and quality of life for heart failure patients. He cares deeply about his patients as well as his colleagues, the hospital, and the School of Medicine. Dr. Lewis is committed to diversity and inclusion, as well as expanding Stanford clinical research initiatives.
A fundamental principle of Dr. Lewis’ practice is his belief that “there is more to life than death,” that cardiovascular care should go beyond helping patients survive to also helping them enjoy the best possible quality of life.
Dr. Lewis has deep expertise in conducting clinical trials examining diagnostic and therapeutic approaches to heart failure. He has done innovative work to create systems for incorporating quality of life measures for cardiovascular patients into electronic health records. This research has received support from the National Heart, Lung and Blood Institute and the National Institutes of Health.
Much of his quality of life research has focused on patient-reported outcomes. Dr. Lewis emphasizes the importance of looking at how a disease, whether chronic or acute, impacts people’s ability to function and perform their activities of daily living. Strategies to improve patients’ well-being focus not only on their physical symptoms but also on depression, anxiety, exercise capacity, and ability to function in daily living.
Dr. Lewis’ commitment to expanding clinical research initiatives will give patients more opportunities to participate in the clinical trials and access the latest care strategies that can translate into better outcomes. The goal is early access to the most advanced technology, pharmacology, and device therapy that can change outcomes for the better. He also envisions forming closer partnerships with community cardiologists and capitalizing further on Stanford’s proximity to and unique relationships with the digital technology leaders of Silicon Valley to enhance the use of digital technology for monitoring patients, optimizing treatment, and tracking outcomes.
He has authored nearly 200 articles published in peer-reviewed journals including the New England Journal of Medicine, Journal of the American College of Cardiology, Circulation, JAMA Cardiology, JAMA Internal Medicine, and many more. He is also on multiple editorial boards for cardiovascular journals and was an associate editor for Circulation–Heart Failure. In addition, he is an author of professional society clinical practice guidelines and scientific statements from both the American Heart Association (AHA) and the Food and Drug Administration.
Dr. Lewis’ honors for clinical care, scholarship, and research include the Joel Gordon Miller Award for community service and leadership from the University of Pennsylvania School of Medicine. He also was one of the first recipients of the Minority Faculty Development Award, which recognizes the research potential of young physicians. Dr. Lewis has received a grant from the Robert Wood Johnson Foundation to study the role of quality of life assessment in clinical decision making in patients with heart failure.
He is a fellow of the American College of Cardiology and the National American Heart Association (AHA) Research Committee. In addition, Dr. Lewis was as a member of the AHA Founders Affiliate Board of Directors, chair of the Council on Clinical Cardiology, and research chair of the Association of Black Cardiologists. He also serves on scientific committees to review grants for the AHA and on the FDA Task Force for the Standardization of Definitions for Endpoint Events in Cardiovascular Trials.
- Cardiovascular Disease
Professor - Med Center Line, Medicine - Cardiovascular Medicine
Board Certification: American Board of Internal Medicine, Advanced Heart Failure and Transplant Cardiology (2014)
Board Certification: American Board of Internal Medicine, Cardiovascular Disease (2003)
Fellowship: Brigham and Women's Hospital Heart Transplant (2002) MA
Fellowship: Brigham and Women's Hospital Cardiovascular Disease Fellowship (2001) MA
Residency: Brigham and Women's Hospital Internal Medicine Residency (1998) MA
Medical Education: Perelman School of Medicine University of Pennsylvania (1995) PA
Cardiovascular Safety and Efficacy of Vadadust for the Treatment of Anemia in Non-Dialysis Dependent CKD: Design and Baseline Characteristics.
American heart journal
Current clinical practice guidelines for anemia management in non-dialysis dependent chronic kidney disease (NDD-CKD) recommend the use of erythropoiesis-stimulating agents (ESAs) as standard of care. Vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates endogenous erythropoietin production. The PRO2TECT program comprises two global, Phase 3, randomized, open-label, active-controlled, sponsor-blind clinical trials to evaluate safety and efficacy of vadadustat vs darbepoetin alfa in adult patients with anemia associated with NDD-CKD. Patients recruited into the ESA-untreated NDD-CKD trial (N=1751) had hemoglobin <10 g/dL and had not received an ESA within 8 weeks prior to inclusion in the study. Patients recruited into the ESA-treated NDD-CKD trial (N=1725) had hemoglobin between 8-11 g/dL (US) or 9-12 g/dL (non-US) and were actively treated with an ESA for anemia associated with CKD. Trial periods in both trials include 1) correction/conversion (weeks 0-23); 2) maintenance (weeks 24-52); 3) long-term treatment (week 53 to end of treatment); and 4) safety follow-up (end-of-treatment to 4 weeks later). The primary safety endpoint is time to first adjudicated major adverse cardiovascular event, defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke, pooled across both trials. The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups. Demographics and baseline characteristics were similar among patients in both trials and broadly representative of the NDD-CKD population. These trials will help to evaluate the safety and efficacy of vadadustat for management of anemia associated with NDD-CKD.
View details for DOI 10.1016/j.ahj.2020.10.068
View details for PubMedID 33129989
Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial.
2020; 19 (1): 175
BACKGROUND: The relationship between blood pressure and mortality in type 2 diabetes (T2DM) is controversial, with concern for increased risk associated with excessively lowered blood pressure.METHODS: We evaluated whether prior cardiovascular disease (CVD) altered the relationship between baseline blood pressure and all-cause mortality in 5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial. Risk of death was assessed in Cox models adjusted for age, sex, race, heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization.RESULTS: Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10mmHg lower SBP 1.05 (95% CI 0.99-1.12) P=0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10mmHg lower SBP 1.13 (95% CI 1.04-1.22) P=0.002) in 2325 patients with additional CVD (index ACS+at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure). In 3527 patients with only the index ACS no significant association was observed (hazard ratio per 10mmHg lower SBP 0.95 (0.86-1.04) P=0.26; P for interaction 0.005).CONCLUSIONS: The association between blood pressure and mortality was modified by additional CVD history in patients with type 2 diabetes and a recent coronary event. When blood pressures measured after an acute coronary event are used to assess the risk of death in patients with type 2 diabetes, the cardiovascular history needs to be taken into consideration. Trial registration ClinicalTrials.gov number NCT01147250, first posted June 22, 2010.
View details for DOI 10.1186/s12933-020-01150-0
View details for PubMedID 33046070
Associations Between Depressive Symptoms and HFpEF-Related Outcomes.
JACC. Heart failure
OBJECTIVES: This study analyzed changes in depressive symptoms in patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the TOPCAT (Aldosterone Antagonist Therapy for Adults With HeartFailure and Preserved Systolic Function) trial.BACKGROUND: There are limited longitudinal data for depressive symptoms in patients with HFpEF.METHODS: In patients enrolled in the United States and Canada (n=1,431), depressive symptoms were measured using Patient Health Questionnaire-9 (PHQ-9). Clinically meaningful changes in PHQ-9 scores were defined as worse (≥3-point increase) or better (≥3-point decrease). Multivariate models were used to identify predictors of change in depressive symptoms. Cox proportional hazard models were used to determine the impact of symptom changes from baseline on subsequent incident cardiovascular events.RESULTS: At 12months, 19% of patients experienced clinically worsening depressive symptoms, 31% better, and 49% unchanged. Independent predictors of clinically meaningful improvement in depressive symptoms included higher baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease, and randomization to spironolactone. After data were adjusted for cardiovascular comorbidities, higher baseline PHQ-9 was associated with all-cause mortality (hazard ratio [HR]: 1.09; 95% confidence interval [CI]: 1.02 to 1.16; p=0.011), whereas worsening depressive symptoms at 12months were associated with cardiovascular death (HR: 2.47; 95%CI: 1.32 to 4.63; p=0.005) and all-cause mortality (HR: 1.82; 95%CI: 1.13 to 2.93; p=0.014). Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p=0.014).CONCLUSIONS: Higher baseline depressive symptoms and worsening depressive symptoms were associated with all-cause mortality. Randomization to spironolactone was associated with modest reduction in depressive symptoms. (Aldosterone Antagonist Therapy for Adults With HeartFailure and Preserved Systolic Function [TOPCAT]; NCT00094302).
View details for DOI 10.1016/j.jchf.2020.06.010
View details for PubMedID 32919912
- Response by Eberly et al to Letter Regarding Article, "Identification of Racial Inequities in Access to Specialized Inpatient Heart Failure Care at an Academic Medical Center". Circulation. Heart failure 2020: CIRCHEARTFAILURE120007193
Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel from the Heart Failure Collaboratory and Academic Research Consortium (HF-ARC).
European journal of heart failure
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation. CONDENSED ABSTRACT: The Heart Failure Collaboratory and Academic Research Consortium multi-stakeholder partnership convened to establish expert consensus definitions and key concepts for heart failure clinical trials including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. With uniform definitions, heart failure interventions can be better standardized, evaluated, and compared between trials and patient populations, and the quality of generated evidence may be strengthened.
View details for DOI 10.1002/ejhf.2018
View details for PubMedID 33017862
Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.
Journal of the American College of Cardiology
2020; 76 (20): 2368–78
The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.
View details for DOI 10.1016/j.jacc.2020.09.544
View details for PubMedID 33183511
- Treatment of Anemia With Darbepoetin Prior to Dialysis Initiation and Clinical Outcomes: Analyses From the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) AMERICAN JOURNAL OF KIDNEY DISEASES 2019; 73 (3): 309–15
Treatment of Anemia With Darbepoetin Prior to Dialysis Initiation and Clinical Outcomes: Analyses From the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).
American journal of kidney diseases : the official journal of the National Kidney Foundation
RATIONALE & OBJECTIVE: Evidence from clinical trials to guide patient preparation for maintenance dialysis therapy is limited. Although anemia is associated with mortality and cardiovascular (CV) disease in individuals initiating maintenance dialysis therapy, it is not known if treatment of anemia before dialysis therapy initiation with erythropoiesis-stimulating agents alters outcomes.STUDY DESIGN: Post hoc analysis of a randomized controlled trial.SETTING & PARTICIPANTS: Participants with type 2 diabetes and chronic kidney disease who progressed to dialysis therapy (n=590) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).EXPOSURE: Randomized treatment assignment (darbepoetin vs placebo).OUTCOMES: All-cause mortality, CV mortality, nonfatal myocardial infarction, heart failure, and stroke within the first 180 days of dialysis therapy initiation.ANALYTICAL APPROACH: Proportional hazards regression.RESULTS: Overall, 590 of 4,038 (14.6%) participants initiated dialysis therapy during the trial (n=298 and 292 in the darbepoetin and placebo groups, respectively). Corresponding hemoglobin levels were 11.3±1.6 and 9.5±1.5g/dL (P<0.001). Death from any cause occurred in 31 (10.4%) participants assigned to darbepoetin and 28 (9.6%) assigned to placebo (HR, 1.16; 95% CI, 0.69-1.93), while death from CV causes occurred in 15 (5.0%) and 13 (4.5%) participants, respectively (HR, 1.21; 95% CI, 0.58-1.93). There were no differences in risk for nonfatal myocardial infarction or heart failure. Stroke occurred in 8 (2.8%) participants assigned to darbepoetin and 1 (0.3%) assigned to placebo (HR, 8.6; 95% CI, 1.1-68.7).LIMITATIONS: Post hoc analyses of a subgroup of study participants.CONCLUSIONS: Despite initiating dialysis therapy with a higher hemoglobin level, prior treatment with darbepoetin was not associated with a reduction in mortality, myocardial infarction, or heart failure in the first 180 days, but a higher frequency of stroke was observed. In the absence of more definitive data, this may inform decisions regarding the use of erythropoiesis-stimulating agents to treat mild to moderate anemia in patients with type 2 diabetes and chronic kidney disease nearing dialysis therapy initiation.
View details for PubMedID 30578152
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
2018; 71 (9): 1021–34
This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.
View details for PubMedID 29495982
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
2018; 137 (9): 961–72
This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.
View details for PubMedID 29483172