Eliseo Guallar

Chair and Professor of the Department of Epidemiology

Professional overview

Dr. Guallar is an epidemiologist whose research is focused on the study of cardiovascular disease epidemiology and prevention, with an emphasis on evaluating the role of environmental and nutritional exposures in the development of cardiovascular disease. This research has made critically important and novel contributions to our understanding of risk factors for chronic disease both in the US and globally. He has published seminal articles and is a leading figure in an emerging field highlighting the risks of exposure to levels of metals previously considered safe for cardiovascular health. In addition to his work in toxic metals, Dr. Guallar has made important contributions to understanding the effects of certain micronutrients and vitamin supplements on cardiovascular disease risk and outcomes. Publications in this area were influential in changing consumer habits and attitudes towards these products. Much of this research has been funded by the National Institutes of Health, the Agency for Healthcare Research and Quality, the American Heart Association, the CDC, and other funders.

Dr. Guallar was the founding director of the Center for Clinical Epidemiology at the Samsung Medical Center and a lead investigator of the Kangbuk Samsung Cohort Study at the Kangbuk Samsung Hospital since its inception in 2010. Dr. Guallar has published over 500 research papers in peer-reviewed journals. He is also a Deputy Editor for Methods at the Annals of Internal Medicine and a past member and Chair of the Cancer, Heart, and Sleep Study Section at the National Institutes of Health.

Prior to teaching at NYU, Dr. Guallar was a Professor of Epidemiology and Medicine at the Johns Hopkins University Bloomberg School of Public Health and a core faculty member of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins. In the Department of Epidemiology, Dr. Guallar was the Director of the Environmental and Occupational Area of Concentration and the Co-Director of the PhD Program. Dr. Guallar was also an adjunct Professor at the Department of Clinical Research Design and Evaluation of the Samsung Advanced Institute for Health Science and Technology, Sungkyunkwan University, in Seoul, Korea.

Education

Diploma of English, Spanish Official School of Languages at Zaragoza (Escuela Oficial de Idiomas de Zaragoza), Zaragoza, Spain

MD, University of Zaragoza, Zaragoza, Spain

MPH, University of Minnesota, Minneapolis, MN

DrPH, Harvard University, Boston, MA

Honors and awards

Six Honor Calls in the MD Program, University of Zaragoza School of Medicine (1981)

Fellow of Spain’s Program of Training of Graduate Research of the Ministry of Education and Science, University of Zaragoza (1988)

Fulbright Scholar, sponsored by Spain’s Ministry of Health and Consumer Affairs (1989)

Faculty Innovation Award, Johns Hopkins University Bloomberg School of Public Health (2001)

Scientist Development Award, American Heart Association (2002)

Fellow of the American Heart Association, Council on Epidemiology and Prevention (2013)

Advising, Mentoring, and Teaching Recognition Award 2014 – 2015, Johns Hopkins University Bloomberg School of Public Health (2015)

High Impact Research Icon, University of Malaya (2015)

Publications

Publications

Clinical N Staging Subclassification for Stage III-N2 NSCLC Patients Undergoing Trimodality Therapy: A Good Beginning Is Half the Battle

Lee, J., Hong, Y. S., Lee, J., Lee, G., Kang, D., Park, J., Jeon, Y. J., Park, S. Y., Cho, J. H., Choi, Y. S., Kim, J., Shim, Y. M., Guallar, E., Cho, J., & Kim, H. K. (n.d.).

Publication year

2025

Journal title

Annals of Thoracic Surgery

10.1016/j.athoracsur.2025.02.026

Abstract

Abstract

Background: Lung cancer patients with stage III-N2 disease may benefit from the subclassification of nodal involvement before decision-making. We aimed to evaluate whether the clinical N descriptor subclassification predicts prognosis in patients undergoing trimodality therapy for stage III-N2 non-small cell lung cancer. Methods: Using our institutional registry between 2003 and 2019, we analyzed 899 consecutive patients with stage III-N2 non-small cell lung cancer undergoing neoadjuvant concurrent chemoradiotherapy followed by surgery. We subclassified clinical N2 into cN2a and cN2b on the basis of imaging and histopathologic results. Recurrence-free survival and overall survival were compared by N2 subclassification and separately by histologic type, using competing risks models and Cox proportional hazards models. Results: By the proposed N subclassification, 503 (56.0%) and 396 (44.0%) patients were assigned to cN2a and cN2b, respectively. During a median follow-up of 53.1 months, 492 patients had recurrence and 477 died. The hazard ratios for recurrence comparing cN2b with cN2a after adjustment for age, sex, comorbidities, clinical T category, and histologic type were 1.22 (95% CI, 1.03-1.46). The adjusted hazard ratios for mortality comparing cN2b to cN2a were 1.43 (1.19-1.71). When stratified by histologic type, cN2b had a higher risk of mortality compared with cN2a in both adenocarcinoma and squamous cell carcinoma. Conclusions: In our study evaluating the International Association for the Study of Lung Cancer's approach to subclassify the clinical N descriptor for stage III-N2 non-small cell lung cancer patients, cN2b had a higher risk of recurrence and mortality compared with cN2a, suggesting that clinical N subclassification may be a valuable predictor for stage III-N2 patients.

Damage Control in the Wake of Political Action That Threatens the Integrity of Medical Research

Laine, C., Chang, S., Chopra, V., Cotton, D., Guallar, E., Wee, C., & Williams, S. (n.d.).

Publication year

2025

Journal title

Annals of internal medicine

Volume

178

Issue

5

Page(s)

745-746

10.7326/ANNALS-25-00985

Deleterious mitochondrial heteroplasmies exhibit increased longitudinal change in variant allele fraction

Kuiper, L. M., Shi, W., Verlouw, J. A., Hong, Y. S., Arp, P., Puiu, D., Broer, L., Xie, J., Newcomb, C., Rich, S. S., Taylor, K. D., Rotter, J. I., Bader, J. S., Guallar, E., Van Meurs, J. B., & Arking, D. E. (n.d.).

Publication year

2025

Journal title

iScience

Volume

28

Issue

6

10.1016/j.isci.2025.112590

Abstract

Abstract

A common feature of human aging is the acquisition of somatic mutations, and mitochondria are particularly prone to mutation, leading to a state of mitochondrial DNA heteroplasmy. Cross-sectional studies have demonstrated that detection of heteroplasmy increases with participant age, a phenomenon that has been attributed to genetic drift. In this large-scale longitudinal study, we measured heteroplasmy in two prospective cohorts (combined n = 1404) at two time points (mean time between visits, 8.6 years), demonstrating that deleterious heteroplasmies were more likely to increase in variant allele fraction (VAF). We further demonstrated that increase in VAF was associated with increased risk of overall mortality. These results challenge the claim that somatic mtDNA mutations arise mainly due to genetic drift, instead suggesting a role for positive selection for a subset of predicted deleterious mutations at the cellular level, despite a negative impact of these mutations on overall mortality.

Hearing changes and trajectories during the menopausal transition and their association with metabolic factors

Jang, Y., Chang, Y., Lee, J., Seo, B., Cho, Y., Kim, M., Park, J. H., Kang, J., Kwon, R., Lim, G. Y., Kim, K. H., Kim, H., Hong, Y. S., Park, J., Zhao, D., Cho, J., Guallar, E., & Ryu, S. (n.d.).

Publication year

2025

Journal title

Maturitas

Volume

201

10.1016/j.maturitas.2025.108686

Abstract

Abstract

Background: Hearing loss is an emerging public health concern, with women typically experiencing deterioration during menopause; however, longitudinal studies across this transition are limited. This study examined hearing changes across the menopausal transition in order to identify distinct patterns of hearing decline from 11 years before to 9 years after the final menstrual period, with the goal of informing strategies for early detection and intervention. Materials and methods: We followed 4448 women aged 42–52 years who underwent regular health exams at the Kangbuk Samsung Hospital Total Healthcare Centers (2014–2018) through 2023. Hearing changes were analyzed using linear mixed-effects models across the menopausal transition. Group-based trajectory modeling was applied to assess heterogeneity in hearing deterioration relative to the final menstrual period. Results: A significant change in average bilateral hearing thresholds was observed across menopausal transition. Hearing change during the menopausal transition varied by obesity, with minimal change in those with obesity and slight improvement in those without during early transition. Group-based trajectory modeling identified two patterns: Group 1 (71.7 %) had stable hearing until the final menstrual period, then declined; Group 2 (28.3 %) showed poorer baseline hearing with a steeper, persistent decline. At baseline, Group 2 exhibited a significantly higher prevalence of overweight/obesity and hyperglycemia than Group 1. Conclusions: Postmenopausal stages were associated with significant hearing decline in middle-aged women. Furthermore, subgroups with metabolically unhealthy profiles exhibited poorer baseline hearing and a steeper decline in hearing, highlighting the need for appropriate screening and management during the menopausal transition.

Impact of tumor size by clinical N subclassification and histology in trimodality-treated N2 non-small cell lung cancer

Lee, J., Lee, J., Hong, Y. S., Lee, G., Park, J., Jeon, Y. J., Park, S. Y., Cho, J. H., Choi, Y. S., Kim, J., Shim, Y. M., Guallar, E., Cho, J., & Kim, H. K. (n.d.).

Publication year

2025

Journal title

Scientific reports

Volume

15

Issue

1

10.1038/s41598-024-82946-y

Abstract

Abstract

The evolving TNM classification has emphasized the tumor size’s role in NSCLC prognosis, reclassifying stage IIIA patients from the previous edition as stage IIIB (T3-4N2M0, 8th edition). However, the prognostic implications of tumor size and survival in stage III NSCLC patients undergoing neoadjuvant therapy remain unexplored. Therefore, we investigated the association between tumor size and mortality in N2 non-small cell lung cancer (NSCLC) patients undergoing neoadjuvant concurrent chemoradiotherapy followed by surgery (trimodality therapy), considering the number of metastatic N2 stations and histology. We analyzed 756 patients with stage III (T1-3N2) NSCLC who underwent trimodality therapy, excluding those with T3 tumors with invasion components or additional nodules (2003–2019). Overall survival was compared using the Cox-proportional hazards model, while the tumor size-survival relationship was estimated using restricted cubic splines. Using 8th TNM edition, 32.1%, 48.5%, and 19.3% were clinical T1, T2, and T3. During a median follow-up of 53.5 months, 398 patients died. The adjusted hazard ratios for overall survival comparing T2 and T3 to T1 were 1.46 (95% confidence interval, 1.14–1.85) and 1.48 (1.10–1.99). For the extent of clinical N2, large tumor size increased the mortality risk in patients with N2b but not in N2a. Tumor size did not increase mortality risk in squamous cell carcinoma patients; however, the mortality risk was increased with larger tumors in adenocarcinoma. These findings raise the importance of considering tumor size in treatment planning and suggesting tailored strategies.

Introducing Annals Guide to Journal Club: The Importance of Interpreting Clinical Research With Scientific Nuance

Wee, C. C., Guallar, E., & Laine, C. (n.d.).

Publication year

2025

Journal title

Annals of internal medicine

Volume

178

Issue

3

Page(s)

445-446

10.7326/ANNALS-25-00326

Menopausal stage transitions and associations with overall and domain-specific perceived stress in middle-aged Korean women

Jang, Y., Chang, Y., Jeon, S. W., Park, J., Seo, B., Kang, J., Kwon, R., Lim, G. Y., Kim, K. H., Kim, H., Hong, Y. S., Park, J., Zhao, D., Cho, J., Guallar, E., & Ryu, S. (n.d.).

Publication year

2025

Journal title

Maturitas

Volume

200

10.1016/j.maturitas.2025.108660

Abstract

Abstract

Background: The menopausal transition, closely linked to later-life health, involves substantial physiological and psychological changes, potentially increasing perceived stress. However, longitudinal studies have reported inconsistent results, with limited data for Asian women, despite the potential for perceived stress to vary with both race and socioeconomic status. Therefore, this study investigated the longitudinal association between menopausal transition and perceived stress among middle-aged Korean women. Materials and methods: We conducted a longitudinal study on 4619 women aged 42–52 who provided written consent in person at the Kangbuk Samsung Hospital Total Healthcare Center between 2014 and 2018. Participants were followed until August 2023, with a median follow-up of 6.6 years (interquartile range: 5.1–7.7), with 2 to 8 repeated comprehensive health screenings. We examined associations between menopausal transition and total scores and domain sub-scores (anger, tension, and depression) on the Perceived Stress Inventory using a linear mixed-effects model. Results: Overall Perceived Stress Inventory and anger scores significantly increased during the late transition stage compared with the pre-menopause stage; however, they decreased during post-menopause. Tension scores showed a similar trend, although the results were not significant. Depression scores significantly increased during the early transition, late transition, and post-menopause stages compared with the pre-menopause stage. Conclusion: Middle-aged Korean women's perceived stress significantly increased during the menopausal transition independent of age, marital status, education, and other confounders. Further research is needed to explore the implications of heightened stress and to assess the potential benefits of targeted interventions for women's health during this period.

Menopausal stage transitions and their associations with overall and individual sleep quality in middle-aged Korean women

Jang, Y., Chang, Y., Park, J., Kim, C., Jeon, S. W., Kang, J., Kwon, R., Lim, G. Y., Kim, K. H., Kim, H., Hong, Y. S., Park, J., Zhao, D., Cho, J., Guallar, E., Park, H. Y., & Ryu, S. (n.d.).

Publication year

2025

Journal title

Journal of Affective Disorders

Volume

368

Page(s)

82-89

10.1016/j.jad.2024.09.050

Abstract

Abstract

Background: Understanding the association between the menopausal transition and declining sleep quality can guide optimal timing for preventive interventions in transitioning women. However, studies lack representation of Asian women and sufficient data on the progression of menopausal stages and sleep quality changes over time in this population. Methods: This study included 3305 women in the pre-menopause stage at baseline. The sleep quality and its components were assessed using the Pittsburgh Sleep Quality Index (PSQI). Menopausal stages were classified as pre-menopause, early transition, late transition, and post-menopause according to the Stages of Reproductive Aging Workshop+10 (STRAW+10) criteria. We estimated the longitudinal association between menopausal stage changes over time and the PSQI score, and examined the effect of being overweight. Results: The trends in the PSQI scores and its components according to the menopausal stage changes over time showed that with the exception of sleep duration and habitual sleep efficiency, an overall decline was noted in sleep health during late transition and post-menopause compared to pre-menopause. These associations were independent of time-variant annual chronological aging, which was not significantly associated with sleep deterioration. Additionally, although the associations between menopausal stages and sleep quality did not significantly differ by adiposity level, the overweight group exhibited worse PSQI scores and components than did the non-overweight group. Limitation: Sleep quality and menopausal stage were assessed using self-reported questionnaires without objective measures. Conclusion: Our study underscores the importance of screening for sleep quality deterioration and implementing appropriate measures for women experiencing menopausal transition.

Response by Zhao et al to Letters Regarding Article, "intracranial Atherosclerotic Disease and Incident Dementia: The ARIC Study (Atherosclerosis Risk in Communities)"

Zhao, D., Guallar, E., & Wasserman, B. A. (n.d.). In Circulation.

Publication year

2025

Volume

151

Issue

12

Page(s)

e766

10.1161/CIRCULATIONAHA.125.073361

Safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis and deferred revascularization

Hong, D., Lee, S. H., Heo, J., Shin, D., Cho, J., Guallar, E., Joh, H. S., Kim, H. K., Ha, J., Choi, K. H., Park, T. K., Yang, J. H., Song, Y. B., Hahn, J. Y., Choi, S. H., Gwon, H. C., Kang, D., & Lee, J. M. (n.d.).

Publication year

2025

Journal title

Revista Espanola de Cardiologia

Volume

78

Issue

7

Page(s)

580-589

10.1016/j.recesp.2024.11.001

Abstract

Abstract

Introduction and objectives: This study investigated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their fractional flow reserve (FFR). Methods: A nationwide cohort study was conducted using the Korean National Health Insurance Service database. A total of 4657 patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their FFR were identified from 2013 to 2020. FFR was indicated in patients with no prior evidence of myocardial ischemia and intermediate coronary artery stenosis (50%-70%) as determined by quantitative coronary angiography. Patients were classified according to whether antiplatelet therapy was initiated after the index procedure. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke, during a 5-year follow-up period. The primary safety outcome was any gastrointestinal bleeding. Results: After propensity score matching, there were 1634 patients in the antiplatelet therapy group and 1634 in the nonantiplatelet therapy group. The risk of MACCE was similar between the 2 groups (24.8% vs 24.7%; adjusted HR, 0.97; 95%CI, 0.84-1.13; P = 0.745). The risk of gastrointestinal bleeding was higher in the antiplatelet therapy group than in the nonantiplatelet therapy group (2.2% vs 1.2%; aHR, 2.07; 95%CI, 1.08-4.00). These results were similar in subgroup analyses. Conclusions: In patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their FFR, antiplatelet therapy may increase the risk of gastrointestinal bleeding without reducing the risk of future ischemic events.

Scalp cooling for preventing persistent chemotherapy-induced alopecia in anthracycline-treated patients: A single-arm trial

Kang, D., Lee, H., Zhao, D., Kim, N., Kim, H., Kim, S., Kim, J. Y., Park, Y. H., Ahn, H. K., Guallar, E., Cho, J., & Ahn, J. S. (n.d.).

Publication year

2025

Journal title

Journal of the American Academy of Dermatology

10.1016/j.jaad.2025.06.023

Staging Obesity Risk Beyond Body Mass Index: Progress Made but More to Do

Wee, C. C., Batch, B. C., & Guallar, E. (n.d.).

Publication year

2025

Journal title

Annals of internal medicine

Volume

178

Issue

8

Page(s)

1199-1200

10.7326/ANNALS-25-02327

Standardization and Prediction to Control Confounding: Estimating Risk Differences and Ratios for Clinical Interpretations and Decision Making

Localio, A. R., Henegan, J. A., Chang, S., Meibohm, A. R., Ross, E. A., Goodman, S. N., Couper, D., Guallar, E., & Griswold, M. E. (n.d.).

Publication year

2025

Journal title

Annals of internal medicine

Volume

178

Issue

6

Page(s)

829-835

10.7326/ANNALS-25-00082

Abstract

Abstract

What is the added risk for death from smoking? Logistic regression has become the most common statistical method to answer such questions in the biomedical literature. However, the typical analyses estimate odds ratios, a metric too often misunderstood and misinterpreted. Although estimates of risks, and their differences and ratios, offer transparent clinical interpretations, commonly used statistical models have known methodological shortcomings. “Standardization” through modeling, weighting, or matching offers a solution. The goals of this article are to review classical concepts of standardization and to link them to regression modeling for causal inference. The authors also describe approaches based on weighting and matching compared with regression-based standardization. Using an example of smoking from the ARIC (Atherosclerosis Risk in Communities) study, they explain the value of standardization, long used in medicine and public health, to estimate risks and their differences and ratios for binary outcomes. The authors demonstrate how standard statistical software using models that best fit the data and respect underlying biological or clinical processes can reexpress results in clinically meaningful metrics. The Supplement offers examples with common software packages.

A Metabolomics Approach to Identify Metabolites Associated With Mortality in Patients Receiving Maintenance Hemodialysis

Al Awadhi, S., Myint, L., Guallar, E., Clish, C. B., Wulczyn, K. E., Kalim, S., Thadhani, R., Segev, D. L., McAdams DeMarco, M., Moe, S. M., Moorthi, R. N., Hostetter, T. H., Himmelfarb, J., Meyer, T. W., Powe, N. R., Tonelli, M., Rhee, E. P., & Shafi, T. (n.d.).

Publication year

2024

Journal title

Kidney International Reports

Volume

9

Issue

9

Page(s)

2718-2726

10.1016/j.ekir.2024.06.039

Abstract

Abstract

Introduction: Uremic toxins contributing to increased risk of death remain largely unknown. We used untargeted metabolomics to identify plasma metabolites associated with mortality in patients receiving maintenance hemodialysis. Methods: We measured metabolites in serum samples from 522 Longitudinal US/Canada Incident Dialysis (LUCID) study participants. We assessed the association between metabolites and 1-year mortality, adjusting for age, sex, race, cardiovascular disease, diabetes, body mass index, serum albumin, Kt/Vurea, dialysis duration, and country. We modeled these associations using limma, a metabolite-wise linear model with empirical Bayesian inference, and 2 machine learning (ML) models: Least absolute shrinkage and selection operator (LASSO) and random forest (RF). We accounted for multiple testing using a false discovery rate (pFDR) adjustment. We defined significant mortality-metabolite associations as pFDR < 0.1 in the limma model and metabolites of at least medium importance in both ML models. Results: The mean age of the participants was 64 years, the mean dialysis duration was 35 days, and there were 44 deaths (8.4%) during a 1-year follow-up period. Two metabolites were significantly associated with 1-year mortality. Quinolinate levels (a kynurenine pathway metabolite) were 1.72-fold higher in patients who died within year 1 compared with those who did not (pFDR, 0.009), wheras mesaconate levels (an emerging immunometabolite) were 1.57-fold higher (pFDR, 0.002). An additional 42 metabolites had high importance as per LASSO, 46 per RF, and 9 per both ML models but were not significant per limma. Conclusion: Quinolinate and mesaconate were significantly associated with a 1-year risk of death in incident patients receiving maintenance hemodialysis. External validation of our findings is needed.

Anemia, CKD, and Cognitive Function: The National Health and Nutrition Examination Survey

Blasco-Colmenares, E., Farag, Y. M., Zhao, D., Guallar, E., & Finkelstein, F. O. (n.d.).

Publication year

2024

Journal title

Kidney360

Volume

5

Issue

6

Page(s)

895-899

10.34067/KID.0000000000000354

Angiotensin Receptor Blockers Versus Angiotensin Converting Enzyme Inhibitors in Acute Myocardial Infarction Without Heart Failure

Kim, J., Kang, D., Park, H., Park, T. K., Lee, J. M., Yang, J. H., Song, Y. B., Choi, J. H., Choi, S. H., Gwon, H. C., Guallar, E., Cho, J., & Hahn, J. Y. (n.d.).

Publication year

2024

Journal title

American Journal of Medicine

Volume

137

Issue

11

Page(s)

1088-1096.e4

10.1016/j.amjmed.2024.07.020

Abstract

Abstract

Background: Whether angiotensin II receptor blockers (ARBs) can be an alternative to angiotensin-converting enzyme inhibitors (ACEIs) in patients without heart failure (HF) after acute myocardial infarction (MI) remains controversial. The aim of this study was to compare clinical outcomes between initial ARB and ACEI therapy in patients with MI without HF. Methods: Between 2010 and 2016, a total of 31,013 patients who underwent coronary revascularization for MI with prescription of ARBs or ACEIs at hospital discharge were enrolled from the Korean nationwide medical insurance data. Patients who had HF at index MI were excluded. The primary outcome was all-cause death. The secondary outcomes included recurrent MI, hospitalization for new heart HF, stroke, and a composite of each outcome. Results: Of 31,013 patients, ARBs were prescribed in 12,685 (40.9%) and ACEIs in 18,328 (59.1%). Patients receiving ARBs had a lower discontinuation rate compared with those receiving ACEIs (28.2% vs 43.5%, adjusted hazard ratio [HR] 0.34; 95% confidence interval [CI] 0.31-0.37; P <.01). During a median follow-up of 2.2 years, 2480 patients died. The incidence rate of all-cause death in patients receiving ARBs and those receiving ACEIs was 27.7 and 22.9 per 1000 person-years, respectively (adjusted HR 1.04; 95% CI 0.95-1.13; P =.40). There were no significant differences in the secondary outcomes between patients receiving ARBs and those receiving ACEIs, except stroke (19.2 vs 13.6 per 1000 person-years; adjusted HR 1.17; 95% CI 1.04-1.32; P =.01). In a subgroup analysis, a higher mortality was observed with ARBs compared with ACEIs in patients with diabetes. Conclusions: In this nationwide cohort, there was no significant difference in the incidence of all-cause death between ARBs and ACEIs as discharge medications in patients with myocardial infarction without heart failure. Angiotensin II receptor blockers would be an alternative to ACEIs for those intolerant to ACEI therapy.

Cost-Effectiveness of Fractional FlowReserve-Guided Treatment for Acute Myocardial Infarction and Multivessel Disease A Prespecified Analysis of the FRAME-AMI Randomized Clinical Trial

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Publication year

2024

Journal title

JAMA network open

Volume

7

Issue

1

Page(s)

E2352427

10.1001/jamanetworkopen.2023.52427

Abstract

Abstract

IMPORTANCE Complete revascularization by non-infarct-related artery (IRA) percutaneous coronary intervention (PCI) in patients with acutemyocardial infarction is standard practice to improve patient prognosis. However, it is unclear whether a fractional flow reserve (FFR)-guided or angiography-guided treatment strategy for non-IRA PCI would be more cost-effective. OBJECTIVE To evaluate the cost-effectiveness of FFR-guided compared with angiography-guided PCI in patients with acutemyocardial infarction and multivessel disease. DESIGN, SETTING, AND PARTICIPANTS In this prespecified cost-effectiveness analysis of the FRAME-AMI randomized clinical trial, patients were randomly allocated to either FFR-guided or angiography-guided PCI for non-IRA lesions between August 19, 2016, and December 24, 2020. Patients were aged 19 years or older, had ST-segment elevationmyocardial infarction (STEMI) or non-STEMI and underwent successful primary or urgent PCI, and had at least 1 non-IRA lesion (diameter stenosis > 50% in a major epicardial coronary artery or major side branch with a vessel diameter of ≥2.0 mm). Data analysis was performed on August 27, 2023. INTERVENTION Fractional flow reserve-guided vs angiography-guided PCI for non-IRA lesions. MAIN OUTCOMES AND MEASURES The model simulated death, myocardial infarction, and repeat revascularization. Future medical costs and benefits were discounted by 4.5%per year. The main outcomes were quality-adjusted life-years (QALYs), direct medical costs, incremental costeffectiveness ratio (ICER), and incremental net monetary benefit (INB) of FFR-guided PCI compared with angiography-guided PCI. State-transition Markov models were applied to the Korean, US, and European health care systems using medical cost (presented in US dollars), utilities data, and transition probabilities from meta-analysis of previous trials. RESULTS The FRAME-AMI trial randomized 562 patients, with a mean (SD) age of 63.3 (11.4) years. Most patients were men (474 [84.3%]). Fractional flow reserve-guided PCI increased QALYs by 0.06 compared with angiography-guided PCI. The total cumulative cost per patient was estimated as $1208 less for FFR-guided compared with angiography-guided PCI. The ICER was -$19 484 and the INB was $3378, indicating that FFR-guided PCI was more cost-effective for patients with acute myocardial infarction and multivessel disease. Probabilistic sensitivity analysis showed consistent results and the likelihood iteration of cost-effectiveness in FFR-guided PCI was 97%. When transition probabilities from the pairwise meta-analysis of the FLOWER-MI and FRAME-AMI trials were used, FFR-guided PCI was more cost-effective than angiography-guided PCI in the Korean, US, and European health care systems, with an INB of $3910, $8557, and $2210, respectively. In probabilistic sensitivity analysis, the likelihood iteration of cost-effectiveness with FFR-guided PCIwas 85%, 82%, and 31% for the Korean, US, and European health care systems, respectively. CONCLUSIONS AND RELEVANCE This cost-effectiveness analysis suggests that FFR-guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI for patients with acute myocardial infarction and multivessel disease. Fractional flow reserve- guided PCI should be considered in determining the treatment strategy for non-IRA stenoses in these patients.

Cost-Effectiveness of Intravascular Imaging-Guided Complex PCI: Prespecified Analysis of RENOVATE-COMPLEX-PCI Trial

Hong, D., Lee, J., Lee, H., Cho, J., Guallar, E., Choi, K. H., Lee, S. H., Shin, D., Lee, J. Y., Lee, S. J., Lee, S. Y., Kim, S. M., Yun, K. H., Cho, J. Y., Kim, C. J., Ahn, H. S., Nam, C. W., Yoon, H. J., Park, Y. H., … Lee, J. M. (n.d.).

Publication year

2024

Journal title

Circulation: Cardiovascular Quality and Outcomes

Volume

17

Issue

3

Page(s)

E010230

10.1161/CIRCOUTCOMES.123.010230

Abstract

Abstract

BACKGROUND: Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain. METHODS: RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, =1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained. RESULTS: A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, -$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis. CONCLUSIONS: The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial

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Publication year

2024

Journal title

BMJ open

Volume

14

Issue

8

10.1136/bmjopen-2024-086971

Abstract

Abstract

Introduction There is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction. Methods and analysis The SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI. A total of 2540 patients will be randomised 1: 1 to continuation of β-blocker therapy or not. Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol or other) and participating centre. The primary study endpoint is a composite of all-cause death, MI and hospitalisation for HF over a median follow-up period of 3.5 years (minimum, 2.5 years; maximum, 4.5 years). Adverse effects related to β-blocker therapy, the occurrence of atrial fibrillation, medical costs and Patient-reported Outcomes Measurement Information system-29 questionnaire responses will also be collected as secondary endpoints. Ethics and dissemination Ethics approval for this study was granted by the Institutional Review Board of Samsung Medical Center (no. 2020-10-176). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Early-onset vasomotor symptoms and development of depressive symptoms among premenopausal women

Choi, H. R., Chang, Y., Park, J., Cho, Y., Kim, C., Kwon, M. J., Kang, J., Kwon, R., Lim, G. Y., Ahn, J., Kim, K. H., Kim, H., Hong, Y. S., Park, J., Zhao, D., Cho, J., Guallar, E., Park, H. Y., & Ryu, S. (n.d.).

Publication year

2024

Journal title

Journal of Affective Disorders

Volume

354

Page(s)

376-384

10.1016/j.jad.2024.03.083

Abstract

Abstract

Background: We investigated the association between vasomotor symptoms (VMSs) and the onset of depressive symptoms among premenopausal women. Methods: This cross-sectional study included 4376 premenopausal women aged 42–52 years, and the cohort study included 2832 women without clinically relevant depressive symptoms at baseline. VMSs included the symptoms of hot flashes and night sweats. Depressive symptoms were evaluated using the Center for Epidemiological Studies Depression Scale; a score of ≥16 was considered to define clinically relevant depressive symptoms. Results: Premenopausal Women with VMSs at baseline exhibited a higher prevalence of depressive symptoms compared with women without VMSs at baseline (multivariable-adjusted prevalence ratio 1.76, 95 % confidence interval [CI] 1.47–2.11). Among the 2832 women followed up (median, 6.1 years), 406 developed clinically relevant depressive symptoms. Women with versus without VMSs had a significantly higher risk of developing clinically relevant depressive symptoms (multivariable-adjusted hazard ratio, 1.72; 95 % CI 1.39–2.14). VMS severity exhibited a dose-response relationship with depressive symptoms (P for trend <0.05). Limitations: Self-reported questionnaires were only used to obtain VMSs and depressive symptoms, which could have led to misclassification. We also could not directly measure sex hormone levels. Conclusions: Even in the premenopausal stage, women who experience hot flashes or night sweats have an increased risk of present and developed clinically relevant depressive symptoms. It is important to conduct mental health screenings and provide appropriate support to middle-aged women who experience early-onset VMSs.

Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity: A Randomized Controlled Trial

Maruthur, N. M., Pilla, S. J., White, K., Wu, B., Maw, M. T. T., Duan, D., Turkson-Ocran, R. A., Zhao, D., Charleston, J., Peterson, C. M., Dougherty, R. J., Schrack, J. A., Appel, L. J., Guallar, E., & Clark, J. M. (n.d.).

Publication year

2024

Journal title

Annals of internal medicine

Volume

177

Issue

5

Page(s)

549-558

10.7326/M23-3132

Abstract

Abstract

BACKGROUND: Time-restricted eating (TRE) lowers body weight in many studies. Whether TRE induces weight loss independent of reductions in calorie intake, as seen in rodent studies, is unknown. OBJECTIVE: To determine the effect of TRE versus a usual eating pattern (UEP) on body weight in the setting of stable caloric intake. DESIGN: Randomized, isocaloric feeding study. (ClinicalTrials.gov: NCT03527368). SETTING: Clinical research unit. PARTICIPANTS: Adults with obesity and prediabetes or diet-controlled diabetes. INTERVENTION: Participants were randomly assigned 1:1 to TRE (10-hour eating window, 80% of calories before 1 p.m.) or UEP (≤16-hour window, ≥50% of calories after 5 p.m.) for 12 weeks. Both groups had the same nutrient content and were isocaloric with total calories determined at baseline. MEASUREMENTS: Primary outcome was change in body weight at 12 weeks. Secondary outcomes were fasting glucose, homeostatic model assessment for insulin resistance (HOMA-IR), glucose area under the curve by oral glucose tolerance test, and glycated albumin. We used linear mixed models to evaluate the effect of interventions on outcomes. RESULTS: All 41 randomly assigned participants (mean age, 59 years; 93% women; 93% Black race; mean BMI, 36 kg/m2) completed the intervention. Baseline weight was 95.6 kg (95% CI, 89.6 to 101.6 kg) in the TRE group and 103.7 kg (CI, 95.3 to 112.0 kg) in the UEP group. At 12 weeks, weight decreased by 2.3 kg (CI, 1.0 to 3.5 kg) in the TRE group and by 2.6 kg (CI, 1.5 to 3.7 kg) in the UEP group (average difference TRE vs. UEP, 0.3 kg [CI, -1.2 to 1.9 kg]). Change in glycemic measures did not differ between groups. LIMITATION: Small, single-site study; baseline differences in weight by group. CONCLUSION: In the setting of isocaloric eating, TRE did not decrease weight or improve glucose homeostasis relative to a UEP, suggesting that any effects of TRE on weight in prior studies may be due to reductions in caloric intake. PRIMARY FUNDING SOURCE: American Heart Association.

Estimating the Effects of Health Policy Initiatives: Where We Are and Where We Need to Go

Russell Localio, A., & Guallar, E. (n.d.).

Publication year

2024

Journal title

Annals of internal medicine

Volume

177

Issue

11

Page(s)

1586-1587

10.7326/M24-0896

Feeling the Heat: Cardiovascular Consequences of Heat Exposure Under Controlled Experimental Conditions

Guallar, E., Bravo, P. E., & Ferrari, V. A. (n.d.).

Publication year

2024

Journal title

Annals of internal medicine

Volume

177

Issue

7

Page(s)

976-977

10.7326/M24-0882

Intracranial Atherosclerotic Disease and Incident Dementia: The ARIC Study (Atherosclerosis Risk in Communities)

Zhao, D., Guallar, E., Qiao, Y., Knopman, D. S., Palatino, M., Gottesman, R. F., Mosley, T. H., & Wasserman, B. A. (n.d.).

Publication year

2024

Journal title

Circulation

Volume

150

Issue

11

Page(s)

838-847

10.1161/CIRCULATIONAHA.123.067003

Abstract

Abstract

BACKGROUND: Studies of the neurovascular contribution to dementia have largely focused on cerebral small vessel disease (CSVD), but the role of intracranial atherosclerotic disease (ICAD) remains unknown in the general population. The objective of this study was to determine the risk of incident dementia from ICAD after adjusting for CSVD and cardiovascular risk factors in a US community-based cohort. METHODS: We acquired brain magnetic resonance imaging examinations from 2011 through 2013 in 1980 Black and White participants in the ARIC study (Atherosclerosis Risk in Communities), a prospective cohort conducted in 4 US communities. Magnetic resonance imaging examinations included high-resolution vessel wall magnetic resonance imaging and magnetic resonance angiography to identify ICAD. Of these participants, 1590 without dementia, without missing covariates, and with adequate magnetic resonance image quality were followed through 2019 for incident dementia. Associations between ICAD and incident dementia were assessed using Cox proportional hazard ratios adjusted for CSVD (characterized by white matter hyperintensities, lacunar infarctions, and microhemorrhages), APOE4 genotype (apolipoprotein E gene ε4), and cardiovascular risk factors. RESULTS: The mean age (SD) of study participants was 77.4 (5.2) years. ICAD was detected in 34.6% of participants. After a median follow-up of 5.6 years, 286 participants developed dementia. Compared with participants without ICAD, the fully adjusted hazard ratios (95% CIs) for incident dementia in participants with any ICAD, with ICAD only causing stenosis ≤50%, and with ICAD causing stenosis >50% in ≥1 vessel were 1.57 (1.17-2.11), 1.41 (1.02-1.95), and 1.94 (1.32-2.84), respectively. ICAD was associated with dementia even among participants with low white matter hyperintensities burden, a marker of CSVD. CONCLUSIONS: ICAD was associated with an increased risk of incident dementia, independent of CSVD, APOE4 genotype, and cardiovascular risk factors. The increased risk of dementia was evident even among participants with low CSVD burden, a group less likely to be affected by vascular dementia, and in participants with ICAD causing only low-grade stenosis. Our results suggest that ICAD may partially mediate the effect that cardiovascular risk factors have on the brain leading to dementia. Both ICAD and CSVD must be considered to understand the vascular contributions to cognitive decline.

Menopausal stages and overactive bladder symptoms in middle-aged women: A cross-sectional study

Park, J., Chang, Y., Kim, J. H., Choi, H. R., Kwon, R., Lim, G. Y., Ahn, J., Kim, K. H., Kim, H., Hong, Y. S., Zhao, D., Cho, J., Guallar, E., Park, H. Y., & Ryu, S. (n.d.).

Publication year

2024

Journal title

BJOG: An International Journal of Obstetrics and Gynaecology

Volume

131

Issue

13

Page(s)

1805-1814

10.1111/1471-0528.17912

Abstract

Abstract

Objective: To examine the prevalence of overactive bladder (OAB) according to menopausal stages in middle-aged women. Design: Cross-sectional study. Setting: Total Healthcare Center in South Korea. Population: Middle-aged Korean women (n=3469, mean age, 49.5 ± 2.9 years). Methods: Menopausal stages were defined according to the Stages of Reproductive Aging Workshop +10 criteria, and menopausal symptoms were assessed using the Korean version of Menopause-Specific Quality of Life (MENQOL). Logistic regression models were used to estimate prevalence ratios with 95% confidence intervals for OAB according to menopausal stage and to assess the associations with menopausal symptoms. Main Outcome Measures: OAB symptoms were evaluated using the Overactive Bladder Symptom Score (OABSS). Results: The prevalence of OAB increased with menopausal stage; however, the multivariable-adjusted prevalence ratios for women in menopausal transition and postmenopausal stage were insignificant (ptrend = 0.160) compared to those for premenopausal women. Among individual OAB symptoms, the multivariable-adjusted prevalence ratios for nocturia increased with menopausal stage in a dose–response manner (ptrend = 0.005 for 1 time/day; ptrend < 0.001 for ≥2 times/day). The association between menopausal stages and nocturia occurring ≥2 times/day was evident in women without OAB and with relatively high MENQOL scores, vasomotor symptoms and difficulty sleeping. Conclusions: The prevalence of OAB, particularly nocturia, increased with menopausal stage, and the association was obvious in women with other menopausal symptoms. This finding underscores the importance of addressing nocturia as a potential menopausal symptom in middle-aged women. Further studies are required to understand the mechanisms linking OAB with menopausal symptoms in middle-aged women.