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2. Clonal hematopoiesis, cardiovascular events and treatment benefit in 63,700 individuals from five TIMI randomized trials

Author

Marston, Nicholas A., Pirruccello, James P., Melloni, Giorgio E. M., Kamanu, Frederick, Bonaca, Marc P., Giugliano, Robert P., Scirica, Benjamin M., Wiviott, Stephen D., Bhatt, Deepak L., Steg, Philippe Gabriel, Raz, Itamar, Braunwald, Eugene, Libby, Peter, Ellinor, Patrick T., Bick, Alexander G., Sabatine, Marc S., and Ruff, Christian T.

Published
2024
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3. Mavacamten: a first-in-class myosin inhibitor for obstructive hypertrophic cardiomyopathy.

Author

Braunwald, Eugene, Saberi, Sara, Abraham, Theodore, Elliott, Perry, and Olivotto, Iacopo

Subjects
Ejection fraction, Myectomy, Myosin, Pressure gradient, Adult, Humans, Benzylamines, Cardiomyopathy, Hypertrophic, Heart, United States, Uracil
Abstract

Mavacamten is a first-in-class, targeted, cardiac-specific myosin inhibitor approved by the US Food and Drug Administration for the treatment of adults with symptomatic New York Heart Association Classes II and III obstructive hypertrophic cardiomyopathy (oHCM). Mavacamten was developed to target the hyper-contractile phenotype, which plays a critical role in the pathophysiology of the disease. In Phase 2 and 3 clinical trials, mavacamten was well tolerated, reduced left ventricular outflow tract gradients, improved exercise capacity and symptoms, and was associated with improvements in other clinically relevant parameters, such as patient-reported outcomes and circulating biomarkers. In addition, treatment with mavacamten was associated with evidence of favourable cardiac remodelling in multi-modality imaging studies. Mavacamten substantially reduced guideline eligibility for septal reduction therapy candidates with oHCM and drug-refractory symptoms. In this article, the available efficacy and safety data from completed and ongoing clinical studies of mavacamten in patients with symptomatic oHCM are reviewed. Longer term extension studies may help address questions related to the positioning of mavacamten in current oHCM management algorithms, interactions with background therapy, as well as the potential for disease modification beyond symptomatic relief of left ventricular outflow tract obstruction.

Published
2023

4. PANEL DISCUSSION

Author

Emmanouilides, George C., primary, Adams, Forrest H., additional, Braunwald, Eugene, additional, Rudolph, Abraham M., additional, and Talner, Norman S., additional

Published
2023
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7. PANEL DISCUSSION

Author

Swan, H. J. C., primary, Braunwald, Eugene, additional, Hugenholtz, Paul G., additional, and Spach, Madison S., additional

Published
2023
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8. PANEL DISCUSSION

Author

Moss, Arthur J., primary, Assali, Nicholas S., additional, Braunwald, Eugene, additional, Downing, S. Evans, additional, Gessner, Ira H., additional, and Rudolph, Abraham M., additional

Published
2023
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10. PANEL DISCUSSION

Author

Hugenholtz, Paul G., primary, Braunwald, Eugene, additional, Franklin, Dean L., additional, Goldberg, Stanley J., additional, Mitchell, Jere H., additional, and Van Citters, Robert L., additional

Published
2023
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12. Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis

Author

Reith, Christina, Preiss, David, Blackwell, Lisa, Emberson, Jonathan, Spata, Enti, Davies, Kelly, Halls, Heather, Harper, Charlie, Holland, Lisa, Wilson, Kate, Roddick, Alistair J, Cannon, Christopher P, Clarke, Robert, Colhoun, Helen M, Durrington, Paul N, Goto, Shinya, Hitman, Graham A, Hovingh, G Kees, Jukema, J Wouter, Koenig, Wolfgang, Marschner, Ian, Mihaylova, Borislava, Newman, Connie, Probsfield, Jeffrey L, Ridker, Paul M, Sabatine, Marc S, Sattar, Naveed, Schwartz, Gregory G, Tavazzi, Luigi, Tonkin, Andrew, Trompet, Stella, White, Harvey, Yusuf, Salim, Armitage, Jane, Keech, Anthony, Simes, John, Collins, Rory, Baigent, Colin, Barnes, Elizabeth, Fulcher, Jordan, Herrington, William G, Kirby, Adrienne, O'Connell, Rachel, Amarenco, Pierre, Arashi, Hiroyuki, Barter, Philip, Betteridge, D John, Blazing, Michael, Blauw, Gerard J, Bosch, Jackie, Bowman, Louise, Braunwald, Eugene, Bulbulia, Richard, Byington, Robert, Clearfield, Michael, Cobbe, Stuart, Dahlöf, Björn, Davis, Barry, de Lemos, James, Downs, John R, Fellström, Bengt, Flather, Marcus, Ford, Ian, Franzosi, Maria Grazia, Fuller, John, Furberg, Curt, Glynn, Robert, Goldbourt, Uri, Gordon, David, Gotto, Jr, Antonio, Grimm, Richard, Gupta, Ajay, Hawkins, C Morton, Haynes, Richard, Holdaas, Hallvard, Hopewell, Jemma, Jardine, Alan, Kastelein, John JP, Kean, Sharon, Kearney, Patricia, Kitas, George, Kjekshus, John, Knatterud, Genell, Knopp, Robert H, Koren, Michael, Krane, Vera, Landray, Martin, LaRosa, John, Latini, Roberto, Lonn, Eva, Lucci, Donata, MacFadyen, Jean, Macfarlane, Peter, MacMahon, Stephen, Maggioni, Aldo, Marchioli, Roberto, Moyé, Lemuel, Murphy, Sabina, Neil, Andrew, Nicolis, Enrico B, Packard, Chris, Parish, Sarah, Pedersen, Terje R, Peto, Richard, Pfeffer, Marc, Poulter, Neil, Pressel, Sara, Probstfield, Jeffrey, Rahman, Mahboob, Robertson, Michele, Sacks, Frank, Schmieder, Roland, Serruys, Patrick, Sever, Peter, Shaw, John, Shepherd, James, Simpson, Lara, Sleight, Peter, Smeeth, Liam, Tobert, Jonathan, Tognoni, Gianni, Varigos, John, Wanner, Christoph, Wedel, Hans, Weis, Stephen, Welch, K Michael, Wikstrand, John, Wilhelmsen, Lars, Wiviott, Stephen, Yamaguchi, Junichi, Young, Robin, and Zannad, Faiez

Published
2024
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15. Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation

Author

Patel, Siddharth M., Braunwald, Eugene, Steffel, Jan, Boriani, Giuseppe, Palazzolo, Michael G., Antman, Elliott M., Bohula, Erin A., Carnicelli, Anthony P., Connolly, Stuart J., Eikelboom, John W., Gencer, Baris, Granger, Christopher B., Morrow, David A., Patel, Manesh R., Wallentin, Lars, Ruff, Christian T., and Giugliano, Robert P.

Published
2024
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16. Transmethylamine‐N‐Oxide Is Associated With Diffuse Cardiac Fibrosis in People Living With HIV

Author

Colaco, Nalini A, Wang, Teresa S, Ma, Yifei, Scherzer, Rebecca, Ilkayeva, Olga R, Desvigne‐Nickens, Patrice, Braunwald, Eugene, Hernandez, Adrian F, Butler, Javed, Shah, Svati H, Shah, Sanjiv J, and Hsue, Priscilla Y

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, HIV/AIDS, Biomedical Imaging, Heart Disease, Heart Disease - Coronary Heart Disease, Nutrition, Cardiovascular, Prevention, 2.1 Biological and endogenous factors, Aetiology, Good Health and Well Being, Aged, Anti-HIV Agents, Bacteria, Biomarkers, Cardiomyopathies, Cross-Sectional Studies, Female, Fibrosis, Gastrointestinal Microbiome, HIV Infections, HIV Long-Term Survivors, Humans, Male, Methylamines, Middle Aged, Myocardium, Predictive Value of Tests, Risk Assessment, Risk Factors, United States, diastolic dysfunction, HIV, myocardial fibrosis, transmethylamine-N-oxide, transmethylamine‐N‐oxide, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background People living with HIV are at increased risk of developing diastolic dysfunction, heart failure, and sudden cardiac death, all of which have been characterized by higher levels of myocardial fibrosis. Transmethylamine-N-oxide (TMAO), a dietary gut metabolite, is linked to the development of myocardial fibrosis in animal models. However, it is unclear whether TMAO plays a role in the development of myocardial fibrosis in people living with HIV. Methods and Results The study population consisted of participants enrolled in the multisite cross-sectional study called CHART-HIV (Characterizing Heart Function on Anti-Retroviral Therapy). Participants underwent echocardiography, cardiac magnetic resonance imaging, biomarker analysis, and targeted assessment of gut-related circulating metabolites; diastolic dysfunction was determined by study-specific criteria. Multivariable linear regression models were performed to examine the relationship of gut-related metabolites with serum and imaging measures of myocardial fibrosis. Models were adjusted for traditional cardiovascular, inflammatory, and HIV-related risk factors. Diastolic dysfunction was present in 94 of 195 individuals (48%) in CHART-HIV; this cohort demonstrated higher prevalence of hypertension, hyperlipidemia, and chronic kidney disease as well as higher plasma levels of both TMAO and choline. TMAO levels were associated with parameters reflecting increased left ventricular filling pressures and with a marker of the innate immune system. TMAO levels correlated with diffuse myocardial fibrosis (R=0.35; P

Published
2021

18. Pulmonary Congestion and Left Ventricular Dysfunction After Myocardial Infarction: Insights From the PARADISE-MI Trial

Author

Petrie, Mark C., Rouleau, Jean L., Claggett, Brian, Jering, Karola, van der Meer, Peter, Køber, Lars, Miao, Zi Michael, Lewis, Eldrin, Granger, Christopher, De Pasqulae, Carmine G., Mann, Douglas, Steg, Philippe Gabriel, Maggioni, Aldo, Amir, Offer, Lefkowitz, Marty, Braunwald, Eugene, Solomon, Scott D, McMurray, John J.V., and Pfeffer, Marc A.

Published
2024
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22. Abstract 14750: Performance of a Polygenic Risk Score for Coronary Artery Disease Across the Spectrum of ASCVD: An Analysis of 60k Patients From 6 TIMI Randomized Trials

Author

Zimerman, Andre, Kamanu, Frederick, Melloni, Giorgio, Roselli, Carolina, Antman, Elliott M, Bhatt, Deepak, Bonaca, Marc P, Cannon, Christopher P, Giugliano, Robert, OʼDonoghue, Michelle, Scirica, Benjamin, Wiviott, Stephen D, Braunwald, Eugene, Ellinor, Patrick T, Sabatine, Marc S, Ruff, Christian, and Marston, Nicholas A

Published
2023
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24. Abstract 12701: Safety and Tolerability of Angiotensin Receptor Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Drug Initiation Setting: A Subgroup Analysis of the PARADISE-MI Trial

Author

De Pasquale, Carmine, Claggett, Brian, Jering, Karola, McMurray, John J, Mann, Douglas L, Granger, Christopher, Kober, Lars, Lewis, Eldrin F, Maggioni, Aldo Pietro P, Rouleau, Jean L, Solomon, Scott, Steg, Philippe G, van der meer, peter, Braunwald, Eugene, and Pfeffer, Marc A

Published
2023
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28. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

Author

Anker, Stefan D, Butler, Javed, Khan, Muhammad Shahzeb, Abraham, William T, Bauersachs, Johann, Bocchi, Edimar, Bozkurt, Biykem, Braunwald, Eugene, Chopra, Vijay K, Cleland, John G, Ezekowitz, Justin, Filippatos, Gerasimos, Friede, Tim, Hernandez, Adrian F, Lam, Carolyn SP, Lindenfeld, JoAnn, McMurray, John JV, Mehra, Mandeep, Metra, Marco, Packer, Milton, Pieske, Burkert, Pocock, Stuart J, Ponikowski, Piotr, Rosano, Giuseppe MC, Teerlink, John R, Tsutsui, Hiroyuki, Van Veldhuisen, Dirk J, Verma, Subodh, Voors, Adriaan A, Wittes, Janet, Zannad, Faiez, Zhang, Jian, Seferovic, Petar, and Coats, Andrew JS

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease, Prevention, Good Health and Well Being, Betacoronavirus, COVID-19, Clinical Trials as Topic, Coronavirus Infections, Europe, Heart Failure, Humans, Informed Consent, Pandemics, Patient Selection, Pneumonia, Viral, Research Design, SARS-CoV-2, Heart failure, Clinical trials, Coronavirus, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

Published
2020

29. Diastolic Dysfunction in Patients With Human Immunodeficiency Virus Receiving Antiretroviral Therapy: Results From the CHART Study

Author

Butler, Javed, Greene, Stephen J, Shah, Svati H, Shah, Sanjiv J, Anstrom, Kevin J, Kim, Raymond J, Kalogeropoulos, Andreas P, Velazquez, Eric J, Hernandez, Adrian F, Desvigne-Nickens, Patrice, Scherzer, Rebecca, Hsue, Priscilla Y, and Braunwald, Eugene

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, HIV/AIDS, Cardiovascular, Infectious Diseases, Clinical Research, Heart Disease, Aetiology, 2.1 Biological and endogenous factors, Cardiomyopathies, Case-Control Studies, Cross-Sectional Studies, HIV, HIV Infections, Heart Atria, Heart Failure, Humans, Quality of Life, Ventricular Dysfunction, Left, Antiretroviral therapy, diastolic dysfunction, human immunodeficiency virus, myocardial fibrosis, Cardiorespiratory Medicine and Haematology, Nursing, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundDiastolic dysfunction (DD) is common and occurs at an earlier age among human immunodeficiency virus-infected (HIV+) individuals, but the mechanisms and consequences of DD among HIV+ individuals are unclear.Methods and resultsThe Characterization of Heart Function on Antiretroviral Therapy (CHART) study was a multicenter cross-sectional case-control study of treated and virally suppressed HIV+ individuals with (DD+) and without DD (DD-). All patients had normal ejection fraction (>50%), no significant valvular disease, and no history of coronary revascularization or persistent atrial fibrillation. Overall, 94 DD+ and 101 DD- patients were included. DD+ patients were older with higher body mass index (BMI) and more likely to have hypertension, renal dysfunction, and dyslipidemia. Groups were similar with respect to sex, race, CD4 count, and HIV RNA copies. N-terminal pro-B-type natriuretic peptide levels (median 36 [23, 85] vs 26 [12, 49] pg/mL, P < .01) and high-sensitivity troponin I (3.6 [2.6, 5.1] vs 2.5 [1.8, 3.5] pg/mL, P < .01) were higher among DD+ patients. The latter had similar left atrial size, but increased stiffness (conduit strain: 23.5 [17.5, 36.9] vs 30.0 [22.9, 37.0], P < .01) and impaired relaxation (reservoir strain: 39.7 [32.0, 58.0] vs 45.9 [37.0, 60.6], P = .04). On cardiac magnetic resonance, the prevalence of focal fibrosis was higher among DD+ patients (19.0% vs 5.3%, P < .01). DD+ patients demonstrated higher levels of carboxyl-terminal telopeptide of collagen type I (P = .04), and trends toward higher interleukin-6 and oxidized low-density lipoprotein levels (P ≤ .08). Kansas City Cardiomyopathy Questionnaire physical limitation (87.1±21.4 vs 93.1±18.1, P = .01) and symptom frequency scores were lower among DD+ patients (86.0±21.5 vs 92.5±16.8, P = .01).ConclusionsIn this contemporary HIV+ population receiving antiretroviral therapy, DD was associated with multiple alterations in cardiac structure and function, including myocardial fibrosis and left atrial abnormalities, and worse quality of life. Further studies are needed to assess longitudinal changes in these parameters and their potential as therapeutic targets to prevent progressive cardiac remodeling and dysfunction in HIV.

Published
2020

31. Foreword

Author

Braunwald, Eugene, primary, Libby, Peter, additional, Bonow, Robert O., additional, Mann, Douglas L., additional, Tomaselli, Gordon F, additional, Bhatt, Deepak L., additional, and Solomon, Scott D., additional

Published
2023
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32. Safety and Tolerability of Angiotensin Receptor-Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Care Setting: A Subgroup Analysis of the PARADISE-MI Trial

Author

De Pasquale, Carmine G., primary, Claggett, Brian, additional, Jering, Karola, additional, McMurray, John J.V., additional, Mann, Douglas, additional, Miao, Zi Michael, additional, Granger, Christopher B., additional, Køber, Lars, additional, Maggioni, Aldo P., additional, Rouleau, Jean-Lucien, additional, Solomon, Scott D., additional, Steg, Philippe Gabriel, additional, van der Meer, Peter, additional, Braunwald, Eugene, additional, and Pfeffer, Marc A., additional

Published
2024
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33. Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials

Author

Reith, Christina, Baigent, Colin, Blackwell, Lisa, Emberson, Jonathan, Spata, Enti, Davies, Kelly, Halls, Heather, Holland, Lisa, Wilson, Kate, Armitage, Jane, Harper, Charlie, Preiss, David, Roddick, Alistair, Keech, Anthony, Simes, John, Collins, Rory, Barnes, Elizabeth, Fulcher, Jordan, Herrington, William G, Kirby, Adrienne, Mihaylova, Borislava, O'Connell, Rachel, Amarenco, Pierre, Barter, Philip, Betteridge (deceased), D John, Blazing, Michael, Bosch, Jackie, Bowman, Louise, Braunwald, Eugene, Cannon, Christopher P, Clearfield, Michael, Cobbe, Stuart, Colhoun, Helen M, Dahlöf, Björn, Davis, Barry, de Lemos, James, Downs, John R, Durrington, Paul N, Fellström, Bengt, Ford, Ian, Franzosi, Maria Grazia, Fuller (deceased), John, Furberg, Curt, Glynn, Robert, Gordon, David, Gotto Jr, Antonio, Grimm, Richard, Gupta, Ajay, Hawkins, C Morton, Hitman, Graham A, Holdaas (deceased), Hallvard, Jardine, Alan, Jukema, J Wouter, Kastelein, John JP, Kean, Sharon, Kjekshus, John, Knatterud (deceased), Genell, Knopp (deceased), Robert H, Koenig, Wolfgang, Koren, Michael, Krane, Vera, Landray, Martin, LaRosa, John, Latini, Roberto, Lonn, Eva, Lucci, Donata, MacFadyen, Jean, Macfarlane, Peter, MacMahon, Stephen, Maggioni, Aldo, Marchioli, Roberto, Marschner, Ian, Moyé, Lemuel, Murphy, Sabina, Neil, Andrew, Nicolis, Enrico B, Packard, Chris, Parish, Sarah, Pedersen, Terje R, Peto, Richard, Pfeffer, Marc, Poulter, Neil, Pressel, Sara, Probstfield, Jeffrey, Rahman, Mahboob, Ridker, Paul M, Robertson, Michele, Sacks, Frank, Sattar, Naveed, Schmieder, Roland, Serruys, Patrick W, Sever, Peter, Shaw (deceased), John, Shepherd (deceased), James, Simpson, Lara, Sleight (deceased), Peter, Tavazzi, Luigi, Tognoni, Gianni, Tonkin, Andrew, Trompet, Stella, Wanner, Christoph, Wedel, Hans, Weis, Stephen, Welch, K Michael, White, Harvey, Wikstrand, John, Wilhelmsen, Lars, Wiviott, Stephen, Young, Robin, Yusuf, Salim, Zannad, Faiez, Arashi, Hiroyuki, Byington, Robert, Clarke, Robert, Flather, Marcus, Goldbourt, Uri, Goto, Shinya, Hopewell, Jemma, Hovingh, Kees, Kearney, Patricia, Kitas, George, Newman, Connie, Sabatine, Marc S, Schwartz, Greg, Smeeth, Liam, Tobert, Jonathan, Varigos, John, and Yamaguchi, Junichi

Published
2022
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38. Diastolic Dysfunction in Individuals With Human Immunodeficiency Virus Infection: Literature Review, Rationale and Design of the Characterizing Heart Function on Antiretroviral Therapy (CHART) Study

Author

Butler, Javed, Kalogeropoulos, Andreas P, Anstrom, Kevin J, Hsue, Priscilla Y, Kim, Raymond J, Scherzer, Rebecca, Shah, Sanjiv J, Shah, Svati H, Velazquez, Eric J, Hernandez, Adrian F, Desvigne-Nickens, Patrice, and Braunwald, Eugene

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Cardiovascular, HIV/AIDS, Clinical Research, Heart Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 2.1 Biological and endogenous factors, Aetiology, Infection, Good Health and Well Being, Anti-Retroviral Agents, Global Health, HIV, HIV Infections, Heart Failure, Diastolic, Humans, Incidence, Prognosis, Stroke Volume, Ventricular Function, Left, Human immunodeficiency virus, diastolic dysfunction, heart failure, pathophysiology, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Nursing, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

Antiretroviral therapy (ART) has been associated with a shift in the epidemiology of human immunodeficiency virus (HIV)-associated cardiomyopathy from a phenotype of primarily left ventricular (LV) systolic dysfunction to LV diastolic dysfunction (DD). Patients with HIV receiving ART have higher rates of DD compared with age-matched control subjects and develop DD at a younger age. However, little is known about the natural history and pathogenesis of DD in virally suppressed HIV-infected patients. Current evidence suggests that immune processes modulate the risk for cardiac involvement in HIV-infected persons. Ongoing inflammation appears to have myocardial effects, and accelerated myocardial fibrosis appears to be a key mediator of HIV-induced DD. The Characterizing Heart Function on Antiretroviral Therapy (CHART) study aims to systematically investigate determinants, mechanisms, and consequences of DD in HIV-infected patients. We will compare ART-treated virally suppressed HIV-infected individuals with and without DD and HIV- individuals with DD regarding (1) systemic inflammation, myocardial stress, and subclinical myocardial necrosis as indicated by circulating biomarkers; (2) immune system activation as indicated by cell surface receptors; (3) myocardial fibrosis according to cardiac magnetic resonance examination; (4) markers of fibrosis and remodeling, oxidative stress, and hypercoagulability; (5) left atrial function according to echocardiographic examination; (6) myocardial stress and subclinical necrosis as indicated by circulating biomarkers; (7) proteomic and metabolic profiles; and (8) phenotype signatures derived from clinical, biomarker, and imaging data.

Published
2018

39. Percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in left main coronary artery disease: an individual patient data meta-analysis

Author

Sabatine, Marc S, Bergmark, Brian A, Murphy, Sabina A, O'Gara, Patrick T, Smith, Peter K, Serruys, Patrick W, Kappetein, A Pieter, Park, Seung-Jung, Park, Duk-Woo, Christiansen, Evald H, Holm, Niels R, Nielsen, Per H, Stone, Gregg W, Sabik, Joseph F, and Braunwald, Eugene

Published
2021
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41. Fibrinolytic Agents in Thromboembolic Diseases: Historical Perspectives and Approved Indications

Author

Rashedi, Sina, additional, Greason, Christie M., additional, Sadeghipour, Parham, additional, Talasaz, Azita H., additional, O'Donoghue, Michelle L., additional, Jimenez, David, additional, Monreal, Manuel, additional, Anderson, Christopher D., additional, Elkind, Mitchell S. V., additional, Kreuziger, Lisa M. Baumann, additional, Lang, Irene M., additional, Goldhaber, Samuel Z., additional, Konstantinides, Stavros V., additional, Piazza, Gregory, additional, Krumholz, Harlan M., additional, Braunwald, Eugene, additional, and Bikdeli, Behnood, additional

Published
2024
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42. Novel Polygenic Risk Score and Established Clinical Risk Factors for Risk Estimation of Aortic Stenosis

Author

Small, Aeron M., primary, Melloni, Giorgio E. M., additional, Kamanu, Frederick K., additional, Bergmark, Brian A., additional, Bonaca, Marc P., additional, O’Donoghue, Michelle L., additional, Giugliano, Robert P., additional, Scirica, Benjamin M., additional, Bhatt, Deepak, additional, Antman, Elliott M., additional, Raz, Itamar, additional, Wiviott, Stephen D., additional, Truong, Buu, additional, Wilson, Peter W. F., additional, Cho, Kelly, additional, O’Donnell, Christopher J., additional, Braunwald, Eugene, additional, Lubitz, Steve A., additional, Ellinor, Patrick, additional, Peloso, Gina M., additional, Ruff, Christian T., additional, Sabatine, Marc S., additional, Natarajan, Pradeep, additional, and Marston, Nicholas A., additional

Published
2024
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43. Lipoprotein(a), C-Reactive Protein, and Cardiovascular Risk in Primary and Secondary Prevention Populations

Author

Small, Aeron M., primary, Pournamdari, Ashley, additional, Melloni, Giorgio E.M., additional, Scirica, Benjamin M., additional, Bhatt, Deepak L., additional, Raz, Itamar, additional, Braunwald, Eugene, additional, Giugliano, Robert P., additional, Sabatine, Marc S., additional, Peloso, Gina M., additional, Marston, Nicholas A., additional, and Natarajan, Pradeep, additional

Published
2024
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45. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial

Author

Mehran, Roxana, Steg, Philippe Gabriel, Pfeffer, Marc A., Jering, Karola, Claggett, Brian, Lewis, Eldrin F., Granger, Christopher, Køber, Lars, Maggioni, Aldo, Mann, Douglas L., McMurray, John J.V., Rouleau, Jean-Lucien, Solomon, Scott D., Ducrocq, Gregory, Berwanger, Otavio, De Pasquale, Carmine G., Landmesser, Ulf, Petrie, Mark, Leng, David Sim Kheng, van der Meer, Peter, Lefkowitz, Martin, Zhou, Yinong, and Braunwald, Eugene

Published
2022
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46. Abstract 12228: Development of a Novel Polygenic Risk Score to Predict Risk of Aortic Stenosis Events

Author

Small, Aeron M, Melloni, Giorgio, Kamanu, Frederick, Roselli, Carolina, Bergmark, Brian A, Bonaca, Marc P, Odonoghue, Michelle L, Giugliano, Robert, Scirica, Benjamin M, Bhatt, Deepak L, Antman, Elliott M, Raz, Itamar, Peloso, Gina, WILSON, PETER, Odonnell, Christopher J, Natarajan, Pradeep, Braunwald, Eugene, Lubitz, Steven A, Ellinor, Patrick T, Ruff, Christian T, Sabatine, Marc S, and Marston, Nicholas F

Published
2022
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50. Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists:insight from the PARADISE MI trial

Author

Schou, Morten, Claggett, Brian, Miao, Zi Michael, Fernandez, Alberto, Filippatos, Gerasimos, Granger, Christopher, Jering, Karola, Maggioni, Aldo P., McCausland, Finnian, Villota, Julio Nuñez, Rouleau, Jean Lucien, Mody, Freny Vaghaiwalla, van der Meer, Peter, Vinereanu, Dragos, McGrath, Martina, Zhou, Yinong, Mann, Douglas L., Solomon, Scott D., Steg, Philippe Gabriel, Braunwald, Eugene, McMurray, John J.V., Pfeffer, Marc A., Køber, Lars, Schou, Morten, Claggett, Brian, Miao, Zi Michael, Fernandez, Alberto, Filippatos, Gerasimos, Granger, Christopher, Jering, Karola, Maggioni, Aldo P., McCausland, Finnian, Villota, Julio Nuñez, Rouleau, Jean Lucien, Mody, Freny Vaghaiwalla, van der Meer, Peter, Vinereanu, Dragos, McGrath, Martina, Zhou, Yinong, Mann, Douglas L., Solomon, Scott D., Steg, Philippe Gabriel, Braunwald, Eugene, McMurray, John J.V., Pfeffer, Marc A., and Køber, Lars

Abstract

Aim It is unknown whether safety and clinical endpoints by use of sacubitril/valsartan (an angiotensin receptor–neprilysin inhibitor [ARNI]) are affected by mineralocorticoid receptor antagonists (MRA) in high-risk myocardial infarction (MI) patients. The aim of this study was to examine whether MRA modifies safety and clinical endpoints by use of sacubitril/valsartan in patients with a MI and left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion. Methods and results Patients (n = 5661) included in the PARADISE MI trial (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) were stratified according to MRA. Primary outcomes in this substudy were worsening heart failure or cardiovascular death. Safety was defined as symptomatic hypotension, hyperkalaemia >5.5 mmol/L, or permanent drug discontinuation. A total of 2338 patients (41%) were treated with MRA. Safety of ARNI compared to ramipril was not altered significantly by ± MRA, and both groups had similar increase in symptomatic hypotension with ARNI. In patients taking MRA, the risk of hyperkalaemia or permanent drug discontinuation was not significantly altered by ARNI (p > 0.05 for all comparisons). The effect of ARNI compared with ramipril was similar in those who were and were not taking MRA (hazard ratio [HR]MRA 0.96, 95% confidence interval [CI] 0.77–1.19 and HRMRA– 0.87, 95% CI 0.71–1.05, for the primary endpoint; p = 0.51 for interaction [Clinical Endpoint Committee adjudicated]); similar findings were observed if investigator-reported endpoints were evaluated (p = 0.61 for interaction). Conclusions Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion., Aim: It is unknown whether safety and clinical endpoints by use of sacubitril/valsartan (an angiotensin receptor–neprilysin inhibitor [ARNI]) are affected by mineralocorticoid receptor antagonists (MRA) in high-risk myocardial infarction (MI) patients. The aim of this study was to examine whether MRA modifies safety and clinical endpoints by use of sacubitril/valsartan in patients with a MI and left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion. Methods and results: Patients (n = 5661) included in the PARADISE MI trial (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) were stratified according to MRA. Primary outcomes in this substudy were worsening heart failure or cardiovascular death. Safety was defined as symptomatic hypotension, hyperkalaemia >5.5 mmol/L, or permanent drug discontinuation. A total of 2338 patients (41%) were treated with MRA. Safety of ARNI compared to ramipril was not altered significantly by ± MRA, and both groups had similar increase in symptomatic hypotension with ARNI. In patients taking MRA, the risk of hyperkalaemia or permanent drug discontinuation was not significantly altered by ARNI (p > 0.05 for all comparisons). The effect of ARNI compared with ramipril was similar in those who were and were not taking MRA (hazard ratio [HR]MRA 0.96, 95% confidence interval [CI] 0.77–1.19 and HRMRA– 0.87, 95% CI 0.71–1.05, for the primary endpoint; p = 0.51 for interaction [Clinical Endpoint Committee adjudicated]); similar findings were observed if investigator-reported endpoints were evaluated (p = 0.61 for interaction). Conclusions: Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion.

Published
2024

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