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607. Predicting In-Hospital Mortality in Patients Undergoing Percutaneous Coronary Intervention

Author

Castro-Dominguez, Yulanka S., primary, Wang, Yongfei, additional, Minges, Karl E., additional, McNamara, Robert L., additional, Spertus, John A., additional, Dehmer, Gregory J., additional, Messenger, John C., additional, Lavin, Kimberly, additional, Anderson, Cornelia, additional, Blankinship, Kristina, additional, Mercado, Nestor, additional, Clary, Julie M., additional, Osborne, Anwar D., additional, Curtis, Jeptha P., additional, and Cavender, Matthew A., additional

Published
2021
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608. Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial

Author

Handberg, Eileen M., primary, Merz, C. Noel Bairey, additional, Cooper-Dehoff, Rhonda M., additional, Wei, Janet, additional, Conlon, Michael, additional, Lo, Margaret C., additional, Boden, William, additional, Frayne, Susan M., additional, Villines, Todd, additional, Spertus, John A., additional, Weintraub, William, additional, O'Malley, Patrick, additional, Chaitman, Bernard, additional, Shaw, Leslee J., additional, Budoff, Matthew, additional, Rogatko, Andre, additional, and Pepine, Carl J., additional

Published
2021
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610. 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report

Author

Benjamin, Ivor J., primary, Valentine, C. Michael, additional, Oetgen, William J., additional, Sheehan, Katherine A., additional, Brindis, Ralph G., additional, Roach, William H., additional, Harrington, Robert A., additional, Levine, Glenn N., additional, Redberg, Rita F., additional, Broccolo, Bernadette M., additional, Hernandez, Adrian F., additional, Douglas, Pamela S., additional, Piña, Ileana L., additional, Benjamin, Emelia J., additional, Coylewright, Megan J., additional, Saucedo, Jorge F., additional, Ferdinand, Keith C., additional, Hayes, Sharonne N., additional, Poppas, Athena, additional, Furie, Karen L., additional, Mehta, Laxmi S., additional, Erwin, John P., additional, Mieres, Jennifer H., additional, Murphy, Daniel J., additional, Weissman, Gaby, additional, West, Colin P., additional, Lawrence, Willie E., additional, Masoudi, Frederick A., additional, Jones, Camara P., additional, Matlock, Daniel D., additional, Miller, Jennifer E., additional, Spertus, John A., additional, Todman, Lynn, additional, Biga, Cathleen, additional, Chazal, Richard A., additional, Creager, Mark A., additional, Fry, Edward T., additional, Mack, Michael J., additional, Yancy, Clyde W., additional, and Anderson, Richard E., additional

Published
2021
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612. Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

Author

Coles, Theresa M., primary, Hernandez, Adrian F., additional, Reeve, Bryce B., additional, Cook, Karon, additional, Edwards, Michael C., additional, Boutin, Marc, additional, Bush, Elizabeth, additional, Degboe, Arnold, additional, Roessig, Lothar, additional, Rudolph, Amy, additional, McNulty, Pauline, additional, Patel, Nikunj, additional, Kay-Mugford, Trish, additional, Vernon, Margaret, additional, Woloschak, Michael, additional, Buchele, Gustavo, additional, Spertus, John A., additional, Roe, Matthew T., additional, Bury, Denise, additional, and Weinfurt, Kevin, additional

Published
2021
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613. Use of Machine Learning Models to Predict Death After Acute Myocardial Infarction

Author

Khera, Rohan, primary, Haimovich, Julian, additional, Hurley, Nathan C., additional, McNamara, Robert, additional, Spertus, John A., additional, Desai, Nihar, additional, Rumsfeld, John S., additional, Masoudi, Frederick A., additional, Huang, Chenxi, additional, Normand, Sharon-Lise, additional, Mortazavi, Bobak J., additional, and Krumholz, Harlan M., additional

Published
2021
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614. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spertus, John A, primary, Fine, Jennifer T, additional, Elliott, Perry, additional, Ho, Carolyn Y, additional, Olivotto, Iacopo, additional, Saberi, Sara, additional, Li, Wanying, additional, Dolan, Chantal, additional, Reaney, Matthew, additional, Sehnert, Amy J, additional, and Jacoby, Daniel, additional

Published
2021
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615. Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults

Author

Nikolovski, Janeta, primary, Koldijk, Martin, additional, Weverling, Gerrit Jan, additional, Spertus, John, additional, Turakhia, Mintu, additional, Saxon, Leslie, additional, Gibson, Mike, additional, Whang, John, additional, Sarich, Troy, additional, Zambon, Robert, additional, Ezeanochie, Nnamdi, additional, Turgiss, Jennifer, additional, Jones, Robyn, additional, Stoddard, Jeff, additional, Burton, Paul, additional, and Navar, Ann Marie, additional

Published
2021
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616. Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry

Author

Sawano, Mitsuaki, primary, Spertus, John A., additional, Masoudi, Frederick A., additional, Rumsfeld, John S., additional, Numasawa, Yohei, additional, Inohara, Taku, additional, Kennedy, Keven, additional, Ueda, Ikuko, additional, Miyata, Hiroaki, additional, Fukuda, Keiichi, additional, and Kohsaka, Shun, additional

Published
2021
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620. Variation in use and dosing escalation of renin angiotensin system, mineralocorticoid receptor antagonist, angiotensin receptor neprilysin inhibitor and beta-blocker therapies in heart failure and reduced ejection fraction: Association of comorbidities

Author

Albert, Nancy M., primary, Tyson, Rachel J., additional, Hill, C. Larry, additional, DeVore, Adam D., additional, Spertus, John A., additional, Duffy, Carol, additional, Butler, Javed, additional, Patterson, J. Herbert, additional, Hernandez, Adrian F., additional, Williams, Fredonia B., additional, Thomas, Laine, additional, and Fonarow, Gregg C., additional

Published
2021
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627. Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire

Author

Peri-Okonny, Poghni A., primary, Wang, Jingyan, additional, Gosch, Kensey L., additional, Patel, Manesh R., additional, Shishehbor, Mehdi H., additional, Safley, David L., additional, Abbott, J. Dawn, additional, Aronow, Herbert D., additional, Mena-Hurtado, Carlos, additional, Jelani, Qurat-Ul-Ain, additional, Tang, Yuanyuan, additional, Bunte, Matthew, additional, Labrosciano, Clementine, additional, Beltrame, John F., additional, Spertus, John A., additional, and Smolderen, Kim G., additional

Published
2021
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628. ANATOMY VERSUS ISCHEMIA IN THE ISCHEMIA-CKD TRIAL: DOES EITHER PREDICT OUTCOME?

Author

Bainey, Kevin, primary, Fleg, Jerome, additional, Hochman, Judith, additional, Jones, Philip, additional, Kunichoff, Dennis, additional, Chernyavskiy, Alexander, additional, Demkow, Marcin, additional, Quijano, Juan Lopez, additional, Escobedo, Jorge, additional, Poh, Kian Keong, additional, Ramos, Ruben, additional, Lima, Eduardo, additional, Schuchlenz, Herwig, additional, Maron, David, additional, O'Brien, Sean, additional, Spertus, John, additional, and Bangalore, Sripal, additional

Published
2021
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629. Comparison of New York Heart Association Class and Patient-Reported Outcomes for Heart Failure With Reduced Ejection Fraction

Author

Greene, Stephen J., primary, Butler, Javed, additional, Spertus, John A., additional, Hellkamp, Anne S., additional, Vaduganathan, Muthiah, additional, DeVore, Adam D., additional, Albert, Nancy M., additional, Duffy, Carol I., additional, Patterson, J. Herbert, additional, Thomas, Laine, additional, Williams, Fredonia B., additional, Hernandez, Adrian F., additional, and Fonarow, Gregg C., additional

Published
2021
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633. Association between sacubitril/valsartan initiation and real‐world health status trajectories over 18 months in heart failure with reduced ejection fraction

Author

Thomas, Merrill, primary, Khariton, Yevgeniy, additional, Fonarow, Gregg C., additional, Arnold, Suzanne V., additional, Hill, Larry, additional, Nassif, Michael E., additional, Chan, Paul S., additional, Butler, Javed, additional, Thomas, Laine, additional, DeVore, Adam D., additional, Hernandez, Adrian F., additional, Albert, Nancy M., additional, Patterson, J. Herbert, additional, Williams, Fredonia B., additional, and Spertus, John A., additional

Published
2021
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634. IN-HOSPITAL MORTALITY RISK PREDICTION FOR PERCUTANEOUS CORONARY INTERVENTIONS: AN UPDATED MODEL FROM THE NCDR CATHPCI REGISTRY

Author

Dominguez, Yulanka Castro, primary, Minges, Karl, additional, Wang, Yongfei, additional, McNamara, Robert, additional, Spertus, John, additional, Dehmer, Gregory, additional, Messenger, John, additional, Mercado, Nestor, additional, Lavin, Kim, additional, Pierre, Dominique, additional, Anderson, Connie, additional, Blankinship, Kristina, additional, Clary, Julie, additional, Osborne, Anwar, additional, Curtis, Jeptha, additional, and Cavender, Matthew, additional

Published
2021
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636. GLOBAL LONGITUDINAL STRAIN AT REST IS NOT PREDICTIVE OF SUBSEQUENT INDUCIBLE ISCHEMIA AMONG PATIENTS WITH NON-OBSTRUCTIVE CORONARY ARTERY DISEASE IN THE CIAO-ISCHEMIA STUDY

Author

Davis, Esther, primary, Crousillat, Daniela, additional, Picard, Michael, additional, Peteiro, Jesus, additional, Lopez-Sendon, Jose, additional, Senior, Roxy, additional, Shapiro, Michael, additional, Pellikka, Patricia, additional, Miller, Todd, additional, El-Hajjar, Mohammad, additional, Alfakih, Khaled, additional, Abdul-Nour, Khaled, additional, Kunichoff, Dennis, additional, Anthopolos, Rebecca, additional, Fleg, Jerome, additional, Spertus, John, additional, Hochman, Judith, additional, Maron, David, additional, and Reynolds, Harmony, additional

Published
2021
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637. Survival After Invasive or Conservative Management of Stable Coronary Disease

Author

Hochman, Judith S., Anthopolos, Rebecca, Reynolds, Harmony R., Bangalore, Sripal, Xu, Yifan, O’Brien, Sean M., Mavromichalis, Stavroula, Chang, Michelle, Contreras, Aira, Rosenberg, Yves, Kirby, Ruth, Bhargava, Balram, Senior, Roxy, Banfield, Ann, Goodman, Shaun G., Lopes, Renato D., Pracoń, Radosław, López-Sendón, José, Maggioni, Aldo Pietro, Newman, Jonathan D., Berger, Jeffrey S., Sidhu, Mandeep S., White, Harvey D., Troxel, Andrea B., Harrington, Robert A., Boden, William E., Stone, Gregg W., Mark, Daniel B., Spertus, John A., Maron, David J., Hochman, Judith S., Maron, David J., Reynolds, Harmony R., Bangalore, Sripal, Mavromichalis, Stavroula, Chang, Michelle, Contreras, Aira, Esquenazi-Karonika, Shari, Gilsenan, Margaret, Gwiszcz, Ewelina, Mathews, Patenne, Mohamed, Samaa, Naumova, Anna, Roberts, Arline, VanLoo, Kerrie, Anthopolos, Rebecca, Xu, Yifan, Troxel, Andrea B., Lu, Ying, Huang, Zhen, Broderick, Samuel, Guzmán, Luis, Selvanayagam, Joseph, Lopes, Renato D., Goodman, Shaun G., Steg, Gabriel, Juliard, Jean-Michel, Doerr, Rolf, Keltai, Matyas, Bhargava, Balram, Thomas, Boban, Sharir, Tali, Nikolsky, Eugenia, Maggioni, Aldo P., Kohsaka, Shun, Escobedo, Jorge, White, Harvey D., Pracoń, Radosław, Bockeria, Olga, López-Sendón, José, Held, Claes, Senior, Roxy, Banfield, Ann, Shaw, Leslee J., Phillips, Lawrence, Berman, Daniel, Kwong, Raymond Y., Picard, Michael H., Chaitman, Bernard R., Ali, Ziad, Min, James, Mancini, G.B. John, Leipsic, Jonathon, Guzmán, Luis, Hillis, Graham, Thambar, Suku, Joseph, Majo, Selvanayagam, Joseph, Beltrame, John, Lang, Irene, Schuchlenz, Herwig, Huber, Kurt, Goetschalckx, Kaatje, Hueb, Whady, Caramori, Paulo Ricardo, de Quadros, Alexandre, Smanio, Paola, Mesquita, Claudio, Lopes, Renato D., Vitola, João, Marin-Neto, José, da Silva, Expedito Ribeiro, Tumelero, Rogério, Andrade, Marianna, Alves, Alvaro Rabelo, Dall’Orto, Frederico, Polanczyk, Carisi, Figueiredo, Estevão, Howarth, Andrew, Gosselin, Gilbert, Cheema, Asim, Bainey, Kevin, Phaneuf, Denis, Diaz, Ariel, Garg, Pallav, Mehta, Shamir, Wong, Graham, Lam, Andy, Cha, James, Galiwango, Paul, Uxa, Amar, Chow, Benjamin (Ben), Hameed, Adnan, Udell, Jacob, Cheema, Asim, Hamid, Magdy, Hauguel-Moreau, Marie, Furber, Alain, Goube, Pascal, Steg, Philippe-Gabriel, Barone-Rochette, Gilles, Thuaire, Christophe, Slama, Michel, Doerr, Rolf, Nickenig, Georg, Bekeredjian, Raffi, Schulze, P. Christian, Merkely, Bela, Fontos, Geza, Vértes, András, Varga, Albert, Bhargava, Balram, Kumar, Ajit, Nair, Rajesh G., Grant, Purvez, Manjunath, Cholenahally, Moorthy, Nagaraja, Satheesh, Santhosh, Nath, Ranjit Kumar, Wander, Gurpreet, Christopher, Johann, Dwivedi, Sudhanshu, Oomman, Abraham, Mathur, Atul, Gadkari, Milind, Naik, Sudhir, Punnoose, Eapen, Kachru, Ranjan, Christopher, Johann, Kaul, Upendra, Sharir, Tali, Kerner, Arthur, Tarantini, Giuseppe, Perna, Gian Piero, Racca, Emanuela, Mortara, Andrea, Monti, Lorenzo, Briguori, Carlo, Leone, Gianpiero, Amati, Roberto, Salvatori, Mauro, Di Chiara, Antonio, Calabro, Paolo, Galvani, Marcello, Provasoli, Stefano, Fukuda, Keiichi, Kohsaka, Shun, Nakano, Shintaro, Laucevicius, Aleksandras, Kedev, Sasko, Khairuddin, Ahmad, Escobedo, Jorge, Riezebos, Robert, Timmer, Jorik, Heald, Spencer, Stewart, Ralph, Ramos, Walter Mogrovejo, Demkow, Marcin, Mazurek, Tomasz, Drozdz, Jarozlaw, Szwed, Hanna, Witkowski, Adam, Ferreira, Nuno, Pinto, Fausto, Ramos, Ruben, Popescu, Bogdan, Pop, Calin, Bockeria, Leo, Bockeria, Olga, Demchenko, Elena, Romanov, Alexander, Bershtein, Leonid, Jizeeri, Ahmed, Stankovic, Goran, Apostolovic, Svetlana, Adjic, Nada Cemerlic, Zdravkovic, Marija, Beleslin, Branko, Dekleva, Milica, Davidovic, Goran, Chua, Terrance, Foo, David, Poh, Kian Keong, Ntsekhe, Mpiko, Sionis, Alessandro, Marin, Francisco, Miró, Vicente, López-Sendón, José, Blancas, Montserrat Gracida, González-Juanatey, José, Fernández-Avilés, Francisco, Peteiro, Jesús, Luena, Jose Enrique Castillo, Held, Claes, Aspberg, Johannes, Rossi, Mariagrazia, Kuanprasert, Srun, Yamwong, Sukit, Johnston, Nicola, Donnelly, Patrick, Moriarty, Andrew, Senior, Roxy, Elghamaz, Ahmed, Gurunathan, Sothinathan, Karogiannis, Nikolaos, Shah, Benoy N., Trimlett, Richard H.J., Rubens, Michael B., Nicol, Edward D., Mittal, Tarun K., Hampson, Reinette, Gamma, Reto, De Belder, Mark, Nageh, Thuraia, Lindsay, Steven, Mavromatis, Kreton, Miller, Todd, Banerjee, Subhash, Reynolds, Harmony, Nour, Khaled, and Stone, Peter

Published
2023
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639. Cost-effectiveness of Empagliflozin in Patients With Heart Failure With Preserved Ejection Fraction

Author

Zheng, Jimmy, Parizo, Justin T., Spertus, John A., Heidenreich, Paul A., and Sandhu, Alexander T.

Abstract

IMPORTANCE: In the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved), empagliflozin significantly reduced hospitalizations for heart failure while improving patient-reported health status compared with placebo. The long-term cost-effectiveness of empagliflozin among patients who have heart failure with preserved ejection fraction (HFpEF) remains unclear. OBJECTIVE: To estimate the cost-effectiveness of empagliflozin in patients with HFpEF. DESIGN, SETTING, AND PARTICIPANTS: This cost-effectiveness analysis performed from October 2021 to April 2022 included a Markov model using estimates of treatment efficacy, event probabilities, and utilities from EMPEROR-Preserved and published literature. Costs were derived from national surveys and pricing data sets. Quality of life was imputed from a heart failure–specific quality-of-life measure. Two analyses were performed, with and without a treatment effect on cardiovascular mortality. Subgroup analyses were based on diabetes status, ejection fraction, and health status impairment due to heart failure. The model reproduced the event rates and risk reduction with empagliflozin observed in EMPEROR-Preserved over 26 months of follow-up; future projections extended across the lifetime of patients. EXPOSURES: Empagliflozin or standard of care. MAIN OUTCOMES AND MEASURES: Hospitalizations for heart failure, life-years, quality-adjusted life-years (QALYs), lifetime costs, and lifetime incremental cost-effectiveness ratio. RESULTS: A total of 5988 patients were included in the analysis, with a mean age of 72 years, New York Heart Association class II to IV heart failure, and left ventricular ejection fraction greater than 40%. At the Federal Supply Schedule price of $327 per month, empagliflozin yielded 0.06 additional QALYs and $26 257 incremental costs compared with standard of care, producing a cost per QALY gained of $437 442. Incremental costs consisted of total drug costs of $29 586 and savings of $3329 from reduced hospitalizations for heart failure. Cost-effectiveness was similar across subgroups. The results were most sensitive to the monthly cost, quality-of-life benefit, and mortality effect of empagliflozin. A price reduction to $153 per month, incremental utility of 0.02, or 8% reduction in cardiovascular mortality would bring empagliflozin to $180 000 per QALY gained, the threshold for intermediate value. Using Medicare Part D monthly pricing of $375 after rebates and $511 before rebates, empagliflozin would remain low value at $509 636 and $710 825 per QALY gained, respectively. Cost-effectiveness estimates were robust to variation in the frequency and disutility of heart failure hospitalizations. CONCLUSIONS AND RELEVANCE: In this economic evaluation, based on current cost-effectiveness benchmarks, empagliflozin provides low economic value compared with standard of care for HFpEF, largely due to its lack of efficacy on mortality and small benefit on quality of life.

Published
2022
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640. The need for increased pragmatism in cardiovascular clinical trials

Author

Usman, Muhammad Shariq, Van Spall, Harriette G. C., Greene, Stephen J., Pandey, Ambarish, McGuire, Darren K., Ali, Ziad A., Mentz, Robert J., Fonarow, Gregg C., Spertus, John A., Anker, Stefan D., Butler, Javed, James, Stefan K., and Khan, Muhammad Shahzeb

Abstract

The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these ‘explanatory’ trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical settings. The concept of ‘pragmatism’ in RCTs addresses this concern by providing counterbalance to the more idealized situation underpinning explanatory RCTs and optimizing effectiveness over efficacy. The central tenets of pragmatism in RCTs are to test interventions in routine clinical settings, with patients who are representative of broad clinical practice, and to reduce the burden on investigators and participants by minimizing the number of trial visits and the intensity of trial-based testing. Pragmatic evaluation of interventions is particularly important in cardiovascular diseases, where the risk of death among patients has remained fairly stable over the past few decades despite the development of new therapeutic interventions. Pragmatic RCTs can help to reveal the ‘real-world’ effectiveness of therapeutic interventions and elucidate barriers to their implementation. In this Review, we discuss the attributes of pragmatism in RCT design, conduct and interpretation as well as the general need for increased pragmatism in cardiovascular RCTs. We also summarize current challenges and potential solutions to the implementation of pragmatism in RCTs and highlight selected ongoing and completed cardiovascular RCTs with pragmatic trial designs.

Published
2022
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650. Exome sequencing identifies rare LDLR and APOA5 alleles conferring risk for myocardial infarction

Author

Do, Ron, Stitziel, Nathan O., Won, Hong-Hee, Jørgensen, Anders Berg, Duga, Stefano, Merlini, Pier Angelica, Kiezun, Adam, Farrall, Martin, Goel, Anuj, Zuk, Or, Guella, Illaria, Asselta, Rosanna, Lange, Leslie A., Peloso, Gina M., Auer, Paul L., Girelli, Domenico, Martinelli, Nicola, Farlow, Deborah N., DePristo, Mark A., Roberts, Robert, Stewart, Alexander F. R., Saleheen, Danish, Danesh, John, Epstein, Stephen E., Sivapalaratnam, Suthesh, Hovingh, Kees G., Kastelein, John J., Samani, Nilesh J., Schunkert, Heribert, Erdmann, Jeanette, Shah, Svati H., Kraus, William E., Davies, Robert, Nikpay, Majid, Johansen, Christopher T., Wang, Jian, Hegele, Robert A., Hechter, Eliana, Marz, Winfried, Kleber, Marcus E., Huang, Jie, Johnson, Andrew D., Li, Mingyao, Burke, Greg L., Gross, Myron, Liu, Yongmei, Assimes, Themistocles L., Heiss, Gerardo, Lange, Ethan M., Folsom, Aaron R., Taylor, Herman A., Olivieri, Oliviero, Hamsten, Anders, Clarke, Robert, Reilly, Dermot F., Yin, Wu, Rivas, Manuel A., Donnelly, Peter, Rossouw, Jacques E., Psaty, Bruce M., Herrington, David M., Wilson, James G., Rich, Stephen S., Bamshad, Michael J., Tracy, Russell P., Cupples, Adrienne L., Rader, Daniel J., Reilly, Muredach P., Spertus, John A., Cresci, Sharon, Hartiala, Jaana, Wilson Tang, W. H., Hazen, Stanley L., Allayee, Hooman, Reiner, Alex P., Carlson, Christopher S., Kooperberg, Charles, Jackson, Rebecca D., Boerwinkle, Eric, Lander, Eric S., Schwartz, Stephen M., Siscovick, David S., McPherson, Ruth, Tybjaerg-Hansen, Anne, Abecasis, Goncalo R., Watkins, Hugh, Nickerson, Deborah A., Ardissino, Diego, Sunyaev, Shamil R., OʼDonnell, Christopher J., Altshuler, David, Gabriel, Stacey, and Kathiresan, Sekar

Published
2015
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