129 results on '"Furtado, Remo H"'
Search Results
2. Early versus delayed coronary angiography in patients with out-of-hospital cardiac arrest and no ST-segment elevation: a systematic review and meta-analysis of randomized controlled trials
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Hamidi, Fardin, Anwari, Elaaha, Spaulding, Christian, Hauw-Berlemont, Caroline, Vilfaillot, Aurélie, Viana-Tejedor, Ana, Kern, Karl B., Hsu, Chiu-Hsieh, Bergmark, Brian A., Qamar, Arman, Bhatt, Deepak L., Furtado, Remo H. M., Myhre, Peder L., Hengstenberg, Christian, Lang, Irene M., Frey, Norbert, Freund, Anne, Desch, Steffen, Thiele, Holger, Preusch, Michael R., and Zelniker, Thomas A.
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- 2024
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3. Sodium–glucose co-transporter-2 inhibitors for hospitalised patients with COVID-19: a prospective meta-analysis of randomised trials
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Vale, Claire, Godolphin, Peter J, Fisher, David, Horby, Peter W, Kosiborod, Mikhail N, Hochman, Judith S, Webster, Katie, Higgins, Julian P T, Althouse, Andrew D, Berwanger, Otavio, Furtado, Remo H M, Gasparyan, Samvel B, Haynes, Richard, Koch, Gary G, Landray, Martin, Leifer, Eric, Marshall, John, Murthy, Srinivas, Neal, Matthew D, Staplin, Natalie, Diaz, Janet, Sterne, Jonathan A C, and Shankar-Hari, Manu
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- 2024
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4. Abstract 12946: Among Patients With Acute Coronary Syndromes, is the Risk of Hyperglycemia for In-Hospital Mortality Similar in Men and Women?
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Nicolau, Jose C, Castro Vintimilla, Santiago A, Rosa, Renato, Bertolin, Adriadne J, Andrade, Maria C, Salis, Leonardo V, Montero Ribera, Jorge L, Quintanilha, Nadia R, Santos, Glaylton S, Baracioli, Luciano M, Giraldez, Roberto R, Lima, Felipe G, Pereira, Cesar C, Nicolau, Andre M, Furtado, Remo H, and Giugliano, Robert P
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- 2023
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5. Effects of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients with Acute Myocardial Infarction
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Scanavini-Filho, Marco Antonio, Berwanger, Otavio, Matthias, Wilson, Aguiar, Miguel O., Chiang, Hsu P., Azevedo, Luciene, Baracioli, Luciano M., Lima, Felipe G., Furtado, Remo H. M., Dalcoquio, Talia F., Menezes, Fernando R., Ferrari, Aline G., de Luca, Fabio, Giugliano, Robert P., Goodman, Shaun, and Nicolau, José C.
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- 2022
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6. Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial
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Kosiborod, Mikhail N, Esterline, Russell, Furtado, Remo H M, Oscarsson, Jan, Gasparyan, Samvel B, Koch, Gary G, Martinez, Felipe, Mukhtar, Omar, Verma, Subodh, Chopra, Vijay, Buenconsejo, Joan, Langkilde, Anna Maria, Ambery, Philip, Tang, Fengming, Gosch, Kensey, Windsor, Sheryl L, Akin, Emily E, Soares, Ronaldo V P, Moia, Diogo D F, Aboudara, Matthew, Hoffmann Filho, Conrado Roberto, Feitosa, Audes D M, Fonseca, Alberto, Garla, Vishnu, Gordon, Robert A, Javaheri, Ali, Jaeger, Cristiano P, Leaes, Paulo E, Nassif, Michael, Pursley, Michael, Silveira, Fabio Serra, Barroso, Weimar Kunz Sebba, Lazcano Soto, José Roberto, Nigro Maia, Lilia, and Berwanger, Otavio
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- 2021
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7. Platelet Reactivity and Coagulation Markers in Patients with COVID-19
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Bertolin, Adriadne J., Dalçóquio, Talia F., Salsoso, Rocío, de M. Furtado, Remo H., Kalil-Filho, Roberto, Hajjar, Ludhmila A., Siciliano, Rinaldo F., Kallás, Esper G., Baracioli, Luciano M., Lima, Felipe G., Giraldez, Roberto R., Cavalheiro-Filho, Cyrillo, Vieira, Alexandra, Strunz, Célia M. C., Giugliano, Robert P., Tantry, Udaya S., Gurbel, Paul A., and Nicolau, José C.
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- 2021
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8. Editorial: Exploring modern approaches to address critical care challenges in risk stratification for cardiology
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Hamidi, Fardin, primary, Furtado, Remo H. M., additional, Fagundes, Antonio, additional, and Zelniker, Thomas A., additional
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- 2023
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9. Relation of High Lipoprotein (a) Concentrations to Platelet Reactivity in Individuals with and Without Coronary Artery Disease
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Salsoso, Rocío, Dalcoquio, Talia F., Furtado, Remo H. M., Franci, André, Barbosa, Carlos J. D. G., Genestreti, Paulo R. R., Strunz, Celia M. C., Lima, Viviane, Baracioli, Luciano M., Giugliano, Robert P., Goodman, Shaun G., Gurbel, Paul A., Maranhão, Raul C., and Nicolau, Jose C.
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- 2020
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10. What Lessons Have We Learned and What Remains to be Clarified for PCSK9 Inhibitors? A Review of FOURIER and ODYSSEY Outcomes Trials
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Furtado, Remo H. M. and Giugliano, Robert P.
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- 2020
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11. Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial
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Arantes, Flávia B. B., Menezes, Fernando R., Franci, Andre, Barbosa, Carlos J. D. G., Dalçoquio, Talia F., Nakashima, Carlos A. K., Baracioli, Luciano M., Furtado, Remo H. M., Nomelini, Quintiliano S. S., Ramires, José A. F., Kalil Filho, Roberto, and Nicolau, José C.
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- 2020
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12. Long-term outcomes among stable post-acute myocardial infarction patients living in rural versus urban areas: insights from the prospective, observational TIGRIS registry
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Nicolau, Jose Carlos, primary, Owen, Ruth, additional, Furtado, Remo H M, additional, Goodman, Shaun G, additional, Granger, Christopher B, additional, Cohen, Mauricio G, additional, Westermann, Dirk, additional, Yasuda, Satoshi, additional, Simon, Tabassome, additional, Hedman, Katarina, additional, Hunt, Phillip R, additional, Brieger, David B, additional, and Pocock, Stuart J, additional
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- 2023
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13. Increased bodyweight and inadequate response to aspirin in individuals with coronary artery disease
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Furtado, Remo H. M., Giugliano, Robert P., Dalcoquio, Talia F., Arantes, Flavia B. B., Barbosa, Carlos J. D. G., Genestreti, Paulo R. R., Franci, André, Menezes, Fernando R., Nakashima, Carlos A. K., Scanavini Filho, Marco A., Ferrari, Aline G., Salsoso, Rocio, Baracioli, Luciano M., and Nicolau, Jose C.
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- 2019
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14. Early versus delayed coronary angiography in patients with out-of-hospital cardiac arrest and no ST-segment elevation: a systematic review and meta-analysis of randomized controlled trials
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Hamidi, Fardin, primary, Anwari, Elaaha, additional, Spaulding, Christian, additional, Hauw-Berlemont, Caroline, additional, Vilfaillot, Aurélie, additional, Viana-Tejedor, Ana, additional, Kern, Karl B., additional, Hsu, Chiu-Hsieh, additional, Bergmark, Brian A., additional, Qamar, Arman, additional, Bhatt, Deepak L., additional, Furtado, Remo H. M., additional, Myhre, Peder L., additional, Hengstenberg, Christian, additional, Lang, Irene M., additional, Frey, Norbert, additional, Freund, Anne, additional, Desch, Steffen, additional, Thiele, Holger, additional, Preusch, Michael R., additional, and Zelniker, Thomas A., additional
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- 2023
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15. Abstract 16688: Effects of Evolocumab in Patients With Prior Percutaneous Coronary Intervention: An Analysis From the Fourier Trial
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Furtado, Remo H, Fagundes, Antonio A, Jr, Oyama, Kazuma, Zelniker, Thomas A, Tang, Minao, Kuder, Julia F, Murphy, Sabina A, Wang, Huei, Hammer, Andrew, Keech, Anthony C, Pedersen, Terje R, Giugliano, Robert, Sabatine, Marc S, and Bergmark, Brian A
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- 2020
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16. The Use of Oral Beta-Blockers and Clinical Outcomes in Patients with Non-ST-Segment Elevation Acute Coronary Syndromes: a Long-Term Follow-Up Study
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Nicolau, Jose C., Furtado, Remo H. M., Baracioli, Luciano M., Lara, Livia M., Dalçóquio, Talia F., Scanavini Junior, Marco A., Pereira, César A. C., Lima, Viviane M., Gonçalves, Talita M., Colodetti, Raíza, Ferrari, Aline G., Lopes, Renato D., and Giugliano, Robert P.
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- 2018
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17. Effects of DPP4 Inhibitor in Platelet Reactivity and Other Cardiac Risk Markers in Patients with Type 2 Diabetes and Acute Myocardial Infarction
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Genestreti, Paulo R. Rizzo, primary, Furtado, Remo H. M., additional, Salsoso, Rocio, additional, Dalçóquio, Talia F., additional, Franci, Andre, additional, Menezes, Fernando R., additional, Caporrino, Cesar, additional, Ferrari, Aline G., additional, Nakashima, Carlos A. K., additional, Scanavini Filho, Marco A., additional, Lima, Felipe G., additional, Giraldez, Roberto R. C. V., additional, Baracioli, Luciano M., additional, and Nicolau, Jose C., additional
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- 2022
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18. P2Y12 inhibitor versus aspirin monotherapy for secondary prevention of cardiovascular events: meta-analysis of randomized trials
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Aggarwal, Devika, primary, Bhatia, Kirtipal, additional, Chunawala, Zainali S, additional, Furtado, Remo H M, additional, Mukherjee, Debabrata, additional, Dixon, Simon R, additional, Jain, Vardhmaan, additional, Arora, Sameer, additional, Zelniker, Thomas A, additional, Navarese, Eliano P, additional, Mishkel, Gregory J, additional, Lee, Cheong J, additional, Banerjee, Subhash, additional, Bangalore, Sripal, additional, Levisay, Justin P, additional, Bhatt, Deepak L, additional, Ricciardi, Mark J, additional, and Qamar, Arman, additional
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- 2022
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19. Dapagliflozin in patients with COVID-19: mind the kidneys – Authors' reply
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Kosiborod, Mikhail N, primary, Esterline, Russell, additional, Oscarsson, Jan, additional, Gasparyan, Samvel B, additional, Furtado, Remo H M, additional, Verma, Subodh, additional, and Berwanger, Otavio, additional
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- 2022
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20. Age-adjusted D-dimer cutoffs to guide anticoagulation in COVID-19 – Authors' reply
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Lopes, Renato D, primary, de Barros e Silva, Pedro Gabriel Melo, additional, Furtado, Remo H M, additional, Alexander, John H, additional, and Berwanger, Otavio, additional
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- 2021
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21. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia
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Guimarães, Patrícia O., primary, Quirk, Daniel, additional, Furtado, Remo H., additional, Maia, Lilia N., additional, Saraiva, José F., additional, Antunes, Murillo O., additional, Kalil Filho, Roberto, additional, Junior, Vagner M., additional, Soeiro, Alexandre M., additional, Tognon, Alexandre P., additional, Veiga, Viviane C., additional, Martins, Priscilla A., additional, Moia, Diogo D.F., additional, Sampaio, Bruna S., additional, Assis, Silvia R.L., additional, Soares, Ronaldo V.P., additional, Piano, Luciana P.A., additional, Castilho, Kleber, additional, Momesso, Roberta G.R.A.P., additional, Monfardini, Frederico, additional, Guimarães, Helio P., additional, Ponce de Leon, Dario, additional, Dulcine, Majori, additional, Pinheiro, Marcia R.T., additional, Gunay, Levent M., additional, Deuring, J. Jasper, additional, Rizzo, Luiz V., additional, Koncz, Tamas, additional, and Berwanger, Otavio, additional
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- 2021
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22. Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial
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Lopes, Renato D, primary, de Barros e Silva, Pedro Gabriel Melo, additional, Furtado, Remo H M, additional, Macedo, Ariane Vieira Scarlatelli, additional, Bronhara, Bruna, additional, Damiani, Lucas Petri, additional, Barbosa, Lilian Mazza, additional, de Aveiro Morata, Júlia, additional, Ramacciotti, Eduardo, additional, de Aquino Martins, Priscilla, additional, de Oliveira, Aryadne Lyrio, additional, Nunes, Vinicius Santana, additional, Ritt, Luiz Eduardo Fonteles, additional, Rocha, Ana Thereza, additional, Tramujas, Lucas, additional, Santos, Sueli V, additional, Diaz, Dario Rafael Abregu, additional, Viana, Lorena Souza, additional, Melro, Lívia Maria Garcia, additional, de Alcântara Chaud, Mariana Silveira, additional, Figueiredo, Estêvão Lanna, additional, Neuenschwander, Fernando Carvalho, additional, Dracoulakis, Marianna Deway Andrade, additional, Lima, Rodolfo Godinho Souza Dourado, additional, de Souza Dantas, Vicente Cés, additional, Fernandes, Anne Cristine Silva, additional, Gebara, Otávio Celso Eluf, additional, Hernandes, Mauro Esteves, additional, Queiroz, Diego Aparecido Rios, additional, Veiga, Viviane C, additional, Canesin, Manoel Fernandes, additional, de Faria, Leonardo Meira, additional, Feitosa-Filho, Gilson Soares, additional, Gazzana, Marcelo Basso, additional, Liporace, Idelzuíta Leandro, additional, de Oliveira Twardowsky, Aline, additional, Maia, Lilia Nigro, additional, Machado, Flávia Ribeiro, additional, de Matos Soeiro, Alexandre, additional, Conceição-Souza, Germano Emílio, additional, Armaganijan, Luciana, additional, Guimarães, Patrícia O, additional, Rosa, Regis G, additional, Azevedo, Luciano C P, additional, Alexander, John H, additional, Avezum, Alvaro, additional, Cavalcanti, Alexandre B, additional, and Berwanger, Otavio, additional
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- 2021
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23. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial
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Furtado, Remo H M, primary, Berwanger, Otavio, additional, Fonseca, Henrique A, additional, Corrêa, Thiago D, additional, Ferraz, Leonardo R, additional, Lapa, Maura G, additional, Zampieri, Fernando G, additional, Veiga, Viviane C, additional, Azevedo, Luciano C P, additional, Rosa, Regis G, additional, Lopes, Renato D, additional, Avezum, Alvaro, additional, Manoel, Airton L O, additional, Piza, Felipe M T, additional, Martins, Priscilla A, additional, Lisboa, Thiago C, additional, Pereira, Adriano J, additional, Olivato, Guilherme B, additional, Dantas, Vicente C S, additional, Milan, Eveline P, additional, Gebara, Otavio C E, additional, Amazonas, Roberto B, additional, Oliveira, Monalisa B, additional, Soares, Ronaldo V P, additional, Moia, Diogo D F, additional, Piano, Luciana P A, additional, Castilho, Kleber, additional, Momesso, Roberta G R A P, additional, Schettino, Guilherme P P, additional, Rizzo, Luiz Vicente, additional, Neto, Ary Serpa, additional, Machado, Flávia R, additional, and Cavalcanti, Alexandre B, additional
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- 2020
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24. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS‐TIMI 54 Trial
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Furtado, Remo H. M., primary, Venkateswaran, Ramkumar V., additional, Nicolau, Jose C., additional, Gurmu, Yared, additional, Bhatt, Deepak L., additional, Storey, Robert F., additional, Steg, P. Gabriel, additional, Magnani, Giuglia, additional, Goto, Shinya, additional, Dellborg, Mikael, additional, Kamensky, Gabriel, additional, Isaza, Daniel, additional, Aylward, Philip, additional, Johanson, Per, additional, and Bonaca, Marc P., additional
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- 2020
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25. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54
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Furtado, Remo H M, primary, Nicolau, Jose C, additional, Magnani, Giulia, additional, Im, Kyungah, additional, Bhatt, Deepak L, additional, Storey, Robert F, additional, Steg, P Gabriel, additional, Spinar, Jindrich, additional, Budaj, Andrzej, additional, Kontny, Frederic, additional, Corbalan, Ramon, additional, Kiss, Robert G, additional, Abola, Maria Teresa, additional, Johanson, Per, additional, Jensen, Eva C, additional, Braunwald, Eugene, additional, Sabatine, Marc S, additional, and Bonaca, Marc P, additional
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- 2019
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26. Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial
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Arantes, Flávia B. B., primary, Menezes, Fernando R., additional, Franci, Andre, additional, Barbosa, Carlos J. D. G., additional, Dalçoquio, Talia F., additional, Nakashima, Carlos A. K., additional, Baracioli, Luciano M., additional, Furtado, Remo H. M., additional, Nomelini, Quintiliano S. S., additional, Ramires, José A. F., additional, Kalil Filho, Roberto, additional, and Nicolau, José C., additional
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- 2019
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27. Performance of acute coronary syndrome approaches in Brazil: a report from the BRACE (Brazilian Registry in Acute Coronary SyndromEs)
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Franken, Marcelo, primary, Giugliano, Robert P, additional, Goodman, Shaun G, additional, Baracioli, Luciano Moreira, additional, Godoy, Lucas Colombo, additional, Furtado, Remo H M, additional, Lima, Felipe Gallego, additional, and Nicolau, Jose Carlos, additional
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- 2019
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28. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials
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Zelniker, Thomas A, primary, Wiviott, Stephen D, additional, Raz, Itamar, additional, Im, Kyungah, additional, Goodrich, Erica L, additional, Bonaca, Marc P, additional, Mosenzon, Ofri, additional, Kato, Eri T, additional, Cahn, Avivit, additional, Furtado, Remo H M, additional, Bhatt, Deepak L, additional, Leiter, Lawrence A, additional, McGuire, Darren K, additional, Wilding, John P H, additional, and Sabatine, Marc S, additional
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- 2019
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29. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54.
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Furtado, Remo H M, Nicolau, Jose C, Magnani, Giulia, Im, Kyungah, Bhatt, Deepak L, Storey, Robert F, Steg, P Gabriel, Spinar, Jindrich, Budaj, Andrzej, Kontny, Frederic, Corbalan, Ramon, Kiss, Robert G, Abola, Maria Teresa, Johanson, Per, Jensen, Eva C, Braunwald, Eugene, Sabatine, Marc S, and Bonaca, Marc P
- Abstract
Aims PEGASUS-TIMI 54 demonstrated that long-term dual antiplatelet therapy (DAPT) with aspirin and ticagrelor reduced the risk of major adverse cardiovascular events (MACE), with an acceptable increase in bleeding, in patients with prior myocardial infarction (MI). While much of the discussion around prolonged DAPT has been focused on stented patients, patients with prior MI without prior coronary stenting comprise a clinically important subgroup. Methods and results This was a pre-specified analysis from PEGASUS-TIMI 54, which randomized 21 162 patients with prior MI (1–3 years) and additional high-risk features to ticagrelor 60 mg, 90 mg, or placebo twice daily in addition to aspirin. A total of 4199 patients had no history of coronary stenting at baseline. The primary efficacy outcome (MACE) was the composite of cardiovascular death, MI, or stroke. Patients without history of coronary stenting had higher baseline risk of MACE [13.2% vs. 8.0%, adjusted hazard ratio (HR) 1.41, 95% confidence interval (CI) 1.15–1.73, in the placebo arm]. The relative risk reduction in MACE with ticagrelor (pooled doses) was similar in patients without (HR 0.82, 95% CI 0.68–0.99) and with prior stenting (HR 0.85, 95% CI 0.75–0.96; P for interaction = 0.76). Conclusion Long-term ticagrelor reduces thrombotic events in patients with prior MI regardless of whether they had prior coronary stenting. These data highlight the benefits of DAPT in prevention of spontaneous atherothrombotic events and indicate that long-term ticagrelor may be considered in high-risk patients with prior MI even if they have not been treated with stenting. ClinicalTrials.gov Identifier NCT01225562. Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]
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- 2020
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30. Morphine and Cardiovascular Outcomes Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography.
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Furtado, Remo H M, Nicolau, José C, Guo, Jianping, Im, Kyungah, White, Jennifer A, Sabatine, Marc S, Newby, L Kristin, and Giugliano, Robert P
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NARCOTICS , *CLINICAL trials , *ANALGESICS , *ACUTE coronary syndrome , *MORPHINE , *CORONARY angiography , *TREATMENT effectiveness , *PLATELET aggregation inhibitors - Abstract
Background: Mechanistic studies have shown that morphine blunts the antiplatelet effects of oral adenosine diphosphate receptor blockers. However, the clinical relevance of this interaction is controversial.Objectives: This study sought to explore the association between morphine and ischemic events in 5,438 patients treated with concomitant clopidogrel presenting with non-ST-segment elevation acute coronary syndromes (NSTEACS) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome) trial. Patients not treated with clopidogrel (n = 3,462) were used as negative controls.Methods: Endpoints were the composite of death, myocardial infarction (MI), recurrent ischemia, or thrombotic bailout at 96 h (4-way endpoint) and the composite of death or MI at 30 days.Results: In patients treated with clopidogrel, morphine use was associated with higher rates of the 4-way endpoint at 96 h (adjusted odds ratio [OR]: 1.40; 95% confidence interval [CI]: 1.04 to 1.87; p = 0.026). There was a trend for higher rates of death or MI at 30 days (adjusted OR: 1.29; 95% CI: 0.98 to 1.70; p = 0.072), driven by events in the first 48 h (adjusted hazard ratio: 1.54; 95% CI: 1.07 to 2.23; p = 0.021). In patients not treated with clopidogrel, morphine was not associated with either the 4-way endpoint at 96 h (adjusted OR: 1.05; 95% CI: 0.74 to 1.49; p = 0.79; pinteraction = 0.36 ) or death or MI at 30 days (adjusted OR: 1.07; 95% CI: 0.77 to 1.48; p = 0.70; pinteraction = 0.46).Conclusions: When used concomitantly with clopidogrel pre-treatment, morphine was associated with higher rates of ischemic events in patients with NSTEACS. (EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome; NCT00089895). [ABSTRACT FROM AUTHOR]- Published
- 2020
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31. Stem‐cell therapy in ST‐segment elevation myocardial infarction with reduced ejection fraction: A multicenter, double‐blind randomized trial.
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Nicolau, José C., Furtado, Remo H. M., Silva, Suzana A., Rochitte, Carlos E., Rassi, Jr, Anis, Moraes, Jr, João B. M. C., Quintella, Edgard, Costantini, Costantino R., Korman, Adrian P. M., Mattos, Marco A., Castello, Jr, Hélio J., Caixeta, Adriano, Dohmann, Hans F. R., de Carvalho, Antonio C. C., and on behalf of the MiHeart/AMI Investigators
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- 2018
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32. Abstract 19023: Is there a Correlation Between Bleeding Risk Score and Platelet Aggregability?
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Arantes, Flavia B, primary, Furtado, Remo H, additional, Barbosa, Carlos J, additional, Franci, André, additional, Menezes, Fernando R, additional, Falcao, Talia D, additional, Nakashima, Carlos A, additional, Baracioli, Luciano M, additional, Ramires, Jose A, additional, and Nicolau, Jose C, additional
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- 2014
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33. Dapagliflozin in patients with COVID-19: mind the kidneys – Authors' reply
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Kosiborod, Mikhail N, Esterline, Russell, Oscarsson, Jan, Gasparyan, Samvel B, Furtado, Remo H M, Verma, Subodh, and Berwanger, Otavio
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- 2021
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34. Abstract 15581: Effect of Dapagliflozin on Atrial Fibrillation/Flutter in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial
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Zelniker, Thomas A, Bonaca, Marc P, Mosenzon, Ofri, Kuder, Julia F, Murphy, Sabina A, Furtado, Remo H, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, Wilding, John P, Budaj, Andrzej, Kiss, Robert Gabor, Padilla, Francisco, Gause-Nilsson, Ingrid A, Langkilde, Anna Maria, Raz, Itamar, Sabatine, Marc S, and Wiviott, Stephen D
- Abstract
Introduction:Atrial fibrillation (AF) and atrial flutter (AFL) are associated with diabetes and its comorbidities including hypertension, obesity, and heart failure (HF). Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been shown to lower blood pressure, reduce weight, have salutary effects on left ventricular remodeling and reduce hospitalization for HF and cardiovascular death in patients with type 2 diabetes (T2D). We therefore hypothesized that SGLT2i may reduce the risk of AF/AFL.Methods:DECLARE-TIMI 58 studied the efficacy and safety of the SGLT2i dapagliflozin in 17160 patients with T2D and either multiple risk factors for (MRF, n=10186) or known atherosclerotic cardiovascular disease (ASCVD, n=6974). Here, we explore the effect of dapagliflozin on the first and total number of AF/AFL events using Cox and negative binomial models, respectively. AF events were identified using a MedDRA preferred term search (?Atrial Fibrillation?, ?Atrial Flutter?) in the safety database.Results:Dapagliflozin reduced the risk of incident AF/AFL by 19% (264 versus 325 events; hazard ratio 0.81, 95% CI 0.68 to 0.95, P=0.009, Fig A). The reduction in AF/AFL events was consistent regardless of presence or absence of a history of AF/AFL at baseline (Prior AF/AFL (n=1116): HR 0.79, 95% CI 0.58 to 1.09, No AF/AFL: HR 0.81, 95% CI 0.67 to 0.98; P-INT 0.89). Similarly, presence of ASCVD (HR 0.78, 95% CI 0.62 to 0.99) versus MRF (HR 0.83, 95% CI 0.66 to 1.04; P-INT 0.72), or a history of HF (HF: HR 0.78, 95% CI 0.55 to 1.11, No HF: HR 0.81, 95% CI 0.68 to 0.97; P-INT 0.88) did not modify the reduction in AF/AFL events observed with dapagliflozin. Dapagliflozin also reduced the total number of AF/AFL events (337 versus 432; rate ratio 0.77, 95% CI 0.64 to 0.92, P=0.005; Fig B).Conclusions:Dapagliflozin appears to reduce both incident AF/AFL as well as the total number of AF/AFL events in patients with T2D. This effect was consistent regardless of the patients? prior history of AF, ASCVD, or HF.
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- 2019
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35. Abstract 13622: Impact of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes and Reduced Left Ventricular Ejection Fraction
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Salsoso, Rocio, Genestreti, Paulo, Franci, Andr?, Dalcoquio, Talia, Nakashima, Carlos A, Scanavini, Marco, Ferrari, Aline G, Furtado, Remo H, Lima, Felipe G, Giraldez, Roberto R, Baracioli, Luciano, and Nicolau, Jose C
- Abstract
Introduction:Dual antiplatelet therapy (DAPT) plays a critical role in secondary prevention after acute coronary syndrome (ACS), but some patients show suboptimal inhibition of platelet aggregability leading to an increased risk of recurrent ischemic events. On the other hand, reduced left ventricular ejection fraction (LVEF) is a major determinant of worse prognosis post-myocardial infarction (MI). However, little is known about the relationship between these two prognostic variables.Hypothesis:High-on treatment platelet reactivity (HPR) may be involved in impaired ventricular function after ACS.Methods:Reduced LVEF was defined as <40%, being the population categorized in LVEF <40% and LVEF ?40%. All patients received DAPT with aspirin and P2Y12antagonists (clopidogrel or ticagrelor). Platelet aggregability was evaluated between 5 and 7 days post-MI using the VerifyNow?P2Y12Assay or the Multiplate?ADP Analyzer. HPR for ADP was defined by VerifyNow as >208 reactions units (PRUs) or by Multiplate as >46 area under the curve (AU*min). Univariate and adjusted models were developed applying the chi-square, parametric and non-parametric test, and logistic regression (HPR as dependent variable) as indicated.Results:Four hundred and forty patients with ACS (61 ? 11 years-old, 69% men) were included in the study. Overall, 64 (14.55%) patients had LVEF <40% (Group I) and 376 (85.45%) LVEF ?40% (Group II). By univariate analysis, HPR incidence was significantly higher in Group I (39.06%) compared with Group II (19.15%), P <0.001). By multivariable analysis, HPR was independently associated with LVEF <40% adjusted odds ratio = 2.362, 95% CI = 1.198-4.657, P = 0.013).Conclusions:Among patients treated with DAPT for ACS, LVEF <40% is associated with poor antiplatelet inhibition. These findings suggest that HPR could influence left ventricular function after ACS, possibly through a worsening of coronary reperfusion. Additional research is desirable in order to test this hypothesis.
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- 2019
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36. Abstract 12938: Adenosine Plasmatic Concentration in Coronary Artery Disease Patients With and Without Chronic Kidney Disease
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Franci, Andre, Barbosa, Carlos, Dalcoquio, Talia, Salsoso, Rocio, Furtado, Remo H, Strunz, Celia, Genestreti, Paulo, Lima, Viviane, Scanavini, Marco, Ferrari, Aline G, Baracioli, Luciano, and Nicolau, Jose C
- Abstract
Introduction:In the PLATO trial, ticagrelor reduced ischemic events when compared to clopidogrel in patients (pts) with acute coronary syndromes. Increase in adenosine plasmatic concentration (APC) has emerged as a potential mechanism to explain such benefit. Moreover, chronic kidney disease (CKD) pts seemed to have even greater benefit with ticagrelor when compared with non-CKD pts, and this is not fully explained. Adenosine has been linked to important effects such as vasodilation, inflammatory modulation, coordination between kidney blood flow and glomerular filtration rate (GFR), among others. APC has been evaluated in different populations, although no data on pts with CKD (GFR < 60 ml/min/1.73m2) is available.Hypothesis:Whether APC is different in coronary artery disease (CAD) pts with and without CKD.Methods:We analyzed baseline data from 65 pts prospectively included in a single-center randomized clinical trial testing clopidogrel vs. ticagrelor in CAD pts with and without CKD. APC was measured before (data presented here) and after intervention, by high-performance liquid chromatography. Student?s t-test and Mann-Whitney were used for univariate analyses and linear regression models correlating APC with creatinine or GFR was also performed.Results:From the total 65 pts included, 33 were in the CKD group (age 71?5years, 70% men, GFR 41?13 ml/min) and 23 pts in the non-CKD group (age 70?5 years, 66% men, GFR 83?15 ml/min). Both groups were comparable for most baseline characteristics (hypertension, diabetes, dyslipidemia, tobacco use, previous myocardial infarction, previous PCI), except that CKD pts had lower ejection fraction (46?13% vs 54?10%; p=0.005). For the main results, mean APC was not significantly different between CKD and non-CKD pts (141?164 vs 139?104 nmol/L; p=0.21), and no independent association was found between APC and creatinine (p=0.11) or APC and GFR (p=0.54).Conclusion:In the first report ever made evaluating APC in CAD pts according to renal function, we did not find any significant difference of APC in pts with or without CKD. Whether the benefit of ticagrelor previously seen in this population was mediated predominantly by platelet inhibition or also by increase in APC should be clarified in further studies.
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- 2019
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37. Abstract 13488: Effect of Dapagliflozin in Reducing Recurrent Myocardial Infarction of Different Infarct Types and Sizes: Insights From Declare-Timi 58
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Furtado, Remo H, Bonaca, Marc P, Zelniker, Thomas A, Raz, Itamar, Goodrich, Erica, Mosenzon, Ofri, Murphy, Sabina, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, Wilding, John, Gause-Nilsson, Ingrid A, Langkilde, Anna Maria, Sabatine, Marc S, and Wiviott, Stephen
- Abstract
Introduction:Sodium glucose transporter 2 inhibitors (SGLT2i) reduce the risk of major adverse cardiovascular events (MACE), including myocardial infarction (MI), in patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD). In DECLARE-TIMI 58, this benefit was seen in patients with ASCVD and particularly in those ones with prior MI. The effect of SGLT2i in reducing MIs of different types and sizes has not previously been reported.Hypothesis:In patients with T2DM and prior MI, dapagliflozin consistently reduces recurrent MI events across a range of infarct types & sizes.Methods:This was a pre-specified sub-analysis from DECLARE-TIMI 58, which randomized 17,160 patients with T2DM to dapagliflozin 10 mg vs. placebo, of whom, 3584 had a history of prior MI at enrollment. All MI events were prospectively adjudicated and classified according to: (1) Universal Definition types 1-5, (2) the presenting electrocardiogram (STEMI vs. NSTEMI), and (3) size based on peak troponin [as multiples of the upper limit of normal (ULN)]. Cox proportional hazards model was used to generate HR and 95 % CI.Results:From the total incident MIs (489) in patients with prior MI from DECLARE-TIMI 58, 316 (65%) were type 1 MIs and 403 (82%) were NSTEMI. From those with biomarkers available (456), 241 (53%) had peak troponin ? 10 X ULN. Besides reducing recurrent MI (HR 0.78; 95 % CI 0.63-0.95; p = 0.016), dapagliflozin appeared to favorably affect the risk of both type 1 (HR 0.80; 95 % CI 0.63-1.02) and type 2 (HR 0.64; 95 % CI 0.42-0.97) MIs. There also appeared to be a favorable reduction across all ranges of infarct sizes based on peak troponin (Figure).Conclusions:In patients with T2DM and prior MI, dapagliflozin consistently reduced recurrent MI across the spectrum of different infarct sizes and types, including those ones caused by a myocardial oxygen supply/demand mismatch. The mechanisms that explain reductions in MI with SGLT2i remain to be determined.
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- 2019
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38. Abstract 10978: Effect of Exercise-based Cardiac Rehabilitation After Acute Myocardial Infarction on HDL Function: A Randomized Clinical Trial
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Dalcoquio, Talia F, Freitas, Fatima, Arantes, Fl?via B, Ferreira-Santos, Larissa, Alves, Leandro, Santos, Mayara, Rondon, Maria Urbana P, Alves, Maria-janieire N, Furtado, Remo H, Negrao, Carlos E, Maranh?o, Raul C, and Nicolau, Jos? C
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Introduction:Exercise training increases high-density lipoprotein cholesterol (HDL-C) levels. However, HDL-C levels only partially reflect the protective functions of HDL, including cholesterol esterification and reverse cholesterol transport. To exert those functions, the transfer of cholesterol to HDL, not only from cells, but also from other lipoproteins is necessary and it was shown by in vitro assay that patients with chronic coronary artery disease have deficient cholesterol transfer to HDL.Hypothesis:Exercise training may improve cholesterol transfer to HDL in post-myocardial infarction (MI) patients.Methods:Sixty-two previously sedentary patients 30?5 days after uncomplicated MI (59.2?9.9 years-old; 74.2%men; 58.1% with ST-elevation MI) were randomized to an intervention group that engaged in a supervised moderate intensity exercise training program (exercise training group) or to a control group that received information about healthy lifestyle but were not trained (control group). All patients were on high intensity statin. HDL-C and transfer of both unesterified (NEC) and esterified cholesterol (EC) to HDL were determined at baseline and at the end of the 3-month follow-up. NEC and EC transfer to HDL was measured by an in vitro assay using racioactively labeled lipid emulsion as cholesterol donor.Results:There were no significant differences on HDL-C levels (p=0.76) or NEC (p=0.48) and EC (p=0.69) transfer to HDL at baseline among groups. Comparisons between baseline and 3-month follow-up measures are depicted in table.Conclusions:In post-MI patients, 3 months of exercise-based cardiac rehabilitation resulted not only in HDL-C increase but also in improvement of NEC and EC transfer to HDL. This indicates a better HDL function and atheroprotective capacity in this high cardiovascular risk population. These findings reinforce the importance of exercise-based cardiac rehabilitation after MI.
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- 2019
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39. Abstract 14152: Morphine/Clopidogrel Interaction and Cardiovascular Outcomes in Patients With Non-ST Elevation Acute Coronary Syndromes - Insights From EARLY-ACS Trial.
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Furtado, Remo H, Nicolau, Jose C, Newby, Kristin L, Guo, Jianping W, Sabatine, Marc S, and Giugliano, Robert P
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ACUTE coronary syndrome , *NEONATAL abstinence syndrome , *MORPHINE , *PERCUTANEOUS coronary intervention , *CLOPIDOGREL , *HEART failure , *MYOCARDIAL infarction - Abstract
Introduction: Morphine is endorsed by all acute coronary syndromes (ACS) guidelines. However, some mechanistic studies have demonstrated that morphine impairs absorption and blunts antiplatelet effect of oral ADP receptor blockers. The clinical relevance of this interaction is controversial. Hypothesis: If morphine delays ADP receptor blocker absorption and decreases the extent of platelet inhibition, then its concomitant use with clopidogrel may increase risk of short-term ischemic events. Methods: This is a post-hoc analysis from the EARLY-ACS trial, which randomized patients with non-ST elevation ACS (NSTEACS) within 24 hours of clinical presentation to early versus delayed provisional epitifibatide. We analyzed morphine use before randomization across two separate populations: those ones that were treated with clopidogrel before randomization (5,438 patients) and those ones that were not (3,462 patients). Outcomes of interest were the composite of death, myocardial infarction, recurrent ischemia with need for urgent revascularization or thrombotic bailout during percutaneous coronary intervention at 96 hours (the same one used for the main trial) and TIMI major or minor bleeding at 120 hours. An inverse probability of treatment weighting (IPTW) propensity score model was developed to adjust for confounders. Results: A total of 1,024 patients were treated with morphine before randomization and 7,876 were not. Patients taking morphine were more likely to have heart failure at baseline, to be on nitrates and to be enrolled in North America. Results for ischemic outcomes are described at Figure 1. There was no association of prior morphine use with bleeding (OR 1.1; 95 % CI 0.79 to 1.52 for the overall cohort). Conclusions: When used together with clopidogrel, NSTEACS patients who received morphine had higher risk of short-term ischemic events. On the other hand, there was no such association when clopidogrel was not given together with morphine. [ABSTRACT FROM AUTHOR]
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- 2018
40. Abstract 14161: Long-Term Secondary Prevention With Ticagrelor for Prior Myocardial Infarction in Patients With No Coronary Stenting: A Sub-Analysis From PEGASUS TIMI 54.
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Furtado, Remo H, Bhatt, Deepak L, Steg, Philippe G, Cohen, Marc, Storey, Robert F, Im, Kyungah W, Sabatine, Marc S, and Bonaca, Marc P
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MYOCARDIAL infarction , *ASPIRIN - Abstract
Introduction: Prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and a P2Y12 inhibitor was initially developed to reduce risk of stent thrombosis. However, data has emerged showing that, in patients with MI, prolonged DAPT is beneficial, irrespective of stenting. Moreover, previous reports have suggested that MI patients not treated with coronary stenting may be at higher long-term risk. Hypothesis: Patients with a history of MI without coronary stenting, when compared with MI patients with a history of stenting, are at higher risk of adverse cardiovascular events and derive similar relative and greater absolute risk reduction with prolonged DAPT. Methods: PEGASUS-TIMI 54 randomized 21,162 patients with prior MI (1-3 years) to ticagrelor 60 mg, 90 mg or placebo twice daily. Primary efficacy outcome was MACE composite of: cardiovascular (CV) death, MI or stroke. History of coronary stenting or not was prespecified as subgroups of interest. Risk of MACE and benefit of ticagrelor (pooled doses) in patients with and without a history of stenting are compared. Results: 4,199 individuals had no history of coronary stenting at baseline whereas 16,891 did. The relative risk reduction (RRR) in MACE with ticagrelor was consistent in patients without (18% RRR) and with prior stenting (15% RRR) (Pint = 0.95, Figure). Given the higher baseline risk, patients without a history of stenting had a higher absolute risk reduction (2.1% vs. 1.0%). Furthermore, ticagrelor reduced all-cause mortality in these high-risk patients. (Figure) Conclusions: Prolonged DAPT with ticagrelor was equally beneficial in reducing relative risk of MACE in patients with and without prior stenting. In the latter group, absolute risk reduction was even higher due to their baseline risk profile. These data indicate that the benefits of long-term DAPT are driven primarily through reduction of de-novo atherothrombosis rather than stent protection. [ABSTRACT FROM AUTHOR]
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- 2018
41. Abstract 14143: Caffeine and Dyspnea With Ticagrelor: A Sub-Analysis From PEGASUS TIMI-54 Trial.
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Furtado, Remo H, Venkateswaran, Ramkumar, Bhatt, Deepak L, Storey, Robert F, Steg, Philippe G, Cohen, Marc, Gurmu, Yared, Johanson, Per, Sabatine, Marc S, and Bonaca, Marc P
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CAFFEINE , *CARDIAC arrest , *DYSPNEA , *ATRIAL fibrillation , *CORONARY disease - Abstract
Introduction: Ticagrelor is associated with dyspnea with a potential mechanism being increased adenosine exposure. Studies have shown reductions in dyspnea from ticagrelor with theophylline. Caffeine shares similar properties to theophylline and could potentially attenuate dyspnea from ticagrelor. However, safety of caffeine in patients with prior MI is debated, especially regarding risk of arrhythmias. Hypothesis: We sought to investigate, in patients with prior MI, whether caffeine consumption at baseline: 1) modifies the risk of dyspnea with ticagrelor; and 2) is associated with cardiovascular risk. Methods: The effect of caffeine on dyspnea was a prespecified analysis from PEGASUS trial (NCT 01225562), which randomized 21,162 patients with prior MI to ticagrelor 60 mg, 90 mg or matching placebo (twice daily). When data regarding potential effect for caffeine on dyspnea related to ticagrelor were reported, a dedicated form was created, which collected caffeine intake at baseline as the number of caffeinated beverages in cups per week. Outcomes of interest were: dyspnea, death due to coronary heart disease, sudden cardiac death and atrial fibrillation. Results: Caffeine intake was recorded for 9,568 patients, with median of 10 cups per week. Patients with higher than median caffeine intake were younger and more commonly obese and smokers. After adjustment, there was no association between caffeine above the median with dyspnea (HR 1.05; 95 % CI 0.93 to 1.19) nor with death due to coronary heart disease (HR 0.72; 95 % CI 0.48 to 1.08), sudden cardiac death (HR 0.76; 95 % CI 0.49 to 1.19) or atrial fibrillation (HR 0.87; 95 % CI 0.56 to 1.35). Both ticagrelor doses increased dyspnea similarly regardless of caffeine intake at baseline (Figure). Conclusions: In high-risk patients with prior MI, caffeine intake did not modify dyspnea associated with ticagrelor. Besides that, there did not appear to be any increased cardiovascular risk associated with caffeine intake. [ABSTRACT FROM AUTHOR]
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- 2018
42. Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials.
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Furtado RHM, Barros E Silva PGM, Fonseca HAR, Serpa-Neto A, Correa TD, Guimarães HP, Pereira AJ, Olivato GB, Zampieri FG, Lisboa T, Junqueira DLM, Lapa MG, Monfardini F, Damiani LP, Echenique LS, Gebara OE, Hoffman Filho CR, Polanczyk CA, Rohde LE, Amazonas R, Machado FR, Avezum A, Azevedo LCP, Veiga VC, Rosa RG, Lopes RD, Cavalcanti AB, and Berwanger O
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- Humans, Arrhythmias, Cardiac chemically induced, Arrhythmias, Cardiac epidemiology, Arrhythmias, Cardiac drug therapy, Azithromycin adverse effects, COVID-19 Drug Treatment, Electrocardiography methods, Hydroxychloroquine therapeutic use, Randomized Controlled Trials as Topic, SARS-CoV-2, COVID-19, Long QT Syndrome chemically induced
- Abstract
The cardiovascular safety from azithromycin in the treatment of several infectious diseases has been challenged. In this prespecified pooled analysis of 2 multicenter randomized clinical trials, we aimed to assess whether the use of azithromycin might lead to corrected QT (QTc) interval prolongation or clinically relevant ventricular arrhythmias. In the COALITION COVID Brazil I trial, 667 patients admitted with moderate COVID-19 were randomly allocated to hydroxychloroquine, hydroxychloroquine plus azithromycin, or standard of care. In the COALITION COVID Brazil II trial, 447 patients with severe COVID-19 were randomly allocated to hydroxychloroquine alone versus hydroxychloroquine plus azithromycin. The principal end point for the present analysis was the composite of death, resuscitated cardiac arrest, or ventricular arrhythmias. The addition of azithromycin to hydroxychloroquine did not result in any prolongation of the QTc interval (425.8 ± 3.6 ms vs 427.9 ± 3.9 ms, respectively, mean difference -2.1 ms, 95% confidence interval -12.5 to 8.4 ms, p = 0.70). The combination of azithromycin plus hydroxychloroquine compared with hydroxychloroquine alone did not result in increased risk of the primary end point (proportion of patients with events at 15 days 17.2% vs 16.0%, respectively, hazard ratio 1.08, 95% confidence interval 0.78 to 1.49, p = 0.65). In conclusion, in patients hospitalized with COVID-19 already receiving standard-of-care management (including hydroxychloroquine), the addition of azithromycin did not result in the prolongation of the QTc interval or increase in cardiovascular adverse events. Because azithromycin is among the most commonly prescribed antimicrobial agents, our results may inform clinical practice. Clinical Trial Registration: NCT04322123, NCT04321278., Competing Interests: Declaration of competing interest Dr. Furtado reports research grants and personal fees from AstraZeneca, Bayer, Servier, and Apsen and research grants (received from his institution) from Pfizer, Libbs, Brazilian Ministry of Health, and University Health Network. Dr. Fonseca received research grants from AstraZeneca, Pfizer, Essity, Aché, Colgate, BioGen, and Brazilian Ministry of Health. Dr. Barros e Silva reports reports fees and research grants from Pfizer, Roche Diagnostics, and Bayer. Dr. Pereira reports research grants from Brazilian Ministry of Health through PROADI-SUS Program (not related to this article). Dr. Polanczyk received research grants and professional fees from AstraZeneca, Bayer, Pfizer, Novartis, Roche, Sanofi, and Brazilian Ministry of Health through PROADI Programs. Dr. Veiga received grants from Brazilian Ministry of Health through PROADI-SUS Program. Dr. Rosa received research grants from Pfizer, Merck Sharp & Dohme, and Brazilian Ministry of Health. Dr. Azevedo received professional fees from Baxter, Nestle, and Merck Sharp & Dohme not related to the present work and research grants from Brazilian Ministry of Health through PROADI-SUS Program. Dr. Avezum reports research grants from Bayer, Sanofi-Pasteur, and Population Health Research Institute. Dr. Cavalcanti reports research grants from Bayer. Dr. Lopes reports research support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer and consulting fees from Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, and Portola. Dr. Berwanger report research grants from Bayer, Pfizer, AstraZeneca, Servier, Novartis, and Boehringer-Ingelheim. The remaining authors have no competing interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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43. P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial.
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Guimarães PO, Franken M, Tavares CAM, Silveira FS, Antunes MO, Bergo RR, Joaquim RM, Hirai JCS, Andrade PB, Pitta FG, Mariani J Jr, Nascimento BR, de Paula JET, Silveira MS, Costa TAO, Dall'Orto FTC, Serpa RG, Sampaio FBA, Ohe LN, Mangione FM, Furtado RHM, Sarmento-Leite R, Monfardini F, Assis SRL, Nicolau JC, Sposito AC, Lopes RD, Onuma Y, Valgimigli M, Angiolillo DJ, Serruys PW, Berwanger O, Bacal F, and Lemos PA
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- Humans, Platelet Aggregation Inhibitors therapeutic use, Ticagrelor therapeutic use, Prasugrel Hydrochloride therapeutic use, Drug Therapy, Combination, Aspirin therapeutic use, Hemorrhage chemically induced, Treatment Outcome, Acute Coronary Syndrome drug therapy, Acute Coronary Syndrome surgery, Percutaneous Coronary Intervention adverse effects, Drug-Eluting Stents
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Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y
12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).- Published
- 2023
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44. Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.
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Stone GW, Farkouh ME, Lala A, Tinuoye E, Dressler O, Moreno PR, Palacios IF, Goodman SG, Esper RB, Abizaid A, Varade D, Betancur JF, Ricalde A, Payro G, Castellano JM, Hung IFN, Nadkarni GN, Giustino G, Godoy LC, Feinman J, Camaj A, Bienstock SW, Furtado RHM, Granada C, Bustamante J, Peyra C, Contreras J, Owen R, Bhatt DL, Pocock SJ, and Fuster V
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- Humans, Enoxaparin therapeutic use, Anticoagulants adverse effects, Blood Coagulation, COVID-19, Thromboembolism prevention & control, Thromboembolism chemically induced
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Background: Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results., Objectives: We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19., Methods: Patients hospitalized with COVID-19 not requiring intensive care unit treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for intensive care unit-level of care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group., Results: Between August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR: 0.85; 95% CI: 0.69-1.04; P = 0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01), and intubation was required in 8.4% vs 6.4% of patients, respectively (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent., Conclusions: Among noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079)., Competing Interests: Funding Support and Author Disclosures Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, and Abbott; has served as a consultant to Daiichi-Sankyo, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; his daughter is an employee at IQVIA; and his employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Farkouh has received institutional research grants from Amgen, AstraZeneca, Novo Nordisk, and Novartis; has received consulting fees from Otitopic; and has received honoraria from Novo Nordisk. Dr Lala has received consulting fees from Merck and Bioventrix; has received honoraria from Zoll Medical and Novartis; has served on an advisory board for Sequana Medical; and is the Deputy Editor for the Journal of Cardiac Failure. Dr Moreno has received honoraria from Amgen, Cuquerela Medical, and Gafney; has received payment for expert testimony from Koskoff, Koskoff & Dominus, Dallas W. Hartman, and Riscassi & Davis PC; and has stock options in Provisio. Dr Goodman has received institutional research grants from Bristol Myers Squibb/Pfizer Alliance, Bayer, and Boehringer Ingelheim; has received consulting fees from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Ferring Pharmaceuticals, HLS Therapeutics, Novartis, Pendopharm/Pharmascience, Pfizer, Regeneron, and Sanofi; has received honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, and Servier; has served on Data Safety and Monitoring boards for Daiichi-Sankyo/American Regent and Novo Nordisk A/C; has served on advisory boards for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Eli Lilly, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier, and Tolmar Pharmaceuticals; has a leadership role in the Novartis Council for Heart Health (unpaid); and otherwise has received salary support or honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Failure Society, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Centre for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, and the TIMI Study Group (Brigham Health). Dr Ricalde has received consulting fees from Medtronic, Servier, and Boston Scientific; has received honoraria from Medtronic, Pfizer, Merck, Boston Scientific, Biosensors, and Bayer; has served on an advisory board for Medtronic; and has leadership roles in SOLACI and Kardiologen. Dr Payro has received consulting fees from Bayer Mexico; has received honoraria from Bayer, Merck, AstraZeneca, Medtronic, and Viatris; has received payments for expert testimony from Bayer; has received travel support from AstraZeneca; has served on an advisory board for Bayer; and his institution has received equipment donated from AstraZeneca. Dr Castellano has received consulting fees and honoraria from Ferrer International, Servier, and Daiichi-Sankyo; and has received travel support from Ferrer International. Dr Hung has served as an advisory board member for Pfizer, Merck, AstraZeneca, Fosun, and Gilead. Dr Nadkarni has received consulting fees from Renalytix, Variant Bio, Qiming Capital, Menarini Health, Daiichi-Sankyo, BioVie, and Cambridge Health; has received honoraria from Daiichi-Sankyo and Menarini Health; has patents for automatic disease diagnoses using longitudinal medical record data, methods, and apparatus for diagnosis of progressive kidney function decline using a machine learning model, electronic phenotyping technique for diagnosing chronic kidney disease, deep learning to identify biventricular structure and function, fusion models for identification of pulmonary embolism, and SparTeN: a novel spatio-temporal deep learning model; has served on a Data Safety and Monitoring Board for CRIC OSMB; has leadership roles for Renalytix scientific advisory board, Pensive Health scientific advisory board, and ASN Augmented Intelligence and Digital Health Committee; has ownership interests in Renalytix, Data2Wisdom LLC, Verici Dx, Nexus I Connect, and Pensieve Health; and his institution receives royalties from Renalytix. Dr Goday has received the Frederick Banting and Charles Best Canada Graduate Scholarship (Doctoral Research Award) from the Canadian Institutes of Health Research. Dr Furtado has received institutional research grants from AstraZeneca, CytoDin, Pfizer, Servier, Amgen, Alliar Diagnostics, and the Brazilian Ministry of Health; has received consulting fees from Biomm and Bayer; has received honoraria from AstraZeneca, Bayer, Servier, and Pfizer; and has received travel support from Servier, AstraZeneca, and Bayer. Dr Granada has received consulting fees, travel support, and stock from Cogent Technologies Corp; and has received stock from Kutai. Dr Contreras has served as a consultant for Merck, CVRx, Novodisk, and Boehringer Ingelheim; and has received educational grants from Alnylam Pharmaceuticals and AstraZeneca. Dr Bhatt has received research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, Cincor, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer Inc, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89bio; has received royalties from Elsevier; has received consultant fees from Broadview Ventures and McKinsey; has received honoraria from the American College of Cardiology, Baim Institute for Clinical Research, Belvoir Publications, Boston Scientific, Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Novartis, Population Health Research Institute, Rutgers University, Canadian Medical and Surgical Knowledge Translation Research Group, Cowen and Company, HMP Global, Journal of the American College of Cardiology, K2P, Level Ex, Medtelligence/ReachMD, MJH Life Sciences, Oakstone CME, Piper Sandler, Population Health Research Institute, Slack Publications, WebMD, Wiley, Society of Cardiovascular Patient Care; has received fees from expert testimony from the Arnold and Porter law firm; has received travel support from the American College of Cardiology, Society of Cardiovascular Patient Care, American Heart Association; has a patent for otagliflozin assigned to Brigham and Women’s Hospital who assigned to Lexicon; has participated on a data safety monitoring board or advisory board for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, AngioWave, Baim Institute, Bayer, Boehringer Ingelheim, Boston Scientific, Cardax, CellProthera, Cereno Scientific, Cleveland Clinic, Contego Medical, Duke Clinical Research Institute, Elsevier Practice Update Cardiology, Janssen, Level Ex, Mayo Clinic, Medscape Cardiology, Merck, Mount Sinai School of Medicine, MyoKardia, NirvaMed, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Population Health Research Institute, and Stasys; serves as a trustee or director for American College of Cardiology, AngioWave, Boston VA Research Institute, Bristol Myers Squibb, DRS.LINQ, High Enroll, Society of Cardiovascular Patient Care, and TobeSoft; has ownership interests in AngioWave, Bristol Myers Squibb, DRS.LINQ, and High Enroll; has other interests in Clinical Cardiology, the NCDR-ACTION Registry Steering Committee; has conducted unfunded research with FlowCo and Takeda, Contego Medical, American Heart Association Quality Oversight Committee, Inaugural Chair, VA CART Research and Publications Committee; and has been a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, St Jude Medical (now Abbott), Phillips SpectraWAVE, Svelte, and Vascular Solutions. Dr Fuster declares that he raised $7 million from patients for this study granted to Mount Sinai Heart, unrelated to industry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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45. Long-term mortality after acute coronary syndromes among patients with normal, mildly reduced, or reduced ejection fraction.
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Furtado RHM, Juliasz MG, Chiu FYJ, Bastos LBC, Dalcoquio TF, Lima FG, Rosa R, Caporrino CA, Bertolin A, Genestreti PRR, Ribeiro AS, Andrade MC, Giraldez RRCV, Baracioli LM, Zelniker TA, and Nicolau JC
- Subjects
- Humans, Stroke Volume, Ventricular Function, Left, Retrospective Studies, Acute Coronary Syndrome, Heart Failure, Ventricular Dysfunction, Left complications
- Abstract
Aims: Left ventricular ejection fraction (LVEF) ≤ 40% is a well-established risk factor for mortality after acute coronary syndromes (ACS). However, the long-term prognostic impact of mildly reduced ejection fraction (EF) (LVEF 41-49%) after ACS remains less clear., Methods and Results: This was a retrospective study enrolling patients admitted with ACS included in a single-centre databank. LVEF was assessed by echocardiography during index hospitalization. Patients were divided in the following categories according to LVEF: normal (LVEF ≥ 50%), mildly reduced (LVEF 41-49%), and reduced (LVEF ≤ 40%). The endpoint of interest was all-cause death after hospital discharge. A multivariable Cox model was used to adjust for confounders. A total of 3200 patients were included (1952 with normal EF, 375 with mildly reduced EF, and 873 with reduced EF). The estimated cumulative incidence rates of mortality at 10 years for patients with normal, mildly reduced, and reduced EF were 24.8%, 33.5%, and 41.3%, respectively. After adjustments, the presence of reduced EF was associated with higher mortality compared with normal EF [adjusted hazard ratio (HR) 1.64; 95% confidence interval (CI) 1.36-1.96; P < 0.001], as was mildly reduced EF compared with normal EF (adjusted HR 1.33; 95% CI 1.05-1.68; P = 0.019). The presence of reduced EF was not associated with a statistically significantly higher mortality compared with mildly reduced EF (adjusted HR 1.23; 95% CI 0.96-1.57; P = 0.095)., Conclusions: In patients with ACS, mildly reduced EF measured in the acute phase was associated with higher long-term mortality compared with patients with normal EF. These data emphasize the importance of anti-remodelling therapies for ACS patients who have LVEF in the mildly reduced range., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2023
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46. The great discovery of DOACs and why physicians insist on misusing it: A paradox of the 21 century.
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Arantes FBB and Furtado RHM
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- Administration, Oral, Anticoagulants, Humans, Physicians
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- 2022
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47. Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B.
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Bonaca MP, Morrow DA, Bergmark BA, Berg DD, Lima JAC, Hoffmann U, Kato Y, Lu MT, Kuder J, Murphy SA, Spinar J, Oude Ophuis T, Kiss RG, Lopez-Sendon J, Averkov O, Wheatcroft SB, Kubica J, Carlos Nicolau J, Furtado RHM, Abuhatzira L, Hirshberg B, Omar SA, Vavere AL, Chang YT, George RT, and Sabatine MS
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- Cholesterol, Female, Humans, Lecithins therapeutic use, Lipoproteins, HDL therapeutic use, Male, Middle Aged, Sterol O-Acyltransferase therapeutic use, Treatment Outcome, Anterior Wall Myocardial Infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Phosphatidylcholine-Sterol O-Acyltransferase therapeutic use, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction drug therapy
- Abstract
Background: High-density lipoprotein plays a key role in reverse cholesterol transport. In addition, high-density lipoprotein particles may be cardioprotective and reduce infarct size in the setting of myocardial injury. Lecithin-cholesterol acyltransferase is a rate-limiting enzyme in reverse cholesterol transport. MEDI6012 is a recombinant human lecithin-cholesterol acyltransferase that increases high-density lipoprotein cholesterol. Administration of lecithin-cholesterol acyltransferase has the potential to reduce infarct size and regress coronary plaque in acute ST-segment-elevation myocardial infarction., Methods: REAL-TIMI 63B (A Randomized, Placebo‑controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction) was a phase 2B multinational, placebo-controlled, randomized trial. Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset and planned for percutaneous intervention were randomly assigned 2:1 to MEDI6012 (2- or 6-dose regimen) or placebo and followed for 12 weeks. The primary outcome was infarct size as a percentage of left ventricular mass by cardiac MRI at 10 to 12 weeks, with the primary analysis in patients with TIMI Flow Grade 0 to 1 before percutaneous intervention who received at least 2 doses of MEDI6012. The secondary outcome was change in noncalcified plaque volume on coronary computed tomographic angiography from baseline to 10 to 12 weeks with the primary analysis in patients who received all 6 doses of MEDI6012., Results: A total of 593 patients were randomly assigned. Patients were a median of 62 years old, 77.9% male, and 95.8% statin naive. Median time from symptom onset to randomization was 146 (interquartile range [IQR], 103-221) minutes and from hospitalization to randomization was 12.7 (IQR, 6.6-24.0) minutes, and the first dose of drug was administered a median of 8 (IQR, 3-13) minutes before percutaneous intervention. The index myocardial infarction was anterior in 69.6% and TIMI Flow Grade 0 to 1 in 65.1% of patients. At 12 weeks, infarct size did not differ between treatment groups (MEDI6012: 9.71%, IQR 4.79-16.38; placebo: 10.48%, [IQR, 4.92-16.61], 1-sided P =0.79. There was also no difference in noncalcified plaque volume (geometric mean ratio, 0.96 [95% CI, NA-1.10], 1-sided P =0.30). There was no significant difference in treatment emergent serious adverse events., Conclusions: Administration of MEDI6012 in patients with acute ST-segment-elevation myocardial infarction did not result in a significant reduction in infarct size or noncalcified plaque volume at 12 weeks. MEDI6012 was well tolerated with no excess in overall serious adverse events., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03578809.
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- 2022
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48. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial.
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Fagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, and Bergmark BA
- Subjects
- Biomarkers, Humans, Proprotein Convertase 9, Risk Factors, Treatment Outcome, Anticholesteremic Agents therapeutic use, Coronary Artery Disease chemically induced, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery, Percutaneous Coronary Intervention
- Abstract
Background: Biomarkers are known to predict major adverse cardiovascular events. However, the association of biomarkers with complex coronary revascularization procedures or high-risk coronary anatomy at the time of revascularization is not understood., Objectives: We examined the associations between baseline biomarkers and major coronary events (MCE) and complex revascularization procedures., Methods: FOURIER was a randomized trial of the proprotein convertase subtilisin-kexin type 9 inhibitor evolocumab vs placebo in 27,564 patients with stable atherosclerosis. We analyzed adjusted associations among the biomarkers, MCE (coronary death, myocardial infarction, or revascularization), and complex revascularization (coronary artery bypass graft or complex percutaneous coronary intervention) using a multimarker score with 1 point assigned for each elevated biomarker (high-sensitivity C-reactive protein ≥2 mg/L; N-terminal pro-B-type natriuretic peptide ≥450 pg/mL; high-sensitivity troponin I ≥6 ng/L; growth-differentiation factor-15 ≥1,800 pg/mL)., Results: When patients were grouped by the number of elevated biomarkers (0 biomarkers, n = 6,444; 1-2 biomarkers, n = 12,439; ≥3 biomarkers, n = 2,761), there was a significant graded association between biomarker score and the risk of MCE (intermediate score: HR
adj : 1.57 [95% CI: 1.38-1.78]; high score: HRadj : 2.90 [95% CI: 2.47-3.40]), and for complex revascularization (intermediate: HRadj : 1.33 [95% CI: 1.06-1.67]; high score: HRadj : 2.07 [95% CI: 1.52-2.83]) and its components (Ptrend <0.05 for each). The number of elevated biomarkers also correlated with the presence of left main disease, multivessel disease, or chronic total occlusion at the time of revascularization (P < 0.05 for each)., Conclusions: A biomarker-based strategy identifies stable patients at risk for coronary events, including coronary artery bypass graft surgery and complex percutaneous coronary intervention, and predicts high-risk coronary anatomy at the time of revascularization. These findings provide insight into the relationships between cardiovascular biomarkers, coronary anatomical complexity, and incident clinical events. (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk [FOURIER]; NCT01764633)., Competing Interests: Funding Support and Author Disclosures The FOURIER trial received grant funding from Amgen. Reagent support was provided by Abbott Laboratories and Roche Diagnostics. The TIMI Study Group has an independent copy of the trial databases. The work of Drs Fagundes and Furtado is supported by the Lemann Foundation Cardiovascular Research Postdoctoral Fellowship – Harvard University/Brigham and Women’s Hospital. Drs Fagundes Jr, Morrow, Oyama, Furtado, Zelniker, Tang, Kuder, Murphy, Giugliano, Sabatine, and Bergmark are members of the TIMI Study Group, which has received institutional grant support through the Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc, Daiichi-Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc, Roche, Siemens Healthcare Diagnostics, Inc, The Medicines Company, and Zora Biosciences. Dr Fagundes has received a grant from The Lemann Foundation as Research Fellowships. Dr Morrow has received consulting fees from InCarda Therapeutics, Merck and Co, Novartis, and Roche Diagnostics. Dr Oyama has received a grant from JSPS Overseas Research Fellowships. Dr Furtado has received research grants and personal fees from AstraZeneca, Bayer, Biomm, and Servier; and has received research grants from Amgen, Pfizer, EMS, Aché, CytoDin, Brazilian Ministry of Health, University Health Network (received from his institution), and Lemann Foundation Research Fellowship. Dr Zelniker has received honoraria from AstraZeneca, Bayer AG, Boehringer Ingelheim, Alkem Lab, and Sun Pharmaceutical Industries; and has received research grants from the German Research Foundation and Austrian Science Funds. Dr Hamer is a stockholder in Amgen Inc; and is an employee of and stockholder in Cardiol Therapeutics Inc. Dr Keech has received grants and personal fees from Abbott and Mylan; has received personal fees from Amgen, AstraZeneca, and Pfizer; has received grants from Sanofi and Novartis; and has received personal fees from Bayer, outside the submitted work. Dr Sever has received grants and personal fees from Amgen and Pfizer. Dr Giugliano has received grants through Brigham and Women's Hospital from Amgen, Ionis, and Merck; has received honoraria from Amgen, Daiichi-Sankyo, and Merck; and has received consultant fees from Amgen, Akcea, Amarin, Boehringer Ingelheim, Bristol Myers Squibb, CVS Caremark, Daiichi-Sankyo, Esperion, GlaxoSmithKline, Merck, Sanofi, and Pfizer. Dr Sabatine has received research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Daiichi-Sankyo, Eisai, Intarcia, Ionis, The Medicines Company, MedImmune, Merck, Novartis, and Pfizer; and has served as a consultant for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Beren Therapeutics, Bristol Myers Squibb, DalCor, Dr Reddy’s Laboratories, Fibrogen, Intarcia, Merck, Moderna, Novo Nordisk, and Silence Therapeutics. Dr Bergmark has received grant support from Pfizer, Ionis, AstraZeneca, and Abbott Vascular; and has received consulting fees from Philips, Abbott Vascular, Servier, Daiichi Sankyo, Janssen, and Quark. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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49. Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial.
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Furtado RHM, Raz I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Aylward P, Dalby AJ, Dellborg M, Dimulescu D, Nicolau JC, Oude Ophuis AJM, Cahn A, Mosenzon O, Gause-Nilsson I, Langkilde AM, Sabatine MS, and Wiviott SD
- Subjects
- Aged, Benzhydryl Compounds adverse effects, Blood Pressure, Female, Glucosides, Humans, Male, Middle Aged, Acute Kidney Injury chemically induced, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 drug therapy, Heart Failure, Myocardial Infarction drug therapy, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
- Abstract
Background: Dapagliflozin improved heart failure and kidney outcomes in patients with type 2 diabetes (T2DM) with or at high risk for atherosclerotic cardiovascular disease in the DECLARE-TIMI 58 trial (Dapagliflozin Effect on Cardiovascular Events - Thrombolysis in Myocardial Infarction 58). Here, the aim was to analyze the efficacy and safety of dapagliflozin stratified according to baseline systolic blood pressure (SBP)., Methods: The DECLARE-TIMI 58 trial randomly assigned patients with T2DM and either previous atherosclerotic cardiovascular disease or atherosclerotic cardiovascular disease risk factors to dapagliflozin or placebo. Patients were categorized by baseline SBP levels: <120, 120 to 129, 130 to 139, 140 to 159, and ≥160 mm Hg (normal, elevated, stage 1, stage 2, and severe hypertension, respectively). Efficacy outcomes of interest were hospitalization for heart failure and a renal-specific composite outcome (sustained decrease in estimated glomerular filtration rate by 40%, progression to end-stage renal disease, or renal death). Safety outcomes included symptoms of volume depletion, lower extremity amputations, and acute kidney injury., Results: The trial comprised 17 160 patients; mean age, 64.0±6.8 years; 37.4% women; median duration of T2DM, 11 years; 40.6% with prevalent cardiovascular disease. Overall, dapagliflozin reduced SBP by 2.4 mm Hg (95% CI, 1.9-2.9; P <0.0001) compared with placebo at 48 months. The beneficial effects of dapagliflozin on hospitalization for heart failure and renal outcomes were consistent across all baseline SBP categories, with no evidence of modification of treatment effect ( P
interactions =0.28 and 0.52, respectively). Among normotensive patients, the hazard ratios were 0.66 (95% CI, 0.42-1.05) and 0.39 (95% CI, 0.19-0.78), respectively, for hospitalization for heart failure and the renal-specific outcome. Events of volume depletion, amputation, and acute kidney injury did not differ with dapagliflozin overall or within any baseline SBP group., Conclusions: In patients with T2DM with or at high atherosclerotic cardiovascular disease risk, dapagliflozin reduced risk for hospitalization for heart failure and renal outcomes regardless of baseline SBP, with no difference in adverse events of interest at any level of baseline SBP. These results indicate that dapagliflozin provides cardiorenal benefits in patients with T2DM at high atherosclerotic cardiovascular disease risk independent of baseline blood pressure., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01730534.- Published
- 2022
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50. Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection: An Analysis of the DARE-19 Randomized Controlled Trial.
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Heerspink HJL, Furtado RHM, Berwanger O, Koch GG, Martinez F, Mukhtar O, Verma S, Gasparyan SB, Tang F, Windsor SL, de Souza-Dantas VC, Del Sueldo M, Frankel R, Javaheri A, Maldonado RA, Morse C, Mota-Gomes M, Shemin D, Silva OL Jr, Tognon AP, Twahirwa M, Buenconsejo J, Esterline R, Oscarsson J, Ambery P, Langkilde AM, and Kosiborod MN
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- Humans, Kidney, COVID-19 complications, Diabetes Mellitus, Type 2 complications, Sodium-Glucose Transporter 2 Inhibitors adverse effects, Acute Kidney Injury chemically induced, Acute Kidney Injury complications
- Abstract
Background and Objectives: Patients who were hospitalized with coronavirus disease 2019 (COVID-19) infection are at high risk of AKI and KRT, especially in the presence of CKD. The Dapagliflozin in Respiratory Failure in Patients with COVID-19 (DARE-19) trial showed that in patients hospitalized with COVID-19, treatment with dapagliflozin versus placebo resulted in numerically fewer participants who experienced organ failure or death, although these differences were not statistically significant. We performed a secondary analysis of the DARE-19 trial to determine the efficacy and safety of dapagliflozin on kidney outcomes in the overall population and in prespecified subgroups of participants defined by baseline eGFR., Design, Setting, Participants, & Measurements: The DARE-19 trial randomized 1250 patients who were hospitalized (231 [18%] had eGFR <60 ml/min per 1.73 m
2 ) with COVID-19 and cardiometabolic risk factors to dapagliflozin or placebo. Dual primary outcomes (time to new or worsened organ dysfunction or death, and a hierarchical composite end point of recovery [change in clinical status by day 30]), and the key secondary kidney outcome (composite of AKI, KRT, or death), and safety were assessed in participants with baseline eGFR <60 and ≥60 ml/min per 1.73 m2 ., Results: The effect of dapagliflozin versus placebo on the primary prevention outcome (hazard ratio, 0.80; 95% confidence interval, 0.58 to 1.10), primary recovery outcome (win ratio, 1.09; 95% confidence interval, 0.97 to 1.22), and the composite kidney outcome (hazard ratio, 0.74; 95% confidence interval, 0.50 to 1.07) were consistent across eGFR subgroups ( P for interaction: 0.98, 0.67, and 0.44, respectively). The effects of dapagliflozin on AKI were also similar in participants with eGFR <60 ml/min per 1.73 m2 (hazard ratio, 0.71; 95% confidence interval, 0.29 to 1.77) and ≥60 ml/min per 1.73 m2 (hazard ratio, 0.69; 95% confidence interval, 0.37 to 1.29). Dapagliflozin was well tolerated in participants with eGFR <60 and ≥60 ml/min per 1.73 m2 ., Conclusions: The effects of dapagliflozin on primary and secondary outcomes in hospitalized participants with COVID-19 were consistent in those with eGFR below/above 60 ml/min per 1.73 m2 . Dapagliflozin was well tolerated and did not increase the risk of AKI in participants with eGFR below or above 60 ml/min per 1.73 m2 ., (Copyright © 2022 by the American Society of Nephrology.)- Published
- 2022
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