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2. Balance of benefit and risk of ticagrelor in patients with diabetes and stable coronary artery disease according to bleeding risk assessment with the CRUSADE score: Data from THEMIS and THEMIS PCI

Author

Ducrocq, Gregory, Bhatt, Deepak L., Lee, Jane J., Kui, Naishu, Fox, Kim M., Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Kiss, Róbert Gábor, James, Stefan, Vinereanu, Dragos, Huber, Kurt, Andersson, Marielle, Himmelmann, Anders, Simon, Tabassome, and Steg, Ph. Gabriel

Published
2022
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3. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial

Author

Wong, KS Lawrence, Amarenco, Pierre, Albers, Gregory W, Denison, Hans, Easton, J Donald, Evans, Scott R, Held, Peter, Himmelmann, Anders, Kasner, Scott E, Knutsson, Mikael, Ladenvall, Per, Minematsu, Kazuo, Molina, Carlos A, Wang, Yongjun, and Johnston, S Claiborne

Subjects
Health Services and Systems, Health Sciences, Neurosciences, Heart Disease, Patient Safety, Heart Disease - Coronary Heart Disease, Brain Disorders, Stroke, Cardiovascular, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Aspirin, Brain Ischemia, Drug Interactions, Female, Hemorrhage, Humans, Ischemic Attack, Transient, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Ticagrelor, Treatment Outcome, aspirin, platelet aggregation inhibitors, stroke, ticagrelor, transient ischemic attack, SOCRATES Steering Committee and Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurology & Neurosurgery, Clinical sciences, Allied health and rehabilitation science
Abstract

Background and purposeSOCRATES (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes), comparing ticagrelor with aspirin in patients with acute cerebral ischemia, found a nonsignificant 11% relative risk reduction for stroke, myocardial infarction, or death (P=0.07). Aspirin intake before randomization could enhance the effect of ticagrelor by conferring dual antiplatelet effect during a high-risk period for subsequent stroke. Therefore, we explored the efficacy and safety of ticagrelor versus aspirin in the patients who received any aspirin the week before randomization.MethodsA prespecified subgroup analysis in SOCRATES (n=13 199), randomizing patients with acute ischemic stroke (National Institutes of Health Stroke Scale score of ≤5) or transient ischemic attack (ABCD2 score of ≥4) to 90-day treatment with ticagrelor or aspirin. Patients in the prior-aspirin group had received any aspirin within the week before randomization. Primary end point was time to stroke, myocardial infarction, or death. Safety end point was PLATO (Study of Platelet Inhibition and Patient Outcomes) major bleeding.ResultsThe 4232 patients in the prior-aspirin group were older, had more vascular risk factors, and vascular disease than the other patients. In the prior-aspirin group, the primary end point occurred in 138/2130 (6.5%) of patients on ticagrelor and in 177/2102 (8.3%) on aspirin (hazard ratio, 0.76; 95% confidence interval, 0.61-0.95; P=0.02); in patients with no prior-aspirin usage an event occurred in 304/4459 (6.9%) and 320/4508 (7.1%) on ticagrelor and aspirin, respectively (hazard ratio, 0.96; 95% confidence interval, 0.82-1.12; P=0.59). The treatment-by-prior-aspirin interaction was not statistically significant (P=0.10). In the prior-aspirin group, major bleeding occurred in 0.7% and 0.4% of patients on ticagrelor and aspirin, respectively (hazard ratio, 1.58; 95% confidence interval, 0.68-3.65; P=0.28).ConclusionsIn this secondary analysis from SOCRATES, fewer primary end points occurred on ticagrelor treatment than on aspirin in patients receiving aspirin before randomization, but there was no significant treatment-by-prior-aspirin interaction. A new study will investigate the benefit-risk of combining ticagrelor and aspirin in patients with acute cerebral ischemia (URL: https://www.clinicaltrials.gov. Unique identifier: NCT03354429).Clinical trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01994720.

Published
2018

5. Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis

Author

Bonaca, Marc P., Bhatt, Deepak L., Simon, Tabassome, Fox, Kim Michael, Mehta, Shamir, Harrington, Robert A., Leiter, Lawrence A., Capell, Warren H., Held, Claes, Himmelmann, Anders, Ridderstrale, Wilhelm, Chen, Jersey, Lee, Jane J., Song, Yang, Andersson, Marielle, Prats, Jayne, Kosiborod, Mikhail, Mcguire, Darren K., Steg, Gabriel, Bonaca, Marc P., Bhatt, Deepak L., Simon, Tabassome, Fox, Kim Michael, Mehta, Shamir, Harrington, Robert A., Leiter, Lawrence A., Capell, Warren H., Held, Claes, Himmelmann, Anders, Ridderstrale, Wilhelm, Chen, Jersey, Lee, Jane J., Song, Yang, Andersson, Marielle, Prats, Jayne, Kosiborod, Mikhail, Mcguire, Darren K., and Steg, Gabriel

Abstract

Background Ticagrelor reduced major adverse cardiovascular events (MACE) and increased bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease. Limb events including revascularization, acute limb ischemia (ALI), and amputation are major morbidities in patients with T2DM and atherosclerosis. Objectives This study sought to determine the effect of ticagrelor on limb events. Methods Patients were randomized to ticagrelor or placebo on top of aspirin and followed for a median of 3 years. MACE (cardiovascular death, myocardial infarction, or stroke), limb events (ALI, amputation, revascularization), and bleeding were adjudicated by an independent and blinded clinical events committee. The presence of peripheral artery disease (PAD) was reported at baseline. Results Of 19,220 patients randomized, 1,687 (8.8%) had PAD at baseline. In patients receiving placebo, PAD was associated with higher MACE (10.7% vs 7.3%; HR: 1.48; P < 0.001) and limb (9.5% vs 0.8%; HR: 10.67; P < 0.001) risk. Ticagrelor reduced limb events (1.6% vs 1.3%; HR: 0.77; 95% CI: 0.61-0.96; P = 0.022) with significant reductions for revascularization (HR: 0.79; 95% CI: 0.62-0.99; P = 0.044) and ALI (HR: 0.24; 95% CI: 0.08-0.70; P = 0.009). The benefit was consistent with or without PAD (HR: 0.80; 95% CI: 0.58-1.11; and HR: 0.76; 95% CI: 0.55-1.05, respectively; P-interaction = 0.81). There was no effect modification of ticagrelor vs placebo based on PAD for MACE (P-interaction = 0.40) or TIMI major bleeding (P-interaction = 0.3239). Conclusions Patients with T2DM and atherosclerosis are at high risk of limb events. Ticagrelor decreased this risk, but increased bleeding. Future trials evaluating the combination of ticagrelor and aspirin would further elucidate the benefit/risk of such therapy in patients with PAD, including those without coronary artery disease. (A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitu

Published
2024
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7. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

Author

Santos, Vladimir, Jain, Ashit, Lendel, Irina, Russo, Michael, Haught, W H, Bouza, Manuel, Gogia, Harinder, Banerjee, Supratim, Kichura, George, Kantaros, Louis, Padron, Francisco, Passi, Rakesh, Stone, Jay, Pursley, Michael, D'Urso, Michael, Gardner, Timothy, Bennett, James, Nour, Khaled, Saini, Satinder, Zhang, Wenwu, Kumbhani, Dharam, Thomas, Dustin, Angiolillo, Dominick, Bertolet, Barry, Roman-Miranda, Amaury, Black, Robert, Manshadi, Ramin, Vaca, Carlos, Blanco, Antonio, Napoli, Mark, Brabham, David, Akyea-Djamson, Ayim, Desai, Pratik, Prasada, Sudhir, Khaira, Ajit, Forgosh, Leslie, Lieber, Ira, Umpierrez, Guillermo, Singal, Dinesh, Londono, Juan, Fraser, Neil, Ruiz, Jose, Vega, Damaris, Rodriguez, Lilia, Brown, Christopher, Syed, Faizullah, Aggarwala, Guarav, Eaves, William, Foster, Michael, Gupta, Dinesh, Avino, David, Asfour, Wail, Tonnessen, Glen, Zhao, Xue-Qiao, Singh, Narendra, Brockmyre, Andrew, Lepor, Norman, Shammas, Nicolas, Blick, David, Hearne, Steven, Prodafikas, John, Carell, Edgar, Izzo, Mark, Karim, Amin, Zakhary, Bosh, Atieh, Mahmoud, Leichter, Steven, Meadows, Charles, Hotchkiss, David, Abu-Fadel, Mazen, Wiseman, Alan, Bander, Jeffrey, Shah, Mahesh, Banerjee, Subhash, Ganim, Ricky, Sopko, Karen, Khan, Misal, Lloret, Ramon, Weirick, Troy, Mehta, Rajendra, Thadani, Udho, Bhargava, Anuj, Kosiborod, Mikhail, Moya, Jaynier, Staniloae, Cezar, Guerra, Yamirka D, Chhabra, Anil, Kosmicki, Douglas, Shaheen, Wassim, Mohammed, Akber, Bitters, J'Cinda, Pattanayak, Jan, Javier, Julian, Srivastava, Sunny, Phillips, Roland, Al-Amin, Jessie, Lillestol, Michael, Simpson, Patrick, Hazan, Lydie, Amin, Amit, Shah, Gopi, Korpas, Denes, Platt, Bruce, Dickert, Jim, Puente, Orlando, Hiotis, Louis, Doyle, Timothy, Rajan, Raj, Meholick, Alan, Gring, Christian, Hage-Korban, Elie, Feldman, Robert, Colfer, Harry, Butman, Samuel, Foster, Malcolm, Hart, Terence, Huling, Randall, Eshaghian, Shervin, Quintana, Ofsman, Cheung, Deanna, Handel, Franklin, Rodriguez, Mara, Suh, David, Gordon, Paul, Pressman, Gregg, Bauer, Michael, French, William, Barettella, Mark, Chatrathi, Sridhar, Suresh, Damodhar, Goldberg, Ronald, Huth, Mark, Younis, Liwa, Rahman, Aref, Mascolo, Richard, Welch, Michelle, Suneja, Randeep, Smith, Stephen, Shurmur, Scott, Agaiby, John, Jingo, Ahmad, Johnston, Janice, Beth, Mary, Vlastaris, Anthony, Kemp, Susan, Taheri, Hamid, Pereira, Edward, Deyoung, Michael, Hawa, Zafir, Smith, Ray, Galski, Thomas, Garas, Samer, Reddy, M, Sharma, Susheel, Hargrove, Joeseph, Treasure, Charles, Emerson, Ronald, Haddad, Tariq, Rohr, Kathryn, Levinson, Larry, Gaona, Raul, Uretsky, Barry, Maheshwari, Hiralal, Lee, Denny, Kinnaman, Stephanie, Singal, Robert, Geohas, Jeffrey, Gigliotti, Osvaldo, Raisinghani, Ajit, Khurana, Charanjit, Hella, Brent, Kelberman, Michael, Voyce, Steven, Singh, Sanjay, Lo, Eric, Singh, Pradeep, Goodfellow, Ross, Fischer, Stuart, Lorraine, Richard, Turner, Traci, Shanes, Jeffrey, Busch, Robert, Broker, Robert, Zaniewski, Michelle, Pounds, Kevin, Debs-Perez, Giselle, Ong, Stephen, Frandsen, Brad, Fullington, Douglas, Jaffrani, Naseem, Khan, Ahtaram, Lee, Marcus, Pouzar, Joe, Revtyak, George, Gonzalez, Julian, Nakhle, Samer, Murillo, Abel, Young, Douglas, Makam, Sashi, Syed, Mushtaq, Woolf, Kevin, Grena, Paul, Alfata, Sarab, Mahal, Sharan, Hoffman, David, Kizhakekuttu, Tinoy, Deering, Joseph, Bhavsar, Janak, Mikesell, Scott, Wilson, William, Wilson, Vance, El, Salah, Spinale, Francis, Kannarkat, Vinod, Rao, Sunder, Hanson, Lenita, Bertsch, John, Gonzalez-Ortiz, Elena, Severino, Norma, Willis, John, Schock, Joel, Bakhtari, Ladan, Gazmuri, Raul, Ansari, Saadat, Hall, Jason, Mehta, Arvind, Shealy, Neal, Zarich, Stuart, Singh, Deovrat, Vora, Kishor, Andrawis, Nabil, Molter, Darron, Maron, David, Cardona, Jose, D'Agostino, Ronald, Arshad, Tamjeed, Samaan, Rodney, Jones, David, Presser, Dale, Heath, John, Green, Sandy, Bittar, George, Henry, Sheldon, Korn, David, Schmedtje, John, Nadar, Venkatesh, Graham, Bruce, Labroo, Ajay, Clavijo, Leonardo, Roseman, Hal, Ledesma, Gilbert, Rosen, Robert, Dor, Isaac, Kirby, William, Sutton, Jennefer, Eder, Frank, Iteld, Bruce, Gomez-Cortes, Jose, Buchbinder, Maurice, Kasper, Joseph, Terrelonge, Antonio, Torres, Gustavo, Jagielo, Ted, Alvarez, Jose, Handelsman, Yehuda, Guillen, Mario, Richwine, Randall, Lewy-Alterbaum, Lorena, Corder, Clinton, Arvind, Moogali, Bolshoun, David, Mikhail, Magdy, Minton, Stephen, Alvarado, Odilon, Abbott, J, Cauthen, Brett, Welter, Ryan, Mintz, Randy, Cox, John, Quick, Annette, Weiss, Melvin, Dy, Johnny, Zebrack, James, Gandelman, Glenn, Hegde, Vinayak, Silver, Marc, DeGregorio, Michele, Lawson, William, Paa, Christopher, Bortnick, Anna, Krolick, Merrill, Sotolongo, Rodolfo, Cheirif, Jorge, Kumar, Priya, Jetty, Preetham, Patel, Ambar, Kruk, Mariusz, Kobielusz-Gembala, Iwona, Rewerska, Barbara, Madrzejewski, Adam, Milewski, Krzysztof, Cygler, Jerzy, Petryka-Mazurkiewicz, Joanna, Jastrzebski, Waldemar, Korecki, Janusz, Fil, Wojciech, Prokopczuk, Janusz, Bochenek, Anna, Wujkowski, Marek, Witek, Robert, Konczakowski, Piotr, Miekus, Pawel, Szczasny, Marcin, Musial, Wlodzimierz, Cymerman, Krzysztof, Lampart, Jacek, Mikosinski, Jacek, Szynal, Slawomir, Fares, Issa, Opolski, Grzegorz, Mazur, Stanislaw, Wozakowska-Kaplon, Beata, Bijata-Bronisz, Renata, Wierucki, Lukasz, Losa, Beata, Drelich, Grzegorz, Konieczny, Marek, Starczewski, Pawel, Pawlowicz, Lidia, Jesionowski, Pawel, Jurowiecki, Jaroslaw, Gniot, Jacek, Czyzycki, Mariusz, Stania, Karol, Kucharczyk-Bauman, Izabela, Busz-Papiez, Benita, Karczmarczyk, Agnieszka, Sudnik, Wanda, Koszek, Alina, Kolodziej, Piotr, Skwarna, Bartosz, Jaramillo, Nicolás, Jankowski, Maciej, Czochra, Wojciech, Kinasz, Leszek, Miklaszewicz, Beata, Stasinska, Teresa, Pluta, Wladyslaw, Basiak, Marcin, Rusicka, Teresa, Niedbal-Yahfouf, Izabela, Popenda, Grazyna, Korzeniak, Romuald, Mirek, Agnieszka, Mariankowski, Rafal, Wojnowski, Lukasz, Korol, Marek, Baszak, Jacek, Podolec, Piotr, Piesiewicz, Wojciech, Zurakowski, Aleksander, Luengas, Carlos, Skura, Marek, Pilecki, Piotr, Majchrzak, Piotr, Krzyzagórska, Ewa, Drozd, Marcin, Kaczmarek, Barbara, Sliwinska, Teresa, Zelazowska, Katarzyna, Sztembis, Rafal, Landa, Katarzyna, Matyszczak-Toniak, Lidia, Strojek, Krzysztof, Piepiorka, Marek, Malinowski, Robert, Górska, Maria, Stolarczyk-Sowa, Edyta, Romanowski, Leszek, Zinka, Elzbieta, Reszka, Zygfryd, Skierkowska, Joanna, Uzunow, Anna, Laskowska-Derlaga, Ewa, Puntus, Ekaterina, Kosmacheva, Elena D, Koziolova, Natalia, Pavlov, Prokhor, Supryadkina, Tatiana, Didenko, Yury, Kopylov, Philipp, Kazakov, Andrei, Aksentiev, Sergei, Vishneva, Elena, Repin, Alexey, Smolenskaya, Olga, Mantserova, Olga, Khrustalev, Oleg, Privalova, Elena, Konstantinov, Vladimir, Boldueva, Svetlana, Ezhov, Andrey, Chernyavsky, Alexander, Kamalov, Gadel, Galyavich, Albert, Zubeeva, Galina, Nechaeva, Galina, Shustov, Sergey, Dzhaiani, Nino, Treshkur, Tatiana, Osokina, Nataliya, Panov, Alexey, Shutemova, Elena, Makukhin, Valeriy, Kropotina, Tatiana, Tsyba, Larisa, Karpov, Yuri, Sizova, J M, Ballyuzek, Marina, Tarasov, Nikolay, Demchenko, Elena, Barbarash, Olga, Moiseev, Valentin, Markov, Valentin, Kuznetsov, Vadim, Viktorova, Inna, Sergienko, Igor, Ermoshkina, Lyudmila, Khasanov, Niyaz, Khlevchuk, Tatiana, Baglikov, Andrey, Shalaev, Sergey, Zonova, Elena, Reznik, Elena, Haisheva, Larisa, Morugova, Tatyana, Lomakin, Nikita, Vishnevsky, Alexander, Shvarts, Yuri, Magnitskaya, Olga, Mikhailusova, Marina, Pavlysh, Elena, Libov, Igor, Zateyschikova, Anna, Kostenko, Victor, Edin, Anton, Khovaeva, Yaroslava, Zakharov, Konstantin, Stryuk, Raisa, Khirmanov, Vladimir, Kanorskiy, Sergey, Yakushin, Sergey, Barabashkina, Anna, Li, Hongwei, Zhao, Qiang, Zhang, Jian, Ma, Jianhua, He, Yong, Luo, Ming, Zhang, Aidong, Zhang, Ningru, Chai, Yingru, Ma, Genshan, Wang, Hao, Liu, Zhigang, He, Lanjie, Song, Zhifang, Dong, Xiaolin, Tao, Liang, Li, Zhanquan, Su, Xi, Kong, Xiangqing, Niu, Heping, Ge, Junbo, Luo, Zhurong, Huang, Wenjun, Peng, Daoquan, Yuan, Zuyi, Milanova, Maria, Tenev, Doncho, Gogov, Antoni, Karageorgiev, Dimitar, Kolchev, Todor, Rusev, Nikolay, Georgieva, Nikolina, Kondov, Rumen, Rusinov, Veselin, Petrov, Ivo, Stanchev, Georgi, Konteva, Mariana, Dincheva, Adriana, Yaneva, Zdravka, Vatova, Ralitsa, Ilieva, Katya, Runev, Nikolai, Kolomanov, Borislav, Petrov, Ivan, Iliev, Nikolay, Tisheva, Snezhanka, Chompalova, Boryana, Tokmakova, Maria, Raev, Dimitar, Byanov, Kolyo, Markov, Dimitar, Mihov, Lenko, Mihov, Atanas, Milcheva, Nora, Minchev, Milen, Mollov, Mihail, Borisov, Borislav, Tihchev, Tihomir, Karakolev, Venelin, Dimov, Bojidar, Georgiev, Svetoslav, Smilov, Lachezar, Koo, Bon K, Ahn, Taehoon, Hong, Soon J, Yoon, Junghan, Oh, Seok K, Jeong, Myung H, Kim, Doo-Il, Chang, Kiyuk, Kim, Weon, Hahn, Joo-Yong, Cha, Kwang S, Lee, Jung-Hee, Choi, Si-Wan, Nam, Chang-Wook, Chae, In-Ho, Park, Yong H, Tahk, Seung-Jea, Shin, Won-Yong, Chae, Jei-Keon, Kim, Byung J, Bae, Jang-Whan, Park, Woo J, Rha, Seung W, Choi, Young J, Hwang, Jin-Yong, Park, Hun S, Baracioli, Luciano, Guimaraes, Fabio, Vasconcellos, Eduardo, Saraiva, José, Pereira, Adamastor, Santos, Queulla, Rossi, Paulo, Maia, Lilia, Madeira, Miguel, Pereira, Marcio, Botelho, Roberto, Reis, Gilmar, Eliaschewitz, Freddy, Borges, Joao, Nascimento, Carlos, Fortes, Jose A, de Souza, Weimar, Pimentel, Pedro, Hissa, Miguel, Franchetti, Marcos, Precoma, Dalton, Ortiz, Costantino, Hernandes, Mauro, Saporito, Wladmir, dos Santos, Fabio R, Kormann, Adrian, Neuenschwander, Fernando, Dutra, Oscar, Rassi, Nelson, Tanajura, Luiz, Souza, Juliana, Junior, Delcio S, Leaes, Paulo, Forte, Adriana, Bonansea, Teresa C, Marin, Jose, Machado, Bruno, Cerqueira, Maria J, Silva, Frederico, Michalaros, Yorghos, Manenti, Euler, Cercato, Cintia, Figueiredo, Estevao, Liu, Ming-En, Wang, Yi-Chih, Lee, Tsung-Ming, Fang, Chih, Wu, Yen-Wen, Ueng, Kwo-Chang, Sheu, Huey-Herng, Lai, Wen T, Hsieh, I-Chang, Chen, Zhih-Cherng, Lee, Mu-Jang, Chiang, Chern, Shyu, Kou-Gi, Hsia, Chien-Hsun, Mar, Guang-Yuan, Chan, Shih-Hung, Wu, Chih-Cheng, Tseng, Wei-Kung, Chang, Kuan-Cheng, Yeh, Hung-I, Wang, Ji-Hung, Hou, Charles, Sorokina, Inna, Dolzhenko, Maryna, Horoshko, Olha, Karpenko, Oleksandr, Rudenko, Leonid, Vakaliuk, Igor, Kulyk, Anna, Levchenko, Olena, Prokhorov, Oleksandr, Reshotko, Dmytro, Sorokivskyy, Mykhaylo, Velichko, Nataliia, Maslovskyi, Valentyn, Teliatnikova, Zinaida, Dotsenko, Sergiy, Krakhmalova, Olena, Kraiz, Igor, Zharinova, Viktoria, Bula, Larysa, Kaydashev, Igor, Molodtsov, Valeriy, Rasputina, Lesya, Pidlisna, Viktoriya, Lysunets, Olena, Kravchenko, Anatoliy, Glushko, Liubomyr, Khomazyuk, Tetyana, Svyshchenko, Yevgeniya, Parkhomenko, Oleksandr, Mankovsky, Boris, Abrahamovych, Orest, Yagensky, Andriy, Stanislavchuk, Mykola, Vasilyeva, Larisa, Sokolova, Liubov, Sychov, Oleg, Tseluyko, Vira, Kyrychenko, Igor, Rishko, Mykola, Furkalo, Sergiy, Gallo, Richard, Bertrand, Olivier, Mehta, Shamir, Constance, Christian, Sussex, Bruce, Zadra, Remo, Kouz, Simon, Chehayeb, Raja, Pandey, Amritanshu, Dion, Danielle, Bailey, Gordon, Hill, Laurie, Ramanathan, Krishnan, Dorsch, Micha, Nanji, Alykhan, Babapulle, Mohan, Montigny, Martine, Gosselin, Gilbert, Dehghani, Payam, Rupka, Dennis, Le May, Michel, Pichette, Francis, St-Maurice, Francois, Teefy, Patrick, Mansour, Samer, Kassam, Saleem, Cheung, Stephen, Siega, Anthony D, O'Keefe, Dennis, Sabbah, Eric, Bell, Alan, Chouinard, Guy, Wong, Brian, Miller, Mark, Gaudet, Daniel, Lachance, Pierre, Bata, Iqbal, Petrella, Robert, Gossard, Denis, Dumas, Richard, Ing, Douglas, Boyrazian, Hagop, Bessoudo, Ricardo, Huynh, Thao T, Hart, Randy, Belle-Isle, Jasmin, Shukla, Dinkar, Kelly, Allan, Mazza, Giuseppe, Cha, James, Henein, Sam, Frechette, Andre, Vizel, Saul, Liutkus, Joanne F, O'Mahony, Michael, Halperin, Frank, Kooy, Jacobus, Graham, John, Bailey, Allan, Wojcik, Ronald, Wilderman, Igor, Turi, Tibor, Motyovszki, Ákos, Merkely, Béla, Király, Csaba, Andrássy, Péter, Sárszegi, Zsolt, Fülöp, Tibor, Zilahi, Zsolt, Édes, István, Papp, Andras, Müller, Gábor, Czigány, Anna, Zólyomi, Szilárd, Korányi, László, Takács, János, Juhász, Ferenc, Benczur, Bela, Kancz, Sándor, Földi, András, Nagy, András C, Bakai, Judit, Greschik, István, Püski, László, Nagy, László, Kirschner, Róbert, Kuchar, Roman, Hajek, Petr, Busak, Ladislav, Michalik, Daniel, Matyasek, Ivo, Marusincova, Ivana, Kucera, Dusan, Jerabek, Ondrej, Honkova, Michaela, Dedek, Vratislav, Rihacek, Ivan, Kos, Pavel, Slaby, Josef, Machkova, Martina, Zidkova, Eva, Elbl, Lubomir, Grunfeldova, Hana, Carda, Jiri, Mrozek, Vladimir, Maly, Jiri, Milkovic, Richard, Malecha, Jan, Skalicka, Hana, Oral, Ivo, Krcova, Eva, Lisa, Libor, Belohlavek, Jan, Miklik, Roman, Cermak, Ondrej, Bednarova, Jana, Peroutka, Zdenek, Spinar, Jindrich, Wilke, Andreas, Appel, Karl-Friedrich, Taggeselle, Jens, Förster, Andreas, Toursarkissian, Nicole, Schmidt, Ekkehard, Bott, Jochen, Al-Zoebi, Ayham, Hennig, Dirk, Fischer, Sabine, Schön, Norbert, Sauter, Joachim, Simonis, Gregor, Nischik, Ruth, Rieker, Werner, Schenkenberger, Isabelle, Behnke, Thomas, Klausmann, Gerhard, Jeserich, Michael, Trenk, Dietmar, Weigmann, Ingo, Reuter, Hannes, Rummel, Reinhard, von Münchhausen, Candy, von Engelhardt, Charlotte, Horibe, Eishun, Shibasaki, Taro, Sato, Tomohiko, Kakuta, Tsunekazu, Michishita, Ichiro, Tan, Michinao, Ishiki, Ryoji, Aoyama, Takahiko, Higashiue, Shinichi, Niijima, Yawara, Idogaki, Akira, Hasegawa, Toru, Kiyosue, Arihiro, Tomobuchi, Yoshiaki, Kawamitsu, Katsunori, Kawasaki, Satsuki, Hata, Yoshiki, Fukui, Kazuki, Seki, Kozaburo, Takenaka, Takashi, Abe, Mitsuru, Utsu, Noriaki, Oono, Atsuyuki, Mitsuo, Kazuhisa, Sueyoshi, Atsushi, Hirohata, Atsushi, Tsujimoto, Mitsuru, Ueda, Osamu, Takase, Shinichi, Suzuki, Masahiro, Sakuragi, Satoru, Yamamoto, Fumi, Fujimoto, Noritaka, Kakinoki, Shigeo, Sugiura, Tatsushi, Sugino, Hiroshi, Nakamura, Toshihiro, Goto, Shinya, Kadokami, Toshiaki, Uehara, Hiroki, Ono, Masahiro, Yokoya, Koichi, Koike, Akihiro, Komatsu, Sei, Sonoda, Masahiro, Ueno, Hideki, Doi, Tomofumi, Takagi, Yuichiro, Fujimoto, Kazuteru, Eki, Yutaka, Okubo, Munenori, Sasaki, Kenichiro, van Eck, Martijn, Ronner, Eelko, The, Salem, van de Wal, Ruud, Nierop, Pieter, de Nooijer, Cornelis, Werner, Henri, Westendorp, Iris, van der Zwaan, Coen, Crijns, Hendrikus, Cornel, Jan H, Strikwerda, Sipke, Bos, Robert, de Melker, Edwin, Kuijper, Adrianus, Louwerenburg, Hans, Plomp, Jacobus, Dantzig, Jan-Melle, Prins, Francisco, van Kesteren, Henricus, Willems, Frank, Amoroso, Giovanni, Carnero, Gabriela, Duronto, Ernesto, Besada, Diego, Chacon, Carolina, Zangroniz, Pedro, Solis, Silvana, Liberman, Alberto, Sernia, Virginia, Alvarisqueta, Andres, Maffei, Laura, Vilamajo, Oscar G, García, Celso, Sicer, Maximiliano, Muntaner, Juan, Bordonava, Anselmo, Albisu, Juan, Zanini, Alejandra, Rista, Lucas, Hominal, Miguel, Estrada, José N, Prado, Aldo, Gosparini, Diego M, Schiavi, Beatriz, Castillo, Armando G, Ruíz, José G, Martinez, Guillermo R, López, Víctor G, Rosas, Enrique L, Lopez, Gabriel R, Cantu, Elias G, de los Ríos Ibarra, Manuel, Padilla, Francisco P, Carrasco, Jose P, Carrillo, Luis V, García, Joel D, Askar, Alfredo N, Salinas, Carlos A, Gamba, Marco A, Sanchez, Carlos G, Cantú, Arnulfo G, Sánchez, Raul V, Madrigal, Jaime C, Urbano, Rafael H, Romo, Andrés Í, González Juanatey, José R, Racugno, Paolo, Fillat, Angel C, de la Torre Hernández, José M, Peláez, Juan A, Cortada, Jorge B, Pavia, Pablo G, Navarro, Manuel J, Asenjo, Roberto M, Díaz, Francisco F, Peligero, Eduard B, Manterola, Fernando A, Ortiz, Antonio F, Mediavilla García, Juan D, Ortuño, Francisco M, Vera, Tomás R, González, Alfonso S, Viñas, Jaime A, Fernández Portales, Francisco J, Mayordomo, Petra S, Ojeda, Francisco B, Domínguez, Antonio R, González, Rosa S, Guerrero, Diego B, Ruiz Nodar, Juan M, Marimon, Xavier G, Margáez, José G, Aguilera, Roberto M, Díaz Fernández, José F, Zamorano Gómez, José L, González, Vicente B, del Blanco, Bruno G, Pérez, Ignacio P, Moreno, Mercé R, Ereño, Ainhoa R, García Lledó, José A, Prieto, Juan, Villablanca, Alex, Raffo, Carlos, Pincetti, Christian, Conejeros, Carlos, Roman, Oscar, Rodriguez, Manuel, Varleta, Paola, Goldberg, Cindy, Sandoval, Jorge, Arriagada, German, Leon, Lucio, Potthoff, Sergio, Cobos, Jorge, Figueroa, Christian, Makotoko, Ellen, Fourie, Nyda, Burgess, Lesley, Nortje, Hendrik, Theron, Rust, Pillai, Perumal, Ranjith, Naresh, Trokis, Julien, Pillay, Soobramoney, Reddy, Jeevren, Nunkoo, Theema, Kapp, Cornelia, Urbach, Dorothea, Distiller, Lawrence, Horak, Adrian, van Zyl, Louis, Coetzee, Kathleen, Punt, Zelda, Bayat, Junaid, Dawood, Saleem, Mitha, Ismail, Padayachee, Trevenesan, Hoosen, Farzana, Dalby, Anthony, Prabhavathi, Gowdaiah, Prakash, Mehta, Vimal, Chag, Milan, Gadkari, Milind, Ramamurthee, Kannaiyan, Das, Asit, Sawhney, Jitendra S, Banerjee, Suvro, Sathe, Prachee, Adhyapak, Srilakshmi, Nguyen, Tuan, Pham, Vinh, Do, Huan, Nguyen, Anh, Nguyen, Hien, Truong, Binh, Jamil-Copley, Shahnaz, Lang, Chim, Pell, Alastair, Zaman, Azfar, Storey, Robert, Swanson, Neil, Smith, Simon, Sharman, David, Braganza, Denise, Hammond, Peter, Moriarty, Andrew, Bain, Stephen, Pye, Maurice, Sharp, Andrew, Blagden, Mark, Randeva, Harpal, Myhill, Timothy, Viswanathan, Girish, Keeling, Philip, Clifford, Piers, Saxena, Manish, Lyons, Kristopher, McMurray, John, Jaafar, Feeroz, Murphy, Clare, Cartwright, Simon, Abouglila, Kamal, Antalik, Lubomir, Krajci, Peter, Urban, Miroslav, Fazekas, Frantisek, Pella, Daniel, Koleny, Daniel, Vykoukalova, Tatiana, Macek, Vladimir, Vinanska, Daniela, Jamriskova, Livia, Such, Slavomir, Fulop, Peter, Farsky, Stefan, Bugan, Viliam, Strbova, Jaroslava, Micko, Karol, Palka Jr, Juraj, Sivak, Vladimir, Kristensen, Dalby, Refsgaard, Jens, Holmvang, Lene, Dixen, Ulrik, Nielsen, Henrik, Egstrup, Kenneth, Jensen, Lisette O, Sykulski, Roman, Rasmussen, Ole, Andries, Alin, Luckow, Anders, Nielsen, Gitte, Sørensen, Torben, Wongvipaporn, Chaiyasith, Chamnarnphol, Noppadol, Srimahachota, Suphot, Sansanayudh, Nakarin, Kuanprasert, Srun, Tresukosol, Damras, Sookananchai, Bancha, Kanadasi, Mehmet, Ozcan, Turkay, Kucuk, Murathan, Ongen, Zeki, Okuyan, Ertugrul, Arat, Alev, Acikel, Sadik, Yalcin, Ahmet, Guray, Umit, Ceyhan, Ceyhun, Ozer, Necla, Arslan, Sakir, Angerås, Oskar, Johnston, Nina, Weiderman, Ann-Charlotte, Bandh, Stellan, Hansen, Ole, Larnefeldt, Hans, Kusiak, Dawid, Lindholm, Carl-Johan, Hedman, Anders, Erlinge, David, Curiac, Dan, Lundman, Pia, Zucconi-Mazzini, Roberto, Aladellie, Layth, Jensen, Jens, Verwerft, Jan, Vrolix, Mathias, Faes, Dirk, Striekwold, Harry, Sinnaeve, Peter, Timmermans, Patrick, Guedes, Antoine, Delforge, Marc, Nimmegeers, Jan, Stammen, Francis, Buysschaert, Ian, Hoffer, Etienne, Hollanders, Geert, Vervoort, Geert, Coussement, Patrick, de Maeseneire, Stefan, Janssens, Luc, Gravdal, Stein A, Risberg, Knut, Gullestad, Lars, Hofseth, Ola D, Nilsen, Dennis, Lappegård, Knut T, van den Heuvel, Christian, Gibbs, Charlotte, Khusrawi, Alamdar, Arora, Satish, Tomala, Tadeusz, Kjærnli, Thorbjørn, Berg-Johansen, Jan, Hagemeier, Robert, Skjelvan, Gunnar, Colquhoun, David, Amerena, John, Morbey, Claire, Hammett, Christopher, Dart, Anthony, Lehman, Ronald, Hamilton, Andrew, Worthley, Matthew, Purnell, Peter, Whelan, Alan, MacIsaac, Richard, Arya, Ktut, Linjawi, Sultan, Proietto, Joseph, Prasad, Lakshman, Rodriguez, Aldo, Godoy, Armando, Rodriguez, Victor, Berrospi, Percy, Chavez, Carlos, Negron, Sandra, Heredia, Javier, Medina, Felix, Manrique, Helard, Cabrera, Walter, Cordova, Fernando, Quinteros, Trinidad, Haro, Jaime M, Regalado, Susana, Guitton, Javier, Arbanil, Hugo, Pansieri, Michel, Decoulx, Eric, Goube, Pascal, de Labriolle, Axel, Labeque, Jean N, Range, Gregoire, Cottin, Yves, Montalescot, Gilles, Cayla, Guillaume, Danchin, Nicolas, Angoulvant, Denis, Ferrario, Emile, Elbaz, Meyer, Dubreuil, Olivier, Steg, Philippe G, Fontaine, Caroline, Sorbets, Emmanuel, Omer, Hafiz, Al-Saif, Shukri, Al-Faleh, Hussam, Al-Shehri, Abdullah, Alshehri, Halia, Bazari, Rasha, Hei, Pak, Ying, Man, Chan, Michael, Wong, Michelle, Ma, Ronald, Siu, Shing C, Tsang, Chiu C, Ferrario, Maurizio, Assanelli, Emilio, Senni, Michele, Piatti, Piermarco, Calabrò, Paolo, Urbinati, Stefano, Michisanti, Massimo, Varbella, Ferdinando, de Cosmo, Salvatore, Trevisan, Roberto, Bellotti, Sandro, Di Pasquale, Giuseppe, Bongo, Angelo S, Uguccioni, Massimo, Mannucci, Edoardo, Mauro, Ciro, Ragonese, Mauro, Fresco, Claudio, Turturo, Maurizio, Marcucci, Rossella, Lievano Triana, Manuel J, Arana, Camilo, Accini, Jose, Botero, Rodrigo, Muzyk-Osikowicz, Marlena, Dada, Fredy T, Vallejo, Gregorio S, Manzur, Fernando, Isaza, Daniel, Molina, Dora, Mesa, Juan G, Quintero, Alvaro, Nyman, Kai, Mäkelä, Jyrki, Strand, Jorma, Nieminen, Sakari, Taurio, Jyrki, Kuusela, Matti, Valle, Timo, Pietilä, Mikko, Kekki, Sakari, Strandberg, Timo, Klutstein, Marc, Greenberg, Gabriel, Rozenman, Yoseph, Chorin, Ehud, Roguin, Ariel, Lewis, Basil, Bashkin, Amir, Tan, Edgar, Prado, Jose P, Ferrolino, Arthur, Babilonia, Noe, Barbas, Benny, Matiga, Generoso, Coching, Raul M, Drexel, Heinz, Brath, Helmut, Schnack, Christoph, Hanusch, Ursula, Fließer-Görzer, Evelyn, Paulweber, Bernhard, Ebenbichler, Christoph, Prager, Rudolf, Huber, Kurt, Wolzt, Michael, Auer, Johann, Berger, Rudolf, Schernthaner, Gerit-Holger, Stanciulescu, Gabriela, Creteanu, Mihai, Spiridon, Marilena, Dobreanu, Viorica, Vinereanu, Dragos, Iosipescu, Laura C, Istratoaie, Octavian, Coman, Ioan, Militaru, Constantin, Cinteza, Mircea, Bhatt, Deepak L, Fox, Kim, Harrington, Robert A, Leiter, Lawrence A, Mehta, Shamir R, Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Diaz, Rafael, Sinnaeve, Peter R, Nicolau, José C, Kerr Saraiva, José F, Corbalán, Ramón, Widimský, Petr, Kristensen, Steen D, Hartikainen, Juha, Darius, Harald, Tse, Hung F, Kiss, Robert G, Pais, Prem, Lev, Eli, de Luca, Leonardo, Ramos López, Gabriel A, Kontny, Frederic, Babilonia, Noe A, Zateyshchikov, Dmitry A, Ruda, Mikhail, Elamin, Omer, Kovář, František, Dalby, Anthony J, Bueno, Héctor, James, Stefan K, Chiang, Chern-En, Ray, Kausik K, Parkhomenko, Alexander, McGuire, Darren K, Kosiborod, Mikhail N, Nguyen, Tuan Q, Chen, Jersey, Leonsson-Zachrisson, Maria, Ridderstråle, Wilhelm, Steg, Philippe Gabriel, Held, Claes, Song, Yang, and Parkhomenko, Alexander N

Published
2019
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9. Safety of ticagrelor in patients with baseline conduction abnormalities: A PLATO (Study of Platelet Inhibition and Patient Outcomes) analysis

Author

Scirica, Benjamin M., Bansilal, Sameer, Davoudi, Farideh, Armstrong, Paul W., Clare, Robert M., Schulte, Phillip J., Pieper, Karen S., Becker, Richard C., James, Stefan K., Storey, Robert F., Steg, Philippe Gabriel, Held, Claes, Himmelmann, Anders, Mahaffey, Kenneth W., Wallentin, Lars, and Cannon, Christopher P.

Published
2018
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12. Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack: an economic evaluation of the THALES trial

Author

Tank, Amarjeet, primary, Johnston, S Claiborne, additional, Jain, Ritika, additional, Amarenco, Pierre, additional, Mellström, Carl, additional, Rikner, Klas, additional, Denison, Hans, additional, Ladenvall, Per, additional, Knutsson, Mikael, additional, Himmelmann, Anders, additional, Evans, Scott R, additional, James, Stefan, additional, Molina, Carlos A, additional, Wang, Yongjun, additional, and Ouwens, Mario, additional

Published
2023
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13. Impact of glycoprotein IIb/IIIa inhibitors on the efficacy and safety of ticagrelor compared with clopidogrel in patients with acute coronary syndromes: Analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial

Author

Shimada, Yuichi J., Bansilal, Sameer, Wiviott, Stephen D., Becker, Richard C., Harrington, Robert A., Himmelmann, Anders, Neely, Benjamin, Husted, Steen, James, Stefan K., Katus, Hugo A., Lopes, Renato D., Steg, Ph. Gabriel, Storey, Robert F., Wallentin, Lars, and Cannon, Christopher P.

Published
2016
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14. Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack : an economic evaluation of the THALES trial

Author

Tank, Amarjeet, Johnston, S. Claiborne, Jain, Ritika, Amarenco, Pierre, Mellstrom, Carl, Rikner, Klas, Denison, Hans, Ladenvall, Per, Knutsson, Mikael, Himmelmann, Anders, Evans, Scott R., James, Stefan, Molina, Carlos A., Wang, Yongjun, Ouwens, Mario, Tank, Amarjeet, Johnston, S. Claiborne, Jain, Ritika, Amarenco, Pierre, Mellstrom, Carl, Rikner, Klas, Denison, Hans, Ladenvall, Per, Knutsson, Mikael, Himmelmann, Anders, Evans, Scott R., James, Stefan, Molina, Carlos A., Wang, Yongjun, and Ouwens, Mario

Abstract

Objective THALES demonstrated that ticagrelor plus aspirin reduced the risk of stroke or death but increased bleeding versus aspirin during the 30 days following a mild-to-moderate acute non-cardioembolic ischaemic stroke (AIS) or high-risk transient ischaemic attack (TIA). There are no cost-effectiveness analyses supporting this combination in Europe. To address this, a cost-effectiveness analysis was performed. Methods Cost-effectiveness was evaluated using a decision tree and Markov model with a short-term and long-term (30-year) horizon. Stroke, mortality, bleeding and EuroQol-5 Dimension (EQ-5D) data from THALES were used to estimate short-term outcomes. Model transitions were based on stroke severity (disabling stroke was defined as modified Rankin Scale >2). Healthcare resource utilisation and EQ-5D data beyond 30 days were based on SOCRATES, another trial in AIS/TIA that compared ticagrelor with aspirin. Long-term costs, survival and disutilities were based on published literature. Unit costs were derived from national databases and discounted at 3% annually from a Swedish healthcare perspective. Results One-month treatment with ticagrelor plus aspirin resulted in 12 fewer strokes, 4 additional major bleeds and cost savings of euro95 000 per 1000 patients versus aspirin from a Swedish healthcare perspective. This translated into increased quality-adjusted life-years (0.04) and reduced societal costs (-euro1358) per patient over a lifetime horizon. Key drivers of cost-effectiveness were number of patients experiencing subsequent disabling stroke and degree of disability. Findings were robust over a range of input assumptions. Conclusion One month of treatment with ticagrelor plus aspirin is likely to improve outcomes and reduce costs versus aspirin in mild-to-moderate AIS or high-risk TIA.Trial registration number NCT03354429.

Published
2023
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15. Real world evidence : Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency

Author

Szymanski, Piotr, Weidinger, Franz, Lordereau-Richard, Isabelle, Himmelmann, Anders, Arca, Marcello, Chaves, Jose, Lee, Charles, Jonker, Carla, Kotecha, Dipak, O'Kelly, James, Plueschke, Kelly, Rys, Andrzej, Segec, Andrej, Wallentin, Lars, Veltrop, Rogier, James, Stefan, Szymanski, Piotr, Weidinger, Franz, Lordereau-Richard, Isabelle, Himmelmann, Anders, Arca, Marcello, Chaves, Jose, Lee, Charles, Jonker, Carla, Kotecha, Dipak, O'Kelly, James, Plueschke, Kelly, Rys, Andrzej, Segec, Andrej, Wallentin, Lars, Veltrop, Rogier, and James, Stefan

Abstract

Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). Real world data has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines. The utility of RWD may be facilitated by common data models, which standardise format and content, and allow data from different health systems to be analysed together. The European Society of Cardiology (ESC) supports the use of RWD in collaboration with national cardiac societies, regulatory authorities, and industry to encourage continuous quality of care improvements at the hospital and country level, to conduct registry-based randomised clinical trials (R-RCT) and to facilitate safety surveillance of novel drugs and devices. The European Medicines Agency (EMA) is developing systems and processes to enable the use of RWD that can help in trial planning, defining clinical contexts, and enhancing outcome assessments. RWD can also contribute to the measurement of the impact of regulatory actions, such as contraindications or restriction of indications by looking at medicines use patterns over time across European Member States. A number of other initiatives from the European Commission and the EMA are underway to strengthen the EU's health security framework, and foster the collection and utilisation of RWD.

Published
2023
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16. PREVALENCE AND IMPACT OF ANGINA IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE AND DIABETES. INSIGHTS FROM THE THEMIS TRIAL

Author

Mesnier, Jules, primary, Bhatt, Deepak L., additional, Zheng, Luke, additional, Fox, Kim Michael, additional, Harrington, Robert A., additional, Leiter, Lawrence A., additional, Mehta, Shamir R., additional, Simon, Tabassome, additional, Andersson, Marielle, additional, Himmelmann, Anders, additional, and Steg, Philippe Gabriel, additional

Published
2023
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19. Biomarkers for risk stratification of patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: Insights from the Platelet Inhibition and Patient Outcomes trial

Author

Velders, Matthijs A., Wallentin, Lars, Becker, Richard C., van Boven, Adrianus J., Himmelmann, Anders, Husted, Steen, Katus, Hugo A., Lindholm, Daniel, Morais, Joao, Siegbahn, Agneta, Storey, Robert F., Wernroth, Lisa, and James, Stefan K.

Published
2015
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20. Platelet-related biomarkers and their response to inhibition with aspirin and p2y12-receptor antagonists in patients with acute coronary syndrome

Author

Lowenstern, Angela, Storey, Robert F., Neely, Megan, Sun, Jie-Lena, Angiolillo, Dominick J., Cannon, Christopher P., Himmelmann, Anders, Huber, Kurt, James, Stefan K., Katus, Hugo A., Morais, Joao, Siegbahn, Agneta, Steg, Phillippe Gabriel, Wallentin, Lars, Becker, Richard C., and On behalf of the PLATO Investigators

Published
2017
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21. Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency

Author

Szymański, Piotr, primary, Weidinger, Franz, additional, Lordereau-Richard, Isabelle, additional, Himmelmann, Anders, additional, Arca, Marcello, additional, Chaves, Jose, additional, Lee, Charles, additional, Jonker, Carla, additional, Kotecha, Dipak, additional, O'Kelly, James, additional, Plueschke, Kelly, additional, Ryś, Andrzej, additional, Segec, Andrej, additional, Wallentin, Lars, additional, Veltrop, Rogier, additional, and James, Stefan, additional

Published
2023
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22. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial

Author

Kotsia, Anna, Brilakis, Emmanouil S., Held, Claes, Cannon, Christopher, Steg, Gabriel P., Meier, Bernhard, Cools, Frank, Claeys, Marc J., Cornel, Jan H., Aylward, Philip, Lewis, Basil S., Weaver, Douglas, Brandrup-Wognsen, Gunnar, Stevens, Susanna R., Himmelmann, Anders, Wallentin, Lars, and James, Stefan K.

Published
2014
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27. Time Course for Benefit and Risk of Ticagrelor and Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack

Author

Wang, Yongjun, primary, Pan, Yuesong, additional, Li, Hao, additional, Amarenco, Pierre, additional, Denison, Hans, additional, Evans, Scott R., additional, Himmelmann, Anders, additional, James, Stefan, additional, Knutsson, Mikael, additional, Ladenvall, Per, additional, Molina, Carlos A., additional, and Johnston, S. Claiborne, additional

Published
2022
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29. Time Course for Benefit and Risk of Ticagrelor and Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack

Author

Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., Johnston, S. Claiborne, Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R., Himmelmann, Anders, James, Stefan, Knutsson, Mikael, Ladenvall, Per, Molina, Carlos A., and Johnston, S. Claiborne

Abstract

Background and Objectives The goal of this work was to investigate the short-term time-course benefit and risk of ticagrelor with aspirin in acute mild-moderate ischemic stroke or high-risk TIA in The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial. Methods In an exploratory analysis of the THALES trial, we evaluated the cumulative incidence of irreversible efficacy and safety outcomes at different time points during the 30-day treatment period. The efficacy outcome was major ischemic events defined as a composite of ischemic stroke or nonhemorrhagic death. The safety outcome was major hemorrhage defined as a composite of intracranial hemorrhage and fatal bleedings. Net clinical impact was defined as the combination of these 2 endpoints. Results This analysis included a total of 11,016 patients (5,523 in the ticagrelor-aspirin group, 5,493 in the aspirin group) with a mean age of 65 years, and 39% were women. The reduction of major ischemic events by ticagrelor occurred in the first week (4.1% vs 5.3%; absolute risk reduction 1.15%, 95% CI 0.36%-1.94%) and remained throughout the 30-day treatment period. An increase in major hemorrhage was seen during the first week and remained relatively constant in the following weeks (absolute risk increase approximate to 0.3%). Cumulative analysis showed that the net clinical impact favored ticagrelor-aspirin in the first week (absolute risk reduction 0.97%, 95% CI, 0.17%-1.77%) and remained constant throughout the 30 days. Discussion In patients with mild-moderate ischemic stroke or high-risk TIA, the treatment effect of ticagrelor-aspirin was present from the first week. The ischemic benefit of ticagrelor-aspirin outweighs the risk of major hemorrhage throughout the treatment period, which may support the use of 30-day treatment with ticagrelor and aspirin in these patients. Classification of Evidence This study provides Class II evidence that, for pa

Published
2022
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30. Differential effect of clopidogrel and ticagrelor on leukocyte count in relation to patient characteristics, biomarkers and genotype : a PLATO substudy.

Author

Nelson, Thomas A, Parker, William A E, Ghukasyan, Tatevik, Westerbergh, Johan, James, Stefan, Siegbahn, Agneta, Becker, Richard C, Himmelmann, Anders, Wallentin, Lars, Storey, Robert F, Nelson, Thomas A, Parker, William A E, Ghukasyan, Tatevik, Westerbergh, Johan, James, Stefan, Siegbahn, Agneta, Becker, Richard C, Himmelmann, Anders, Wallentin, Lars, and Storey, Robert F

Abstract

Inflammation plays a key role in cardiovascular disease by contributing to atherothrombosis. The PLATelet inhibition and patient Outcomes (PLATO) study (NCT00391872) compared ticagrelor to clopidogrel in patients with acute coronary syndromes and demonstrated fewer cardiovascular events with ticagrelor but lower white blood cell counts (WBC) with clopidogrel. In this further analysis of the PLATO biomarker substudy, we assessed associations between WBC and clinical characteristics, biomarker levels, and CYP2C19 polymorphisms.On-treatment mean (SD) WBC in the clopidogrel group was mildly reduced at each stage of follow-up compared with either the ticagrelor group (1 month: 7.27 (2.1) and 7.67 (2.23) x109/L for clopidogrel and ticagrelor, respectively; p < .001) or following cessation of clopidogrel (7.23 (1.97) x109/L, at 6 months vs 7.56 (2.28) x109/L after treatment cessation; P < .001). This occurred independently of baseline biomarkers and CYP2C19 genotype (where known). Adjusting for clinical characteristics and other biomarkers, no significant interaction was detected between clinical risk factors and the observed effect of clopidogrel on WBC.Clopidogrel weakly suppresses WBC, independent of clinical characteristics, baseline inflammatory biomarker levels, and CYP2C19 genotype. Further work is required to determine the mechanism for this effect and whether it contributes to clopidogrel's efficacy as well as therapeutic interaction with anti-inflammatory drugs.

Published
2022
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31. Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease : a European economic evaluation of the THEMIS trial.

Author

Steg, Philippe Gabriel, Bhatt, Deepak L, James, Stefan, Darlington, Oliver, Hoskin, Louise, Simon, Tabassome, Fox, Kim M, Leiter, Lawrence A, Mehta, Shamir R, Harrington, Robert A, Himmelmann, Anders, Ridderstråle, Wilhelm, Andersson, Marielle, Bueno, Héctor, De Luca, Leonardo, Tank, Amarjeet, Mellström, Carl, McEwan, Phil, Steg, Philippe Gabriel, Bhatt, Deepak L, James, Stefan, Darlington, Oliver, Hoskin, Louise, Simon, Tabassome, Fox, Kim M, Leiter, Lawrence A, Mehta, Shamir R, Harrington, Robert A, Himmelmann, Anders, Ridderstråle, Wilhelm, Andersson, Marielle, Bueno, Héctor, De Luca, Leonardo, Tank, Amarjeet, Mellström, Carl, and McEwan, Phil

Abstract

AIMS: To conduct a health economic evaluation of ticagrelor in patients with type 2 diabetes and coronary artery disease (CAD) from a multinational payer perspective. Cost-effectiveness and cost-utility of ticagrelor were evaluated in the overall effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) trial population and in the predefined patient group with prior percutaneous coronary intervention. METHODS AND RESULTS: A Markov model was developed to extrapolate patient outcomes over a lifetime horizon. The primary outcome was incremental cost-effectiveness ratios (ICERs), which were compared with conventional willingness-to-pay thresholds [€47 000/quality-adjusted life-year (QALY) in Sweden and €30 000/QALY in other countries].Treatment with ticagrelor resulted in QALY gains of up to 0.045 in the overall population and 0.099 in patients with percutaneous coronary intervention (PCI). Increased costs and benefits translated to ICERs ranged between €27 894 and €42 252/QALY across Sweden, Germany, Italy, and Spain in the overall population. In patients with prior PCI, estimated ICERs improved to €18 449, €20 632, €20 233, and €13 228/QALY in Sweden, Germany, Italy, and Spain, respectively, driven by higher event rates and treatment benefit. CONCLUSION: Based on THEMIS results, ticagrelor plus aspirin compared with aspirin alone may be cost-effective in some European countries in patients with T2DM and CAD and no prior myocardial infarction (MI) or stroke. Additionally, ticagrelor is likely to be cost-effective across European countries in patients with a history of PCI.

Published
2022
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32. Cost–effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial

Author

Steg, Philippe Gabriel, primary, Bhatt, Deepak L, additional, James, Stefan K, additional, Darlington, Oliver, additional, Hoskin, Louise, additional, Simon, Tabassome, additional, Fox, Kim M, additional, Leiter, Lawrence A, additional, Mehta, Shamir R, additional, Harrington, Robert A, additional, Himmelmann, Anders, additional, Ridderstråle, Wilhelm, additional, Andersson, Marielle, additional, Bueno, Héctor, additional, De Luca, Leonardo, additional, Tank, Amarjeet, additional, Mellström, Carl, additional, and McEwan, Phil, additional

Published
2022
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37. The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial

Author

Husted, Steen, James, Stefan K., Bach, Richard G., Becker, Richard C., Budaj, Andrzej, Heras, Magda, Himmelmann, Anders, Horrow, Jay, Katus, Hugo A., Lassila, Riita, Morais, Joao, Nicolau, José C., Steg, Ph. Gabriel, Storey, Robert F., Wojdyla, Daniel, and Wallentin, Lars

Published
2014
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38. Association Between Achieved ω-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk

Author

Nissen, Steven E., primary, Lincoff, A. Michael, additional, Wolski, Kathy, additional, Ballantyne, Christie M., additional, Kastelein, John J. P., additional, Ridker, Paul M., additional, Ray, Kausik K., additional, McGuire, Darren K., additional, Mozaffarian, Dariush, additional, Koenig, Wolfgang, additional, Davidson, Michael H., additional, Garcia, Michelle, additional, Katona, Brian G., additional, Himmelmann, Anders, additional, Loss, Larrye E., additional, Poole, Matthew, additional, Menon, Venu, additional, and Nicholls, Stephen J., additional

Published
2021
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39. Differential effect of clopidogrel and ticagrelor on leukocyte count in relation to patient characteristics, biomarkers and genotype: a PLATO substudy

Author

Nelson, Thomas A., primary, Parker, William A.E., additional, Ghukasyan Lakic, Tatevik, additional, Westerbergh, Johan, additional, James, Stefan K., additional, Siegbahn, Agneta, additional, Becker, Richard C., additional, Himmelmann, Anders, additional, Wallentin, Lars, additional, and Storey, Robert F., additional

Published
2021
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41. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial.

Author

UCL - (MGD) Service de neurologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IONS/NEUR - Clinical Neuroscience, Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R, Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A, Johnston, S Claiborne, THALES Steering Committee and Investigators, Vandermeeren, Yves, UCL - (MGD) Service de neurologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IONS/NEUR - Clinical Neuroscience, Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R, Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A, Johnston, S Claiborne, THALES Steering Committee and Investigators, and Vandermeeren, Yves

Abstract

Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup. To evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5). The THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021. Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days. The primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding. In total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those in the ticagrelor group and 9.1% (150 of 1641) for those in the placebo group (hazard ratio, 0.84; 95% CI, 0.6

Published
2021

42. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke : An Exploratory Analysis of the THALES Randomized Clinical Trial.

Author

Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R, Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A, Johnston, S Claiborne, Wang, Yongjun, Pan, Yuesong, Li, Hao, Amarenco, Pierre, Denison, Hans, Evans, Scott R, Himmelmann, Anders, James, Stefan, Birve, Filip, Ladenvall, Per, Molina, Carlos A, and Johnston, S Claiborne

Abstract

Importance: Prior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup. Objective: To evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5). Design, Setting, and Participants: The THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021. Interventions: Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days. Main Outcomes and Measures: The primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding. Results: In total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those

Published
2021
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43. Diabetes-Related Factors and the Effects of Ticagrelor Plus Aspirin in the THEMIS and THEMIS-PCI Trials

Author

Leiter, Lawrence A., primary, Bhatt, Deepak L., additional, McGuire, Darren K., additional, Teoh, Hwee, additional, Fox, Kim, additional, Simon, Tabassome, additional, Mehta, Shamir R., additional, Lev, Eli I., additional, Kiss, Róbert G., additional, Dalby, Anthony J., additional, Bueno, Héctor, additional, Ridderstråle, Wilhelm, additional, Himmelmann, Anders, additional, Prats, Jayne, additional, Liu, Yuyin, additional, Lee, Jane J., additional, Amerena, John, additional, Kosiborod, Mikhail N., additional, and Steg, Philippe Gabriel, additional

Published
2021
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44. Abstract MP4: Ticagrelor Plus Aspirin Versus Aspirin Alone in Acute Ischemic Stroke or TIA - Analysis of Bleeding Events in the THALES Trial

Author

Molina, Carlos, primary, Amarenco, Pierre, additional, Ladenvall, Per, additional, Aunes, Maria, additional, Denison, Hans, additional, Evans, Scott, additional, Himmelmann, Anders, additional, Jahreskog, Marianne, additional, James, Stefan, additional, Knutsson, Mikael, additional, Nylander, Sven, additional, Röther, Joachim, additional, Wang, Yongjun, additional, and Johnston, S. Claiborne, additional

Published
2021
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46. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk

Author

Nicholls, Stephen J., primary, Lincoff, A. Michael, additional, Garcia, Michelle, additional, Bash, Dianna, additional, Ballantyne, Christie M., additional, Barter, Philip J., additional, Davidson, Michael H., additional, Kastelein, John J. P., additional, Koenig, Wolfgang, additional, McGuire, Darren K., additional, Mozaffarian, Dariush, additional, Ridker, Paul M, additional, Ray, Kausik K., additional, Katona, Brian G., additional, Himmelmann, Anders, additional, Loss, Larrye E., additional, Rensfeldt, Martin, additional, Lundström, Torbjörn, additional, Agrawal, Rahul, additional, Menon, Venu, additional, Wolski, Kathy, additional, and Nissen, Steven E., additional

Published
2020
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47. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial

Author

Gregersen, Ida, primary, Michelsen, Annika E., additional, Lunde, Ngoc Nguyen, additional, Åkerblom, Axel, additional, Lakic, Tatevik G., additional, Skjelland, Mona, additional, Ryeng Skagen, Karolina, additional, Becker, Richard C., additional, Lindbäck, Johan, additional, Himmelmann, Anders, additional, Solberg, Rigmor, additional, Johansen, Harald T., additional, James, Stefan K., additional, Siegbahn, Agneta, additional, Storey, Robert F., additional, Kontny, Frederic, additional, Aukrust, Pål, additional, Ueland, Thor, additional, Wallentin, Lars, additional, and Halvorsen, Bente, additional

Published
2020
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49. 403-P: Impact of Diabetes-Related Factors and Background Antihyperglycemic Therapy on the Efficacy and Safety of Ticagrelor Added to Aspirin: Insights from the THEMIS Trial

Author

LEITER, LAWRENCE A., primary, BHATT, DEEPAK L., additional, MCGUIRE, DARREN K., additional, FOX, KIM, additional, SIMON, TABASSOME, additional, MEHTA, SHAMIR, additional, LEV, ELI, additional, KISS, ROBERT G., additional, DALBY, ANTHONY J., additional, BUENO, HECTOR, additional, RIDDERSTRÅLE, WILHELM, additional, HIMMELMANN, ANDERS, additional, PRATS, JAYNE, additional, LIU, YUYIN, additional, LEE, JANE J., additional, AMERENA, JOHN, additional, KOSIBOROD, MIKHAIL N., additional, and STEG, PHILIPPE G., additional

Published
2020
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50. Differential effect of clopidogrel and ticagrelor on leukocyte count in relation to patient characteristics, biomarkers and genotype: a PLATO substudy.

Author

Nelson, Thomas A., Parker, William A.E., Ghukasyan Lakic, Tatevik, Westerbergh, Johan, James, Stefan K., Siegbahn, Agneta, Becker, Richard C., Himmelmann, Anders, Wallentin, Lars, and Storey, Robert F.

Subjects
LEUKOCYTE count, TICAGRELOR, CLOPIDOGREL, ACUTE coronary syndrome, CYTOCHROME P-450 CYP2C19
Abstract

Inflammation plays a key role in cardiovascular disease by contributing to atherothrombosis. The PLATelet inhibition and patient Outcomes (PLATO) study (NCT00391872) compared ticagrelor to clopidogrel in patients with acute coronary syndromes and demonstrated fewer cardiovascular events with ticagrelor but lower white blood cell counts (WBC) with clopidogrel. In this further analysis of the PLATO biomarker substudy, we assessed associations between WBC and clinical characteristics, biomarker levels, and CYP2C19 polymorphisms. On-treatment mean (SD) WBC in the clopidogrel group was mildly reduced at each stage of follow-up compared with either the ticagrelor group (1 month: 7.27 (2.1) and 7.67 (2.23) x109/L for clopidogrel and ticagrelor, respectively; p <.001) or following cessation of clopidogrel (7.23 (1.97) x109/L, at 6 months vs 7.56 (2.28) x109/L after treatment cessation; P <.001). This occurred independently of baseline biomarkers and CYP2C19 genotype (where known). Adjusting for clinical characteristics and other biomarkers, no significant interaction was detected between clinical risk factors and the observed effect of clopidogrel on WBC. Clopidogrel weakly suppresses WBC, independent of clinical characteristics, baseline inflammatory biomarker levels, and CYP2C19 genotype. Further work is required to determine the mechanism for this effect and whether it contributes to clopidogrel's efficacy as well as therapeutic interaction with anti-inflammatory drugs. [ABSTRACT FROM AUTHOR]

Published
2022
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