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1. Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry

Author

Schmoeckel, Michael, Thielmann, Matthias, Hassan, Kambiz, Geidel, Stephan, Schmitto, Jan, Meyer, Anna L., Vitanova, Keti, Liebold, Andreas, Marczin, Nandor, Bernardi, Martin H., Tandler, Rene, Lindstedt, Sandra, Matejic-Spasic, Marijana, Wendt, Daniel, Deliargyris, Efthymios N., and Storey, Robert F.

Published
2024
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8. Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose

Author

Gibson, C. Michael, Mack, Michael J., Lee, Victoria T., Schneider, David J., Sellke, Frank W., Ohman, E. Magnus, Thourani, Vinod H., Doros, Gheorghe, Kroger, Hans, Cutlip, Donald E., and Deliargyris, Efthymios N.

Published
2022
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9. The role of hemoadsorption in cardiac surgery – a systematic review

Author

Matejic-Spasic, Marijana, primary, Lindstedt, Sandra, additional, Lebreton, Guillaume, additional, Dzemali, Omer, additional, Suwalski, Piotr, additional, Folliguet, Thierry, additional, Geidel, Stephan, additional, Klautz, Robert J.M., additional, Baufreton, Christophe, additional, Livi, Ugolino, additional, Gunaydin, Serdar, additional, Deliargyris, Efthymios N., additional, Wendt, Daniel, additional, and Thielmann, Matthias, additional

Published
2024
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11. Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial

Author

Chandrasekhar, Jaya, Sartori, Samantha, Mehran, Roxana, Aquino, Melissa, Vogel, Birgit, Asgar, Anita W., Webb, John G., Tchetche, Didier, Dumonteil, Nicolas, Colombo, Antonio, Windecker, Stephan, Claessen, Bimmer E., ten Berg, Jurriën M., Hildick-Smith, David, Wijngaard, Peter, Lefèvre, Thierry, Deliargyris, Efthymios N., Hengstenberg, Christian, Anthopoulos, Prodromos, and Dangas, George D.

Published
2021
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16. Usefulness of Clopidogrel Loading in Patients Who Underwent Transcatheter Aortic Valve Implantation (from the BRAVO-3 Randomized Trial)

Author

Nijenhuis, Vincent Johan, ten Berg, Jurrien Maria, Hengstenberg, Christian, Lefèvre, Thierry, Windecker, Stephan, Hildick-Smith, David, Kupatt, Christian, Van Belle, Eric, Tron, Christophe, Hink, Hans Ulrich, Colombo, Antonio, Claessen, Bimmer, Sartori, Samantha, Chandrasekhar, Jaya, Mehran, Roxana, Anthopoulos, Prodromos, Deliargyris, Efthymios N., and Dangas, George

Published
2019
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20. Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention

Author

Ono, Masafumi, Onuma, Yoshinobu, Kawashima, Hideyuki, Hara, Hironori, Gao, Chao, Wang, Rutao, O'Leary, Neil, Benit, Edouard, Janssens, Luc, Ferrario, Maurizio, Żurakowski, Aleksander, Dominici, Marcello, Huber, Kurt, Buszman, Paweł, Garg, Scot, Wykrzykowska, Joanna J, Piek, Jan J, Jüni, Peter, Hamm, Christian, Windecker, Stephan, Vranckx, Pascal, Deliargyris, Efthymios N, Bhatt, Deepak L, Storey, Robert F, Valgimigli, Marco, Serruys, Patrick W, Graduate School, Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, Ono, Masafumi/0000-0002-3919-5648, Gao, Chao/0000-0002-0390-8060, and Storey, Robert/0000-0002-6677-6229

Subjects
Ticagrelor, FOCUSED UPDATE, proton pump inhibitor, Myocardial Infarction, 610 Medicine & health, THERAPY, DEFINITIONS, Humans, Radiology, Nuclear Medicine and imaging, ticagrelor monotherapy, RISK, OUTCOMES, drug interaction, Aspirin, OMEPRAZOLE, percutaneous coronary intervention, Proton Pump Inhibitors, General Medicine, dual antiplatelet therapy, Treatment Outcome, CLOPIDOGREL, PLATELET INHIBITION, Cardiology and Cardiovascular Medicine, 610 Medizin und Gesundheit, Platelet Aggregation Inhibitors, CLINICAL-TRIALS
Abstract

Background Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events. Aims We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI). Methods This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm. Results Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12-1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92-1.19; p(interaction) = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27-1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83-1.28; p(interaction) = 0.008). Conclusions In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies. Clinical Trial Registration URL: The GLOBAL LEADERS trial was supported by unrestricted grants from AstraZeneca, Biosensors, and The Medicines Company. ECRI (European Cardiovascular Research Institute) was formally the sponsor of the study. GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company. P. J. is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. This study was completed, in part, with funding from the Canada Research Chairs Program. Open access funding provided by IReL.

Published
2022

21. Efficacy and Safety of Cangrelor in Preventing Periprocedural Complications in Patients With Stable Angina and Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The CHAMPION PHOENIX Trial

Author

Abtan, Jérémie, Steg, P. Gabriel, Stone, Gregg W., Mahaffey, Kenneth W., Gibson, C. Michael, Hamm, Christian W., Price, Matthew J., Abnousi, Freddy, Prats, Jayne, Deliargyris, Efthymios N., White, Harvey D., Harrington, Robert A., and Bhatt, Deepak L.

Published
2016
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22. Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials

Author

Giustino, Gennaro, Mehran, Roxana, Bansilal, Sameer, Feit, Frederick, Lincoff, Michael, Deliargyris, Efthymios N., Kirtane, Ajay J., Généreux, Philippe, Redfors, Bjorn, Prats, Jayne, Bernstein, Debra, Brener, Sorin J., Skerjanec, Simona, Lansky, Alexandra J., Francese, Dominic P., Dangas, George D., and Stone, Gregg W.

Published
2016
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25. Outcomes With Cangrelor Versus Clopidogrel on a Background of Bivalirudin: Insights From the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI])

Author

White, Harvey D., Bhatt, Deepak L., Gibson, C. Michael, Hamm, Christian W., Mahaffey, Kenneth W., Price, Matthew J., Steg, Ph. Gabriel, Stone, Gregg W., Cortese, Bernardo, Wilensky, Michael, Deliargyris, Efthymios N., Liu, Tiepu, Prats, Jayne, and Harrington, Robert A.

Published
2015
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26. Bivalirudin Versus Heparin With or Without Glycoprotein IIb/IIIa Inhibitors in Patients With STEMI Undergoing Primary Percutaneous Coronary Intervention: Pooled Patient-Level Analysis From the HORIZONS-AMI and EUROMAX Trials

Author

Stone, Gregg W., Mehran, Roxana, Goldstein, Patrick, Witzenbichler, Bernhard, van’t Hof, Arnoud, Guagliumi, Giulio, Hamm, Christian W., Généreux, Philippe, Clemmensen, Peter, Pocock, Stuart J., Gersh, Bernard J., Bernstein, Debra, Deliargyris, Efthymios N., and Steg, Philippe Gabriel

Published
2015
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27. Acute Stent Thrombosis After Primary Percutaneous Coronary Intervention: Insights From the EUROMAX Trial (European Ambulance Acute Coronary Syndrome Angiography)

Author

Clemmensen, Peter, Wiberg, Sebastian, van't Hof, Arnoud, Deliargyris, Efthymios N., Coste, Pierre, ten Berg, Jurrien, Cavallini, Claudio, Hamon, Martial, Dudek, Dariusz, Zeymer, Uwe, Tabone, Xavier, Kristensen, Steen D., Bernstein, Debra, Anthopoulos, Prodromos, Prats, Jayne, and Steg, Philippe Gabriel

Published
2015
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31. Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition)

Author

Groves, Elliott M., Bhatt, Deepak L., Steg, Philippe Gabriel, Deliargyris, Efthymios N., Stone, Gregg W., Gibson, C. Michael, Hamm, Christian W., Mahaffey, Kenneth W., White, Harvey D., Angiolillo, Dominick J., Prats, Jayne, Harrington, Robert A., and Price, Matthew J.

Published
2018
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32. Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials

Author

Qaderdan, Khalid, Vos, Gerrit-Jan A., McAndrew, Thomas, Steg, Philippe Gabriel, Hamm, Christian W., van‘t Hof, Arnoud, Mehran, Roxana, Deliargyris, Efthymios N., Bernstein, Debra, Stone, Gregg W., and ten Berg, Jurriën M.

Published
2017
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33. Reversal and removal of oral antithrombotic drugs in patients with active or perceived imminent bleeding.

Author

Cao, Davide, Amabile, Nicolas, Chiarito, Mauro, Lee, Victoria T, Angiolillo, Dominick J, Capodanno, Davide, Bhatt, Deepak L, Mack, Michael J, Storey, Robert F, Schmoeckel, Michael, Gibson, C Michael, Deliargyris, Efthymios N, and Mehran, Roxana

Subjects
ORAL medication, FIBRINOLYTIC agents, HEMORRHAGE, PLATELET aggregation inhibitors, CARDIOVASCULAR diseases
Abstract

Remarkable progress has been made in the pharmacological management of patients with cardiovascular disease, including the frequent use of antithrombotic agents. Nonetheless, bleeding complications remain frequent and potentially life-threatening. Therapeutic interventions relying on prompt antithrombotic drug reversal or removal have been developed to assist clinicians in treating patients with active bleeding or an imminent threat of major bleeding due to urgent surgery or invasive procedures. Early phase studies on these novel strategies have shown promising results using surrogate pharmacodynamic endpoints. However, the benefit of reversing/removing antiplatelet or anticoagulant drugs should always be weighed against the possible prothrombotic effects associated with withdrawal of antithrombotic protection, bleeding, and surgical trauma. Understanding the ischemic-bleeding risk tradeoff of antithrombotic drug reversal and removal strategies in the context of urgent high-risk settings requires dedicated clinical investigations, but challenges in trial design remain, with relevant practical, financial, and ethical implications. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent

Author

Tripathi, Ritu, primary, Morales, Jesus, additional, Lee, Victoria, additional, Gibson, C Michael, additional, Mack, Michael J, additional, Schneider, David J, additional, Douketis, James, additional, Sellke, Frank W, additional, Ohman, Magnus E, additional, Thourani, Vinod H, additional, Storey, Robert F, additional, and Deliargyris, Efthymios N, additional

Published
2022
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38. Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION

Author

Peterson, Benjamin E., primary, Harrington, Robert A., additional, Stone, Gregg W., additional, Steg, Ph. Gabriel, additional, Gibson, C. Michael, additional, Hamm, Christian W., additional, Price, Matthew J., additional, Lopes, Renato D., additional, Leonardi, Sergio, additional, Prats, Jayne, additional, Deliargyris, Efthymios N., additional, Mahaffey, Kenneth W., additional, White, Harvey D., additional, and Bhatt, Deepak L., additional

Published
2022
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39. Management of perioperative bleeding risk in patients on antithrombotic medications undergoing cardiac surgery : a systematic review

Author

Matejic-Spasic, Marijana, Hassan, Kambiz, Thielmann, Matthias Klaus, Geidel, Stephan, Storey, Robert F., Schmoeckel, Michael, Adamson, Harriet, Deliargyris, Efthymios N., and Wendt, Daniel

Subjects
Medizin
Abstract

Background: Antithrombotic drugs increase the risk of bleeding, especially in patients who need urgent surgery without an adequate wash-out period. This review aims to evaluate perioperative bleeding complications in patients on dual antiplatelet therapy (DAPT) or direct-acting oral anticoagulants (DOACs) undergoing high-bleeding risk cardiovascular surgery and to present currently available potential solutions to mitigate antithrombotic therapy-related bleeding complications. Methods: As a first step, we searched for relevant articles, over the last 10 years, in Medline (PubMed) and abstracted clinical information based on pre-defined criteria for bleeding complications. In the next step, an additional search evaluating potential solutions to mitigate bleeding complications was performed. The literature screening and selection process followed the principles derived from the PRISMA statement. Results: From all reviewed studies, a total of 19 articles could be included evaluating the risk for bleeding in cardiac surgery related to DAPT or DOACs and 10 papers evaluating antithrombotic drug reversal or removal in the setting of cardiovascular surgery. Reported bleeding rates ranged between 18% and 41%. The variability of the reported data is remarkable. Idarucizumab is reported to provide optimal perioperative hemostasis in up to 93% of patients. It has been observed that andexanet alfa causes unresponsiveness to the anticoagulant effects of heparin. Antithrombotic removal by intraoperative hemoadsorption is found to be associated with a significant decrease in re-thoracotomy rate, overall procedure duration, administered transfusion volumes, chest-tube drainage, and length of hospitalization. Discussion: Bleeding complications in patients treated with DAPT or DOACs in cardiac surgery are high. New costly reversal agents are available but have not been sufficiently tested in the cardio-surgical setting so far. Interestingly, bleeding-related complications seem to be effectively reduced by applying innovative intraoperative hemoadsorption techniques. Expected results from the ongoing trials should provide better insights concerning the efficacy and safety of several potential solutions. Currently, the variability of reports and the deficit of high-quality studies in this specific setting represent the major limitation for the unbiased conclusion of this review. CA extern

Published
2022

42. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

Author

Cavender, Matthew A., primary, Harrington, Robert A., additional, Stone, Gregg W., additional, Steg, Ph. Gabriel, additional, Gibson, C. Michael, additional, Hamm, Christian W., additional, Price, Matthew J., additional, Lopes, Renato D., additional, Leonardi, Sergio, additional, Deliargyris, Efthymios N., additional, Prats, Jayne, additional, Mahaffey, Kenneth W., additional, White, Harvey D., additional, Bhatt, Deepak L., additional, Huber, Kurt, additional, Lima, Valter C., additional, Jorgova-Makedonska, Julia B., additional, Widimský, Petr, additional, Kobulia, Bondo, additional, Radke, Peter W., additional, Bramucci, Ezio, additional, Witkowski, Adam, additional, Shlyakhto, Evgeny, additional, Van de Werf, Frans, additional, Faxon, David P., additional, Ohman, E. Magnus, additional, Verheugt, Freek W.A., additional, Weaver, W. Douglas, additional, Tijssen, Jan G.P., additional, Wilson, Matthew, additional, Mangum, Stacey, additional, Melloni, Chiara, additional, Brennan, Matthew J., additional, Tricoci, Pierluigi, additional, Harrison, Robert, additional, Barros, Pedro, additional, Armaganijan, Luciana, additional, Anderson, Monique, additional, Bagai, Akshay, additional, Généreux, Philippe, additional, Brener, Sorin J., additional, LaSalle, Laura, additional, Benzer, Werner, additional, Delle-Karth, Georg, additional, Leisch, Franz, additional, Abdalla Saad, Jamil, additional, Abizaid, Alexandre, additional, Augusto Formiga Areas, Carlos, additional, Ribeiro, Expedito E., additional, Rossi Dos Santos, Fabio, additional, Tadeu Tumelero, Rogerio, additional, Vieira Botelho, Roberto, additional, Atzev, Borislav, additional, Boichev, Boicho, additional, Grigorov, Georgi, additional, Penkov, Nikolay, additional, Petrov, Ivo, additional, Zehirov, Boris, additional, Cervinka, Pavel, additional, Coufal, Zdenek, additional, Hajek, Petr, additional, Horak, David, additional, Kala, Petr, additional, Kmonicek, Petr, additional, Kocka, Viktor, additional, Mrozek, Jan, additional, Simek, Stanislav, additional, Sitar, Jan, additional, Stasek, Josef, additional, Tousek, Frantisek, additional, Chapidze, Gulnara, additional, Emukhvari, Nodar, additional, Khabeishvili, George, additional, Mamatsashvili, Merab, additional, Shaburishvili, Tamaz, additional, Behrens, Steffen, additional, Darius, Harald, additional, Dissmann, Martin, additional, Fichtlscherer, Stephan, additional, Franz, Wolfgang, additional, Geisler, Tobias, additional, Genth-Zotz, Sabine, additional, Goldmann, Britta, additional, Heuer, Hubertus, additional, Hoffmann, Stefan, additional, Mugge, Andreas, additional, Poerner, Tudor, additional, Radke, Peter, additional, Richardt, Gert, additional, Stellbrink, Christoph, additional, Werner, Nikos, additional, De Servi, Stefano, additional, Galasso, Gennaro, additional, Menozzi, Alberto, additional, Musumeci, Giuseppe, additional, Picchi, Andrea, additional, Presbitero, Patrizia, additional, Devlin, Gerard, additional, Sasse, Alexander, additional, Scott, Douglas, additional, Stewart, Ralph, additional, Andrzej, Szyszka, additional, Dubaniewicz, Witold, additional, Gasior, Zbigniew, additional, Kasprzak, Jaroslaw, additional, Kleinrok, Andrzej, additional, Kornacewicz-Jach, Zdzislawa, additional, Rynkiewicz, Andrzej, additional, Sosnowski, Cezary, additional, Targonski, Radoslaw, additional, Trebacz, Jaroslaw, additional, Zinka, Elzbieta, additional, Barbarash, Olga, additional, Dovgalevsky, Yakov, additional, Gordeev, Ivan, additional, Kalinina, Svetlana, additional, Kosmachova, Elena, additional, Markov, Valentin, additional, Pavlov, Prokhor, additional, Shalaev, Sergey, additional, Shogenov, Zaur, additional, Sukmanova, Irina, additional, Vasilieva, Elena, additional, Yakovlev, Alexey, additional, Boonbaichaiyapruck, Sarana, additional, Chamnarnphol, Noppadol, additional, Kaewsuwanna, Pinij, additional, Kuanprasert, Srun, additional, Piyayotai, Dilok, additional, Amine, Maged, additional, Angiolillo, Dominick, additional, Arif, Imran, additional, Blankenship, James, additional, Brilakis, Emmanouil, additional, Chan, Michael, additional, Cinderella, Joseph, additional, Davis, Brent, additional, Devireddy, Chandanreddy, additional, Dorogy, Mark, additional, Douglas, John, additional, Ferrier, Norman, additional, Fisher, Daniel, additional, Foster, Robert, additional, French, William, additional, Galla, John, additional, Gimple, Lawrence, additional, Gogia, Harinder, additional, Gogo, Prospero, additional, Gollapudi, Raghava, additional, Gruberg, Luis, additional, Hermiller, James, additional, Heuser, Richard, additional, Iwaoka, Robert, additional, Jafar, Zubair, additional, Kimmelstiel, Carey, additional, Kinlay, Scott, additional, Leggett, James, additional, Leimgruber, Pierre, additional, Letts, Dustin, additional, Lipsitt, Michael, additional, Low, Reginald, additional, Martinez-Arraras, Joaquin, additional, Mayhew, Marc, additional, McLaurin, Brent, additional, McWhirter, Paul, additional, Mirza, Ayoub, additional, Negus, Brian, additional, Nygaard, Thomas, additional, O’Riordan, William, additional, Paulus, Richard, additional, Petersen, John, additional, Picon, Hector, additional, Picone, Mark, additional, Rivera, Ernesto, additional, Rizik, David, additional, Rodriguez, Arsenio, additional, Saucedo, Jorge, additional, Scott, J. Christopher, additional, Sethi, Virender, additional, Shroff, Adhir, additional, Siegel, Craig, additional, Spriggs, Douglas, additional, Steinberg, Daniel, additional, Stillabower, Michael, additional, Stuckey, Thomas, additional, Suarez, Jose, additional, Tauth, Jeffrey, additional, Temizer, Dogan, additional, Vidovich, Mladen, additional, Voeltz, Michele, additional, Waltman, Jonathan, additional, and Wilensky, Michael, additional

Published
2021
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43. The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX

Author

Gutierrez, J. Antonio, Harrington, Robert A., Blankenship, James C., Stone, Gregg W., Steg, Ph. Gabriel, Gibson, C. Michael, Hamm, Christian W., Price, Matthew J., Généreux, Philippe, Prats, Jayne, Deliargyris, Efthymios N., Mahaffey, Kenneth W., White, Harvey D., Bhatt, Deepak L., Bhatt, DL, Stone, GW, Mahaffey, KW, Gibson, CM, Steg, PG, Hamm, CW, Price, MJ, Leonardi, S, Gallup, D, Bramucci, E, Radke, PW, Widimsky, P, Tousek, F, Tauth, J, Spriggs, D, McLaurin, BT, Angiolillo, DJ, Genereux, P, Liu, T, Prats, J, Todd, M, Skerjanec, S, White, HD, and Harrington, RA

Published
2016
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46. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial

Author

Tomaniak, Mariusz, Chichareon, Ply, Onuma, Yoshinobu, Deliargyris, Efthymios N., Takahashi, Kuniaki, Kogame, Norihiro, Modolo, Rodrigo, Chang, Chun Ching, Rademaker-Havinga, Tessa, Storey, Robert F., Dangas, George D., Bhatt, Deepak L., Angiolillo, Dominick J., Hamm, Christian, Valgimigli, Marco, Windecker, Stephan, Steg, Philippe Gabriel, Vranckx, Pascal, Serruys, Patrick W., Bertrand, Olivier F., Plante, Sylvain, Van Geuns, Robert-Jan, Hofma, Sjoerd H., Royaards, Kees-Jan, Slagboom, Ton, Suryapranata, Harry, Umans, Victor A. W. M., Rensing, Benno, van der Harst, Pim, Magro, Michael, Barbato, Emanuel, Aminian, Adel, Benit, Edouard, Janssens, Luc, Vrolix, Mathias, Buysschaert, Ian, Carrie, Didier, Barraud, Pascal, Teiger, Emmanuel, Koning, Ren, Farzin, Beygui, Morelle, Jean-francois, Isaaz, Karl, Maillard, Luc, Abdellaoui, Mohamed, Brunel, Philippe, Angioi, Michael, Lantelme, Pierre, Sabate, Manel, Albarran Gonzalez-Trevilla, Agustin, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, and Cardiovascular Centre (CVC)

Subjects
Male, Ticagrelor, Internationality, Time Factors, medicine.medical_treatment, 030204 cardiovascular system & hematology, Severity of Illness Index, Tertiary Care Centers, Coronary artery disease, 0302 clinical medicine, Cause of Death, 030212 general & internal medicine, 610 Medicine & health, Original Investigation, Aspirin, DUAL ANTIPLATELET THERAPY, Continuity of Patient Care, Clopidogrel, Treatment Outcome, CLOPIDOGREL, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, INTERVENTION, medicine.drug, Acute coronary syndrome, medicine.medical_specialty, Hemorrhage, Risk Assessment, Drug Administration Schedule, 03 medical and health sciences, Percutaneous Coronary Intervention, Internal medicine, medicine, Humans, Acute Coronary Syndrome, Dose-Response Relationship, Drug, RECEPTOR, business.industry, Percutaneous coronary intervention, IN-VITRO, medicine.disease, Survival Analysis, PLATO, Conventional PCI, business, Platelet Aggregation Inhibitors, Follow-Up Studies
Abstract

Key PointsQuestionWhat are the benefits and risks of continuing aspirin in addition to P2Y12 receptor inhibition with ticagrelor among patients with acute coronary syndrome between 1 month and 12 months after percutaneous coronary intervention? FindingsIn this nonprespecified, post hoc analysis of the GLOBAL LEADERS randomized clinical trial, beyond 1 month after percutaneous coronary intervention in acute coronary syndrome, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. MeaningThe findings of this hypothesis-generating analysis pave the way for further trials evaluating aspirin-free antiplatelet strategies after percutaneous coronary intervention.ImportanceThe role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. ObjectiveTo evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and ParticipantsThis is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. InterventionsThe experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and MeasuresThe primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. ResultsOf 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P=.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P=.004). Conclusions and RelevanceBetween 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial RegistrationClinicalTrials.gov identifier: NCT01813435.This secondary analysis of the GLOBAL LEADERS randomized clinical trial evaluates the benefit and risks of aspirin in addition to ticagrelor among patients with acute coronary syndrome beyond 1 month after percutaneous coronary intervention.

Published
2019

49. Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial

Author

Zeymer, Uwe, van ʼt Hof, Arnoud, Adgey, Jennifer, Nibbe, Lutz, Clemmensen, Peter, Cavallini, Claudio, ten Berg, Jurrien, Coste, Pierre, Huber, Kurt, Deliargyris, Efthymios N., Day, Jonathan, Bernstein, Debra, Goldstein, Patrick, Hamm, Christian, and Steg, Philippe Gabriel

Published
2014
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50. Bivalirudin Started during Emergency Transport for Primary PCI

Author

Steg, Philippe Gabriel, van ʼt Hof, Arnoud, Hamm, Christian W., Clemmensen, Peter, Lapostolle, Frédéric, Coste, Pierre, Ten Berg, Jurrien, Van Grunsven, Pierre, Eggink, Gerrit Jan, Nibbe, Lutz, Zeymer, Uwe, dellʼ Orto, Marco Campo, Nef, Holger, Steinmetz, Jacob, Soulat, Louis, Huber, Kurt, Deliargyris, Efthymios N., Bernstein, Debra, Schuette, Diana, Prats, Jayne, Clayton, Tim, Pocock, Stuart, Hamon, Martial, and Goldstein, Patrick

Published
2013
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