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A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study
1 Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
2 Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. piotr.niezgoda1986@gmail.com.
3 Department of Health Promotion, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
4 Department of Geriatrics, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
5 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland.
6 Department of Cardiology, Medical University of Vienna, Austria.
7 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
8 Center of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
9 Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland.
10 Department of Cardiology, Center of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland.
11 Department of Invasive Cardiology, University Hospital, Bialystok, Poland.
12 Department of Cardiology, Tuchola Hospital, Tuchola, Poland.
13 3rd Department of Cardiology, Silesian Center for Heart Diseases, Faculty of Medicine in Zabrze, Medical University of Silesia, Zabrze, Poland.
14 Department of Cardiology and Intensive Cardiological Care, Specialized Municipal Hospital, Torun, Poland.
15 Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Poland.
16 Department of Invasive Cardiology, Central Clinical Hospital MSWiA, Warsaw, Poland.
17 Department of Cardiology, University Hospital No. 2, Pomeranian Medical University, Szczecin, Poland.
18 Department of Cardiology and Cardiac Surgery, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland.
19 Department of Cardiology, Provincial Hospital, Elblag, Poland.
20 1st Department of Cardiology, Medical University of Gdansk, Poland.
21 Institute of Medical Sciences, Collegium Medicum, Jan Kochanowski University, Kielce, Poland.
22 1st Department and Chair of Cardiology, Medical University of Lodz, Bieganski Hospital, Lodz, Poland.
23 Department of Cardiology and Internal Medicine, Medical Faculty, University of Warmia and Mazury in Olsztyn, Poland.
24 Department of Cardiology, Voivodal Specialist Hospital in Olsztyn, Poland.
25 Department of Cardiology, Podhalanski Specialized Hospital, Nowy Targ, Poland.
26 University of Information Technology and Management in Rzeszow, Poland.
27 Department of Cardiology, The Pope John Paul II Hospital in Zamosc, Poland.
28 The National Institute of Cardiology, Department of Cardiology, Bielanski Hospital, Warsaw, Poland.
29 Department of Cardiology, Center for Heart Diseases, Military Hospital, Wroclaw, Poland.
30 Jagiellonian University Medical College, Institute of Cardiology, Department of Interventional Cardiology, The John Paul II Hospital in Krakow, Poland.
31 Chair and 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
32 Center for Invasive Cardiology, Electrotherapy and Angiology, Krosno, Poland.
33 Department of Cardio-oncology, Medical University of Lodz, Poland.
34 Medical College University of Rzeszow, Poland.
35 Department of Cardiology, Provincial Hospital in Wroclaw, Poland.
36 Department of Cardiology and Intensive Cardiological Care, Rydygier Provincial Hospital, Torun, Poland.
37 Department of Cardiology, 1st Military Hospital, Lublin, Poland.
38 Department of Cardiology, Medical University of Bialystok, Poland.
39 Department of Cardiology, Wolski Hospital, Warszawa, Poland.
40 Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
41 Center for Invasive Cardiology IKARDIA, Naleczow, Poland.
42 Department of Interventional Cardiology, Medical University of Lodz, Poland.
43 Malopolska Cardiovascular Center of Polish-American Heart Clinics, Chrzanow, Poland.
44 Pavia, Italy.
45 Postgraduate Medical School, University of Hertfordshire, Stevenage, United Kingdom.
46 Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom.
A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study
1 Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
2 Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. piotr.niezgoda1986@gmail.com.
3 Department of Health Promotion, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
4 Department of Geriatrics, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
5 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland.
6 Department of Cardiology, Medical University of Vienna, Austria.
7 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
8 Center of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
9 Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland.
10 Department of Cardiology, Center of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland.
11 Department of Invasive Cardiology, University Hospital, Bialystok, Poland.
12 Department of Cardiology, Tuchola Hospital, Tuchola, Poland.
13 3rd Department of Cardiology, Silesian Center for Heart Diseases, Faculty of Medicine in Zabrze, Medical University of Silesia, Zabrze, Poland.
14 Department of Cardiology and Intensive Cardiological Care, Specialized Municipal Hospital, Torun, Poland.
15 Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Poland.
16 Department of Invasive Cardiology, Central Clinical Hospital MSWiA, Warsaw, Poland.
17 Department of Cardiology, University Hospital No. 2, Pomeranian Medical University, Szczecin, Poland.
18 Department of Cardiology and Cardiac Surgery, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland.
19 Department of Cardiology, Provincial Hospital, Elblag, Poland.
20 1st Department of Cardiology, Medical University of Gdansk, Poland.
21 Institute of Medical Sciences, Collegium Medicum, Jan Kochanowski University, Kielce, Poland.
22 1st Department and Chair of Cardiology, Medical University of Lodz, Bieganski Hospital, Lodz, Poland.
23 Department of Cardiology and Internal Medicine, Medical Faculty, University of Warmia and Mazury in Olsztyn, Poland.
24 Department of Cardiology, Voivodal Specialist Hospital in Olsztyn, Poland.
25 Department of Cardiology, Podhalanski Specialized Hospital, Nowy Targ, Poland.
26 University of Information Technology and Management in Rzeszow, Poland.
27 Department of Cardiology, The Pope John Paul II Hospital in Zamosc, Poland.
28 The National Institute of Cardiology, Department of Cardiology, Bielanski Hospital, Warsaw, Poland.
29 Department of Cardiology, Center for Heart Diseases, Military Hospital, Wroclaw, Poland.
30 Jagiellonian University Medical College, Institute of Cardiology, Department of Interventional Cardiology, The John Paul II Hospital in Krakow, Poland.
31 Chair and 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
32 Center for Invasive Cardiology, Electrotherapy and Angiology, Krosno, Poland.
33 Department of Cardio-oncology, Medical University of Lodz, Poland.
34 Medical College University of Rzeszow, Poland.
35 Department of Cardiology, Provincial Hospital in Wroclaw, Poland.
36 Department of Cardiology and Intensive Cardiological Care, Rydygier Provincial Hospital, Torun, Poland.
37 Department of Cardiology, 1st Military Hospital, Lublin, Poland.
38 Department of Cardiology, Medical University of Bialystok, Poland.
39 Department of Cardiology, Wolski Hospital, Warszawa, Poland.
40 Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
41 Center for Invasive Cardiology IKARDIA, Naleczow, Poland.
42 Department of Interventional Cardiology, Medical University of Lodz, Poland.
43 Malopolska Cardiovascular Center of Polish-American Heart Clinics, Chrzanow, Poland.
44 Pavia, Italy.
45 Postgraduate Medical School, University of Hertfordshire, Stevenage, United Kingdom.
46 Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom.
The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).
Conflict of interest: Jacek Kubica — received lecture honoraria from AstraZeneca; Piotr Adamski — none; Piotr Niezgoda — none; Aldona Kubica — received lecture honoraria from AstraZeneca; Przemysław Podhajski — none; Malwina Barańska — none; Julia M. Umińska — none; Łukasz Pietrzykowski — none; Małgorzata Ostrowska — none; Jolanta M. Siller-Matula — received personal fees from Bayer, BMS, Chiesi, and Daiichi, not related to this publication; Jolita Badarienė — received an investigator’s fee and lecture honoraria from AstraZeneca, investigator’s fee from Amgen, and lecture honoraria from Bayer; Stanisław Bartuś — none; Andrzej Budaj — received investigator’s fee, advisory board and lecture honoraria from AstraZeneca, Bayer, Bristol Myers Squibb, Glaxo-SmithKline, Sanofi Aventis, investigator’s fee and lecture honoraria from Novartis, and investigator’s fee from Eisai and Amgen; Sławomir Dobrzycki — none; Łukasz Fidor — none; Mariusz Gąsior — none; Jacek Gessek — none; Marek Gierlotka — none; Robert Gil — none; Jarosław Gorący — none; Paweł Grzelakowski — none; Tomasz Hajdukiewicz — none; Miłosz Jaguszewski — received lecture honoraria from AstraZeneca; Marianna Janion — none; Jarosław Kasprzak — received lecture honoraria from AstraZeneca and Bayer; Adam Kern — none; Artur Klecha — none; Andrzej Kleinrok — none; Wacław Kochman — none; Bartosz Krakowiak — none; Jacek Legutko — received advisory board and lecture honoraria from AstraZeneca and Gedeon Richter; Maciej Lesiak — received speaker and consultancy honoraria from AstraZeneca and Bayer; Marcin Nosal — none; Grzegorz Piotrowski — none; Andrzej Przybylski — none; Tomasz Roleder — none; Grzegorz Skonieczny — none; Grzegorz Sobieszek — none; Agnieszka Tycińska — none; Dariusz Wojciechowski — none; Wojciech Wojakowski — received lecture honoraria from AstraZeneca; Jarosław Wójcik — none; Marzenna Zielińska — none; Aleksander Żurakowski — none; Giuseppe Specchia — none; Diana A. Gorog — received lecture honoraria from AstraZeneca and Boehringer Ingelheim, and a grant from Bayer; Eliano P. Navarese — received grants from Abbott, Amgen, and lecture honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron
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