open access

Vol 28, No 4 (2021)
Invited Review Article
Submitted: 2021-03-24
Accepted: 2021-04-07
Published online: 2021-06-02
Get Citation

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

Jacek Kubica1, Piotr Adamski1, Piotr Niezgoda1, Aldona Kubica2, Przemysław Podhajski1, Malwina Barańska1, Julia M. Umińska3, Łukasz Pietrzykowski2, Małgorzata Ostrowska1, Jolanta M. Siller-Matula45, Jolita Badarienė67, Stanisław Bartuś8, Andrzej Budaj9, Sławomir Dobrzycki10, Łukasz Fidor11, Mariusz Gąsior12, Jacek Gessek13, Marek Gierlotka14, Robert Gil15, Jarosław Gorący16, Paweł Grzelakowski17, Tomasz Hajdukiewicz18, Miłosz Jaguszewski19, Marianna Janion20, Jarosław Kasprzak21, Adam Kern2223, Artur Klecha24, Andrzej Kleinrok2526, Wacław Kochman27, Bartosz Krakowiak28, Jacek Legutko29, Maciej Lesiak30, Marcin Nosal31, Grzegorz Piotrowski32, Andrzej Przybylski33, Tomasz Roleder34, Grzegorz Skonieczny35, Grzegorz Sobieszek36, Agnieszka Tycińska37, Dariusz Wojciechowski38, Wojciech Wojakowski39, Jarosław Wójcik40, Marzenna Zielińska41, Aleksander Żurakowski42, Giuseppe Specchia43, Diana A. Gorog4445, Eliano P. Navarese1
DOI: 10.5603/CJ.a2021.0056
·
Pubmed: 34096012
·
Cardiol J 2021;28(4):607-614.
Affiliations
  1. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  2. Department of Health Promotion, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  3. Department of Geriatrics, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  4. Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland
  5. Department of Cardiology, Medical University of Vienna, Austria
  6. Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
  7. Center of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
  8. Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland
  9. Department of Cardiology, Center of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland
  10. Department of Invasive Cardiology, University Hospital, Bialystok, Poland
  11. Department of Cardiology, Tuchola Hospital, Tuchola, Poland
  12. 3rd Department of Cardiology, Silesian Center for Heart Diseases, Faculty of Medicine in Zabrze, Medical University of Silesia, Zabrze, Poland
  13. Department of Cardiology and Intensive Cardiological Care, Specialized Municipal Hospital, Torun, Poland
  14. Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Poland
  15. Department of Invasive Cardiology, Central Clinical Hospital MSWiA, Warsaw, Poland
  16. Department of Cardiology, University Hospital No. 2, Pomeranian Medical University, Szczecin, Poland
  17. Department of Cardiology and Cardiac Surgery, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland
  18. Department of Cardiology, Provincial Hospital, Elblag, Poland;
  19. 1st Department of Cardiology, Medical University of Gdansk, Poland
  20. Institute of Medical Sciences, Collegium Medicum, Jan Kochanowski University, Kielce, Poland
  21. 1st Department and Chair of Cardiology, Medical University of Lodz, Bieganski Hospital, Lodz, Poland
  22. Department of Cardiology and Internal Medicine, Medical Faculty, University of Warmia and Mazury in Olsztyn, Poland
  23. Department of Cardiology, Voivodal Specialist Hospital in Olsztyn, Poland
  24. Department of Cardiology, Podhalanski Specialized Hospital, Nowy Targ, Poland
  25. University of Information Technology and Management in Rzeszow, Poland
  26. Department of Cardiology, The Pope John Paul II Hospital in Zamosc, Poland
  27. The National Institute of Cardiology, Department of Cardiology, Bielanski Hospital, Warsaw, Poland
  28. Department of Cardiology, Center for Heart Diseases, Military Hospital, Wroclaw, Poland
  29. Jagiellonian University Medical College, Institute of Cardiology, Department of Interventional Cardiology, The John Paul II Hospital in Krakow, Poland
  30. Chair and 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
  31. Center for Invasive Cardiology, Electrotherapy and Angiology, Krosno, Poland
  32. Department of Cardio-oncology, Medical University of Lodz, Poland
  33. Medical College University of Rzeszow, Poland
  34. Department of Cardiology, Provincial Hospital in Wroclaw, Poland
  35. Department of Cardiology and Intensive Cardiological Care, Rydygier Provincial Hospital, Torun, Poland
  36. Department of Cardiology, 1st Military Hospital, Lublin, Poland
  37. Department of Cardiology, Medical University of Bialystok, Poland
  38. Department of Cardiology, Wolski Hospital, Warszawa, Poland
  39. Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  40. Center for Invasive Cardiology IKARDIA, Naleczow, Poland
  41. Department of Interventional Cardiology, Medical University of Lodz, Poland
  42. Malopolska Cardiovascular Center of Polish-American Heart Clinics, Chrzanow, Poland
  43. Pavia, Italy
  44. Postgraduate Medical School, University of Hertfordshire, Stevenage, United Kingdom
  45. Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom

open access

Vol 28, No 4 (2021)
Invited review articles — Clinical cardiology
Submitted: 2021-03-24
Accepted: 2021-04-07
Published online: 2021-06-02

Abstract

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).

Abstract

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).

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Keywords

acute coronary syndrome, ticagrelor, antiplatelet therapy, de-escalation, ELECTRA-SIRIO 2

About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 28, No 4 (2021)

Article type

Invited Review Article

Pages

607-614

Published online

2021-06-02

Page views

1324

Article views/downloads

903

DOI

10.5603/CJ.a2021.0056

Pubmed

34096012

Bibliographic record

Cardiol J 2021;28(4):607-614.

Keywords

acute coronary syndrome
ticagrelor
antiplatelet therapy
de-escalation
ELECTRA-SIRIO 2

Authors

Jacek Kubica
Piotr Adamski
Piotr Niezgoda
Aldona Kubica
Przemysław Podhajski
Malwina Barańska
Julia M. Umińska
Łukasz Pietrzykowski
Małgorzata Ostrowska
Jolanta M. Siller-Matula
Jolita Badarienė
Stanisław Bartuś
Andrzej Budaj
Sławomir Dobrzycki
Łukasz Fidor
Mariusz Gąsior
Jacek Gessek
Marek Gierlotka
Robert Gil
Jarosław Gorący
Paweł Grzelakowski
Tomasz Hajdukiewicz
Miłosz Jaguszewski
Marianna Janion
Jarosław Kasprzak
Adam Kern
Artur Klecha
Andrzej Kleinrok
Wacław Kochman
Bartosz Krakowiak
Jacek Legutko
Maciej Lesiak
Marcin Nosal
Grzegorz Piotrowski
Andrzej Przybylski
Tomasz Roleder
Grzegorz Skonieczny
Grzegorz Sobieszek
Agnieszka Tycińska
Dariusz Wojciechowski
Wojciech Wojakowski
Jarosław Wójcik
Marzenna Zielińska
Aleksander Żurakowski
Giuseppe Specchia
Diana A. Gorog
Eliano P. Navarese

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