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 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

doi:10.5603/CJ.a2021.0056

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 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 GorącyPaweł 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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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).

Original language	English
Pages (from-to)	607-614
Number of pages	8
Journal	Cardiology Journal (CJ)
Volume	28
Issue number	4
Early online date	2 Jun 2021
DOIs	https://doi.org/10.5603/CJ.a2021.0056
Publication status	Published - 2 Jun 2021

Keywords

Acute coronary syndrome
Antiplatelet therapy
De-escalation
ELECTRA-SIRIO 2
Ticagrelor
Aspirin
Humans
Platelet Aggregation Inhibitors
Acute Coronary Syndrome/diagnosis
Percutaneous Coronary Intervention

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© 2021 Via Medica. This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license. https://creativecommons.org/licenses/by/4.0/
Final published version, 205 KBLicence: CC BY

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Kubica, J., Adamski, P., Niezgoda, P., Kubica, A., Podhajski, P., Barańska, M., Umińska, J. M., Pietrzykowski, Ł., Ostrowska, M., Siller-Matula, J. M., Badarienė, J., Bartuś, S., Budaj, A., Dobrzycki, S., Fidor, Ł., Gąsior, M., Gessek, J., Gierlotka, M., Gil, R., ... Navarese, E. P. (2021). 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. Cardiology Journal (CJ), 28(4), 607-614. https://doi.org/10.5603/CJ.a2021.0056

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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",

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).",

keywords = "Acute coronary syndrome, Antiplatelet therapy, De-escalation, ELECTRA-SIRIO 2, Ticagrelor, Aspirin, Humans, Platelet Aggregation Inhibitors, Acute Coronary Syndrome/diagnosis, Percutaneous Coronary Intervention",

author = "Jacek Kubica and Piotr Adamski and Piotr Niezgoda and Aldona Kubica and Przemys{\l}aw Podhajski and Malwina Bara{\'n}ska and Umi{\'n}ska, {Julia M.} and {\L}ukasz Pietrzykowski and Ma{\l}gorzata Ostrowska and Siller-Matula, {Jolanta M.} and Jolita Badarienė and Stanis{\l}aw Bartu{\'s} and Andrzej Budaj and S{\l}awomir Dobrzycki and {\L}ukasz Fidor and Mariusz G{\c a}sior and Jacek Gessek and Marek Gierlotka and Robert Gil and Jaros{\l}aw Gor{\c a}cy and Pawe{\l} Grzelakowski and Tomasz Hajdukiewicz and Mi{\l}osz Jaguszewski and Marianna Janion and Jaros{\l}aw Kasprzak and Adam Kern and Artur Klecha and Andrzej Kleinrok and Wac{\l}aw Kochman and Bartosz Krakowiak and Jacek Legutko and Maciej Lesiak and Marcin Nosal and Grzegorz Piotrowski and Andrzej Przybylski and Tomasz Roleder and Grzegorz Skonieczny and Grzegorz Sobieszek and Agnieszka Tyci{\'n}ska and Dariusz Wojciechowski and Wojciech Wojakowski and Jaros{\l}aw W{\'o}jcik and Marzenna Zieli{\'n}ska and Aleksander {\.Z}urakowski and Giuseppe Specchia and Gorog, {Diana A.} and Navarese, {Eliano P.}",

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year = "2021",

month = jun,

day = "2",

doi = "10.5603/CJ.a2021.0056",

language = "English",

volume = "28",

pages = "607--614",

journal = "Cardiology Journal (CJ)",

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Kubica, J, Adamski, P, Niezgoda, P, Kubica, A, Podhajski, P, Barańska, M, Umińska, JM, Pietrzykowski, Ł, Ostrowska, M, Siller-Matula, JM, Badarienė, J, Bartuś, S, Budaj, A, Dobrzycki, S, Fidor, Ł, Gąsior, M, Gessek, J, Gierlotka, M, Gil, R, Gorący, J, Grzelakowski, P, Hajdukiewicz, T, Jaguszewski, M, Janion, M, Kasprzak, J, Kern, A, Klecha, A, Kleinrok, A, Kochman, W, Krakowiak, B, Legutko, J, Lesiak, M, Nosal, M, Piotrowski, G, Przybylski, A, Roleder, T, Skonieczny, G, Sobieszek, G, Tycińska, A, Wojciechowski, D, Wojakowski, W, Wójcik, J, Zielińska, M, Żurakowski, A, Specchia, G, Gorog, DA & Navarese, EP 2021, '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', Cardiology Journal (CJ), vol. 28, no. 4, pp. 607-614. https://doi.org/10.5603/CJ.a2021.0056

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. / Kubica, Jacek; Adamski, Piotr; Niezgoda, Piotr et al.
In: Cardiology Journal (CJ), Vol. 28, No. 4, 02.06.2021, p. 607-614.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Kubica, Jacek

AU - Adamski, Piotr

AU - Niezgoda, Piotr

AU - Kubica, Aldona

AU - Podhajski, Przemysław

AU - Barańska, Malwina

AU - Umińska, Julia M.

AU - Pietrzykowski, Łukasz

AU - Ostrowska, Małgorzata

AU - Siller-Matula, Jolanta M.

AU - Badarienė, Jolita

AU - Bartuś, Stanisław

AU - Budaj, Andrzej

AU - Dobrzycki, Sławomir

AU - Fidor, Łukasz

AU - Gąsior, Mariusz

AU - Gessek, Jacek

AU - Gierlotka, Marek

AU - Gil, Robert

AU - Gorący, Jarosław

AU - Grzelakowski, Paweł

AU - Hajdukiewicz, Tomasz

AU - Jaguszewski, Miłosz

AU - Janion, Marianna

AU - Kasprzak, Jarosław

AU - Kern, Adam

AU - Klecha, Artur

AU - Kleinrok, Andrzej

AU - Kochman, Wacław

AU - Krakowiak, Bartosz

AU - Legutko, Jacek

AU - Lesiak, Maciej

AU - Nosal, Marcin

AU - Piotrowski, Grzegorz

AU - Przybylski, Andrzej

AU - Roleder, Tomasz

AU - Skonieczny, Grzegorz

AU - Sobieszek, Grzegorz

AU - Tycińska, Agnieszka

AU - Wojciechowski, Dariusz

AU - Wojakowski, Wojciech

AU - Wójcik, Jarosław

AU - Zielińska, Marzenna

AU - Żurakowski, Aleksander

AU - Specchia, Giuseppe

AU - Gorog, Diana A.

AU - Navarese, Eliano P.

N1 - © 2021 Via Medica. This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license. https://creativecommons.org/licenses/by/4.0/

PY - 2021/6/2

Y1 - 2021/6/2

N2 - 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).

AB - 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).

KW - Acute coronary syndrome

KW - Antiplatelet therapy

KW - De-escalation

KW - ELECTRA-SIRIO 2

KW - Ticagrelor

KW - Aspirin

KW - Humans

KW - Platelet Aggregation Inhibitors

KW - Acute Coronary Syndrome/diagnosis

KW - Percutaneous Coronary Intervention

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U2 - 10.5603/CJ.a2021.0056

DO - 10.5603/CJ.a2021.0056

M3 - Article

C2 - 34096012

AN - SCOPUS:85111079959

SN - 1897-5593

VL - 28

SP - 607

EP - 614

JO - Cardiology Journal (CJ)

JF - Cardiology Journal (CJ)

IS - 4

ER -

Kubica J, Adamski P, Niezgoda P, Kubica A, Podhajski P, Barańska M et al. 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. Cardiology Journal (CJ). 2021 Jun 2;28(4):607-614. Epub 2021 Jun 2. doi: 10.5603/CJ.a2021.0056

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

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