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

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De-escalation of antiplatelet therapy after acute coronary syndrome — a way to improve medication adherence?

“…Earlier DAPT termination is justified only in high bleeding risk patients [1][2][3]. Recently, Kubica et al [4] proposed a DAPT de-escalation strategy based on the pathophysiological premises providing a rationale for a randomized clinical trial. They designed the Evaluation of 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 aspirin versus DAPT with standard-dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischaemic efficacy in ACS patients [4].…”

“…Recently, Kubica et al [4] proposed a DAPT de-escalation strategy based on the pathophysiological premises providing a rationale for a randomized clinical trial. They designed the Evaluation of 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 aspirin versus DAPT with standard-dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischaemic efficacy in ACS patients [4]. The authors stressed that an increased ischaemic risk occurs in the early period after ACS, with elevated rates of clinical events clustering during the first month, while the bleeding risk is related to the duration and dose of the antiplatelet treatment and the majority of bleeding events occur after 30 days post-ACS [5].…”

“…The ELECTRA-SIRIO 2 trial has been designed taking into account all these premises [4]. Patients with ACS will be randomised in a 1:1:1 ratio into one of three arms: standard-dose ticagrelor (90 mg b.i.d) with aspirin (100 mg q.d.)…”

“…The primary safety composite endpoint of this trial is the first occurrence of type 2, 3 or 5 bleeding according to the BARC criteria within 12 months after ACS. The primary efficacy endpoint is the composite of death from any MEDICAL RESEARCH JOURNAL 2021 www.journals.viamedica.pl/medical_research_journal cause, first nonfatal MI, or first nonfatal stroke [4]. To date, the de-escalation of antiplatelet therapy in ACS patients based on lowering the dose of ticagrelor with or without discontinuation of aspirin has never been tested in a large randomised clinical trial.…”

“…The primary hypothesis of the ELECTRA-SIRIO 2 trial is that monotherapy with low-dose ticagrelor will lead to improved safety (reduction of clinically relevant bleeding) with the same efficacy (no increase of adverse ischaemic events) in comparison to standard-dose ticagrelor with aspirin in ACS patients [4].…”