Although oral P2Y inhibitors are key in the management of patients with non-ST elevation acute coronary syndrome (NSTE-ACS), the optimal timing of their administration is not well defined.
to compare downstream and upstream oral P2Y inhibitors administration strategies in NSTE-ACS patients undergoing invasive management.
We performed a randomized, adaptive, open-label, multi-center, clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention (PCI) were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was superiority of the downstream over the upstream strategy on the combination of efficacy and safety events (net clinical benefit).
We randomized 1449 patients to downstream or upstream oral P2Y inhibitor administration. A prespecified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46 [-2.90; 1.90]).These results were confirmed among patients undergoing PCI (72% of population) and regardless of the timing of coronary angiography (within or after 24 hours from enrolment).
Downstream and upstream oral P2Y inhibitors administration strategies were associated with low incidence of ischemic and bleeding events and minimal numerical difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of one strategy over the other. [Funded by the Italian Society of Interventional Cardiology (SICI-GISE)].
Copyright © 2020. Published by Elsevier Inc.
About The Expert
Giuseppe Tarantini
Marco Mojoli
Ferdinando Varbella
Roberto Caporale
Stefano Rigattieri
Giuseppe Andò
Plinio Cirillo
Simona Pierini
Andrea Santarelli
Paolo Sganzerla
Luisa Cacciavillani
Luciano Babuin
Nicoletta De Cesare
Ugo Limbruno
Alberto Massoni
Andrea Rognoni
Daniela Pavan
Flavia Belloni
Carlo Cernetti
Luca Favero
Francesco Saia
Luca Nai Fovino
Giulia Masiero
Loris Roncon
Valeria Gasparetto
Marco Ferlini
Federico Ronco
Roberta Rossini
Paolo Canova
Daniela Trabattoni
Alessandra Russo
Vincenzo Guiducci
Carlo Penzo
Fabio Tarantino
Ciro Mauro
Elena Corrada
Giovanni Esposito
Sergio Berti
Matteo Martinato
Danila Azzolina
Dario Gregori
Dominick J Angiolillo
Giuseppe Musumeci
References
PubMed