Downloaded from http://journals.lww.com/cardiovascularpharm by BhDMf5ePHKbH4TTImqenVPdd2D9XRrfdVmA+9rifv75fAHQcq+oJB8rqFcX5jVtkutrDVejgX8c= on 08/24/2020 ORIGINAL ARTICLE Low-Dose Ticagrelor in Patients With High Ischemic Risk and Previous Myocardial Infarction: A Multicenter Prospective Real-World Observational Study Arturo Cesaro, MD,*† Vittorio Taglialatela, MD,‡ Felice Gragnano, MD,*† Elisabetta Moscarella, MD,*† Fabio Fimiani, BSc,*† Marzia Conte, MD,*† Valeria Barletta, MD,*† Emanuele Monda, MD,†§ Giuseppe Limongelli, MD, PhD,†§ Salvatore Severino, MD,¶ Plinio Cirillo, MD, PhD,‡ and Paolo Calabrò, MD, PhD*† Abstract: Prolonged dual antiplatelet therapy after 12 months in patients with previous myocardial infarction (MI) is attractive to reduce long-term ischemic complications. In the PEGASUS-TIMI 54, the use of low-dose ticagrelor (60 mg b.i.d.) plus aspirin after 12 months from MI reduced the risk of ischemic events, at the price of limited increase on bleeding complications. However, data on the use of low-dose ticagrelor in real-world practice lack. We aim at providing data on prescription/eligibility criteria and outcomes in patients receiving low-dose ticagrelor in the real-world setting. We enrolled consecutive patients eligible for ticagrelor 60 mg according to Italian national regulation in 3 high-volume centers and collected 1-year outcomes. The primary objective of the study is to generate real-world data about clinical characteristics, eligibility criteria, major adverse cardiovascular events, bleeding, and adverse event in patients receiving low-dose ticagrelor from our cohort. One hundred eighty-one patients were consecutively enrolled with a median follow-up of 18 months. The most used and the least used prescription criteria were multivessel coronary disease (72.4%) and chronic kidney disease (15.5%), respectively. At 1-year follow-up, the rate of major adverse cardiovascular events was 4.97%; of these, 3.86% of patients had a MI, and 1.1% had a stroke/transient ischemic attack, whereas no major bleeding occurred. In conclusion, in a real- world study, including patients with previous MI, low-dose tica- grelor for prolonged dual antiplatelet therapy showed to be effective and safe, with no major bleeding occurring at follow-up. Key Words: DAPT, ticagrelor, real-life, myocardial infarction (J Cardiovasc Pharmacol Ô 2020;76:173–180) INTRODUCTION Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the cornerstone treatment in patients with myocardial infarction (MI). 1–3 However, the optimal DAPT duration in patients at high ischemic risk remains controversial. After acute coronary syndrome (ACS), the European Society of Cardiology (ESC) guidelines 4 recommend for a 12- month therapy with potent P2Y12 receptor inhibitors, namely ticagrelor or prasugrel, in association with aspirin, whereas the use of clopidogrel should be restricted when these drugs are not available or contraindicated. Discussing the extension of the DAPT after 12 months, guidelines claim that the DAPT could be continued after this time frame in patients without bleeding complications and that low-dose ticagrelor should be preferred over clopidogrel and prasugrel. 4 The endorsement of preferring low-dose ticagrelor over other P2Y12 inhibitors is based on the PEGASUS-TIMI 54 study, 5 which demonstrated that in patients with previous MI—from 1 to 3 years earlier—and additional ischemic risk factors the use of ticagrelor 60 mg bis in die (b.i.d.) reduced the risk of cardiovascular death, MI, and stroke compared with placebo, showing a better safety profile than the 90 mg dosage. Therefore, ticagrelor 60 mg has been approved and is currently available for treating these patients with extended DAPT beyond 12 months. As a randomized controlled trial, the PEGASUS-TIMI 54 study mandates for strict inclusion and exclusion criteria, thus potentially limiting the generalizability of its findings to clinical practice. To date, real-world data on the use of ticagrelor 60 mg in contemporary post-MI patients lack. We aimed at reporting real-life data on the use of extended DAPT with low-dose ticagrelor in patients at high ischemic risk and previous MI, analyzing indications and eligibility criteria as well as long-term efficacy and safety outcomes. METHODS Study Design A multicenter prospective observational cohort study was designed according to the STROBE checklist. 6 Between June 2017 and April 2019, we prospectively enrolled all Received for publication April 21, 2020; accepted May 14, 2020. From the *Department of Translational Medical Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy; †Division of Clinical Cardiology, A.O.R.N. “Sant’Anna e San Sebastiano,” Caserta, Italy; ‡Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy; §Division of Cardiology, Monaldi Hospital, Naples, Italy; and ¶Division of Cardiology, Casa di cura “S. Michele,” Maddaloni (CE), Italy. The authors report no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.jcvp.org). Reprints: Paolo Calabrò, MD, Division of Clinical Cardiology, A.O.R.N. Sant’Anna e San Sebastiano, Caserta 81100, Italy (e-mail: paolo. calabro@unicampania.it). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. 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