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      Real-World Use of Novel P 2Y 12 Inhibitors in Patients with Acute Myocardial Infarction: A Treatment Paradox

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          Abstract

          Objective: To assess the real-world use, clinical outcomes, and adherence to novel P 2Y 12 inhibitors. Methods: We evaluated 1,093 consecutive acute myocardial infarction patients undergoing a percutaneous intervention. Patients were derived from a prospective, multicenter, nationwide registry and were followed for 30 days; 381 patients (35%) received clopidogrel, 468 (43%) received prasugrel, and 244 (22%) received ticagrelor. Patients treated with clopidogrel were older and more likely to suffer from chronic renal failure and stroke and/or present with non-ST-elevation myocardial infarction (NSTEMI) (p < 0.01 for all). Independent predictors of undertreatment with novel P 2Y 12 inhibitors included: older age (OR 0.17; 95% CI 0.1-0.27, p < 0.0001), a prior stroke (OR 0.41; 95% CI 0.2-0.68, p = 0.008), and NSTEMI (OR 0.37; 95% CI 0.26-0.54, p < 0.0001). Results: Novel P 2Y 12 inhibitors were associated with a lower incidence of cardiovascular events, major bleeding, and/or death (7.6 vs.11%, HR 0.67; 95% CI 0.43-1, p = 0.05). However, after a multivariate analysis this trend was not statistically significant. Patients discharged with ticagrelor versus thienopyridines demonstrated a higher rate of crossover to other P 2Y 12 inhibitors (11 vs. 5%, p = 0.03). Conclusions: In a real-world cohort, there was an underutilization of novel P 2Y 12 inhibitors which was more pronounced in higher-risk subsets that might benefit from novel P 2Y 12 inhibitors at least as much as other patients.

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          Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial.

          Lars Wallentin, Daniel Wojdyla, R. Harrington … (2010)
          Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates. Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant. In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding. URL:http://www.clinicatrials.gov. Unique identifier: NCT00391872.
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            Early Clopidogrel Versus Prasugrel Use Among Contemporary STEMI and NSTEMI Patients in the US: Insights From the National Cardiovascular Data Registry

            Matthew W. Sherwood, Stephen Wiviott, S. Andrew Peng … (2014)
            Background P2Y12 antagonist therapy improves outcomes in acute myocardial infarction (MI) patients. Novel agents in this class are now available in the US. We studied the introduction of prasugrel into contemporary MI practice to understand the appropriateness of its use and assess for changes in antiplatelet management practices. Methods and Results Using ACTION Registry‐GWTG (Get‐with‐the‐Guidelines), we evaluated patterns of P2Y12 antagonist use within 24 hours of admission in 100 228 ST elevation myocardial infarction (STEMI) and 158 492 Non‐ST elevation myocardial infarction (NSTEMI) patients at 548 hospitals between October 2009 and September 2012. Rates of early P2Y12 antagonist use were approximately 90% among STEMI and 57% among NSTEMI patients. From 2009 to 2012, prasugrel use increased significantly from 3% to 18% (5% to 30% in STEMI; 2% to 10% in NSTEMI; P for trend <0.001 for all). During the same period, we observed a decrease in use of early but not discharge P2Y12 antagonist among NSTEMI patients. Although contraindicated, 3.0% of patients with prior stroke received prasugrel. Prasugrel was used in 1.9% of patients ≥75 years and 4.5% of patients with weight <60 kg. In both STEMI and NSTEMI, prasugrel was most frequently used in patients at the lowest predicted risk for bleeding and mortality. Despite lack of supporting evidence, prasugrel was initiated before cardiac catheterization in 18% of NSTEMI patients. Conclusions With prasugrel as an antiplatelet treatment option, contemporary practice shows low uptake of prasugrel and delays in P2Y12 antagonist initiation among NSTEMI patients. We also note concerning evidence of inappropriate use of prasugrel, and inadequate targeting of this more potent therapy to maximize the benefit/risk ratio.
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              Contemporary Use of Ticagrelor in Interventional Practice (from Blue Cross Blue Shield of Michigan Cardiovascular Consortium)

              Amrita Karve, Milan Seth, Manoj Sharma … (2015)
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                Author and article information

                Journal
                Journal ID (publisher-id): CRD
                Journal ID (nlm-ta): Cardiology
                Journal ID (doi): 10.1159/issn.0008-6312
                Title: Cardiology
                Abbreviated Title: Cardiology
                Publisher: S. Karger AG (Basel, Switzerland karger@ 123456karger.com http://www.karger.com )
                ISSN (Print): 0008-6312
                ISSN (Electronic): 1421-9751
                Publication date (Print): December 2016
                Publication date (Electronic): 23 August 2016
                Volume: 136
                Issue: 1
                Pages: 21-28
                Affiliations
                aThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel Aviv University, Tel Aviv, bThe Heart Institute, Rabin Medical Center, Petach Tikvah, cNeufeld Cardiac Research Institute, Sackler School of Medicine, Tel Aviv University, Tel Aviv, dIntensive Cardiac Care Unit, Soroka Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beersheba, eDepartment of Cardiology, Galilee Medical Center, Nahariya, Faculty of Medicine in the Galilee, Bar-Ilan University, Safed, fDepartment of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, gDepartment of Cardiology, Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, and hDepartment of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
                Article
                Publisher ID: CRD2017136001021 Other ID: Cardiology 2017;136:21-28
                DOI: 10.1159/000447396
                PubMed ID: 27548273
                SO-VID: 7a6f6dc8-b9a3-421b-a447-580b3deac33d
                Copyright © © 2016 S. Karger AG, Basel
                License:

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                Date received : 26 February 2016
                Date accepted : 31 May 2016
                Page count
                Figures: 2, Tables: 3, References: 21, Pages: 8
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Medicine,General social science
                Keywords: Percutaneous coronary intervention,P2Y12 Inhibitors,Acute coronary syndrome,Antiplatelet therapy
                Data availability:
                ScienceOpen disciplines: Medicine, General social science
                Keywords: Percutaneous coronary intervention, P2Y12 Inhibitors, Acute coronary syndrome, Antiplatelet therapy

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