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      Safety and Effectiveness of Contemporary P2Y 12 Inhibitors in an East Asian Population With Acute Coronary Syndrome: A Nationwide Population‐Based Cohort Study

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          Abstract

          Background

          Prior reports indicate that the effect of P2Y 12 inhibitors may be different in East Asian patients (“East Asian paradox”); therefore, understanding the outcomes associated with potent P2Y 12 inhibitors in different populations is clinically important.

          Methods and Results

          In this observational cohort study using administrative healthcare data sets, we compared safety and effectiveness of contemporary P2Y 12 inhibitors in patients with acute coronary syndrome. The primary safety outcomes were major and any bleeding, and the primary effectiveness outcomes were major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) and all‐cause mortality. Among 70 715 patients with acute coronary syndrome, 56 216 (79.5%) used clopidogrel, 11 402 (16.1%) used ticagrelor, and 3097 (4.4%) used prasugrel. The median follow‐up period was 18.0 months (interquartile range: 9.6–26.4 months). In a propensity‐matched cohort, compared with clopidogrel, ticagrelor was associated with a higher risk of any bleeding (hazard ratio: 1.23; 95% CI, 1.14–1.33) but a lower risk of mortality (hazard ratio: 0.76; 95% CI, 0.63–0.91). Prasugrel, compared with clopidogrel, was associated with higher risks of any bleeding (hazard ratio: 1.23; 95% CI, 1.06–1.43) and major bleeding (hazard ratio: 1.50; 95% CI, 1.01–2.21) but a similar risk of effectiveness outcomes. No significant difference was noted between ticagrelor and prasugrel with respect to key safety or effectiveness outcomes. Several sensitivity analyses showed similar results.

          Conclusions

          In East Asian patients with acute coronary syndrome, compared with clopidogrel, ticagrelor was associated with an increased risk of bleeding but a decreased risk of mortality. Prasugrel was associated with an increase of any bleeding without difference in effectiveness outcomes. The risks of bleeding and ischemic events were similar between ticagrelor and prasugrel.

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          Most cited references22

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          Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease.

          Peripheral artery disease is considered to be a manifestation of systemic atherosclerosis with associated adverse cardiovascular and limb events. Data from previous trials have suggested that patients receiving clopidogrel monotherapy had a lower risk of cardiovascular events than those receiving aspirin. We wanted to compare clopidogrel with ticagrelor, a potent antiplatelet agent, in patients with peripheral artery disease.
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            Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack.

            Ticagrelor may be a more effective antiplatelet therapy than aspirin for the prevention of recurrent stroke and cardiovascular events in patients with acute cerebral ischemia.
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              Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI.

              Guideline recommendations on the use of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention (PCI) have been formulated by both the ACC/AHA and the ESC. These recommendations are based primarily on large, phase III, randomized, controlled trials of the P2Y12 inhibitors clopidogrel, prasugrel, and ticagrelor. However, few East Asian patients have been included in the trials to assess the use of these agents, particularly the newer agents prasugrel and ticagrelor. Additionally, an increasing body of data suggests that East Asian patients have differing risk profiles for both thrombophilia and bleeding compared with white patients, and that a different 'therapeutic window' of on-treatment platelet reactivity might be appropriate in East Asian patients. Furthermore, a phenomenon referred to as the 'East Asian paradox' has been described, in which East Asian patients have a similar or even a lower rate of ischaemic events after PCI compared with white patients, despite a higher level of platelet reactivity during DAPT. Recognizing these concerns, the World Heart Federation has undertaken this evidence-based review and produced this expert consensus statement to determine the antiplatelet treatment strategies that are most appropriate for East Asian patients.
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                Author and article information

                Contributors
                dwpark@amc.seoul.kr
                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                16 July 2019
                16 July 2019
                : 8
                : 14 ( doiID: 10.1002/jah3.2019.8.issue-14 )
                : e012078
                Affiliations
                [ 1 ] Division for Healthcare Technology Assessment Research National Evidence‐based Healthcare Collaborating Agency Seoul Republic of Korea
                [ 2 ] Department of Insurance Benefits National Health Insurance Service Wonju Korea
                [ 3 ] Division of Cardiology Asan Medical Center University of Ulsan College of Medicine Seoul Republic of Korea
                Author notes
                [*] [* ] Correspondence to: Duk‐Woo Park, MD, PhD, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 388‐1 Poongnap‐dong, Songpa‐gu, Seoul 138‐736, Korea. E‐mail: dwpark@ 123456amc.seoul.kr
                [†]

                Dr Yun and Dr Yun Jung Kim contributed equally to this work.

                Article
                JAH34267
                10.1161/JAHA.119.012078
                6662138
                31310570
                aebeca72-9adb-4a6c-801a-bf4cd62f4c0d
                © 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 04 April 2019
                : 11 June 2019
                Page count
                Figures: 5, Tables: 6, Pages: 35, Words: 12591
                Funding
                Funded by: National Evidence‐based Healthcare Collaborating Agency (NECA)
                Award ID: NECA‐A‐16‐003
                Categories
                Original Research
                Original Research
                Heart Failure
                Custom metadata
                2.0
                jah34267
                16 July 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.5 mode:remove_FC converted:16.07.2019

                Cardiovascular Medicine
                acute coronary syndrome,antiplatelet agent,ethics,anticoagulants,ethics and policy,acute coronary syndromes

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