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      Relationship Between Platelet Reactivity and Ischemic and Bleeding Events After Percutaneous Coronary Intervention in East Asian Patients: 1‐Year Results of the PENDULUM Registry

      research-article
      Author(s): , MD, PhD 1 , , , MD 8 , , MD 9 , , MD 10 , , MD, PhD 11 , , MD, PhD 12 , , MD, PhD 13 , , MD, PhD 14 , , MD 15 , , MD, PhD 2 , , MD 3 , , BPharm 4 , , BPharm 5 , , MD, PhD 1 , , MD, PhD 6 , , PhD 7 , for the PENDULUM Registry Investigators*
      Publication date (Electronic):
      Journal: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
      Publisher: John Wiley and Sons Inc.
      Keywords: antiplatelet therapy, bleeding, ischemic, P2Y12, percutaneous coronary intervention, Acute Coronary Syndromes, Treatment

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          Abstract

          Background

          The balance between ischemic and bleeding events and their association with platelet reactivity in patients receiving antiplatelet therapy after percutaneous coronary intervention ( PCI), which differs among regions, is not fully evaluated for East Asians. We examined ischemic/bleeding events and platelet reactivity in Japanese patients undergoing PCI and determined associations between high/low platelet reactivity and clinical outcomes.

          Methods and Results

          PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) is a prospective, multicenter registry of Japanese patients with PCI. Primary end points were incidence of first major adverse cardiac and cerebrovascular events ( MACCE) and first major bleeding events at 12 months post‐ PCI. Platelet reactivity (P2Y 12 reaction unit [PRU] value) was measured at 12 to 48 hours post‐ PCI; patients were grouped as having high PRU (>208), optimal PRU (>85 to ≤208), and low PRU (≤85). MACCE and major bleeding occurred in 4.4% and 2.8% of 6267 patients, respectively. The mean±SD PRU value was 182.1±77.1. MACCE was significantly higher in the high PRU (5.7%; n=2227) versus the optimal PRU group (3.6%; n=3002). The hazard ratio (HR) for high PRU versus optimal PRU level was significantly higher for MACCE (adjusted HR, 1.53; 95% CI, 1.14–2.06 [ P=0.004]); stent thrombosis followed the same trend. Incidence of major bleeding did not differ significantly between groups. A high PRU level was significantly associated with MACCE in both patients with and patients without acute coronary syndrome.

          Conclusions

          These real‐world data suggest an association between high platelet reactivity and cardiovascular events in Japanese patients undergoing PCI. The trend was the same in both patients with and patients without acute coronary syndrome.

          REGISTRATION

          URL: https://www.umin.ac.jp/ctr. Unique identifier: UMIN 000020332.

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          Most cited references37

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          Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

          Roxana Mehran, Sunil V Rao, Deepak Bhatt … (2011)
          Article 0 comments Cited 782 times – based on 0 reviews     Review now
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            Ticagrelor versus clopidogrel in patients with acute coronary syndromes.

            Lars Wallentin, Richard C. Becker, Andrzej Budaj … (2009)
            Ticagrelor is an oral, reversible, direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that has a more rapid onset and more pronounced platelet inhibition than clopidogrel. In this multicenter, double-blind, randomized trial, we compared ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-to-600-mg loading dose, 75 mg daily thereafter) for the prevention of cardiovascular events in 18,624 patients admitted to the hospital with an acute coronary syndrome, with or without ST-segment elevation. At 12 months, the primary end point--a composite of death from vascular causes, myocardial infarction, or stroke--had occurred in 9.8% of patients receiving ticagrelor as compared with 11.7% of those receiving clopidogrel (hazard ratio, 0.84; 95% confidence interval [CI], 0.77 to 0.92; P<0.001). Predefined hierarchical testing of secondary end points showed significant differences in the rates of other composite end points, as well as myocardial infarction alone (5.8% in the ticagrelor group vs. 6.9% in the clopidogrel group, P=0.005) and death from vascular causes (4.0% vs. 5.1%, P=0.001) but not stroke alone (1.5% vs. 1.3%, P=0.22). The rate of death from any cause was also reduced with ticagrelor (4.5%, vs. 5.9% with clopidogrel; P<0.001). No significant difference in the rates of major bleeding was found between the ticagrelor and clopidogrel groups (11.6% and 11.2%, respectively; P=0.43), but ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting (4.5% vs. 3.8%, P=0.03), including more instances of fatal intracranial bleeding and fewer of fatal bleeding of other types. In patients who have an acute coronary syndrome with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding. (ClinicalTrials.gov number, NCT00391872.) 2009 Massachusetts Medical Society
            Article 0 comments Cited 677 times – based on 0 reviews     Review now
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              Prasugrel versus clopidogrel in patients with acute coronary syndromes.

              Stephen Wiviott, Eugene Braunwald, Carolyn McCabe … (2007)
              Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention. To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding. The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P=0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P=0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P=0.23) and fatal bleeding (0.4% vs. 0.1%; P=0.002). In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591 [ClinicalTrials.gov].) Copyright 2007 Massachusetts Medical Society.
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                Author and article information

                Contributors
                Masato Nakamura: masato@oha.toho-u.ac.jp
                Journal
                Journal ID (nlm-ta): J Am Heart Assoc
                Journal ID (iso-abbrev): J Am Heart Assoc
                Journal ID (doi): 10.1002/(ISSN)2047-9980
                Journal ID (publisher-id): JAH3
                Journal ID (hwp): ahaoa
                Title: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2047-9980
                Publication date (Electronic): 12 May 2020
                Publication date Collection: 18 May 2020
                Volume: 9
                Issue: 10 ( doiID: 10.1002/jah3.v9.10 )
                Electronic Location Identifier: e015439
                Affiliations
                [ 1 ] Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan
                [ 2 ] Department of Cardiology Tokyo Women’s Medical University Tokyo Japan
                [ 3 ] Department of Cardiology Rinku General Medical Center Izumisano Japan
                [ 4 ] Medical Science Department Daiichi Sankyo Co., Ltd. Tokyo Japan
                [ 5 ] Medical Affairs Planning Department Daiichi Sankyo Co., Ltd. Tokyo Japan
                [ 6 ] Department of Cardiology Kawasaki Medical School Kurashiki Japan
                [ 7 ] Department of Medical Statistics School of Medicine Toho University Tokyo Japan
                [ 8 ] Department of Cardiology Kurashiki Central Hospital Kurashiki Japan
                [ 9 ] Department of Cardiology Sakurakai Takahashi Hospital Kobe Japan
                [ 10 ] Department of Cardiology Asahi General Hospital Asahi Japan
                [ 11 ] Department of Cardiology Ota Memorial Hospital Ota Japan
                [ 12 ] Department of Cardiology Cardiovascular Center Ogikubo Hospital Tokyo Japan
                [ 13 ] Department of Cardiology Miyazaki Medical Association Hospital Miyazaki Japan
                [ 14 ] Department of Cardiology Himeji Cardiovascular Center Himeji Japan
                [ 15 ] Department of Cardiology Sakakibara Heart Institute Tokyo Japan
                Author notes
                [*] [* ]Correspondence to: Masato Nakamura, MD, PhD, Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, 2‐22‐36, Ohashi, Meguro‐ku, Tokyo 153‐8515, Japan. E‐mail: masato@ 123456oha.toho-u.ac.jp
                [†]

                A complete list of the PENDULUM Registry Investigators can be found in Appendix S1.

                Article
                Publisher ID: JAH35142
                DOI: 10.1161/JAHA.119.015439
                PMC ID: 7660889
                PubMed ID: 32394794
                SO-VID: 7e38fa11-7718-49c8-be52-4223ac83b99c
                Copyright © © 2020 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                Date received : 16 January 2020
                Date accepted : 08 April 2020
                Page count
                Figures: 5, Tables: 3, Pages: 14, Words: 8800
                Funding
                Funded by: Daiichi Sankyo Co., Ltd
                Categories
                Subject: Original Research
                Subject: Original Research
                Subject: Coronary Heart Disease
                Custom metadata
                source-schema-version-number 2.0
                cover-date 18 May 2020
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.2 mode:remove_FC converted:06.10.2020

                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: antiplatelet therapy,bleeding,ischemic,p2y12,percutaneous coronary intervention,acute coronary syndromes,treatment
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: antiplatelet therapy, bleeding, ischemic, p2y12, percutaneous coronary intervention, acute coronary syndromes, treatment

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