Ticagrelor Effects on Myocardial Infarction and the Impact of Event Adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:63

Article

Mahaffey, Kenneth W.^1,2  Held, Claes^3,4  Wojdyla, Daniel M.¹  James, Stefan K.^3,4  Katus, Hugo A.⁵  Husted, Steen⁶  Steg, Philippe Gabriel^7,8,9  Cannon, Christopher P.¹⁰  Becker, Richard C.¹  Storey, Robert F.¹¹  Khurmi, Nardev S.¹²  Nicolau, Jose C.¹³  Yu, Cheuk-Man¹⁴  Ardissino, Diego¹⁵  Budaj, Andrzej¹⁶  Morais, Joao¹⁷  Montgomery, Debra¹  Himmelmann, Anders¹⁸  Harrington, Robert A.^2,4  Wallentin, Lars³ 

[1] Duke Univ, Duke Clin Res Inst, Durham, NC USA

[2] Stanford Univ, Dept Med, Stanford, CA 94305 USA

[3] Uppsala Univ, Dept Med Sci, Uppsala, Sweden

[4] Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden

[5] Heidelberg Univ, Med Klin, Heidelberg, Germany

[6] Hosp Unit West, Dept Med, Herning Holstbro, Denmark

[7] INSERM Unite 698, Paris, France

[8] Dept Hosp Univ FIRE, Hop Bichat, AP HP, Paris, France

[9] Univ Paris Diderot, Sorbonne Paris Cite, Paris, France

[10] Brigham & Womens Hosp, TIMI Study Grp, Boston, MA 02115 USA

[11] Univ Sheffield, Dept Cardiovasc Sci, Sheffield, S Yorkshire, England

[12] AstraZeneca Res & Dev, Wilmington, DE USA

[13] Univ Sao Paulo, Sch Med, Heart Inst InCor, Sao Paulo, Brazil

[14] Chinese Univ Hong Kong, Inst Vasc Med, Prince Wales Hosp, Hong Kong, Hong Kong, Peoples R China

[15] Azienda Osped Univ Parma, Parma, Italy

[16] Grochowski Hosp, Postgrad Med Sch, Warsaw, Poland

[17] Santo Andres Hosp, Leiria, Portugal

[18] AstraZeneca Res & Dev, Molndal, Sweden

关键词: acute coronary syndrome(s);    adjudication;    clinical events committee;    clopidogrel;    myocardial infarction;    outcomes;    ticagrelor;   

DOI  :  10.1016/j.jacc.2014.01.038

来源: Elsevier

【 摘 要 】

Objectives This study sought to report the treatment effect of ticagrelor on myocardial infarction (MI) and the strategy for and impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. Background In PLATO, ticagrelor reduced cardiovascular death, MI, or stroke in patients with acute coronary syndromes (ACS). Methods A CIinical events committee (CEC) prospectively defined and adjudicated all suspected MI events, on the basis of events reported by investigators and by triggers on biomarkers. Treatment comparisons used CEC-adjudicated data, and per protocol, exCIuded silent MI. Results Overall, 1,299 (610 ticagrelor, 689 CIopidogrel) MIs reported by the CEC occurred during the trial. Of these, 1,097 (504 ticagrelor, 593 CIopidogrel) contributed to the primary composite endpoint. Site investigators reported 1,198 (580 ticagrelor, 618 CIopidogrel) MIs. Ticagrelor significantly reduced overall MI rates (12-month CEC-adjudicated Kaplan-Meier rates: 5.8% ticagrelor, 6.9% CIopidogrel; hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.75 to 0.95). Nonprocedural MI (HR: 0.86; 95% CI: 0.74 to 1.01) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor. MIs related to coronary artery bypass graft surgery were few, but numerical excess was observed in patients assigned ticagrelor. Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance (HR: 0.88; 95% CI: 0.78 to 1.00). ConCIusions In patients with ACS, ticagrelor significantly reduced the incidence of MI compared with CIopidogrel, with consistent results across most MI subtypes. CEC procedures identified more MI endpoints compared with site investigators. (A Comparison of Ticagrelor [AZD6140] and CIopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872) (C) 2014 by the American College of Cardiology Foundation

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