Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: Lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial

Marco Valgimigli, Francesco Costa, Yuliya Lokhnygina, Robert M. Clare, Lars Wallentin, David J. Moliterno, Paul W. Armstrong, Harvey D. White, Claes Held, Philip E. Aylward, Frans Van DeWerf, Robert A. Harrington, Kenneth W. Mahaffey, Pierluigi Tricoci

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    Abstract

    Aims Dual antiplatelet therapy reduces non-fatal ischaemic events after acute coronary syndrome (ACS) but increases bleeding to a similar extent. We sought to determine the prognostic impact of myocardial infarction (MI) vs. bleeding during an extended follow-up period to gain insight into the trade-off between efficacy and safety among patients after ACS. Methods and results In 12 944 patients with non-ST-segment elevation ACS from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial, we investigated the relative impact of MI and bleeding Occurring>30 days post-ACS and subsequent all-cause mortality. Bleeding was graded according to Bleeding Academic Research Consortium (BARC) criteria. MI was associated with a five-fold increase in mortality. BARC type 2 and 3, but not type 1, bleeding had a significant impact on mortality. MI was associated with a greater risk of mortality compared with BARC 2 [relative risk (RR) 3.5; 95% confidence interval (CI) 2.08-4.77; P<0.001] and BARC 3a bleeding (RR 2.23; 95% CI 1.36-3.64; P =0.001), and a risk similar to BARC 3b bleeding (RR 1.37; 95% CI 0.81-2.30; P=0.242). Risk of death after MI was significantly lower than after BARC 3c bleeding (RR 0.22; 95% CI 0.13-0.36; P<0.001). MI and bleeding had similar time-associations with mortality, which remained significant for several months, still being higher early after the event. Conclusion In patients treated with antiplatelet therapy after ACS, both MI and bleeding significantly impacted mortality with similar time-dependency. Although BARC 2 and 3a bleeding were less prognostic for death than MI, the risk of mortality was equivalent between BARC 3b bleeding and MI, and was higher following BARC 3c bleeding.

    Original languageEnglish
    Pages (from-to)804-810
    Number of pages9
    JournalEuropean Heart Journal
    Volume38
    Issue number11
    Early online date13 Nov 2016
    DOIs
    Publication statusPublished - 14 Mar 2017

    Keywords

    • Acute coronary syndrome
    • Bleeding
    • DAPT
    • Myocardial infarction

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    Valgimigli, M., Costa, F., Lokhnygina, Y., Clare, R. M., Wallentin, L., Moliterno, D. J., Armstrong, P. W., White, H. D., Held, C., Aylward, P. E., Van DeWerf, F., Harrington, R. A., Mahaffey, K. W., & Tricoci, P. (2017). Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: Lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial. European Heart Journal, 38(11), 804-810. https://doi.org/10.1093/eurheartj/ehw525