Tradeoff between bleeding and stent thrombosis in different dual antiplatelet therapy regimes: Importance of case fatality rates and effective treatment durations

Raban V Jeger, Matthias E Pfisterer, Rikke Sørensen, Stefanie von Felten, Hannes Alber, Piero O Bonetti, Franz Eberli, Paul Erne, Giovanni Pedrazzini, Hans Rickli, Søren Galatius, Christoph A Kaiser, BASKET and BASKET-PROVE investigators

    10 Citations (Scopus)

    Abstract

    BACKGROUND: The tradeoff between stent thrombosis (ST) and major bleeding (MB) of 12- versus 6-month dual antiplatelet therapy (DAPT) after coronary stent implantation has not been clearly defined.

    METHODS: Definite/probable ST and MB (TIMI major and Bleeding Academic Research Consortium (BARC) ≥ 3) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration, that is, BASKET (6 months; n = 557) and BASKET-PROVE (12 months; n = 2,314), between months 0 to 6 (DAPT in both trials), 7 to 12 (DAPT in BASKET-PROVE only), and 13 to 24 (aspirin in both trials) using propensity score-adjusted, time-stratified Cox proportional hazard models.

    RESULTS: Overall, event rates were low with fewer ST but similar MB in prolonged DAPT. Analysis of the 3 periods showed a uniform pattern for ST (interaction DAPT/period; P = .145) but an inconsistent pattern for MB (interaction DAPT/period; P < .001 for TIMI major and P = .046 for BARC ≥ 3), with more MB occurring during months 7 to 12 with prolonged DAPT. Considering observed case fatality rates of 31% with ST and 11% with MB, the extrapolated prevention of 27 ST deaths and the excess of 5 MB deaths resulted in an expected benefit of 22 survivors/10,000 patients treated over 2 years with prolonged DAPT.

    CONCLUSION: Despite overall low event rates, prolonged DAPT was associated with more MB during months 7 to 12 according to the interaction DAPT/period. Given the higher observed case fatality rates of ST versus MB, 12- versus 6-month DAPT was associated with an extrapolated reduction in mortality. Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations, specifically with regard to ongoing trials.

    Original languageEnglish
    JournalAmerican Heart Journal
    Volume168
    Issue number5
    Pages (from-to)698-705
    Number of pages8
    ISSN0002-8703
    DOIs
    Publication statusPublished - Nov 2014

    Keywords

    • Aged
    • Angina Pectoris
    • Aspirin
    • Coronary Thrombosis
    • Drug Therapy, Combination
    • Drug-Eluting Stents
    • Female
    • Hemorrhage
    • Humans
    • Maintenance Chemotherapy
    • Male
    • Middle Aged
    • Myocardial Infarction
    • Percutaneous Coronary Intervention
    • Platelet Aggregation Inhibitors
    • Prosthesis Failure
    • Risk Assessment
    • Sirolimus
    • Ticlopidine
    • Time Factors
    • Treatment Outcome

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