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  • 2016 - Pioneer Af-Pci (Rivaroxaban in Pci)

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    This document summarizes the design and results of the PIONEER AF-PCI trial, which compared different antithrombotic regimens for patients with atrial fibrillation undergoing percutaneous coronary intervention. The trial had three parallel groups randomized to either rivaroxaban with a P2Y12 inhibitor, very low dose rivaroxaban and dual antiplatelet therapy, or a vitamin K antagonist and dual antiplatelet therapy. The primary safety outcome was clinically significant bleeding, while the main secondary efficacy outcome was major adverse cardiovascular events. The trial found that rivaroxaban-based regimens reduced bleeding without increasing cardiovascular events compared to standard therapy. However, the trial had limitations including a small number

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    (Rivaroxaban in Pci)

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    2016 - Pioneer Af-pci (Rivaroxaban in Pci)

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    This document summarizes the design and results of the PIONEER AF-PCI trial, which compared different antithrombotic regimens for patients with atrial fibrillation undergoing percutaneous coronary intervention. The trial had three parallel groups randomized to either rivaroxaban with a P2Y12 inhibitor, very low dose rivaroxaban and dual antiplatelet therapy, or a vitamin K antagonist and dual antiplatelet therapy. The primary safety outcome was clinically significant bleeding, while the main secondary efficacy outcome was major adverse cardiovascular events. The trial found that rivaroxaban-based regimens reduced bleeding without increasing cardiovascular events compared to standard therapy. However, the trial had limitations including a small number

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    6 views8 pages

    2016 - Pioneer Af-Pci (Rivaroxaban in Pci)

    Uploaded by

    Alaa
    This document summarizes the design and results of the PIONEER AF-PCI trial, which compared different antithrombotic regimens for patients with atrial fibrillation undergoing percutaneous coronary intervention. The trial had three parallel groups randomized to either rivaroxaban with a P2Y12 inhibitor, very low dose rivaroxaban and dual antiplatelet therapy, or a vitamin K antagonist and dual antiplatelet therapy. The primary safety outcome was clinically significant bleeding, while the main secondary efficacy outcome was major adverse cardiovascular events. The trial found that rivaroxaban-based regimens reduced bleeding without increasing cardiovascular events compared to standard therapy. However, the trial had limitations including a small number

    Copyright:

    © All Rights Reserved
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    of 8

     Multicenter, open-label, 3-parallel-group, randomized, controlled trial

    PIONEER AF - PCI
    – Study Design
    No ASA

    Group 1 Rivaroxaban 15 mg/OD + P2Y12 inhibit

    10mg for CrCl 30-50 mL/min.

    > 18ys, AF, Rivaroxaban 2.5 mg/BID + Rivaroxaban 15


    R Group 2 DAPT mg/OD + ASA
    PCI with stent

    Predefined DAPT duration 1, 6, 12 ms.


    <72 hs of Sheath removal,
    INR must be < 2.5 at Group 3 VKA + DAPT VKA + ASA
    randomization

    AF: Atrial Fibrillation; PCI: Percutaneous Coronary Intervention; ASA: Acetyl Salcelic Acid;
    R: Randomization; OD: Once Daily; BID: Twice Daily; DAPT: Dual Antiplatelets Therapy;
    ms: Months; VKA: Vit-K Antagonists.
    End At 12 ms
    Adapted from: Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients
    with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI
    – Endpoints
    Primary (Safety) Secondary (Efficacy)

    The occurrence of clinically significant bleeding The occurrence of a major adverse cardiovascular
    (a composite of: event (a composite of:
    • major bleeding • Death from cardiovascular causes,
    • or minor bleeding according to Thrombolysis • Myocardial infarction, or stroke),
    in Myocardial Infarction [TIMI] criteria
    • or bleeding requiring medical attention; Each component of the major adverse cardiovascular
    event end point, and stent thrombosis.

    Adapted from: Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients
    with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI
    – Acute Coronary Syndrome
    Population

    ACS Type

    STEMI NSTEMI UA

    ACS NON-ACS

    Adapted from: Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients
    with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI
    – CHADS-VASc score
    3.40% 1.60%

    9.30%
    13.10%

    15.80%

    19.50%

    17.60%

    19.70%

    0 1 2 3 4 5 6 7

    Adapted from: Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients
    with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI Safer

    – Safety Endpoints Mainly driven by


    “Bleeding requiring medical attention” !!

    Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients with Atrial
    Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI Non-Significant
    difference
    – Efficacy Endpoints

    Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients with Atrial
    Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi:
    10.1056/NEJMoa1611594.
    PIONEER AF - PCI Non-Significant
    difference
    – Study Limitations
    Published Study 1 Other Sources 2

    the number of secondary efficacy end points in this It should be noted that both of the dosing regimens
    study was small, and the trial was not powered to of rivaroxaban (15 mg daily or 2.5 mg twice daily)
    definitively establish either superiority or used in the trial have not been formally investigated
    noninferiority. and are not FDA approved for AF or acute coronary
    syndromes. And, while lower than approved doses of
    rivaroxaban were used in this trial, a lower INR target
    was not tested.

    For one individual component of the composite Not blinded


    efficacy end point (stroke) within one stratum of Not powered for efficacy
    DAPT duration (6 months), the efficacy results were Little ethnic/racial diversity, which is problematic
    significantly in favor of standard therapy versus considering the high incidence of polymorphisms
    therapy with very-low-dose rivaroxaban plus DAPT leading to "clopidogrel resistance" in Asian
    populations
     
    Stratification to 1, 6, or 12 months of DAPT was based Small number of patients compared to previous trials
    on clinician choice, and patients were not randomly of DOACs
    assigned to a duration of DAPT. Limited presentation of adverse events
    Patient characteristics were imbalanced across the
    strata of DAPT durations

    1. Gibson CM, Mehran R, Bode C, et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J
    Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594.
    2. https://www.wikijournalclub.org/wiki/PIONEER_AF-PCI

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