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Poster Networking

Arterial Thromboembolism

Session: Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients with LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction
(REWARF-STEMI): A Pilot Randomized Clinical Trial

PB0043 - Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients with LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction (REWARF-STEMI): A Pilot Randomized Clinical Trial

Sunday, June 23, 2024
13:45 – 14:45 ICT
Room: Exhibition Hall

    Presenting Author(s)

  • Parham Sadeghipour, MD

    Professor
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

    • Co-Author(s)

  • YJ

    Yaser Jenab

    Professor
    Tehran Heart Center
    Tehran, Tehran, Iran

  • RM

    Reza Mohseni-Badalabadi

    Assistant Professor
    Tehran Heart Center
    Tehran, Tehran, Iran

  • RK

    Raheleh Kaviani

    Assistant Professor
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • KH

    Kaveh Hosseini

    Assistant Professor
    Tehran Heart Center
    Tehran, Tehran, Iran

  • YP

    Yeganeh Pasebani

    Researcher
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • HK

    Hamid Khederlou

    Assistant Professor
    Department of Cardiology, Zanjan University of Medical Sciences, Zanjan, Iran
    Zanjan, Zanjan, Iran

  • AR

    Ali Rafati

    Researcher
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • ZM

    Zohre Mohammadi

    Researcher
    Tehran Heart Center
    Tehran, Tehran, Iran

  • SJ

    Sepehr Jamalkhani

    Researcher
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • AT

    Azita.H. Talasaz

    Professor
    Tehran Heart Center
    Tehran, Tehran, Iran

  • MF

    Melody Farrashi

    Assistant Professor
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • MM

    Mohsen Maadani

    Associate Professor
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • HB

    Hooman Bakhshandeh

    Associate Professor
    Rajaie Cardiovascular Medical and Research Center
    Tehran, Tehran, Iran

  • AK

    Ajay J. Kirtane

    Professor
    Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY
    New York, New York, United States

  • GP

    Gregory Piazza

    Associate Professor
    Cardiovascular Medicine Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
    Boston, Massachusetts, United States

  • HK

    Harlan M. Krumholz

    Professor
    Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
    New Haven, Connecticut, United States

  • RM

    Roxana Mehran

    Professor
    The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
    New York, New York, United States

  • GL

    Gregory Y.H Lip

    Professor
    Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom,
    Liverpool, England, United Kingdom

  • BB

    Behnood Bikdeli

    Assistant Professor
    Cardiovascular Medicine Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
    Boston, Massachusetts, United States

Background: The role of direct oral anticoagulants (DOACs) in the treatment of left ventricle thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.

Aims: To compare the effect of rivaroxaban- (15 mg/d) versus warfarin-based (INR 2-2.5) antithrombotic regimens in patients with STEMI complicated by LVT.

Methods: In an open-label, parallel-group randomized clinical trial, adult patients with STEMI complicated by LVT identified by two-dimensional transthoracic echocardiography (2D-TTE), were screened at two heart hospitals in Tehran, Iran. Main exclusion criteria were anticoagulation for other reasons, active bleeding, and glomerular filtration rate < 30 ml/min. The primary outcome was 3-month complete LVT resolution in 2D TTE by the imaging core laboratory. Thrombotic and bleeding outcomes were adjudicated blinded to treatment assignment. A prospective pooled analysis was planned on prior RCTs and the current RCT comparing DOAC- versus warfarin-based antithrombotic regimens in patients with STEMI complicated by LVT.

Results: A total of 50 patients (age:55 [50-61] years, 9 [18%] females) were enrolled between June 2020 through November 2022. Three-month complete LVT resolution was noted in 19/25 (76.0%) patients assigned to rivaroxaban- versus 13/24 (54.2%) patients assigned to warfarin-based antithrombotic regimens (relative risk [RR]: 1.40, 95% confidence interval [CI]: 0.91-2.15; P = 0.12). No thrombotic or major bleeding events occurred during the 3-month follow-up. The pooled analysis of a total of 227 STEMI patients complicated by LVT, showed a numerically better complete LVT resolution with DOACs (93/115 [80.8%] versus 79/112 [70.5%], RR: 1.14, 95% CI [0.98-1.32], P=0.08) and fewer major bleeding (2/116 [1.7%] and 9/112 [8%], absolute risk reduction: -0.06, 95% CI: [-0.12 to 0.00], P=0.05).

Conclusion(s): The current RCT and the ensuing pooled analysis, although limited by a small sample size, suggest that DOACs are safe, with at least similar and potentially more favorable outcomes with respect to complete LVT resolution and major bleeding.