Prosthesis; Cardiac, Heart, Functional Disturbance as Result Clinical Trial
Official title:
Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study
Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF). The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial comparing dabigatran etexilate to warfarin was the only randomized controlled study in patient with mechanical valve prosthesis, but it was terminated prematurely because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. To date, novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for patients with mechanical valves.
Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients
with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences
in patients with VTE.
Warfarin and similar vitamin K antagonists (VKA) have been the standard therapy for patients
with a metallic valve, or bioprosthesis with atrial fibrillation (AF). Warfarin works by
binding to vitamin K epoxide reductase to inhibit vitamin K-dependent coagulation factors II,
VII, IX, and X. For all its extensive use, warfarin has many clinical shortcomings, including
variable pharmacokinetic and pharmacodynamics properties, a narrow therapeutic index range,
and numerous interactions with certain foods and drugs. All of these factors contribute to
the need for frequent coagulation laboratory monitoring and dosage adjustments.
Even with the appropriate use of therapy, the incidence of thromboembolic events is still
substantial: 1-4% per year. Furthermore, bleeding risk is significant, ranging from 2% to 9%
per year. The VKA's narrow therapeutic index and they have a complex pharmacology, e.g. long
pharmacologic inertia and the common interaction with other drugs. These features make the
management of these drugs a challenge for physicians and their patients.
The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial
comparing dabigatran etexilate to warfarin was the only randomized controlled study in
patient with mechanical valve prosthesis, but it was terminated prematurely because of an
excess of thromboembolic and bleeding events among patients in the dabigatran group. Most
thromboembolic events among patients in the dabigatran group occurred in population A
(patients who had started a study drug within 7 days after valve surgery), with fewer
occurring in population B (patients who had undergone valve implantation more than 3 months
before randomization). Besides, stroke, death and major bleeding occurred only in population
A. In this study, rivaroxaban will be used in patients with mechanical valves and unstable
INR in a before and after designed.
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