Stroke Clinical Trial
Official title:
Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis
Mechanical heart valves (MHV) demand lifelong anticoagulation with vitamin K antagonists (VKA) due to the high thrombogenicity of the prosthesis. Rivaroxaban has previously been tested in experimental and animal models with encouraging results. The investigators recently sent for publication an experiment with 7 patients who used rivaroxaban in metallic prosthesis with encouraging results. In this way it was decided to do a randomized non-inferiority clinical trial comparing rivaroxaban with warfarin in patients with metallic prosthesis.
For patients with severe and symptomatic valvular heart disease, valve replacement surgery
improves morbidity and mortality outcomes. It is estimated that four million valve
replacement procedures have been performed over the last 50 years and it remains the only
definitive treatment for most patients with advanced heart valve disease.1 Patients who
received mechanical heart valves (MHV) had a significantly lower mortality, higher cumulative
incidence of bleeding and, in some age groups, stroke than did recipients of a biologic
prosthesis. In addition, MHV demands lifelong anticoagulation with vitamin K antagonists
(VKA), most commonly warfarin, due to the high thrombogenicity of the prosthesis. Even with
the appropriate use of therapy, there is a high incidence of thromboembolic events: 1% to 4%
per year. Furthermore, bleeding risk is significant, ranging from 2% to 9% per year.4 Indeed,
variability in the international normalized ratio (INR) is a major independent predictor of
reduced survival in patients with MHV.5 Due to the narrow therapeutic index, interactions,
genetic variants, and need for blood monitoring of patients taking VKAs, alternatives to
warfarin have now been made available: specifically, inhibitors that directly target Factor
IIa (dabigatran) or Xa (rivaroxaban, apixaban, edoxaban).6 RE-ALIGN was a prospective,
randomized, phase 2, open-label trial that randomized 252 patients within a 2:1 unblinded
fashion to either dabigatran or warfarin, with patients stratified according to interval
since replacement (within three to seven days in population A; >three months in population
B). Unfortunately, the trial was terminated prematurely because of an excess of
thromboembolic and bleeding events among patients in the dabigatran group. The negative
results of this study can be explained by the selection of 50 ng/mL as the target dabigatran
trough level, the possibility of this drug inducing downstream effects on the coagulation
cascade that impair its ability to blunt the postoperative hypercoagulable state relative to
warfarin and the inclusion of early postoperative patients (population A) since it is a phase
of high incidence of thromboembolic events.
On the other hand, rivaroxaban has already been tested in experimental9 and animal models10
with encouraging results. According to these findings, the investigators hypothesized that a
direct Factor Xa inhibitor could be evaluated in patients with MHV for prevention of
thromboembolic events.
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