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This website is intended to provide information to an international audience outside the USA and UK
This is Max*:
*This is a fictional patient case.
How can Max get the best protection from venous thromboembolism (VTE) with a treatment regimen that fits his lifestyle?
The risk of recurrent VTE events after treatment discontinuation is dependent upon the risk factors causing the initial VTE episode. Despite receiving adequate treatment for initial events, up to 40% of patients will experience a recurrent VTE event within 10 years of treatment discontinuation.1 The European Society of Cardiology (ESC) guidelines highlight that ‘oral anticoagulants are highly effective in preventing recurrent VTE during treatment, but they do not eliminate the risk of subsequent recurrence after the discontinuation of treatment.’2
Some patients will have a clear indication for extended anticoagulation. Patients with cancer, a second unprovoked VTE event or high-risk thrombophilia should always be considered for extended therapy beyond 6 months, or for as long as their risk factors persist, to protect them from VTE recurrence.2-4 On the other hand, the risk of VTE recurrence in patients with VTE provoked by major transient factors, such as surgery, is low once the risk factor is no longer present, and they generally do not need long-term treatment.3-5 The need for anticoagulation in patients with unprovoked VTE or VTE provoked by minor persistent transient risk factors is patient dependent, although recurrence risks of over 10% within 1 year mean that extended anticoagulation treatment should be considered for these patients.3,4,6
The cumulative risk of VTE recurrence is high in patients with unprovoked VTE and provoked VTE with minor persistent risk factors 1 year after stopping anticoagulation treatment.3
VTE, venous thromboembolism.
The decision to administer extended therapy to patients depends upon the balance between the risk of recurrent events and the risk of bleeding events in each individual. Patients rely on their physician to make the right choice, so it is crucial that treatment decisions are based on strong clinical evidence.3,7
The efficacy and safety profile of rivaroxaban for extended treatment was first demonstrated in the EINSTEIN EXT study where rivaroxaban 20 mg once daily (od) was superior to placebo for the reduction of recurrent VTE events in patients who had already received
6–12 months anticoagulation (1.3% versus 7.1% [hazard ratio=0.18; 95% confidence interval 0.09–0.39; p<0.001]). Risk of major bleeding was low but was not significantly increased statistically versus placebo (0.7% versus 0%; p=0.11).8 Additionally, EINSTEIN CHOICE demonstrated the flexibility of rivaroxaban dosing by comparing the efficacy and safety of rivaroxaban 20 mg od or 10 mg od with 100 mg od aspirin treatment over 12 months in 3365 patients who were equipoise for the continuation of anticoagulation treatment. The patient population included those with provoked and unprovoked VTE who had been treated for 6–12 months prior to study. Patients receiving rivaroxaban 20 mg od or 10 mg od showed a reduction in the occurrence of recurrent VTE events superior to the 4.4% of patients treated with aspirin (1.5% and 1.2%, respectively, versus 4.4%). Rivaroxaban 20 mg and rivaroxaban 10 mg od were associated with similar incidences of major bleeding events (0.5% and 0.4%, respectively, versus 0.3%) and clinically relevant non-major bleeding events compared to aspirin (2.7% and 2.0%, respectively, versus 1.8%).7
Patients receiving treatment with 100 mg aspirin had higher occurrence of recurrent VTE events than those receiving 20 mg and 10 mg rivaroxaban treatment.7
*There was no significant difference in major and CRMN bleeding between any treatment groups.
CI, confidence interval; CRMN, clinically relevant non-major bleeding; HR, hazard ratio; VTE, venous thromboembolism.
Notably, there was a considerable risk of recurrence in patients treated with aspirin when their index event was provoked (3.6%) and unprovoked (5.6%) VTE. However, rivaroxaban reduced the relative risk of recurrence by approximately 70% compared with aspirin in both cases, demonstrating the benefit of extended anticoagulation even in patients with provoking risk factors.7
More information regarding EINSTEIN EXT and EINSTEIN CHOICE trial results can be found here.
Each patient has a unique risk profile and personal needs that can complicate prediction of the optimum treatment duration. Risk stratification can help guide treatment decisions and tailor the rivaroxaban dosing regimen individually.
In patients who require extended anticoagulation, rivaroxaban dosing can be altered to suit a patient’s risk profiles; physicians have a choice of two doses, depending on what the patient needs. The summary of product characteristics for rivaroxaban indicate that rivaroxaban 10 mg od should be used in preference to rivaroxaban 20 mg od for extended prevention of recurrent VTE, unless patients have complicating comorbidities putting them at high risk of recurrent DVT or pulmonary embolism (PE), or those who have developed recurrent DVT or PE on extended prevention with rivaroxaban 10 mg od.11
The summary of product characteristics for rivaroxaban outlines the dosing regimen for extended prevention VTE events.11
*Not recommended in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; #complicated co-morbidities or recurrent PE or DVT on extended prevention with rivaroxaban 10 mg od.
DVT, deep vein thrombosis; PE, pulmonary embolism; od, once daily
International guidelines highlight the importance of patient-centric treatment decision making in maintaining treatment adherence.2,4 A 2019 French National survey found that regarding choice of treatment, 81.5% of patients preferred oral anticoagulation to injectable alternatives. This preference remains high across different treatment durations from 6 weeks to indefinite, and very few patients (5.8%) preferred twice-daily intake.12 This is consistent with results from EINSTEIN DVT and EINSTEIN PE, which demonstrated a higher patient reported satisfaction and reduced patient-reported treatment burden with rivaroxaban than standard therapy (enoxaparin/vitamin K antagonist) over 12 months.13,14
The simplicity of oral once daily dosing of rivaroxaban without the need of injections, provides patients with effective treatment that protects them from potentially life-threatening events while allowing them to live their lives how they want – an important factor for those like Max, who require extended therapy. Rivaroxaban offers him tailored long-term protection from VTE with a low risk of bleeding and a convenient regimen that he can stick to throughout his busy life for as long as his risk persists.