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Background <p>Both bleeding and adverse ischemic events increase with age, compounding the benefit–risk balance of anticoagulants in older patients. We present analyses using benefit–risk methods to better understand the age-dependence of the benefit–risk profile of rivaroxaban in patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).</p> Methods <p>Randomized controlled trial data from the ROCKET-AF (NVAF) and EINSTEIN DVT, EINSTEIN PE, EINSTEIN-Extension, and EINSTEIN CHOICE in (VTE) were used. For ROCKET-AF, benefits and risks were assessed with incidence rates for key thrombotic and bleeding endpoints and a net clinical benefit (NCB) measure. Cumulative incidences (estimated by the Kaplan–Meier method) were estimated at day 185 for EINSTEIN and EINSTEIN Extension and 1 year for EINSTEIN CHOICE. Incidence differences were calculated for the overall population and age subgroups of &lt; 65, 65–75, and &gt; 75 years.</p> Results <p>In ROCKET-AF, rate differences in the composite NCB outcome (vascular death, stroke, myocardial infarction, fatal bleeding, critical organ bleeding, and non-CNS systemic embolism) favored rivaroxaban overall and by age &lt; 65, 65–75, and &gt; 75 years (−84, −25, −61, and −150 cases per 10,000 patient-years, respectively). In the pooled EINSTEIN DVT and EINSTEIN PE studies, cumulative incidence differences for the composite NCB outcome (recurrent VTE and major bleeding) were −103, 3, −105, and −544 per 10,000 patients, respectively. For extended VTE treatment with rivaroxaban versus placebo in EINSTEIN-Extension, NCB results were −536, −492, −556, and −601 per 10,000 patients, respectively. In the EINSTEIN CHOICE analysis, NCB favored rivaroxaban 20 mg versus aspirin (−284, −255, −339, and −338, respectively) and rivaroxaban 10 mg versus aspirin (−339, −328, −485, and −80, respectively).</p> Conclusions <p>This analysis demonstrated a positive benefit–risk profile with rivaroxaban versus trial comparators in older patients with NVAF or VTE, with benefit–risk increasingly favoring rivaroxaban with increasing age.</p> <p><b>Clinical Trial Registration:</b> <a href="http://ClinicalTrials.gov">http://ClinicalTrials.gov</a>, identifiers: NCT00403767 (ROCKET-AF), NCT00440193 (EINSTEIN DVT), NCT00439777 (EINSTEIN PE), NCT00439725 (EINSTEIN Extension), and NCT02064439 (EINSTEIN CHOICE).</p>

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Benefit–Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月31日

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  • Paul P. Dobesh,
  • Albert A. Volkl,
  • Ákos Ferenc Pap,
  • C. V. Damaraju,
  • Bennett Levitan,
  • Zhong Yuan,
  • Alpesh N. Amin

摘要

Background

Both bleeding and adverse ischemic events increase with age, compounding the benefit–risk balance of anticoagulants in older patients. We present analyses using benefit–risk methods to better understand the age-dependence of the benefit–risk profile of rivaroxaban in patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).

Methods

Randomized controlled trial data from the ROCKET-AF (NVAF) and EINSTEIN DVT, EINSTEIN PE, EINSTEIN-Extension, and EINSTEIN CHOICE in (VTE) were used. For ROCKET-AF, benefits and risks were assessed with incidence rates for key thrombotic and bleeding endpoints and a net clinical benefit (NCB) measure. Cumulative incidences (estimated by the Kaplan–Meier method) were estimated at day 185 for EINSTEIN and EINSTEIN Extension and 1 year for EINSTEIN CHOICE. Incidence differences were calculated for the overall population and age subgroups of < 65, 65–75, and > 75 years.

Results

In ROCKET-AF, rate differences in the composite NCB outcome (vascular death, stroke, myocardial infarction, fatal bleeding, critical organ bleeding, and non-CNS systemic embolism) favored rivaroxaban overall and by age < 65, 65–75, and > 75 years (−84, −25, −61, and −150 cases per 10,000 patient-years, respectively). In the pooled EINSTEIN DVT and EINSTEIN PE studies, cumulative incidence differences for the composite NCB outcome (recurrent VTE and major bleeding) were −103, 3, −105, and −544 per 10,000 patients, respectively. For extended VTE treatment with rivaroxaban versus placebo in EINSTEIN-Extension, NCB results were −536, −492, −556, and −601 per 10,000 patients, respectively. In the EINSTEIN CHOICE analysis, NCB favored rivaroxaban 20 mg versus aspirin (−284, −255, −339, and −338, respectively) and rivaroxaban 10 mg versus aspirin (−339, −328, −485, and −80, respectively).

Conclusions

This analysis demonstrated a positive benefit–risk profile with rivaroxaban versus trial comparators in older patients with NVAF or VTE, with benefit–risk increasingly favoring rivaroxaban with increasing age.

Clinical Trial Registration: http://ClinicalTrials.gov, identifiers: NCT00403767 (ROCKET-AF), NCT00440193 (EINSTEIN DVT), NCT00439777 (EINSTEIN PE), NCT00439725 (EINSTEIN Extension), and NCT02064439 (EINSTEIN CHOICE).