BACKGROUND:Novel anticoagulations (NOACs) are increasingly prescribed for the prevention of stroke in premenopausal women with atrial fibrillation. Small studies suggest NOACs are associated with a higher risk of abnormal uterine bleeds than vitamin K antagonists (VKAs). Because there is no direct empirical evidence on the benefit/risk profile of rivaroxaban compared to VKAs in this subgroup, we synthesize available indirect evidence, estimate decision uncertainty on the treatments, and assess whether further research in premenopausal women is warranted.
METHODS:A Markov model with annual cycles and a lifetime horizon was developed comparing rivaroxaban (the most frequently prescribed NOAC in this population) and VKAs. Clinical event rates, associated quality adjusted life years, and health care costs were obtained from different sources and adjusted for gender, age, and history of stroke. A Monte Carlo simulation with 10,000 iterations was then performed for a hypothetical cohort of premenopausal women, estimated to be reflective of the population of premenopausal women with AF in The Netherlands.
RESULTS:In the simulation, rivaroxaban is the better treatment option for the prevention of ischemic strokes in premenopausal women in 61% of the iterations. Similarly, this is 98% for intracranial hemorrhages, 24% for major abnormal uterine bleeds, 1% for minor abnormal uterine bleeds, 9% for other major extracranial hemorrhages, and 23% for other minor extracranial hemorrhages. There is a 78% chance that rivaroxaban offers the most quality-adjusted life years. The expected value of perfect information in The Netherlands equals 122 quality-adjusted life years and 22 million Euros.
CONCLUSIONS:There is a 22% risk that rivaroxaban offers a worse rather than a better benefit/risk profile than vitamin K antagonists in premenopausal women. Although rivaroxaban is preferred over VKAs in this population, further research is warranted, and should preferably take the shape of an internationally coordinated registry study including other NOACs.
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【Uncertainty on the effectiveness and safety of rivaroxaban in premenopausal women with atrial fibrillation: empirical evidence needed.].
【利伐沙班对绝经前房颤妇女的有效性和安全性尚不确定：需要经验证据。】
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DOI：10.1186/s12872-017-0692-1文章类型：杂志文章
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背景：为预防绝经前患有房颤的女性中风，越来越多地采用新型抗凝剂（NOAC）。小型研究表明，与维生素K拮抗剂（VKA）相比，NOAC与异常子宫出血的风险更高。由于在该亚组中尚无关于利伐沙班与VKA相比获益/风险概况的直接经验证据，因此我们综合了可用的间接证据，估计了治疗的决策不确定性，并评估了是否有必要对绝经前妇女进行进一步研究。
方法：比较了利伐沙班（该人群中最常开处方的NOAC）和VKA，建立了一个具有年度周期和寿命范围的马尔可夫模型。从不同来源获得临床事件发生率，相关的质量调整生命年和医疗保健费用，并对性别，年龄和中风病史进行调整。然后，对假设的绝经前女性队列进行了10,000次迭代的Monte Carlo模拟，估计该群体反映了荷兰的AF绝经前女性人群。
结果：在模拟中，在61％的迭代中，利伐沙班是预防绝经前女性缺血性卒中的较好治疗选择。同样，颅内出血为98％，严重异常子宫出血为24％，轻度异常子宫出血为1％，其他重大颅外出血为9％，其他轻度颅外出血为23％。利伐沙班有78％的机会提供最优质的生命周期。在荷兰，完美信息的预期价值相当于122个质量调整的生命年和2200万欧元。
结论：在绝经前妇女中，利伐沙班比维生素K拮抗剂提供更差的益处/风险比有22％的风险。尽管在该人群中利伐沙班优于VKA，但有必要进行进一步的研究，并应采用国际协调的注册研究形式，包括其他NOAC。
方法：比较了利伐沙班（该人群中最常开处方的NOAC）和VKA，建立了一个具有年度周期和寿命范围的马尔可夫模型。从不同来源获得临床事件发生率，相关的质量调整生命年和医疗保健费用，并对性别，年龄和中风病史进行调整。然后，对假设的绝经前女性队列进行了10,000次迭代的Monte Carlo模拟，估计该群体反映了荷兰的AF绝经前女性人群。
结果：在模拟中，在61％的迭代中，利伐沙班是预防绝经前女性缺血性卒中的较好治疗选择。同样，颅内出血为98％，严重异常子宫出血为24％，轻度异常子宫出血为1％，其他重大颅外出血为9％，其他轻度颅外出血为23％。利伐沙班有78％的机会提供最优质的生命周期。在荷兰，完美信息的预期价值相当于122个质量调整的生命年和2200万欧元。
结论：在绝经前妇女中，利伐沙班比维生素K拮抗剂提供更差的益处/风险比有22％的风险。尽管在该人群中利伐沙班优于VKA，但有必要进行进一步的研究，并应采用国际协调的注册研究形式，包括其他NOAC。
