Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, University of Murcia, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
Br J Clin Pharmacol. 2022 Jan;88(1):282-289. doi: 10.1111/bcp.14961. Epub 2021 Jul 13.
The net benefit of oral anticoagulants (OACs) in atrial fibrillation (AF) is poorly understood. We aimed to determine the NNT for net effect (NNT ) using calculator of absolute stroke risk (CARS) in anticoagulated patients with AF in real-world and clinical trial cohorts.
Post-hoc analysis of patient-level data from the real-world Murcia AF Project and AMADEUS clinical trial. Baseline risk of stroke was determined using CARS. The risk of stroke and major bleeding events with OAC were determined using the number of respective events at 1-year. NNT was calculated as a reciprocal of the net effect of absolute risk reduction with OAC (NNT = 1/(absolute risk reduction of stroke[ARR ] - absolute risk increase of major bleeding[ARI ])).
In total, 3511 patients were included (1306 [37.2%] real-world patients and 2205 [62.8%] clinical trial participants). The absolute 1-year stroke risk was similar across both cohorts. In the real-world cohort, OAC was associated with a 4.0% ARR , 25 NNT , 1.0% ARI , 100 NNT and 34 NNT . In the clinical trial cohort, OAC was associated with a 3.8% ARR , 27 NNT , 1.6% ARI , 63 NNT and 46 NNT . In both cohorts, the NNT was significantly lower in patients with an excess stroke risk of ≥2% by CARS.
Overall, the NNT approach in AF incorporates information regarding baseline risk of stroke and major bleeding, and relative effects of OAC with the potential to include multiple additional outcomes and weighting of events based on their perceived effects by individual patients.
在心房颤动（AF）中，口服抗凝剂（OAC）的净获益尚不清楚。我们旨在通过计算器评估绝对卒中风险（CARS）确定 AF 患者 OAC 治疗的净效应（NNT ），该分析包括真实世界和临床试验队列。
对真实世界 Murcia AF 项目和 AMADEUS 临床试验的患者水平数据进行事后分析。使用 CARS 确定卒中的基线风险。使用 OAC 治疗 1 年时各自事件的数量确定卒中风险和主要出血事件的风险。NNT 计算为 OAC 绝对风险降低的净效应的倒数（NNT = 1/（OAC 绝对卒中风险降低[ARR] - 主要出血绝对风险增加[ARI]））。
共纳入 3511 例患者（1306 例[37.2%]为真实世界患者，2205 例[62.8%]为临床试验参与者）。两个队列的 1 年绝对卒中风险相似。在真实世界队列中，OAC 与 4.0%的 ARR 、25 NNT 、1.0%的 ARI 、100 NNT 和 34 NNT 相关。在临床试验队列中，OAC 与 3.8%的 ARR 、27 NNT 、1.6%的 ARI 、63 NNT 和 46 NNT 相关。在两个队列中，CARS 评估的卒中风险超过 2%的患者的 NNT 明显更低。
总的来说，AF 中的 NNT 方法结合了卒中风险和大出血的基线信息，以及 OAC 的相对效果，具有纳入多个额外结局的潜力，并基于个体患者对事件的感知效果对其进行加权。
