Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
J Am Coll Cardiol. 2024 Jul 23;84(4):354-364. doi: 10.1016/j.jacc.2024.05.002. Epub 2024 May 19.
ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation.
To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHADS-VASc score.
We performed a subgroup analysis according to baseline CHADS-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding.
Baseline CHADS-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHADS-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHADS-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHADS-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds.
One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHADS-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHADS-VASc score <4. A substantial intermediate group (CHADS-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248).
ARTESiA(依度沙班降低装置检出的无症状性心房颤动患者血栓栓塞事件的发生率)研究表明,与阿司匹林相比,依度沙班可显著降低有症状或无症状性心房颤动患者的卒中和全身性栓塞(SE)风险,但会增加大出血事件。
为帮助临床决策,作者根据基线 CHADS-VASc 评分评估了依度沙班的疗效和安全性。
我们根据基线 CHADS-VASc 评分进行了亚组分析,并评估了卒中/SE 和大出血的相对和绝对差异。
基线 CHADS-VASc 评分<4 的患者有 1578 例(39.4%),评分 4 的患者有 1349 例(33.6%),评分>4 的患者有 1085 例(27.0%)。对于 CHADS-VASc>4 的患者,依度沙班的卒中发生率为 0.98%/年,阿司匹林为 2.25%/年;与阿司匹林相比,依度沙班预防了每 100 例患者年 1.28 次(95%CI:0.43-2.12)卒中/SE,导致了 0.68 次(95%CI:-0.23 至 1.57)大出血。对于 CHADS-VASc<4 的患者,依度沙班的卒中/SE 发生率为 0.85%/年,阿司匹林为 0.97%/年。依度沙班预防了每 100 例患者年 0.12 次(95%CI:-0.38 至 0.62)卒中/SE,导致了 0.33 次(95%CI:-0.27 至 0.92)大出血。对于 CHADS-VASc=4 的患者,依度沙班预防了每 100 例患者年 0.32 次(95%CI:-0.16 至 0.79)卒中/SE,导致了 0.28 次(95%CI:-0.30 至 0.86)大出血。
ARTESiA 中四分之一的有症状或无症状性心房颤动患者 CHADS-VASc 评分>4,年卒中/SE 风险为 2.2%。对于这些患者,依度沙班预防卒中/SE 的获益大于风险。对于 CHADS-VASc<4 的患者则相反。存在一个大量的中间群体(CHADS-VASc=4),患者的偏好将影响治疗决策。(依度沙班降低装置检出的无症状性心房颤动患者血栓栓塞事件的发生率;NCT01938248)。