Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands.
Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands; Currently: Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Thromb Res. 2020 Jun;190:69-75. doi: 10.1016/j.thromres.2020.04.007. Epub 2020 Apr 14.
Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) prevent thromboembolism in atrial fibrillation (AF). DOAC have a fixed dosing regimen and obviate INR monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA. However, some VKA users appreciate the monitoring. A high time in the therapeutic range (TTR) leads to a lower impact on QoL. We assessed the influence of switching from well-controlled VKA to a DOAC on QoL.
In the GAInN study, 241 patients with AF, a TTR ≥ 70%, and neither bleeding nor thrombosis while on VKA were randomised to switching to DOAC (n = 121) or continuing VKA (n = 120). Health-related (SF-36) and anticoagulation-related QoL (PACT-Q) was assessed at baseline and after six and twelve months of follow-up.
SF-36 development did not differ between groups. After one year, average PACT-Q Convenience improvement was 2.5 (0.3-4.7) higher on DOAC. DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp. (95%CI 1-43) in patients who scored <95/100 at baseline. The probability to meaningfully improve on PACT-Q Satisfaction was 12 pp. (95%CI 0-25) higher on DOAC. However, 5 (4.1%) and 4 (3.3%) DOAC users resumed VKA because of side-effects and patient preference. Switching from well-controlled VKA to DOAC for AF leads to a higher probability of improved PACT-Q convenience and satisfaction, but also to a higher risk of side-effects. Arguably only patients who are not satisfied with VKA should switch, because they have more to gain by switching.
直接口服抗凝剂（DOAC）和维生素 K 拮抗剂（VKA）可预防房颤（AF）中的血栓栓塞。DOAC 具有固定的剂量方案，无需进行 INR 监测。因此，DOAC 对生活质量（QoL）的影响可能小于 VKA。但是，一些 VKA 用户会欣赏监测。较高的治疗窗时间（TTR）会降低对 QoL 的影响。我们评估了从控制良好的 VKA 切换至 DOAC 对 QoL 的影响。
在 GAInN 研究中，241 例 AF 患者，TTR≥70%，且在 VKA 治疗期间无出血或血栓形成，被随机分配至切换至 DOAC（n=121）或继续 VKA（n=120）治疗。在基线和随访 6 个月和 12 个月时评估与健康相关的（SF-36）和抗凝相关的 QoL（PACT-Q）。
两组间 SF-36 评分的变化无差异。一年后，DOAC 的 PACT-Q 便利性平均改善 2.5（0.3-4.7）分。便利性评分<95/100 的患者中，DOAC 组有 6 个百分点（95%CI-4-16）更有可能改善>5 分；22 个百分点（95%CI 1-43）在基线时评分<95/100 的患者。DOAC 组在 PACT-Q 满意度方面有意义的改善概率高 12 个百分点（95%CI 0-25）。然而，有 5（4.1%）和 4（3.3%）例 DOAC 患者因副作用和患者偏好而恢复使用 VKA。从控制良好的 VKA 切换至 DOAC 治疗 AF 可提高 PACT-Q 便利性和满意度的改善概率，但也会增加副作用的风险。或许只有对 VKA 不满意的患者才应该切换，因为他们切换后获益更多。
