新型抗凝血劑用於同時患有心房顫動及瓣膜性心臟病病人的處方現況及成效分析

Abstract

背景 瓣膜性心臟病的病人通常伴隨著心房顫動，但新型口服抗凝血劑用於此類病患之療效尚未明確，因此本研究的目標是探討同時患有瓣膜性心臟病及心房顫動的病人，使用新型抗凝血劑(Dabigatran, Rivaroxaban, Apixaban)與傳統口服抗凝血劑(Warfarin)的處方現況比較及成效分析。

方法 本研究為一回溯性研究，以「衛生福利部衛生福利資料科學中心」之全人口檔進行分析，首先篩選出同時有心房顫動及瓣膜性心臟病，且有任何一筆口服抗凝血劑處方的病人，以傾向分數配對法校正新型及傳統口服抗凝血劑的使用族群間差異，並利用Cox比例風險模式評估兩個族群發生事件的風險。

結果 本研究共納入21,280人。相較於warfarin，新型抗凝血劑有較低的靜脈栓塞(HR: 0.40, 95% CI: 0.23-0.69)、綜合出血(HR: 0.81, 95% CI: 0.74-0,89)及顱內出血(HR: 0.50, 95% CI: 0.40-0.62)風險。但是在嚴重瓣膜心臟病的病人，新型抗凝血劑有較高的栓塞風險(HR: 1.89, 95% CI: 1.18-3.01)，尤其是經歷瓣膜手術的病人(HR: 2.96, 95% CI: 1.49-5.88)。而在不同的新型抗凝血劑之間，dabigatran及rivaroxaban有較低的顱內出血風險;在綜合出血的表現上，dabigatran更勝一籌(HR: 0.77, 95% CI: 0.68-0.87)。

結論 新型口服抗凝血劑相較於傳統口服抗凝血劑對同時患有心房顫動及瓣膜性心臟病的病人來說是個更安全的選擇。然而在不同的新型口服抗凝血劑之中，dabigatran及rivaroxaban相對於warfarin有較低的顱內出血風險。針對嚴重瓣膜性心臟病，尤其是做過瓣膜手術的病人則不建議使用新型抗凝血劑。

Background Although valvular heart disease (VHD) was often escorted by atrial fibrillation (AF), the outcome of non-vitamin K anticoagulants (NOAC) use in this population was unclear. The goal of our research was to investigate the effectiveness and safety of NOACs compared to warfarin in Asians with AF and VHD.

Methods A retrospective cohort study using Health and Welfare Data in Taiwan was performed. Patients with AF and VHD, and prescribed with either NOACs (dabigatran, rivaroxaban, apixaban) or warfarin were included. Propensity score matching was used to balance baseline characteristics. Cox proportional hazards models were applied to evaluate the relationship between the medication and outcome of interests.

Results There were 21,280 patients included in this study. Compared to warfarin, NOACs had a lower risk of venous thromboembolism (HR: 0.40, 95% CI: 0.23-0.69), composite bleeding (HR: 0.81, 95% CI: 0.74-0.89) and intracranial hemorrhage (HR: 0.50, 95% CI: 0.40-0.62). Severe VHD patients, however, possessed a higher stroke risk with NOAC use (HR: 1.89, 95% CI: 1.18-3.01). This phenomenon was even apparent among patients with previous valve surgery (HR: 2.96, 95% CI: 1.49-5.88). Among NOACs, dabigatran and rivaroxaban had a lower risk of intracranial hemorrhage. Significant decreased overall bleeding risk was also found in dabigatran (HR: 0.77, 95% CI: 0.68-0.87).

Conclusions NOACs versus warfarin were safer choices for patients with comorbid AF and VHD. Among NOACs, dabigatran and rivaroxaban versus warfarin were associated with a lower risk of intracranial hemorrhage. However, among patients with severe VHD, especially those with previous valve surgery, NOACs were not recommended.