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比较阿哌沙班、利伐沙班和依诺肝素在急性癌症相关性静脉血栓栓塞症中的应用。

Comparison of apixaban to rivaroxaban and enoxaparin in acute cancer-associated venous thromboembolism.

机构信息

Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.

Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida.

出版信息

Am J Hematol. 2019 Nov;94(11):1185-1192. doi: 10.1002/ajh.25604. Epub 2019 Aug 19.

DOI:10.1002/ajh.25604
PMID:31378995
Abstract

To provide direct comparison between apixaban and rivaroxaban in patients with acute cancer-associated venous thromboembolism (Ca-VTE), consecutive patients treated with apixaban, rivaroxaban, or enoxaparin at Mayo Thrombophilia Clinic (March 1, 2013 to January 31, 2018)) were followed prospectively. The primary effectiveness outcome was venous thromboembolism (VTE) recurrence, and the secondary was mortality. The primary safety outcome was major bleeding, the secondary clinically relevant safety outcome was non-major bleeding (CRNMB), and the third a composite of major and CRNMB. There were 750 patients treated for acute Ca-VTE with apixaban (n = 224), rivaroxaban (n = 163), and enoxaparin (n = 363) within 14 days of diagnosis and for at least 3 months, or until study event. Recurrent VTE was diagnosed in 11 receiving apixaban, 7 receiving rivaroxaban (apixaban vs rivaroxaban hazard ratio (HR) 1.31, 95% confidence interval (95% CI) 0.51-3.36) and 17 in the enoxaparin receiving group (apixaban vs enoxaparin HR 1.14, 95% CI: 0.54, 2.42 and rivaroxaban vs enoxaparin HR 0.85, 95% Cl: 0.36, 2.06). There were 82 deaths in apixaban, 74 rivaroxaban (apixaban vs rivaroxaban HR 1.67, 95% Cl: 1.20, 2.33) and 171 in enoxaparin group (rivaroxaban vs enoxaparin HR 0.73, 95% Cl: 0.56, 0.96). Major bleeding occurred in 11 apixaban, 12 rivaroxaban (apixaban vs rivaroxaban HR 0.73, 95% Cl: 0.32, 1.66) and 21 enoxaparin group (apixaban vs enoxaparin HR 0.89, 95% Cl: 0.43, 1.84 and rivaroxaban vs enoxaparin HR 1.23, 95% Cl: 0.61, 2.50). The CRNMB rate was higher in rivaroxaban compared to apixaban (P = .03) and LMWH (P = .01) groups. Recurrence of VTE and major bleeding were similar in apixaban, rivaroxaban, and enoxaparin groups. Rivaroxaban was associated with higher CRNMB but lower mortality compared to apixaban and enoxaparin.

摘要

为了在急性癌症相关静脉血栓栓塞症(Ca-VTE)患者中直接比较阿哌沙班和利伐沙班,前瞻性连续随访了在梅奥血栓形成诊所接受阿哌沙班、利伐沙班或依诺肝素治疗的患者(2013 年 3 月 1 日至 2018 年 1 月 31 日)。主要有效性结局是静脉血栓栓塞症(VTE)复发,次要结局是死亡率。主要安全性结局是大出血,次要临床相关安全性结局是非大出血(CRNMB),第三个结局是大出血和 CRNMB 的复合结局。在诊断后 14 天内接受阿哌沙班(n=224)、利伐沙班(n=163)和依诺肝素(n=363)治疗的 750 例急性 Ca-VTE 患者中,至少接受了 3 个月的治疗,或直至研究事件发生。阿哌沙班组有 11 例出现 VTE 复发,利伐沙班组有 7 例(阿哌沙班 vs 利伐沙班危险比(HR)1.31,95%置信区间(95%CI)0.51-3.36),依诺肝素组有 17 例(阿哌沙班 vs 依诺肝素 HR 1.14,95%CI:0.54,2.42 和利伐沙班 vs 依诺肝素 HR 0.85,95%Cl:0.36,2.06)。阿哌沙班组有 82 例死亡,利伐沙班组有 74 例(阿哌沙班 vs 利伐沙班 HR 1.67,95%Cl:1.20,2.33),依诺肝素组有 171 例(利伐沙班 vs 依诺肝素 HR 0.73,95%Cl:0.56,0.96)。阿哌沙班组有 11 例发生大出血,利伐沙班组有 12 例(阿哌沙班 vs 利伐沙班 HR 0.73,95%Cl:0.32,1.66),依诺肝素组有 21 例(阿哌沙班 vs 依诺肝素 HR 0.89,95%Cl:0.43,1.84 和利伐沙班 vs 依诺肝素 HR 1.23,95%Cl:0.61,2.50)。与阿哌沙班相比,利伐沙班组的 CRNMB 发生率更高(P=0.03)和 LMWH(P=0.01)组。阿哌沙班、利伐沙班和依诺肝素组的 VTE 复发和大出血发生率相似。与阿哌沙班和依诺肝素相比,利伐沙班与更高的 CRNMB 但更低的死亡率相关。

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