Liu Xianchen, Thompson John, Phatak Hemant, Mardekian Jack, Porcari Anthony, Johnson Margot, Cohen Alexander T
Dr. Alexander T. Cohen, Thrombosis and Thrombophilia Unit, Department of Haematology, Guy's and St Thomas' Hospitals NHS Foundation Trust, Westminster Bridge Road, London SE1 7EH, UK, Tel.: +44 20 7188 2736, Fax: +44 20 7188 2717, E-mail:
Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.
Treatment with apixaban versus placebo for 12 months significantly reduced symptomatic recurrent venous thromboembolism (VTE) or all-cause death without increasing the rate of major bleeding in the AMPLIFY-EXT trial. This analysis examined the effects of apixaban versus placebo on the rate of all-cause hospitalisations, time to first hospitalisation, and predictors of first hospitalisation in patients with VTE enrolled in AMPLIFY-EXT. Treatment with apixaban 2.5 mg and 5 mg twice daily significantly reduced the rate of all-cause hospitalisations versus placebo (hazard ratio [95% confidence interval], 0.64 [0.43, 0.95]; p=0.026 and 0.54 [0.36, 0.82]; p=0.004, respectively). Apixaban prolonged mean time to first hospitalisation versus placebo by 43 and 49 days for the 2.5-mg and 5-mg twice-daily groups, respectively. Median length of hospital stay during the first hospitalisation was longer for placebo than for apixaban 2.5 mg or 5 mg twice daily (7.0, 5.0, and 4.5 days, respectively). Treatment with apixaban was a significant predictor of lower rates of hospitalisations versus placebo, and severe/moderate renal impairment was a significant predictor of an increased rate. This study supports extended use of apixaban for reducing all-cause hospitalisations and extending time to first hospitalisation in patients with VTE enrolled in AMPLIFY-EXT (www.clinicaltrials.gov registration: #NCT00633893).
在AMPLIFY-EXT试验中,与安慰剂相比,阿哌沙班治疗12个月可显著降低有症状的复发性静脉血栓栓塞症(VTE)或全因死亡的发生率,且不增加大出血发生率。本分析研究了阿哌沙班与安慰剂对AMPLIFY-EXT试验中VTE患者全因住院率、首次住院时间以及首次住院预测因素的影响。阿哌沙班2.5毫克每日两次和5毫克每日两次治疗与安慰剂相比,显著降低了全因住院率(风险比[95%置信区间],分别为0.64[0.43,0.95];p = 0.026和0.54[0.36,0.82];p = 0.004)。阿哌沙班2.5毫克每日两次组和5毫克每日两次组与安慰剂相比,首次住院的平均时间分别延长了43天和49天。安慰剂组首次住院期间的中位住院时间长于阿哌沙班2.5毫克每日两次组或5毫克每日两次组(分别为7.0天、5.0天和4.5天)。与安慰剂相比,阿哌沙班治疗是住院率降低的显著预测因素,而中重度肾功能损害是住院率增加的显著预测因素。本研究支持在AMPLIFY-EXT试验中(www.clinicaltrials.gov注册编号:#NCT00633893)的VTE患者中延长使用阿哌沙班以降低全因住院率并延长首次住院时间。