Lack of consistency in the relationship between asymptomatic DVT detected by venography and symptomatic VTE in thromboprophylaxis trials
Lack of consistency in the relationship between asymptomatic DVT detected by venography and symptomatic VTE in thromboprophylaxis trials
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DOI：
10.1160/th14-12-1006
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发表时间：
2015-11-01
影响因子：
6.7
通讯作者：
Eikelboom, John W.
中科院分区：
文献类型：
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作者：
Chan, Noel C.;Stehouwer, Alexander C.;Eikelboom, John W.
通过强制性静脉造影检测到的无症状深静脉血栓形成（DVT）是一种替代结局，包括最近血栓预防试验中的大多数疗效结局事件。在这些临床试验中，该替代指标估计血栓形成和出血事件之间权衡的有效性需要无症状DVT和症状性静脉血栓栓塞（VTE）之间的一致关系。在这篇高质量静脉血栓栓塞预防试验的系统性综述中，我们检查了在广泛适应症范围内无症状性DVT与有症状性静脉血栓栓塞比率的一致性。从2012年美国胸科医师学会抗血栓指南中VTE预防章节中列出的引文中识别研究。符合以下条件的研究合格：1）是一项比较抗凝剂与标准治疗的随机试验; 2）至少纳入500例受试者; 3）报告了无症状或所有DVT发生率; 4）报告了症状性VTE发生率。在26项合格试验中，19项试验在骨科患者中进行，5项在普外科患者中进行，2项在普通内科患者中进行。无症状DVT和症状性VTE的总体中位发生率（范围）分别为9.11%（0.75 - 54.87%）和0.49%（0.00 - 3.10%）。中位比值为14.53，范围很广（2.75 - 103.86）。尽管进行了适应症和抗凝剂特异性分析，但比值仍存在广泛的变异性。在替代抗凝剂的VTE预防试验中，无症状性DVT与有症状性VTE的比值存在很大差异，因此无法根据静脉造影DVT为主的复合结局判断血栓形成和出血事件之间的权衡。
Asymptomatic deep-vein thrombosis (DVT) detected by mandatory venography, a surrogate outcome, comprises most of the efficacy outcome events in recent thromboprophylaxis trials. The validity of this surrogate to estimate trade-off between thrombotic and bleeding events in these clinical trials requires a consistent relationship between asymptomatic DVT and symptomatic venous thromboembolism (VTE). In this systematic review of high quality VTE prevention trials, we examined the consistency of the ratios of asymptomatic DVT to symptomatic VTE across a broad range of indications. Studies were identified from citations listed in the chapters on VTE prevention in the antithrombotic guidelines by the American College of Chest Physicians, 2012. A study was eligible if it: 1) was a randomised trial comparing an anticoagulant with standard of care; 2) included at least 500 participants; 3) reported asymptomatic or all DVT rates; and 4) re-ported symptomatic VTE rates. Of the 26 eligible trials, 19 trials were conducted in orthopaedic patients, five in general surgery patients and two in general medical patients. The overall median rates (ranges) for asymptomatic DVT and symptomatic VTE were 9.11% (0.75 to 54.87%) and 0.49% (0.00 to 3.10%), respectively. The median ratio was 14.53, with a wide range (2.75 to 103.86). Wide variability in the ratios persisted despite indication-and anticoagulant-specific analyses. In VTE prevention trials of alternative anticoagulants, the wide variability in the ratios of asymptomatic DVT to symptomatic VTE precludes judging the trade-off between thrombotic and bleeding events on the basis of composite outcomes dominated by venographic DVT.