A clinical outcome-based prospective study on venous thromboembolism after cancer surgery -: The @RISTOS project
A clinical outcome-based prospective study on venous thromboembolism after cancer surgery -: The @RISTOS project
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DOI：
10.1097/01.sla.0000193959.44677.48
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发表时间：
2006-01-01
影响因子：
9
通讯作者：
Plaino, F
中科院分区：
文献类型：
--
作者：
Agnelli, G;Bolis, G;Plaino, F
背景资料：癌症手术后静脉血栓栓塞（VTE）的流行病学是基于静脉造影筛查深静脉血栓（DVT）预防性VTE的临床试验。然而，无症状静脉造影检测到的DVT的临床相关性尚不清楚，这些临床试验的人群不一定代表整个癌症手术人群。目的：本研究的目的是评估在广泛的连续癌症手术患者中临床明显VTE的发生率，并确定VTE的危险因素。方法：@RISTOS是一项在接受普外科、泌尿科或妇科手术的患者中进行的前瞻性观察性研究。患者进行了评估，临床上明显的静脉血栓栓塞发生手术后30 - 5天或更长的时间，如果住院时间超过35天。所有的结果事件进行了评估，由一个独立的Adjudication Committee. Results：共2373例患者被纳入本研究：1238（52%）进行一般，685（29%）泌尿，450（19%）妇科手术。81.6%的患者进行了院内预防，30.7%的患者进行了出院后预防。50例患者（2.1%）被裁定为受到临床上明显的VTE影响（DVT，0.42%;非致死性肺栓塞，0.88%;死亡0.80%）。静脉血栓栓塞的发生率在普外科为2.83%，妇科为2.0%，泌尿外科为0.87%。40%的事件发生在手术后21天内。总死亡率为1.72%;在46.3%的病例中，死亡是由VTE引起的。在多变量分析中，确定了5个风险因素：60岁以上（2.63，95%置信区间，1.21 - 5.71），既往VTE（5.98，2.13 - 16.80），晚期癌症（2.68，1.37 - 5.24），麻醉持续2小时以上（4.50，1.06 - 19.04），卧床休息超过3天（4.37，2.45 - 7.78）.结论：静脉血栓栓塞仍然是癌症手术的常见并发症，术后晚期发生的事件比例很高。在接受癌症手术的患者中，VTE是术后30天死亡的最常见原因。
Background Data: The epidemiology of venous throinboembolism (VTE) after cancer surgery is based on clinical trials oil VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population.Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE.Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee.Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic Surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21-5.71), previous VTE (5.98, 2.13-16.80), advanced cancer (2.68, 1.37-5.24), anesthesia lasting more than 2 hours (4.50, 1.06-19.04), and bed rest longer than 3 days (4.37, 2.45-7.78).Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion of events occurring late after surgery. In patients undergoing cancer surgery, VTE is the most common cause of death at 30 days after surgery.