Perrotta Carla, Chahla Jorge, Badariotti Gustavo, Ramos Jorge
School of Public Health, University College Dublin, Dublin, Ireland.
Center for Regenerative Sports Medicine (CRSM), Vail, Colorado, USA.
Cochrane Database Syst Rev. 2020 May 6;5(5):CD005259. doi: 10.1002/14651858.CD005259.pub4.
Knee arthroscopy (KA) is a routine orthopedic procedure recommended to repair cruciate ligaments and meniscus injuries and in eligible patients, to assist the diagnosis of persistent knee pain. KA is associated with a small risk of thromboembolic events. This systematic review aims to assess if pharmacological or non-pharmacological interventions may reduce this risk. This review is the second update of the review first published in 2007.
To assess the efficacy and safety of interventions, whether mechanical, pharmacological, or in combination, for thromboprophylaxis in adult patients undergoing KA.
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the CENTRAL, MEDLINE, Embase and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 14 August 2019.
We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs), whether blinded or not, of all types of interventions used to prevent deep vein thrombosis (DVT) in males and females aged 18 years and older undergoing KA. There were no restrictions on language or publication status.
Two authors independently selected studies for inclusion, assessed trial quality with the Cochrane 'Risk of bias' tool, and extracted data. A third author addressed discrepancies. We contacted study authors for additional information when required. We used GRADE to assess the certainty of the evidence.
This update adds four new studies, bringing the total of included studies to eight and involving 3818 adult participants with no history of thromboembolic disease undergoing KA. Studies compared daily subcutaneous (sc) low-molecular-weight heparin (LMWH) versus control (five studies); oral rivaroxaban 10 mg versus placebo (one study); daily sc LMWH versus graduated compression stockings (GCS) (one study); and aspirin versus control (one study). The incidence of pulmonary embolism (PE) in all trials combined was low, with seven cases in 3818 participants.There were no deaths in any of the intervention or control groups. LMWH versus control When compared with control, LMWH probably results in little to no difference in the incidence of PE in patients undergoing KA (risk ratio (RR) 1.81, 95% confidence interval (CI) 0.49 to 6.65; 1820 participants; 3 studies; moderate-certainty evidence). LMWH showed no reduction of the incidence of symptomatic DVT (RR 0.61, 95% CI 0.18 to 2.03; 1848 participants; 4 studies; moderate-certainty evidence). LMWH may reduce the risk of asymptomatic DVT but the evidence is very uncertain (RR 0.14, 95% CI 0.03 to 0.61; 369 participants; 2 studies; very low-certainty evidence). There was no evidence of an increased risk of all adverse events combined (RR 1.85, 95% CI 0.95 to 3.59; 1978 participants; 5 studies; moderate-certainty evidence). No evidence of a clear effect on major bleeding (RR 0.98, 95% CI 0.06 to 15.72; 1451 participants; 1 study; moderate-certainty evidence), or minor bleeding was observed (RR 1.79, 95% CI 0.84 to 3.84; 1978 participants; 5 studies; moderate-certainty evidence). Rivaroxaban versus placebo One study with 234 participants compared oral rivaroxaban 10 mg versus placebo. No evidence of a clear impact on the risk of PE (no events in either group), symptomatic DVT (RR 0.16, 95% CI 0.02 to 1.29; moderate-certainty evidence); or asymptomatic DVT (RR 0.95, 95% CI 0.06 to 15.01; very low-certainty evidence) was detected. Only bleeding adverse events were reported. No major bleeds occurred in either group and there was no evidence of differences in minor bleeding between the groups (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence). Aspirin versus control One study compared aspirin with control. No PE, DVT or asymptomatic events were detected in either group. Adverse events including pain and swelling were reported but it was not clear what groups these were in. No bleeds were reported. LMWH versus GCS One study with 1317 participants compared the use of LMWH versus GCS. There was no clear difference in the risk of PE (RR 1.00, 95% CI 0.14 to 7.05; low-certainty evidence). LMWH use did reduce the risk of DVT compared to people using GCS (RR 0.17, 95% CI 0.04 to 0.75; low-certainty evidence). No clear difference in effects was seen between the groups for asymptomatic DVT (RR 0.47, 95% CI 0.21 to 1.09; very low-certainty evidence); major bleeding (RR 3.01, 95% CI 0.61 to 14.88; moderate-certainty evidence) or minor bleeding (RR 1.16, 95% CI 0.64 to 2.08; moderate-certainty evidence). Levels of thromboembolic events were higher in the GCS group than in any other group. We downgraded the certainty of the evidence for imprecision resulting from overall small event numbers; risk of bias due to concerns about lack of blinding, and indirectness as we were uncertain about the direct clinical relevance of asymptomatic DVT detection.
AUTHORS' CONCLUSIONS: There is a small risk that healthy adult patients undergoing KA will develop venous thromboembolism (PE or DVT). There is moderate- to low-certainty evidence of no benefit from the use of LMWH, aspirin or rivaroxaban in reducing this small risk of PE or symptomatic DVT. There is very low-certainty evidence that LMWH use may reduce the risk of asymptomatic DVT when compared to no treatment but it is uncertain how this directly relates to incidence of DVT or PE in healthy patients. No evidence of differences in adverse events (including major and minor bleeding) was seen, but data relating to this were limited due to low numbers of events in the studies reporting within the comparisons.
膝关节镜检查(KA)是一种常规的骨科手术,推荐用于修复交叉韧带和半月板损伤,并在符合条件的患者中辅助诊断持续性膝关节疼痛。KA与血栓栓塞事件的小风险相关。本系统评价旨在评估药物或非药物干预措施是否可以降低这种风险。本评价是2007年首次发表的评价的第二次更新。
评估机械、药物或联合干预措施对接受KA的成年患者进行血栓预防的有效性和安全性。
本次更新中,Cochrane血管信息专家于2019年8月14日检索了Cochrane血管专业注册库、Cochrane中心对照试验注册库、MEDLINE、Embase和CINAHL数据库,以及世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册库。
我们纳入了所有用于预防18岁及以上接受KA的男性和女性深静脉血栓形成(DVT)的干预措施的随机对照试验(RCT)和对照临床试验(CCT),无论是否采用盲法。对语言或发表状态没有限制。
两位作者独立选择纳入研究,使用Cochrane“偏倚风险”工具评估试验质量,并提取数据。第三位作者解决分歧。必要时,我们联系研究作者获取更多信息。我们使用GRADE评估证据的确定性。
本次更新增加了四项新研究,使纳入研究总数达到八项,涉及3818名无血栓栓塞疾病史的接受KA的成年参与者。研究比较了每日皮下注射低分子肝素(LMWH)与对照组(五项研究);口服利伐沙班10 mg与安慰剂(一项研究);每日皮下注射LMWH与分级压力袜(GCS)(一项研究);以及阿司匹林与对照组(一项研究)。所有试验中肺栓塞(PE)的发生率较低,3818名参与者中有7例。干预组或对照组均无死亡病例。LMWH与对照组相比,与对照组相比,LMWH可能导致接受KA的患者发生PE的发生率几乎没有差异(风险比(RR)1.81,95%置信区间(CI)0.49至6.65;1820名参与者;3项研究;中等确定性证据)。LMWH未显示出有症状DVT发生率的降低(RR 0.61,95%CI 0.18至2.03;1848名参与者;4项研究;中等确定性证据)。LMWH可能降低无症状DVT的风险,但证据非常不确定(RR 0.14,95%CI 0.03至0.61;369名参与者;2项研究;极低确定性证据)。没有证据表明所有不良事件的综合风险增加(RR 1.85,95%CI 0.95至3.59;1978名参与者;5项研究;中等确定性证据)。没有证据表明对大出血有明显影响(RR 0.98,95%CI 0.06至15.72;1451名参与者;1项研究;中等确定性证据),也未观察到小出血(RR 1.79,95%CI 0.84至3.84;1978名参与者;5项研究;中等确定性证据)。利伐沙班与安慰剂一项纳入234名参与者的研究比较了口服利伐沙班10 mg与安慰剂。没有证据表明对PE风险有明显影响(两组均无事件发生)、有症状DVT(RR 0.16,95%CI 0.02至1.29;中等确定性证据)或无症状DVT(RR 0.95,95%CI 0.06至15.01;极低确定性证据)。仅报告了出血不良事件。两组均未发生大出血,且两组之间小出血无差异证据(RR 0.63,95%CI 0.18至2.19;中等确定性证据)。阿司匹林与对照组一项研究比较了阿司匹林与对照组。两组均未检测到PE、DVT或无症状事件。报告了包括疼痛和肿胀在内的不良事件,但不清楚这些事件属于哪些组。未报告出血情况。LMWH与GCS一项纳入1317名参与者的研究比较了LMWH与GCS的使用情况。PE风险没有明显差异(RR 1.00,95%CI 0.14至7.05;低确定性证据)。与使用GCS的人相比,使用LMWH确实降低了DVT的风险(RR 0.17,95%CI 0.04至0.75;低确定性证据)。两组在无症状DVT(RR 0.47,95%CI 0.21至1.09;极低确定性证据)、大出血(RR 3.01,95%CI 0.61至14.88;中等确定性证据)或小出血(RR 1.16,95%CI 0.64至2.08;中等确定性证据)方面没有明显的效果差异。GCS组的血栓栓塞事件水平高于任何其他组。由于总体事件数量少导致的不精确性、对缺乏盲法的担忧导致的偏倚风险以及我们对无症状DVT检测的直接临床相关性不确定导致的间接性,我们降低了证据的确定性。
接受KA的健康成年患者有发生静脉血栓栓塞(PE或DVT)的小风险。有中等至低确定性证据表明,使用LMWH、阿司匹林或利伐沙班在降低这种小风险的PE或有症状DVT方面没有益处。有极低确定性证据表明,与不治疗相比,使用LMWH可能降低无症状DVT的风险,但不确定这与健康患者DVT或PE的发生率有何直接关系。未观察到不良事件(包括大出血和小出血)有差异的证据,但由于比较中报告的研究中事件数量少,与此相关的数据有限。