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低剂量与常规剂量阿司匹林用于全髋关节置换术后静脉血栓栓塞症预防的效果无差异。

No Difference Between Low- and Regular-dose Aspirin for Venous Thromboembolism Prophylaxis After THA.

机构信息

M. Faour, N. S. Piuzzi, D. P. Brigati, A. K. Klika, M. M. Mont, W. K. Barsoum, C. Higuera-Rueda, Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA N. S. Piuzzi, Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

出版信息

Clin Orthop Relat Res. 2019 Feb;477(2):396-402. doi: 10.1097/CORR.0000000000000613.

Abstract

BACKGROUND

Aspirin is established as an effective prophylaxis for venous thromboembolism (VTE) after THA; however, there is no consensus as to whether low- or regular-dose aspirin is more effective at preventing VTE.

QUESTIONS/PURPOSES: (1) Is there a difference in the incidence of symptomatic VTE within 90 days of elective THA using low-dose aspirin compared with regular-dose aspirin? (2) Is there a difference in the risk of significant bleeding (gastrointestinal and wound bleeding) and mortality between low- and standard-dose aspirin within 90 days after surgery?

METHODS

We retrospectively evaluated 7488 patients in our database who underwent THA between September 2012 and December 2016. A total of 3936 (53%) patients received aspirin alone for VTE prophylaxis after THA. During the study period, aspirin was prescribed as a monotherapy for VTE prophylaxis after surgery in low-risk patients (no history of VTE, recent orthopaedic surgery, hypercoagulable state, history of cardiac arrhythmia requiring anticoagulation, or receiving anticoagulation for any other medical conditions before surgery). Patients were excluded if aspirin use was contraindicated because of peptic ulcer disease, intolerance, or other reasons. Patients received aspirin twice daily (BID) for 4 to 6 weeks after surgery and were grouped into two cohorts: a low-dose (81 mg BID) aspirin group (n = 1033) and a standard-dose (325 mg BID) aspirin group (n = 2903). The primary endpoint was symptomatic VTE (deep vein thrombosis [DVT] and pulmonary embolism [PE]). Secondary endpoints included significant bleeding (gastrointestinal [GI] and wound) and mortality. Exploratory univariate analyses were used to compare confounders between the study groups. Multivariate regression was used to control for confounding variables (including age, sex, body mass index, comorbidities, and surgeon) as we compared the study groups with respect to the proportion of patients who developed symptomatic VTE, bleeding (GI or wound), and mortality within 90 days of surgery.

RESULTS

The 90-day incidence of symptomatic VTE was 1.0% in the 325-mg group and 0.6% in the 81-mg group (p = 0.35). Symptomatic DVT incidence was 0.8% in the 325-mg group and 0.5% in the 81-mg group (p = 0.49), and the incidence of symptomatic PE was 0.3% in the 325-mg group and 0.2% in the 81-mg group (p = 0.45). Furthermore, bleeding was observed in 0.8% of the 325-mg group and 0.5% of the 81-mg group (p = 0.75), and 90-day mortality was not different (0.1%) between the groups (p = 0.75). After accounting for confounders, regression analyses showed no difference between aspirin doses and the 90-day incidence of symptomatic VTE (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.29-2.85; p = 0.85) or symptomatic DVT (OR, 0.96; 95% CI, 0.26-3.59; p = 0.95).

CONCLUSIONS

We found no difference in the incidence of symptomatic VTE after THA with low-dose compared with standard-dose aspirin. In the absence of compelling evidence to the contrary, low-dose aspirin appears to be a reasonable option for VTE prophylaxis in otherwise healthy patients undergoing elective THA.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

阿司匹林已被确立为全髋关节置换术(THA)后预防静脉血栓栓塞症(VTE)的有效药物;然而,低剂量与常规剂量阿司匹林在预防 VTE 方面哪一种更有效,目前尚无共识。

问题/目的:(1)与常规剂量阿司匹林相比,低剂量阿司匹林在择期 THA 后 90 天内,症状性 VTE 的发生率是否存在差异?(2)在手术后 90 天内,低剂量与标准剂量阿司匹林在重大出血(胃肠道和伤口出血)和死亡率方面的风险是否存在差异?

方法

我们回顾性评估了我们数据库中 7488 例接受 THA 的患者。共有 3936 例(53%)患者在 THA 后单独使用阿司匹林预防 VTE。在研究期间,低风险患者(无 VTE 病史、近期骨科手术、高凝状态、需要抗凝的心律失常病史或手术前因其他医疗条件接受抗凝治疗)术后使用阿司匹林作为 VTE 预防的单一药物。如果因消化性溃疡病、不耐受或其他原因而禁忌使用阿司匹林,则排除患者。患者术后每天接受两次阿司匹林(BID)治疗,持续 4 至 6 周,并分为两组:低剂量(81mg BID)阿司匹林组(n=1033)和标准剂量(325mg BID)阿司匹林组(n=2903)。主要终点是症状性 VTE(深静脉血栓形成[DVT]和肺栓塞[PE])。次要终点包括重大出血(胃肠道[GI]和伤口)和死亡率。我们使用探索性单变量分析比较了研究组之间的混杂因素。使用多元回归控制混杂变量(包括年龄、性别、体重指数、合并症和外科医生),因为我们比较了研究组之间在手术后 90 天内发生症状性 VTE、出血(GI 或伤口)和死亡率的比例。

结果

325mg 组 90 天症状性 VTE 的发生率为 1.0%,81mg 组为 0.6%(p=0.35)。325mg 组症状性 DVT 的发生率为 0.8%,81mg 组为 0.5%(p=0.49),症状性 PE 的发生率为 0.3%,81mg 组为 0.2%(p=0.45)。此外,325mg 组出血发生率为 0.8%,81mg 组为 0.5%(p=0.75),90 天死亡率两组之间无差异(0.1%,p=0.75)。在考虑混杂因素后,回归分析显示阿司匹林剂量与症状性 VTE(比值比[OR],0.90;95%置信区间[CI],0.29-2.85;p=0.85)或症状性 DVT(OR,0.96;95%CI,0.26-3.59;p=0.95)的 90 天发生率之间无差异。

结论

与标准剂量阿司匹林相比,我们发现低剂量阿司匹林在 THA 后症状性 VTE 的发生率没有差异。在没有相反的有力证据的情况下,低剂量阿司匹林似乎是择期 THA 中健康患者预防 VTE 的合理选择。

证据水平

III 级,治疗性研究。

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