P. Kasina, L. J. Lapidus, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden A. Wall, O. Rolfson, J. Kärrholm, S. Nemes, B. I. Eriksson, M. Mohaddes, Department of Orthopedics, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden O. Rolfson, J. Kärrholm, B. I. Eriksson, M. Mohaddes, University of Gothenburg, Sahlgrenska University Hospital, Mölndal, Sweden O. Rolfson, J. Kärrholm, B. I. Eriksson, M. Mohaddes, Department of Orthopedics, Sahlgrenska University Hospital, Mölndal, Sweden O. Rolfson, J. Kärrholm, S. Nemes, M. Mohaddes, Swedish Hip Arthroplasty Register, Registercentrum VGR, Gothenburg, Sweden S. Nemes, Svenska Höftprotesregistret, Registercentrum Västra Götaland, Göteborg, Sweden.
Clin Orthop Relat Res. 2019 Jun;477(6):1335-1343. doi: 10.1097/CORR.0000000000000714.
Although the use of thromboprophylaxis is well established, there is no consensus on the preferred thromboprophylaxis regimen after THA; large, population-based studies offer an opportunity to examine this problem in a robust way that can complement results from randomized trials.
QUESTIONS/PURPOSES: Using data from a large national registry, we asked: (1) Is there any difference between low-molecular weight heparin (LMWH) and new oral anticoagulants in preventing symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), after THA? (2) Are there any differences in safety parameters, such as bleeding, reoperations and mortality, between LMWH and new oral anticoagulants?
Between 2008 and 2012, 78,066 THAs were performed in Sweden. This study evaluated 32,663 (42%) of them, selected through the merger of several national registries. These patients underwent unilateral THA due to primary osteoarthritis. They had not experienced any venous thromboembolic events 5 years before the index operation and were not prescribed potent antithrombotic agents, of any type, in the 6 months before the index operation. Additionally, their postoperative thromboprophylaxis was confirmed in a national registry by purchase of prescribed medications. We divided the cohort into two groups: those patients who received new oral anticoagulants (5752, 18%) and those who received LMWH (26,881, 82%) as postoperative thromboprophylaxis. Our primary endpoints were the frequencies of symptomatic DVT and symptomatic PE within 3 months of surgery. Our secondary comparison was a between-group comparison of bleeding (by way of diagnostic coding), reoperation, and mortality within 3 months of surgery. Odds ratios (OR) are presented with 95% confidence intervals (CIs) as pooled results for the two groups after adjustment for duration of thromboprophylaxis (short or extended for at least 28 days), year of the index operation, Elixhauser comorbidity index, sex, age and previous treatment with platelet aggregation inhibitors.
The risk of symptomatic DVT was lower in the group that received new oral anticoagulants than the group that received LMWH (0.3% versus 0.6%, OR, 0.47; 95% CI, 0.27-0.76; p = 0.026). The risk of symptomatic PE was lower in the group that received new oral anticoagulants than the group that received LMWH (0.1% versus 0.4%, OR, 0.36; 95% CI, 0.16-0.69; p = 0.005). There was no difference in the risk of bleeding (by way of diagnostic coding) (OR, 1.03; 95% CI, 0.82-1.28; p = 0.688), reoperation (OR, 1.02; 95% CI, 0.71-1.44; p = 0.860) or mortality (OR, 0.83; 95% CI, 0.31-1.88; p = 0.883) between groups.
New oral anticoagulants were associated with a lower risk of symptomatic DVT and symptomatic PE in this large, registry study, and we observed no differences in the risk of bleeding, reoperation, or death between the groups. Although we were able to control for a number of potential confounding variables, we cannot ascertain the indications that drove the prescription decisions in this setting, and there were important between-group differences in terms of duration of thromboprophylaxis (new oral anticoagulants generally were used for a longer period of time after surgery). Future studies, preferably large randomized trials with pragmatic inclusion criteria, to analyze symptomatic DVT, symptomatic PE and death are needed to confirm or refute our findings.
Level III, therapeutic study.
尽管使用血栓预防措施已得到广泛认可,但对于全髋关节置换术后首选的血栓预防方案尚未达成共识;大型基于人群的研究为以稳健的方式检查这一问题提供了机会,这可以补充随机试验的结果。
问题/目的:利用来自大型国家注册中心的数据,我们提出以下问题:(1)在全髋关节置换术后预防有症状的深静脉血栓(DVT)和肺栓塞(PE)方面,低分子肝素(LMWH)和新型口服抗凝剂(NOACs)之间是否存在差异?(2)在安全性参数方面,如出血、再次手术和死亡率,LMWH 和 NOACs 之间是否存在差异?
2008 年至 2012 年,瑞典共进行了 78066 例全髋关节置换术。本研究评估了其中的 32663 例(42%),通过合并多个国家注册中心的数据进行选择。这些患者因原发性骨关节炎行单侧全髋关节置换术,在指数手术前 5 年内未经历任何静脉血栓栓塞事件,在指数手术前 6 个月内未服用任何类型的强效抗血栓药物。此外,通过购买处方药物,国家注册中心可确认患者术后的血栓预防措施。我们将队列分为两组:接受新型口服抗凝剂(5752 例,18%)和接受 LMWH(26881 例,82%)作为术后血栓预防的患者。我们的主要终点是手术后 3 个月内有症状的 DVT 和有症状的 PE 的频率。我们的次要比较是手术后 3 个月内出血(通过诊断编码)、再次手术和死亡率的组间比较。对于两个组,我们呈现了比值比(OR)及其 95%置信区间(CI),这是在调整了血栓预防持续时间(至少 28 天的短期或延长)、指数手术年份、Elixhauser 合并症指数、性别、年龄和之前使用血小板聚集抑制剂的情况下的汇总结果。
与接受 LMWH 的患者相比,接受新型口服抗凝剂的患者发生有症状的 DVT 的风险较低(0.3%比 0.6%,OR,0.47;95%CI,0.27-0.76;p=0.026)。与接受 LMWH 的患者相比,接受新型口服抗凝剂的患者发生有症状的 PE 的风险较低(0.1%比 0.4%,OR,0.36;95%CI,0.16-0.69;p=0.005)。两组之间在出血(通过诊断编码)(OR,1.03;95%CI,0.82-1.28;p=0.688)、再次手术(OR,1.02;95%CI,0.71-1.44;p=0.860)或死亡率(OR,0.83;95%CI,0.31-1.88;p=0.883)的风险无差异。
在这项大型登记研究中,新型口服抗凝剂与较低的有症状 DVT 和有症状 PE 风险相关,我们观察到两组之间在出血、再次手术或死亡的风险无差异。尽管我们能够控制许多潜在的混杂变量,但我们无法确定导致该环境下处方决策的指征,而且两组之间在血栓预防持续时间(新型口服抗凝剂通常在手术后使用更长的时间)方面存在重要差异。需要进一步的研究,最好是有实用纳入标准的大型随机试验,以分析有症状的 DVT、有症状的 PE 和死亡,以证实或反驳我们的发现。
III 级,治疗性研究。