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导管定向溶栓与全身溶栓治疗肺栓塞的结局比较:国家行政索赔的真实世界分析。

Outcomes of catheter-directed versus systemic thrombolysis for the treatment of pulmonary embolism: A real-world analysis of national administrative claims.

机构信息

Department of Medicine, Division of Cardiovascular Medicine, Maine Medical Center, Portland, ME, USA.

Division of Cardiovascular Critical Care Services, Maine Medical Center, Portland, ME, USA.

出版信息

Vasc Med. 2020 Aug;25(4):334-340. doi: 10.1177/1358863X20903371. Epub 2020 Apr 27.

Abstract

Catheter-directed thrombolysis (CDT) and systemic thrombolysis (ST) are used to treat intermediate/high-risk pulmonary embolism (PE) in the absence of comparative safety and effectiveness data. We utilized a large administrative database to perform a comparative safety and effectiveness analysis of catheter-directed versus systemic thrombolysis. From the Optum Clinformatics Data Mart private-payer insurance claims database, we identified 100,744 patients hospitalized with PE between 2004 and 2014. We extracted demographic characteristics, high-risk PE features, components of the Elixhauser Comorbidity Index, and outcomes including intracranial hemorrhage (ICH), all-cause bleeding, and mortality among all patients receiving CDT and ST. We used propensity score methods to compare outcomes between matched cohorts adjusted for observed confounders. A total of 1915 patients (1.9%) received either CDT ( = 632) or ST ( = 1283). Patients in the CDT group had fewer high-risk features including less shock (5.4 vs 11.1%; < 0.001) and cardiac arrest (6.8 vs 11.0%; = 0.004). In 1:1 propensity-matched groups, ICH rates were 1.9% in both the CDT and ST groups ( = 1.0). All-cause bleeding was higher in the CDT group (15.9 vs 8.7%; < 0.001), while in-hospital mortality was lower (6.5 vs 10.0%; = 0.02). Among a nationally representative cohort of patients with PE at higher risk for mortality, CDT was associated with similar ICH rates, increased all-cause bleeding, and lower short and intermediate-term mortality when compared with ST. The competing risks and benefits of CDT in real-world practice suggest the need for large-scale randomized clinical trials with appropriate comparator arms.

摘要

导管溶栓治疗(CDT)和全身溶栓治疗(ST)用于治疗无对照安全性和有效性数据的中高危肺栓塞(PE)。我们利用一个大型行政数据库,对导管溶栓治疗与全身溶栓治疗进行了安全性和有效性的比较分析。从 Optum Clinformatics Data Mart 私人支付者保险索赔数据库中,我们确定了 2004 年至 2014 年间因 PE 住院的 100744 名患者。我们提取了人口统计学特征、高危 PE 特征、Elixhauser 合并症指数的组成部分,以及所有接受 CDT 和 ST 治疗的患者的颅内出血(ICH)、所有原因出血和死亡率等结果。我们使用倾向评分方法,根据观察到的混杂因素,对匹配队列的结果进行比较。共有 1915 名患者(1.9%)接受了 CDT(=632)或 ST(=1283)治疗。CDT 组患者的高危特征较少,包括休克发生率较低(5.4%比 11.1%;<0.001)和心搏骤停发生率较低(6.8%比 11.0%;=0.004)。在 1:1 倾向评分匹配组中,CDT 和 ST 组的 ICH 发生率均为 1.9%(=1.0)。CDT 组的全因出血发生率更高(15.9%比 8.7%;<0.001),而住院死亡率更低(6.5%比 10.0%;=0.02)。在一个代表更高死亡率风险的患者的全国代表性队列中,与 ST 相比,CDT 与相似的 ICH 发生率、增加的全因出血率和较低的短期和中期死亡率相关。CDT 在真实世界实践中的竞争风险和获益表明,需要进行大规模的随机临床试验,并设置适当的对照组。

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