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