Crawford Jacquelyn, Roe Austin, Brumit Jessica, Wilson Vera, Tharp Jen
Department of Pharmacy, Johnson City Medical Center, Johnson City, TN, USA.
Ann Pharmacother. 2025 Mar;59(3):232-237. doi: 10.1177/10600280241271264. Epub 2024 Aug 20.
Thrombolysis is recommended in the setting of massive pulmonary embolism (PE) for reperfusion of vessels but carries a serious concern for increased bleed risk. In October 2022, our institution adopted tenecteplase as the formulary thrombolytic. Previous literature is unclear regarding the bleed risk of tenecteplase in massive PE, and no study has yet compared safety outcomes with the current standard of care, alteplase.
The objective of this study was to compare the incidence of bleeding with tenecteplase versus alteplase in massive PE patients.
This was a retrospective, observational cohort study that included adults who received tenecteplase or alteplase for massive PE. The primary outcome was major bleeding as defined by the International Society on Thrombosis and Hemostasis (ISTH). Secondary outcomes included incidence of symptomatic intracranial hemorrhage (ICH), in-hospital mortality, administration of reversal agents, and length of stay.
A total of 44 patients met inclusion criteria with 20 patients in the alteplase cohort and 24 in the tenecteplase cohort. Seventeen percent of tenecteplase patients compared with 5% of alteplase patients experienced bleeding. The mortality rate was 83% vs 75%, respectively. In addition, 1 patient in the tenecteplase cohort experienced a symptomatic ICH and 2 patients required initiation of massive transfusion protocol.
Although this study was limited in sample size, these results suggest that there may be reason for concern of higher bleeding rates in patients treated with tenecteplase in the setting of massive PE.
在大面积肺栓塞(PE)的情况下,推荐进行溶栓以实现血管再灌注,但出血风险增加是一个严重问题。2022年10月,我们机构采用替奈普酶作为处方溶栓药物。以往文献对于替奈普酶在大面积PE中的出血风险尚不明确,且尚无研究将其安全性结果与当前的标准治疗药物阿替普酶进行比较。
本研究的目的是比较替奈普酶与阿替普酶在大面积PE患者中的出血发生率。
这是一项回顾性观察队列研究,纳入了接受替奈普酶或阿替普酶治疗大面积PE的成年人。主要结局是国际血栓与止血协会(ISTH)定义的大出血。次要结局包括有症状性颅内出血(ICH)的发生率、住院死亡率、使用逆转剂的情况以及住院时间。
共有44例患者符合纳入标准,其中阿替普酶队列20例,替奈普酶队列24例。替奈普酶组1�% 的患者出现出血,而阿替普酶组为5%。死亡率分别为83% 和75%。此外,替奈普酶队列中有1例患者发生有症状性ICH,2例患者需要启动大量输血方案。
尽管本研究样本量有限,但这些结果表明,在大面积PE患者中,接受替奈普酶治疗的患者出血率可能更高,值得关注。