UNASSIGNED: A systematic review and meta-analysis of studies reporting on patients with massive PE indexed by PubMed and the Cochrane Library over a 10-year period (2010-2020) was conducted. Studies with adequate information to specify a cohort of patients with high-risk PE defined by the American Heart Association and European Society of Cardiology criteria and their clinical outcomes were included. Incidences were calculated as weighted averages with 95% CIs.
UNASSIGNED: A total of 27 publications spanning 1517 patients were identified that met the search criteria for high-risk PE. In-hospital all-cause mortality averaged 28.3% (95% CI, 20.9%-37.0%) in patients at high risk, comparable to the 30-day all-cause mortality of 30.2% (95% CI, 22.3%-39.6%). In-hospital major bleeding was 13.8% (95% CI, 9.3%-20.0%), and intracranial hemorrhage was reported in 3.6% (95% CI, 2.2%-5.9%). The risk of bias in publications was graded as low-to-moderate, with substantial heterogeneity among the studies.
UNASSIGNED: This systematic review and meta-analysis provided low-quality to moderate-quality evidence documenting mortality, major bleeding, and other complications in patients meeting the American Heart Association and European Society of Cardiology criteria for high-risk PE. This information was used to inform the design of the FLowTriever for Acute Massive Pulmonary Embolism (FLAME) study (NCT04795167), a study evaluating an advanced therapy for patients with high-risk PE.
■对PubMed和Cochrane图书馆在10年期间(2010-2020年)报告的大量PE患者的研究进行了系统评价和荟萃分析。纳入了具有足够信息的研究,以指定由美国心脏协会和欧洲心脏病学会标准定义的高危PE患者及其临床结局。发病率以加权平均数计算,CI为95%。
■共有27篇出版物涵盖1517名患者,符合高危PE的搜索标准。高危患者的住院全因死亡率平均为28.3%(95%CI,20.9%-37.0%),与30日全因死亡率30.2%相当(95%CI,22.3%-39.6%).住院大出血为13.8%(95%CI,9.3%-20.0%),颅内出血报告为3.6%(95%CI,2.2%-5.9%).出版物中的偏倚风险被评为低到中等,研究之间存在很大的异质性。
■本系统综述和荟萃分析提供了低质量到中等质量的证据来记录死亡率,大出血,符合美国心脏协会和欧洲心脏病学会高危PE标准的患者的其他并发症。此信息用于告知FLowTriever用于急性大面积肺栓塞(FLAME)研究的设计(NCT04795167),一项评估高危PE患者晚期治疗的研究。