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Midterm Prognosis of Patients With Pulmonary Embolism Receiving Catheter-Directed Thrombolysis or Systemic Thrombolysis: A Nationwide Population-Based Study.

ABSTRACT: Background This study compared the efficacy and safety between catheter-directed thrombolysis (CDT) and systemic thrombolysis for patients with acute pulmonary embolism (PE) with midterm follow-up. Methods and Results We conducted a prospective open cohort study by using data from the Taiwan National Health Insurance Research Database for 2001 to 2013. Patients who were first admitted for PE and were treated by either systemic thrombolysis or CDT were included and compared. Inverse probability of treatment weighting, based on the propensity score, was used to mitigate possible selection bias. A total of 145 CDT-treated and 1158 systemic thrombolysis-treated patients with PE were included. The in-hospital mortality rate was significantly lower in the CDT group (12.7% versus 21.4%; odds ratio, 0.49; 95% CI, 0.36-0.67) after inverse probability of treatment weighting. No significant differences between the groups were observed for the safety (bleeding) outcomes. In patients who survived the index PE admission, the 1-year all-cause mortality rate was significantly lower in the CDT group after inverse probability of treatment weighting (12.2% versus 13.2%; hazard ratio [HR], 0.73; 95% CI, 0.56-0.94). Treatment with CDT was also associated with lower risks of recurrent PE (9.3% versus 17.5%; subdistribution HR, 0.52; 95% CI, 0.41-0.66). The difference remained through the last follow-up. Conclusions Among patients with PE requiring reperfusion therapy, those accepting CDT had lower all-cause mortality and recurrent PE over both short-term and midterm follow-up periods than those receiving systemic thrombolysis. The bleeding risk was similar for both groups. These findings should be cautiously validated in future randomized trials.

SUBMITTER: Lin DS

PROVIDER: S-EPMC8174309 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSystemic thrombolysis (ST) and catheter-directed intervention (CDI) are both used in the treatment of acute pulmonary embolism (PE), but the comparative outcomes of these two therapies remain unclear. The objective of this study was to compare short-term mortality and safety outcomes between the two treatments using a large national database.MethodsPatients presenting with acute PE were identified in the National Inpatient Sample (NIS) from 2009 to 2012. Comorbidities, clinical characteristics, and invasive procedures were identified using International Classification of Diseases, Ninth Revision (ICD) codes and the Elixhauser comorbidity index. To adjust for anticipated baseline differences between the two treatment groups, propensity score matching was used to create a matched ST cohort with clinical and comorbid characteristics similar to those of the CDI cohort. Subgroups of patients with and without hemodynamic shock were analyzed separately. Primary outcomes were in-hospital mortality, overall bleeding risk, and hemorrhagic stroke risk.ResultsOf 263,955 subjects with acute PE, 1.63% (n = 4272) received ST and 0.55% (n = 1455) received CDI. ST subjects were older, had more chronic comorbidities, and had higher rates of respiratory failure (ST, 27.9% [n = 1192]; CDI, 21.2% [n = 308]; P < .001) and shock (ST, 18.2% [n = 779]; CDI, 12% [n = 174]; P < .001). CDI subjects had higher rates of concurrent deep venous thrombosis (ST, 35.8% [n = 1530]; CDI, 45.9% [n = 668]; P < .001) and vena cava filter placement (ST, 31.1% [n = 1328]; CDI, 57% [n = 830]; P < .001). In the unmatched cohort, ST subjects had higher in-hospital mortality (ST, 16.7% [n = 714]; CDI, 9.4% [n = 136]; P < .001) and hemorrhagic stroke rates (ST, 2.2% [n = 96]; CDI, 1.4% [n = 20]; P = .041). After propensity matching, 1430 patients remained in each cohort; baseline characteristics of the matched cohorts did not differ significantly using standardized difference comparisons. Analysis of the matched cohorts did not demonstrate a significant effect of CDI on in-hospital mortality or overall bleeding risk but did show a significant protective effect against hemorrhagic stroke compared with ST (odds ratio, 0.47; 95% confidence interval, 0.27-0.82; P = .01). Subgroup analysis showed decreased odds of hemorrhagic stroke for CDI in the nonshock subgroup and increased procedural bleeding for CDI but no difference in hemorrhagic stroke risk in the shock subgroup.ConclusionsST for acute PE may not improve in-hospital mortality compared with CDI but increases the overall risk of hemorrhagic stroke compared with CDI. Further prospective studies should examine the comparative effectiveness and safety of these two treatments.

Project description:AIMS:Data on the early course and use of systemic thrombolysis in pregnant women with pulmonary embolism associated or not with haemodynamic failure are scarce. We investigated these aspects using the information from the German Nationwide Inpatient Registry (years 2005-2016). METHODS AND RESULTS:In Germany, all diagnoses referring to hospitalized patients are coded according to the International Classification of Diseases and Related Health Problems, 10th Revision with German Modification. We analysed data of pregnant women aged 18-50 years for whom the following diagnoses were recorded during hospitalization: (i) pulmonary embolism (I26) during pregnancy or peripartum (O09) or (ii) obstetric thromboembolism (O88.2). Haemodynamic failure at any time during the in-hospital stay was defined as need for cardiopulmonary resuscitation (OPS code 8-77) or the presence of shock (International Classification of Diseases and Related Health Problems, 10th Revision with German Modification code R57). The primary study outcome was in-hospital death. A total of 8 271 327 births were registered in Germany from 2005 to 2016. During this 12 year time period, there were 1846 hospitalizations for pregnancy-associated pulmonary embolism in patients aged 18-50, corresponding to 2.2 [95% confidence interval (CI): 2.1-2.3] cases every 10 000 births and 0.2% of all hospitalizations for pulmonary embolism in Germany. The median age was 31 years, and the median length of hospitalization was 8 days. A total of 63 deaths were reported, corresponding to an overall in-hospital fatality rate of 3.4% (95% CI: 2.7-4.4) and a pulmonary embolism-related mortality rate of 0.8 (95% CI: 0.6-1.0) per 100 000 (live) births per year. Pulmonary embolism-related deaths in hospitalized pregnant women represented 14% of all maternal deaths recorded in Germany between 2005 and 2016. A total of 135 (7.3%) women had haemodynamic failure, of whom 51 (37.8%) received systemic thrombolysis and 50 (37.0%) died. CONCLUSIONS:Pulmonary embolism-related fatality remains substantial in pregnant women with pulmonary embolism and represents a frequent cause of maternal mortality. The use of systemic thrombolysis was reported in one third of pregnant women with pulmonary embolism and haemodynamic failure. Better preventive and management strategies should be urgently implemented in this vulnerable patient group.

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Midterm Prognosis of Patients With Pulmonary Embolism Receiving Catheter-Directed Thrombolysis or Systemic Thrombolysis: A Nationwide Population-Based Study.

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