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Outcomes of catheter-directed thrombolysis vs. standard medical therapy in patients with acute submassive pulmonary embolism.

ABSTRACT: Background:Catheter-directed thrombolysis (CDL) is increasingly being used for the treatment of submassive and massive pulmonary embolism. Although this therapy has been shown to be effective at reducing right ventricle strain, the impact on clinical outcomes remains unclear. We therefore aimed to evaluate the outcomes of CDL compared to standard anticoagulation for submassive pulmonary embolism patients in a large cohort. Methods:We conducted a retrospective observational study of consecutive patients with a primary diagnosis of submassive pulmonary embolism admitted to an intensive care unit within our health system between June 2014 and April 2016. We compared the outcome of patients treated with systemic anticoagulation (medical therapy) vs. catheter-based delivery of tissue plasminogen activator (tPA) (CDL). CDL patients were matched with medical therapy controls using a propensity-score matching algorithm based on the components of the simplified pulmonary embolism severity index (sPESI) score. Results:Unadjusted mortality rates were 3.0% for CDL vs. 10.4% for medical therapy at 30 days and 8.1% for CDL vs. 22.9% for medical therapy at 1 year. In the propensity-score matched cohort, mortality rates were 3.1% for CDL vs. 6.1% for medical therapy at 30 days and 8.2% for CDL vs. 18.2% for medical therapy at 1 year. Length of stay was significantly shorter in the CDL group. The index admission bleeding and transfusion rates were not increased in the CDL group. Conclusions:In patients presenting with acute submassive pulmonary embolism who are admitted to an intensive care unit, the group treated with CDL experienced reduced mortality at 30 days and 1 year when compared to medical therapy without increase in bleeding. Further randomized studies are required to confirm these findings.

SUBMITTER: D'Auria S

PROVIDER: S-EPMC7144676 | biostudies-literature | 2020 Jan-Mar

REPOSITORIES: biostudies-literature

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Outcomes of catheter-directed thrombolysis vs. standard medical therapy in patients with acute submassive pulmonary embolism.

D'Auria Stephen S Sezer Ahmet A Thoma Floyd F Sharbaugh Michael M McKibben Jeffrey J Maholic Robert R Avgerinos Efthymios D ED Rivera-Lebron Belinda N BN Toma Catalin C

Pulmonary circulation 20200101 1

<h4>Background</h4>Catheter-directed thrombolysis (CDL) is increasingly being used for the treatment of submassive and massive pulmonary embolism. Although this therapy has been shown to be effective at reducing right ventricle strain, the impact on clinical outcomes remains unclear. We therefore aimed to evaluate the outcomes of CDL compared to standard anticoagulation for submassive pulmonary embolism patients in a large cohort.<h4>Methods</h4>We conducted a retrospective observational study o ...[more]

PMID: 32292583

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Project description:BackgroundThe benefit of catheter-directed therapy (CDT) for submassive pulmonary embolism (sPE) has been the subject of debate. We sought to determine the short- and long-term mortality and outcomes of CDT compared with anticoagulation for patients with sPE.MethodsWe performed a single healthcare network, multihospital, retrospective cohort study of hospitalizations for sPE from 2012 to 2019. sPE was defined as the presence of right heart strain or elevated biomarkers (troponin I or B-type natriuretic peptide). Patients with massive PE and those who had undergone systemic thrombolysis were excluded. The sPE groups included therapeutic anticoagulation alone or anticoagulation plus CDT (ie, thrombolysis or suction thrombectomy). The primary outcome was mortality at 1, 3, and 5 years. The other measured outcomes included PE-related death, short term mortality (30 days and 3 and 6 months), 30-day treatment-related complications (eg, bleeding, transfusion, stroke), chronic thromboembolic pulmonary hypertension, and 6-minute walk test at 1 year. After 1:1 nearest-neighbor propensity score matching, Kaplan-Meier survival plots were generated, and the treatment groups were compared using log-rank testing. We used Cox multivariate analysis to evaluate the outcomes after clustering at the hospital level, generating matched hazard ratios (mHRs) with associated 95% confidence intervals (CIs).ResultsOf 6746 sPE hospitalizations, the patients who had received CDT were younger (age, 58.9 ± 15.5 years vs 61.5 ± 17.4 years; P = .004), were more frequently White (92.5% vs 85.7%; P < .001), and had presented with a higher mean heart rate (104.6 bpm vs 94.9 bpm; P < .001), lower median systolic blood pressure (129 mm Hg vs 135 mm Hg; P < .001), and a greater incidence of right heart strain (79.2% vs 20.3%; P < .001). A total of 470 patients were matched, with 235 in the CDT group and 235 in the anticoagulation-only group. CDT was associated with a lower risk of mortality compared with anticoagulation at 1 year (7.6% vs 9.8%; mHR, 0.77; 95% CI, 0.65-0.92; P = .004), 3 years (11.1% vs 16.6%; mHR, 0.64; 95% CI, 0.55-0.73; P < .001), and 5 years (14.5% vs 19.1%; mHR, 0.71; 95% CI, 0.66-0.77; P < .001). Anticoagulation alone resulted in a greater incidence of PE-related deaths at 1, 3, and 5 years. The mortality at 30 days and 3 months was similar; however, CDT had resulted in better survival at 6 months (mHR, 0.81; 95% CI, 0.68-0.97; P = .02). No differences were found between the two groups in the incidence of bleeding complications at 30 days, development of chronic thromboembolic pulmonary hypertension, or the mean walking distance at 1 year.ConclusionsCDT plus anticoagulation for sPE was associated with improved long-term survival compared with anticoagulation alone, with a lower incidence of PE-related death and a low complication rate. CDT should be considered for select patients with sPE given its survival benefit.

Project description:ObjectivesThe aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE).BackgroundCatheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism.MethodsAdults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days.ResultsEighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group.ConclusionsIn the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.

Project description:BACKGROUND:Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question. METHODS:Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm. CONCLUSIONS:SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging patients.

Project description:ImportanceThe optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown.ObjectiveTo assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE.Design, setting, and participantsThe Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020.InterventionsPatients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy.Main outcomes and measuresThe proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes.ResultsThe study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group.Conclusions and relevanceThis prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial.Trial registrationClinicalTrials.gov Identifier: NCT05172115.

Dataset Information

Outcomes of catheter-directed thrombolysis vs. standard medical therapy in patients with acute submassive pulmonary embolism.

Publications

Outcomes of catheter-directed thrombolysis vs. standard medical therapy in patients with acute submassive pulmonary embolism.

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