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Estudio primario

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Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial.

Revista JACC. Cardiovascular interventions
Año 2021
Enlaces Pubmed DOI PubMed Central

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OBJECTIVES: The 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). BACKGROUND: Catheter-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. METHODS: Adults 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. RESULTS: Eighty-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. CONCLUSIONS: In 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.

Estudio primario

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Incomplete echocardiographic recovery at 6 months predicts long-term sequelae after intermediate-risk pulmonary embolism. A post-hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial.

Revista Clinical research in cardiology : official journal of the German Cardiac Society
Año 2019
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INTRODUCTION: Symptoms and functional limitation are frequently reported by survivors of acute pulmonary embolism (PE). However, current guidelines provide no specific recommendations on which patients should be followed after acute PE, when follow-up should be performed, and which tests it should include. Definition and classification of late PE sequelae are evolving, and their predictors remain to be determined. METHODS: In a post hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial, we focused on 219 survivors of acute intermediate-risk PE with clinical and echocardiographic follow-up 6 months after randomisation as well as over the long term (median, 3 years after acute PE). The primary outcome was a composite of (1) confirmed chronic thromboembolic pulmonary hypertension (CTEPH) or (2) 'post-PE impairment' (PPEI), defined by echocardiographic findings indicating an intermediate or high probability of pulmonary hypertension along with New York Heart Association functional class II-IV. RESULTS: Confirmed CTEPH or PPEI occurred in 29 (13.2%) patients, (6 with CTEPH and 23 with PPEI). A history of chronic heart failure at baseline and incomplete or absent recovery of echocardiographic parameters at 6 months predicted CTEPH or PPEI at long-term follow-up. CONCLUSIONS: CTEPH or PPEI occurs in almost one out of seven patients after acute intermediate-risk PE. Six-month echocardiographic follow-up may be useful for timely detection of late sequelae.

Estudio primario

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Clinical efficacy of low dose recombinant tissue-type plasminogen activator for the treatment of acute intermediate-risk pulmonary embolism.

Revista Saudi medical journal
Año 2018
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OBJECTIVES: To investigate the efficacy and safety of initial thrombolysis by recombinant tissue-type plasminogen activator (rt-PA) in compared with anticoagulant therapy in patients with acute intermediate-risk pulmonary embolism (PE).  Methods: Sixty-six patients with acute intermediate-risk PE were randomly assigned to receive rt-PA or LMWH between June 2014 and June 2017 in our department. We obtained information regarding the difference in the right ventricle/left ventricle (RV/LV) ratio, pulmonary artery systolic pressure (PASP), clinical symptoms improvement, PE-related mortality, hemodynamic decompensation, recurrent PE, and major and minor bleeding.  Results: In the rt-PA group, the mean PASP was reduced from 52.0±12.2 at baseline to 34.8±9.4 (p less than 0.001) and the mean RV/LV ratio was reduced from 1.26±0.22 at baseline to 0.96±0.18 (p less than 0.001) at 24 hours. In the LMWH group, the mean PASP was 53.4±12.8 at baseline and 48.5±11.9 at 24 hours (p=0.11), and the mean RV/LV ratio was 1.22±0.19 at baseline and 1.17±0.21 at 24 hours (p=0.31). In comparison with the LMWH group, there was a significant reduction in PASP and an improvement in the symptom severity in the rt-PA group. At 90 days, there was no difference in mortality, recurrent venous thromboembolism and major bleeding as a safety outcome, but increased minor bleeding and decreased hemodynamic decompensation occurred in the rt-PA group. Conclusions: In patients with acute intermediate-risk PE, low dose thrombolytic therapy is considered safe and effective, it can be recommended as an alternative option in clinical treatment.

Estudio primario

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Value of thrombolytic therapy for submassive pulmonary embolism patients

Revista The Egyptian Journal of Chest Diseases and Tuberculosis
Año 2018
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Background and aim of the study The aim of this study was to assess the value of streptokinase in patients with submassive pulmonary embolism (PE) due to unavailability of tissue plasminogen activator in our locality due to limited income sources. Patients and methods A prospective randomized controlled trial was conducted on a total number of 52 patients with a confirmed diagnosis of submassive PE confirmed by computed tomographic pulmonary angiography were further investigated by echocardiography and cardiac biomarkers after ethical approval from the IRB and confirmed written consent from the patients or first-degree relative. The study was conducted between January 2017 and December 2017, at the Chest Department, Mansoura University Hospitals, and the Cardiology Department, Specialized Internal Medicine Hospital, Faculty of Medicine, Mansoura University. Results Fifty-two patients who were diagnosed as having submassive PE were enrolled; 24 patients were randomized to the thrombolytic group (TG) and 28 to the anticoagulant group (AG) by simple randomization through opening a closed envelope. The two groups were compared as regards demographic data, pulmonary artery systolic pressure (PASP), presence of comorbidities (diabetes mellitus) and presence of malignancy or concomitant deep venous thrombosis as risk factors, and the incidence of unprovoked PE without any statistically significant results.The PASP measured 72 h after therapy in the TG was improved with statistically significant difference when compared with that measured before starting therapy (P<0.001). In contrast, there was no statistically significant difference in the changes in PASP before and after therapy in the AG (P=0.06). Thereafter, PASP measured 72 h after therapy in TG was lower, with statistically significant difference than that measured 72 hours after therapy in AG (P<0.001). As regards the effect of therapy in TG, 12 of 50 still had pulmonary hypertension in the follow-up echocardiography carried out 72 h after starting therapy versus 24 of 28 in AG with statistically significant difference (P=0.003). Moreover, hospital stay in TG was lower than that of AG (6.5±1.5 vs. 7.6±1.66, P=0.013). No bleeding was detected in both groups. Conclusion Thrombolytic therapy should be considered over anticoagulation as first-line management in submassive PE causing right ventricular dysfunction without hypotension. Clinical implications Early identification of submassive PE and start of thrombolytic therapy after exclusion of bleeding risk in the patient for thrombolysis can improve outcome and decrease hospital stay.

Estudio primario

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Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism.

Revista Journal of the American College of Cardiology
Año 2017
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<b>BACKGROUND: </b>The long-term effect of thrombolytic treatment of pulmonary embolism (PE) is unknown.<b>OBJECTIVES: </b>This study investigated the long-term prognosis of patients with intermediate-risk PE and the effect of thrombolytic treatment on the persistence of symptoms or the development of late complications.<b>METHODS: </b>The PEITHO (Pulmonary Embolism Thrombolysis) trial was a randomized (1:1) comparison of thrombolysis with tenecteplase versus placebo in normotensive patients with acute PE, right ventricular (RV) dysfunction on imaging, and a positive cardiac troponin test result. Both treatment arms received standard anticoagulation. Long-term follow-up was included in the third protocol amendment; 28 sites randomizing 709 of the 1,006 patients participated.<b>RESULTS: </b>Long-term (median 37.8 months) survival was assessed in 353 of 359 (98.3%) patients in the thrombolysis arm and in 343 of 350 (98.0%) in the placebo arm. Overall mortality rates were 20.3% and 18.0%, respectively (p = 0.43). Between day 30 and long-term follow-up, 65 deaths occurred in the thrombolysis arm and 53 occurred in the placebo arm. At follow-up examination of survivors, persistent dyspnea (mostly mild) or functional limitation was reported by 36.0% versus 30.1% of the patients (p = 0.23). Echocardiography (performed in 144 and 146 patients randomized to thrombolysis and placebo, respectively) did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. Chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in 4 (2.1%) versus 6 (3.2%) cases (p = 0.79).<b>CONCLUSIONS: </b>Approximately 33% of patients report some degree of persistent functional limitation after intermediate-risk PE, but CTEPH is infrequent. Thrombolytic treatment did not affect long-term mortality rates, and it did not appear to reduce residual dyspnea or RV dysfunction in these patients. (Pulmonary Embolism Thrombolysis study [PEITHO]; NCT00639743).

Estudio primario

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Efficacy and Safety of Thrombolytic Therapy in Acute Submassive Pulmonary Embolism: Follow-Up Study.

Revista Journal of clinical medicine research
Año 2017
Enlaces Pubmed DOI PubMed Central

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BACKGROUND: Thrombolysis in acute submassive pulmonary embolism (PE) remains controversial. So we studied impact of thrombolytic therapy in acute submassive PE in terms of mortality, hemodynamic status, improvement in right ventricular function, and safety in terms of major and minor bleeding. METHOD: A single-center, prospective, randomized study of 86 patients was conducted at LPS Institute of Cardiology, G.S.V.M. Medical College, Kanpur, India. Patients received thrombolysis (single bolus of tenecteplase) with unfractionated heparin (UFH, group I) or placebo with UFH (group II). RESULT: Mean age of patients was 54.35 ± 12.8 years with male dominance (M:F = 70%:30%). Smoking was the most common risk factor seen in 29% of all patients, followed by recent history of immobilization (25%), history of surgery or major trauma within past 1 month (15%), dyslipidemia (10%) and diabetes mellitus (10%). Dyspnea was the most common symptom in 80% of all patients, followed by chest pain in 55% and syncope in 6%. Primary efficacy outcome occurred significantly better in group I vs. group II (4.5% vs. 20%; P = 0.04), and significant difference was also found in hemodynamic decompensation (4.5% vs. 20%; P = 0.04), the fall in mean pulmonary artery systolic pressure (PASP) (28.8% vs. 22.5%; P = 0.03), improvement in right ventricular (RV) function (70% vs. 40%; P = 0.001) and mean hospital stay (8.1 ± 2.5 vs. 11.1 ± 2.14 days; P = 0.001). There was no difference in mortality and major bleeding as safety outcome but increased minor bleeding occurred in group I patients (16% vs. 12%; P = 0.04). CONCLUSION: Patients with acute submassive PE do not derive overall mortality benefit, recurrent PE and rehospitalization with thrombolytic therapy but had improved clinical outcome in form of decrease in hemodynamic decompensation, mean hospital stay, PASP and improvement of RV function with similar risk of major bleed but at cost of increased minor bleeding.

Estudio primario

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Comparison of acute and convalescent biomarkers of inflammation in patients with acute pulmonary embolism treated with systemic fibrinolysis vs. placebo.

Revista Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
Año 2017
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: Previous studies have associated biomarkers indicative of acute inflammation with pulmonary embolism, which may amplify coagulation, inhibit fibrinolysis and increase risk of venous thromboembolism (VTE) recurrence. The aim of this study was to measure inflammatory and hemostatic biomarkers in acute submassive pulmonary embolism at diagnosis and 3-month follow-up and to test the impact of treatment with fibrinolysis. Secondary analysis of a multicenter, double-blinded, randomized controlled trial including patients with submassive pulmonary embolism. Blood samples were obtained within 24 h of diagnosis and prior to bolus-dose tenecteplase (TNK) or placebo; all patients received standard anticoagulation and blood was redrawn 3 months later. Plasma concentrations of inflammatory [Interleukin 6 (IL-6), C-reactive protein (CRP), myeloperoxidase (MPO)] and hemostatic [plasminogen activator inhibitor-1 (PAI-1), fibrinogen, thrombin-activatable fibrinolysis inhibitor and D-dimer] biomarkers were quantified. The median values of the biomarkers of inflammation (IL-6, CRP, MPO) were all significantly decreased at 3-month follow-up, ranging from a 60 to 91% reduction over this time period. Concentrations of PAI-1 and fibrinogen did not change significantly. D-dimer concentration at 3-month follow-up was lower in patients treated with fibrinolysis vs. placebo and appeared to have a trend toward significance (placebo 310 vs. TNK 220 ng/ml, P = 0.051). Acute pulmonary embolism causes marked but transient inflammation, as demonstrated by the significant elevation in the inflammatory biomarkers at diagnosis, followed by their reduction in more than 80% of patients at 3-month follow-up.

Estudio primario

No clasificado

Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.

Revista Vascular
Año 2017
Enlaces Pubmed DOI PubMed Central

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Objective The hemodynamic benefits of catheter-directed thrombolysis for acute pulmonary embolism have not been clearly defined beyond the periprocedural period. The objective of this study is to report midterm outcomes of catheter-directed thrombolysis for treatment of acute pulmonary embolism. Methods Records of all patients undergoing catheter-directed thrombolysis for high- or intermediate-risk pulmonary embolism were retrospectively reviewed. Endpoints were clinical success, procedure-related complications, mortality, and longitudinal echocardiographic parameter improvement. Results A total of 69 patients underwent catheter-directed thrombolysis (mean age 59 ± 15 y, 56% male). Eleven had high-risk and 58 intermediate-risk pulmonary embolism. Baseline characteristics did not differ by pulmonary embolism subtype. Fifty-two percent of patients underwent ultrasound-assisted thrombolysis, 39% standard catheter-directed thrombolysis, and 9% other interventional therapy; 89.9% had bilateral treatment. Average treatment time was 17.7 ± 11.3 h with average t-Pa dose of 28.5 ± 19.6 mg. The rate of clinical success was 88%. There were two major (3%) and six minor (9%) periprocedural bleeding complications with no strokes. All echocardiographic parameters demonstrated significant improvement at one-year follow-up. Pulmonary embolism-related in-hospital mortality was 3.3%, and estimated survival was 81.2% at one year. Conclusions Catheter-directed thrombolysis is safe and effective for treatment of acute pulmonary embolism, with sustained hemodynamic improvement at one year. Further prospective large-scale studies are needed to determine comparative effectiveness of interventions for acute pulmonary embolism.

Estudio primario

No clasificado

Comparison between systemic and catheter thrombolysis in patients with pulmonary embolism.

Autores Yoo JW , Choi HC , Lee SJ , Cho YJ , Lee JD , Kim HC
Revista The American journal of emergency medicine
Año 2016
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BACKGROUND: Although systemic thrombolysis (ST) or catheter-directed therapy (CDT) is performed in patients with acute massive or submassive pulmonary embolism (PE), clinical data comparing between both therapies remain limited. We compared clinical outcomes between ST and CDT in patients with acute massive and submassive PE. METHODS: From January 2005 to June 2015, clinical outcomes of patients with acute massive or submassive PE receiving ST or CDT were evaluated and compared retrospectively. RESULTS: Of 72 patients, 44 were treated with ST; and 28, with CDT. The mean age was 63.9 ± 17 years old. The proportion of male sex was higher in patients receiving CDT compared to that with ST (46.4% vs 20.5%; P = .02). Half of patients presented with massive PE, and cardiac arrest occurred in 11 patients (15.3%). No difference was observed between the 2 groups with respect to 7-day mortality (13.6% in ST vs 10.7% in CDT), inhospital mortality (13.6% in ST vs 14.3% in CDT), and major bleeding complication (16.7% in ST vs 16.7% in CDT). Cardiac arrest (odds ratio, 6.286; 95% confidence interval, 1.081-36.555; P = .041) was associated with 14-day mortality. CONCLUSIONS: Similar clinical outcomes were shown between ST and CDT in patients with acute massive or submassive PE.

Estudio primario

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Embolia Pulmonar respuesta a la fragmentación, Embolectomía, y el catéter de trombólisis (PERFECTO): Resultados iniciales de un registro multicéntrico prospectivo.

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Revista Chest
Año 2015
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ANTECEDENTES: la trombólisis sistémica para el embolismo pulmonar agudo (PE) lleva hasta un 20% de riesgo de hemorragia grave, incluyendo un riesgo del 2% al 5% de accidente cerebrovascular hemorrágico. Se evaluó la seguridad y eficacia de la terapia dirigida por catéter (CDT) como una alternativa de tratamiento de la EP aguda. MÉTODOS: Ciento un pacientes consecutivos que recibieron CDT para la EP aguda fueron prospectivamente matriculados en un registro multicéntrico. PE Massive (n = 28) y PE submasiva (n = 73) fueron tratados con trombectomía inmediata dirigida por catéter mecánica o farmacomecánica y / o la trombólisis dirigida por catéter a través de las dosis bajas de infusión de fármaco cada hora con activador del plasminógeno tisular (tPA) o la uroquinasa. El éxito clínico se definió como el cumplimiento de todos los criterios siguientes: estabilización de la hemodinámica; mejora de la hipertensión pulmonar, la tensión cardíaca derecha, o ambas cosas; y la supervivencia al alta hospitalaria. los resultados de seguridad primarios fueron las principales complicaciones relacionadas con el procedimiento y los eventos de hemorragia. RESULTADOS: Cincuenta y tres hombres y 48 mujeres (edad media, 60 años [rango, 22-86 años], con una media de IMC, 31,03 ± 7,20 kg / m2) fueron incluidos en el estudio. Las dosis trombolíticos promedio fueron de 28,0 ± 11 mg tPA (n = 76) y 2.697.101 ± 936.287 unidades internacionales para la uroquinasa (n = 23). El éxito clínico se logró en 24 de 28 pacientes con embolia pulmonar masiva (85,7%; IC del 95%, 67,3% -96,0%) y 71 de 73 pacientes con EP submasiva (97,3%; IC del 95%, 90,5% -99,7%). La presión arterial pulmonar media mejoró de 51,17 ± 14,06 a 37,23 ± 15,81 mm Hg (n = 92) (P <0,0001). Entre los pacientes monitorizados con la ecocardiografía de seguimiento, 57 de 64 (89,1%; IC del 95%, 78,8% -95,5%; P <0,0001) mostró una mejoría en la cepa lado derecho del corazón. No hubo complicaciones mayores relacionadas con el procedimiento, hemorragias mayores, o los accidentes cerebrovasculares hemorrágicos. CONCLUSIONES: CDT mejora los resultados clínicos en pacientes con EP agudo y reducir al mínimo el riesgo de hemorragia grave. En los centros con experiencia, CDT es un tratamiento seguro y eficaz tanto de EP masiva aguda y submasiva. PRUEBA DE REGISTRO: ClinicalTrials.gov; No .: NCT01097928; URL: www.clinicaltrials.gov.