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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
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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

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Aleatorizado, ensayo controlado de la trombólisis dirigida por catéter asistida por ultrasonido para la embolia pulmonar aguda de riesgo intermedio.

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Revista Circulation
Año 2014
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Este artículo está incluido en 7 Revisiones sistemáticas Revisiones sistemáticas (7 referencias)

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ANTECEDENTES: En los pacientes con embolia pulmonar aguda, la trombólisis sistémica mejora del ventrículo derecho (VD) de dilatación, se asocia con hemorragia grave, y se retiene en muchos pacientes en riesgo. Este ensayo controlado aleatorio multicéntrico investigó si asistida por ultrasonido dirigida por catéter de trombólisis (USAT) es superior a la anticoagulación sola en la reversión de la dilatación del VD en pacientes con riesgo intermedio. MÉTODOS Y RESULTADOS: Cincuenta y nueve pacientes (63 ± 14 años) con embolia pulmonar del lóbulo principal o menor aguda y RV ecocardiográfico a izquierda dimensión ventricular (RV LV /) Relación de ≥1.0 fueron aleatorizados para recibir heparina no fraccionada y un régimen de 10 a USAT 20 mg del activador del plasminógeno tisular recombinante de más de 15 horas (n = 30; grupo USAT) o heparina no fraccionada sola (n = 29; grupo de heparina). El resultado primario fue la diferencia en la relación de RV / LV desde el inicio hasta 24 horas. Los resultados de seguridad incluyen la muerte, hemorragia mayor y menor, y el tromboembolismo venoso recurrente a los 90 días. En el grupo de USAT, la proporción media de RV / LV se redujo de 1,28 ± 0,19 al inicio del estudio a 0,99 ± 0,17 a las 24 horas (p <0,001); en el grupo de heparina, significan RV / LV proporciones fueron 1,20 ± 0,14 y 1,17 ± 0,20, respectivamente (P = 0,31). El descenso medio en la relación / LV RV desde el inicio hasta 24 horas fue de 0,30 ± 0,20 frente a 0,03 ± 0,16 (p <0,001), respectivamente. A los 90 días, hubo 1 muerte (en el grupo de heparina), no hay sangrado mayor, 4 menores episodios de sangrado (3 en el grupo USAT y 1 en el grupo de heparina; P = 0,61), y no hay tromboembolismo venoso recurrente. CONCLUSIONES: En pacientes con embolia pulmonar de riesgo intermedio, un régimen USAT estandarizada fue superior a la anticoagulación con heparina solos en la reversión de dilatación del VD a las 24 horas, sin un aumento de complicaciones de sangrado. ENSAYO CLÍNICO DE REGISTRO URL: http://www.clinicaltrials.gov. Identificador único: NCT01166997.

Estudio primario

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La fibrinolisis en pacientes con embolia pulmonar de riesgo intermedio.

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Revista The New England journal of medicine
Año 2014
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ANTECEDENTES: El papel de la terapia fibrinolítica en pacientes con embolia pulmonar de riesgo intermedio es controvertido. MÉTODOS: En un estudio aleatorizado, doble ciego, se comparó tenecteplasa más heparina con placebo más heparina en pacientes normotensos con TEP de riesgo intermedio. Los pacientes elegibles tenían disfunción ventricular derecha en la ecocardiografía o tomografía computarizada, así como la lesión miocárdica como lo indica una prueba positiva para la troponina I cardiaca o troponina T. El resultado primario fue la muerte o descompensación hemodinámica (o colapso) en los 7 días después de la aleatorización. Los principales resultados de seguridad fueron hemorragia extracraneal grave y accidente cerebrovascular isquémico o hemorrágico plazo de 7 días después de la aleatorización. Resultados: De los 1.006 pacientes que se sometieron a la aleatorización, 1005 se incluyeron en el análisis por intención de tratar. Muerte o hemodinámica descompensación se produjo en 13 de 506 pacientes (2,6%) en el grupo de tenecteplasa en comparación con 28 de 499 (5,6%) en el grupo placebo (odds ratio, 0,44; intervalo de confianza del 95%, 0,23 a 0,87; P = 0,02 ). Entre la aleatorización y 7 días, con un total de 6 pacientes (1,2%) en el grupo de tenecteplasa y 9 (1,8%) en el grupo placebo murió (P = 0,42). Hemorragia extracraneal ocurrió en 32 pacientes (6,3%) en el grupo de tenecteplasa y 6 pacientes (1,2%) en el grupo placebo (p <0,001). Stroke ocurrió en 12 pacientes (2,4%) en el grupo de tenecteplasa y fue hemorrágico en 10 pacientes; 1 paciente (0,2%) en el grupo placebo tuvo un accidente cerebrovascular, que era hemorrágica (P = 0,003). Durante el día 30, un total de 12 pacientes (2,4%) en el grupo de tenecteplasa y 16 pacientes (3,2%) en el grupo placebo había muerto (P = 0,42). Conclusiones: En los pacientes con embolia pulmonar de riesgo intermedio, terapia fibrinolítica impidieron descompensación hemodinámica, pero aumentó el riesgo de hemorragia grave y accidente cerebrovascular. (Financiado por el Programa Hospitalario de Recherche Clinique en Francia y otros; PEITHO número EudraCT, 2006-005328-18;. Número ClinicalTrials.gov, NCT00639743).

Estudio primario

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El tratamiento de la embolia pulmonar submasiva con tenecteplasa o placebo: resultados cardiopulmonares a los 3 meses: multicéntrico, doble ciego, aleatorizado y controlado con placebo.

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Revista Journal of thrombosis and haemostasis : JTH
Año 2014
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ANTECEDENTES: La embolia pulmonar aguda (PE) puede empeorar la calidad de vida debido a la disnea persistente o intolerancia al ejercicio. OBJETIVO: Probar si la tenecteplasa aumenta la probabilidad de un resultado orientado al paciente compuesta favorable después submasiva PE. MÉTODOS: Los pacientes normotensos con EP y del ventrículo derecho (VD) cepa (por ecocardiografía o biomarcadores) se inscribieron en ocho hospitales. Todos los pacientes recibieron heparina de bajo peso molecular seguido por la asignación aleatoria ya sea a un bolo único basada en el peso de la tenecteplasa o placebo, administrado de una manera doble ciego. El resultado primario compuesto incluye: (i) la muerte, shock circulatorio, intubación o hemorragia grave en 5 días o (ii) EP recurrente, la capacidad funcional pobre (disfunción del VD, ya sea con disnea en reposo o intolerancia al ejercicio) o un SF36 (®) Física Componente Resumen (PCS) puntuación <30 en 90 días de seguimiento. RESULTADOS: Ochenta y tres pacientes fueron asignados al azar; 40 a la tenecteplasa y 43 con placebo. El ensayo fue interrumpido prematuramente. Dentro de 5 días, los resultados adversos ocurrieron en tres pacientes tratados con placebo (muerte en uno y la intubación en dos) y un paciente tratado con tenecteplasa (hemorragia intracraneal mortal). A los 90 días, los resultados adversos se produjeron en 13 pacientes únicos tratados con placebo y cinco pacientes tratados con tenecteplasa únicas Así, 16 (37%) tratados con placebo y seis (15%) de los pacientes tratados con tenecteplasa tenían al menos un resultado adverso (exactamente dos P -sided = 0,017). CONCLUSIONES: El tratamiento de los pacientes con embolia pulmonar submasiva con tenecteplasa se asocia con una mayor probabilidad de un resultado compuesto favorable.