0000000000054150

AUTHOR

Klaus Empen

showing 5 related works from this author

Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: Rationale and design of the HoT-PE Trial

2016

SummaryPulmonary embolism (PE) is a potentially life-threatening acute cardiovascular syndrome. However, more than 95 % of patients are haemodynamically stable at presentation, and among them are patients at truly low risk who may qualify for immediate or early discharge. The Home Treatment of Pulmonary Embolism (HoT-PE) study is a prospective international multicentre single-arm phase 4 management (cohort) trial aiming to determine whether home treatment of acute lowrisk PE with the oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe. Patients with confirmed PE, who have no right ventricular dysfunction or free floating thrombi in the right atrium or ventricle, are eligib…

medicine.medical_specialtyAdministration OralHome treatment; Management trial; Pulmonary embolism; Risk stratification; Rivaroxaban; HematologySelf Administration030204 cardiovascular system & hematology03 medical and health sciences0302 clinical medicinePatient satisfactionQuality of lifeRivaroxabanRecurrenceRisk FactorsInternal medicinemedicineHumansProspective Studies030212 general & internal medicineIntensive care medicineProspective cohort studyEarly dischargeRisk stratificationRivaroxabanbusiness.industryPulmonary embolismHome treatmentManagement trialHematologymedicine.diseaseHome Care ServicesComorbidityPatient DischargePulmonary embolismCohortQuality of LifebusinessFactor Xa Inhibitorsmedicine.drug
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Dabigatran after Short Heparin Anticoagulation for Acute Intermediate-Risk Pulmonary Embolism: Rationale and Design of the Single-Arm PEITHO-2 Study

2017

AbstractPatients with intermediate-risk pulmonary embolism (PE) may, depending on the method and cut-off values used for definition, account for up to 60% of all patients with PE and have an 8% or higher risk of short-term adverse outcome. Although four non-vitamin K-dependent direct oral anticoagulants (NOACs) have been approved for the treatment of venous thromboembolism, their safety and efficacy as well as the optimal anticoagulation regimen using these drugs have not been systematically investigated in intermediate-risk PE. Moreover, it remains unknown how many patients with intermediate-high-risk and intermediate-low-risk PE were included in most of the phase III NOAC trials. The ongo…

MaleRiskmedicine.medical_specialtypulmonary embolismDrug-Related Side Effects and Adverse Reactionsmedicine.medical_treatmentHemorrhageintermediate risk030204 cardiovascular system & hematologyDabigatran03 medical and health sciencesYoung Adult0302 clinical medicineRecurrenceInternal medicineGermanymedicineHumansdabigatran030212 general & internal medicineProspective StudiesProspective cohort studySurvival analysisvenous thromboembolism recurrencebusiness.industryHeparinAnticoagulantsHematologyThrombolysisHeparinReference Standardsmedicine.diseaseThrombosisSurvival Analysis3. Good healthPulmonary embolismright ventricular functionRegimenTreatment OutcomeResearch Designmajor bleedingAcute Diseasedabigatran; intermediate risk; major bleeding; pulmonary embolism; right ventricular function; venous thromboembolism recurrenceFemalebusinessmedicine.drugFollow-Up Studies
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Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism Internation…

2021

Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will c…

medicine.medical_specialtypulmonary embolismVentricular Dysfunction Rightmedicine.medical_treatment2720 HematologyHemodynamicsHemorrhage610 Medicine & health030204 cardiovascular system & hematologyintermediate-high-risk; prognosis; pulmonary embolism; randomized trial; reduced-dose thrombolysis03 medical and health sciences0302 clinical medicineFibrinolytic AgentsInternal medicinemedicinerandomized trialHumansThrombolytic TherapyDecompensationStrokeHeparinbusiness.industry10031 Clinic for AngiologyHematologyThrombolysismedicine.diseasereduced-dose thrombolysis3. Good healthPulmonary embolismRegimenTreatment OutcomeBlood pressure030228 respiratory systemTissue Plasminogen ActivatorHeart failureAcute DiseaseCardiologyprognosisintermediate-high-riskbusiness
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Survival and quality of life after early discharge in low-risk pulmonary embolism.

2020

IntroductionEarly discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes.MethodsThe multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, …

Pulmonary and Respiratory Medicinemedicine.medical_specialtyPopulationPatient subgroups030204 cardiovascular system & hematology03 medical and health sciences0302 clinical medicineQuality of lifeInternal medicineSurveys and QuestionnairesMedicineHumansProspective StudieseducationEarly dischargeAgededucation.field_of_studyRivaroxabanbusiness.industrymedicine.diseaseInterim analysisPatient Discharge3. Good healthPulmonary embolism030228 respiratory systemAmbulatoryQuality of LifeFemalebusinessPulmonary Embolismmedicine.drugThe European respiratory journal
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Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2) : a multinational, multicentre, single-ar…

2021

BACKGROUND: Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran), is effective and safe. METHODS: We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. …

Malemedicine.medical_specialtyPopulationAdministration OralHemorrhage030204 cardiovascular system & hematologyDrug Administration ScheduleDabigatran03 medical and health sciences0302 clinical medicineRisk FactorsInternal medicinemedicineHumans030212 general & internal medicineeducationAgedAged 80 and overeducation.field_of_studyRIGHT-VENTRICULAR DYSFUNCTION VENOUS THROMBOEMBOLISM DABIGATRAN MANAGEMENT WARFARIN HOSPITALIZATION RATIONALE HEPARIN DESIGNHeparinbusiness.industryAnticoagulantsVenous ThromboembolismHematologyGuidelineHeparinMiddle AgedInterim analysismedicine.diseaseThrombosisDabigatran3. Good healthPulmonary embolismClinical trialTreatment OutcomeFemalePulmonary EmbolismbusinessFollow-Up Studiesmedicine.drug
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