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RESEARCH PRODUCT
Reduced-Dose Intravenous Thrombolysis for Acute Intermediate–High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial
Marc Philip RighiniKlaus EmpenStavros KonstantinidesKerstin De WitAntoniu PetrisAndreas ZirlikHarald BinderDavid JiménezPeter VerhammePiotr PruszczykPhilippe GirardMareike LankeitWalter AgenoMelanie FerreiraEric VicautBarco StefanoSebastian SchellongOlivier SanchezNicolas MeneveauDaniel DuerschmiedMenno V. HuismanGuy MeyerGilles ChatellierGilles ChatellierSandrine KatsahianBranislav StefanovicStephan RosenkranzMatija KozakAnais Charles-nelsonsubject
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-riskbusinessdescription
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 compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations. ispartof: THROMBOSIS AND HAEMOSTASIS vol:122 issue:05 pages:857-866 ispartof: location:Germany status: published
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-09-24 |