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Hamostaseologie 2019; 39(02): 117-127
DOI: 10.1055/s-0038-1673413
Review Article
Georg Thieme Verlag KG Stuttgart · New York

Optimizing the Personalized, Risk-Adjusted Management of Pulmonary Embolism: An Integrated Clinical Trial Programme

Stefano Barco
1   Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University-Mainz, Mainz, Germany
,
Stavros V. Konstantinides
1   Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University-Mainz, Mainz, Germany
› Author Affiliations
Further Information

Publication History

04 July 2018

14 August 2018

Publication Date:
18 October 2018 (online)

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Abstract

Acute pulmonary embolism (PE) contributes significantly to the global burden of cardiovascular disease. The severity of the acute PE event determines the expected estimated risk of early death. This risk is influenced by the degree of dysfunction of the right ventricle (RV), as assessed by the presence of acute RV pressure overload on imaging and/or elevated cardiac biomarkers, and by demographic and clinical factors, including relevant comorbidities. Haemodynamic instability and cardiogenic shock is at the top of the PE severity spectrum, as it represents the most extreme manifestation of RV failure and a key determinant of poor prognosis. Ideally, risk-adjusted treatment should implement: (1) optimized timing and regimens of reperfusion therapy for unstable patients; (2) early discharge and continuation of anticoagulation treatment at home (low-risk PE); or (3) hospital admission and clinical/haemodynamic monitoring in patients at intermediate risk. The challenge is now to provide the basis for a comprehensive personalized, risk-adjusted care for patients with acute PE. The aim of the integrated academic clinical trial programme of the Center for Thrombosis and Hemostasis at the University of Mainz is to develop and prospectively validate, in multinational studies, strategies for reperfusion and anticoagulant treatment of acute PE across the entire spectrum of early risk as well as clinical pathways for post-PE patient care and follow-up.

Zusammenfassung

Akute Lungenembolie (PE) trägt signifikant zur globalen Belastung von Herz-Kreislauf-Erkrankungen bei. Die Schwere des akuten PE-Ereignisses bestimmt das erwartete geschätzte Risiko eines frühen Todes. Dieses Risiko wird durch den Grad der Dysfunktion des rechten Ventrikels (RV) beeinflusst, der durch die akute RV-Drucküberlastung auf Bildgebung und / oder erhöhte kardiale Biomarker sowie durch demographische und klinische Faktoren, einschließlich relevanter Komorbiditäten, beurteilt wird. Die hämodynamische Instabilität und der kardiogene Schock stehen an der Spitze des PE-Schweregrads, da sie die extremste Manifestation des RV-Versagens darstellen und eine Schlüsseldeterminante für eine schlechte Prognose darstellen. Im Idealfall sollte eine risikoadjustierte Behandlung Folgendes umfassen: (1) optimiertes Timing und Regime der Reperfusionstherapie für instabile Patienten; (2) frühzeitige Entlassung und Fortsetzung der Antikoagulationsbehandlung zu Hause (Low-Risk-PE); oder (3) Krankenhausaufnahme und klinisches / hämodynamisches Monitoring bei Patienten mit mittlerem Risiko. Die Herausforderung besteht nun darin, die Basis für eine umfassende personalisierte, risikoadjustierte Versorgung von Patienten mit akutem PE zu schaffen. Ziel des integrierten akademischen klinischen Studienprogramms des Zentrums für Thrombose und Hämostase an der Universität Mainz ist es, in multinationalen Studien Strategien zur Reperfusion und Antikoagulansbehandlung akuter PE auch über das gesamte Frührisiko hinweg zu entwickeln und prospektiv zu validieren als klinische Pfade für Post-PE-Patientenversorgung und Follow-up.

Keywords

pulmonary embolism - risk stratification - clinical trials - anticoagulation - systemic thrombolysis

Schlüsselwörter

Lungenembolie - Risikostratifizierung - klinische Studien - Antikoagulation - systemische Thrombolyse

Financial Support and Sponsorship

The work of Stefano Barco and Stavros V. Konstantinides is supported by the German Federal Ministry of Education and Research (BMBF 01EO1003 and 01EO1503).


 

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