Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten – Das Beispiel Paclitaxel

Randomized controlled trials and real-world evidence for the market access and surveillance of high-risk products—the example of paclitaxel

A PAVK to this article was published on 27 November 2020


In den Jahren 2018 und 2020 haben zwei Metaanalysen zu kumulativen Ergebnissen von randomisierten und kontrollierten Studien eine erhöhte Sterblichkeit nach der Anwendung Paclitaxel-beschichteter Stents bzw. Ballons in den Gefäßen der unteren Extremitäten berichtet. Im Anschluss daran entwickelte sich eine angeregte globale Diskussion über die Validität dieser Assoziation, wobei die Ergebnisse zahlreicher Beobachtungsstudien mit klinischen und administrativen Registerdaten die Anwendungssicherheit beschichteter Medizinprodukte nahelegten. Dieser Artikel fasst die Entwicklung und Verbreitung Paclitaxel-beschichteter Ballons und Stents zur Behandlung der peripheren arteriellen Verschlusskrankheit in der klinischen Praxis, in Studien und in Leitlinien zusammen. Hierbei wird ein besonderer Fokus auf die neue Medizinprodukteregulation der Europäischen Union gelegt, die weitreichende Implikationen für die Marktzulassung und Überwachung von Hochrisikomedizinprodukten hat.


In 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validity of this association, while various observational studies using clinical and administrative registries proved the safety of coated devices. This article aimed to summarize the development and adoption of paclitaxel-coated balloons and stents for the treatment of peripheral arterial occlusive disease in clinical practice, research, and practice guidelines. It especially focusses on the European Unionʼs medical device regulation, which has far-reaching implications for the market approval and monitoring of high-risk medical devices.

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Diese Arbeit ist durch Mittel der RABATT-Studie gefördert worden (Innovationsfonds des Gemeinsamen Bundesausschusses, Förderkennzeichen 01VSF18035, PI: CAB).

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Correspondence to Priv.-Doz. Dr. C.-A. Behrendt.

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C.-A. Behrendt ist Vorsitzender des Medical Device Epidemiology Network (MDEpiNet) Verband Deutschland e. V. i.G. und beratend tätig im wissenschaftlichen Beirat einer akkreditierten benannten Stelle (MEDCERT). U. Rother, G. Rümenapf, C. Uhl, H. Görtz und D. Böckler geben an, dass kein Interessenkonflikt besteht.

Für diesen Beitrag wurden von den Autoren keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.

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Behrendt, CA., Rother, U., Rümenapf, G. et al. Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten – Das Beispiel Paclitaxel. Gefässchirurgie 26, 110–117 (2021). https://doi.org/10.1007/s00772-020-00713-5

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  • Routinedaten
  • Versorgungsforschung
  • Validität
  • Qualitätsindikatoren
  • Administrative Daten


  • Routine data
  • Health-care research
  • Validity
  • Quality indicators
  • Administrative data