BIOFLOW-II

BIOFLOW-II

NCT01356888

Study of the Orsiro Drug Eluting Stent System

Conclusion

  • Target Lesion Failure (TLF) comparable to Xience Prime* although separating over time in favor of Orsiro out to 48 months
  • Absence of definite or probable stent thrombosis also in high risk populations such as diabetic and small vessel subgroup out to 48 months
  • The results of this prospective, randomized study confirms the safety and efficacy of Orsiro

Study Design

A prospective, multi-center, randomized, controlled trial comparing the Orsiro DES to Xience PrimeCoordinating clinical investigators: Prof. Stephan Windecker, Bern, Switzerland and Dr. Thierry Lefèvre, Massy, FrancePrimary endpoint: In-Stent Late Lumen Loss (LLL) at 9 months

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Results at 48 months

TLF rate – All subjects

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TLF rate – Small vessel population

TLF defined as composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Grafting (CABG) and clinically-driven TLR.

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All subject stent thrombosis results at 48 monthsNo definite and no probable stent thrombosis occurred in either arm through 48 months

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Orsiro Image

Vascular Intervention

Drug-Eluting Stent

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Orsiro Image

Vascular Intervention

Clinical Study


Disclaimer
© BIOTRONIK AG – All rights reserved.
Specifications are subject to modification, revision and improvement.

*Xience and Xience Prime are registered trademarks of Abbott Cardiovascular Systems.
Reference: Ton Slagboom on behalf of the BIOFLOW-II Investigators, Poster, euroPCR 2017