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BIOFLOW II

Orsiro currently not available in the US.

 

Conclusions

  • With comparable in-stent late lumen loss Orsiro met the primary objective of the BIOFLOW-II trial
    and showed non inferiority to Xience Prime at 9 months, hence performing as best in class
  • The 24-month results of this prospective, randomized study confirms the safety and efficacy of
    Orsiro with a low TLF rate and the absence of definite stent thrombosis in high risk diabetic and
    small vessel populations
  • The Orsiro OCT subgroup shows excellent strut coverage at 9 months (98.3%), indicating good healing
    after Orsiro implantation

Study Design 

A prospective, multi-center, randomized, controlled trial
comparing the Orsiro hybrid DES to Xience Prime

Coordinating clinical investigators

  • Prof. Stephan Windecker, Bern, Switzerland
  • Dr. Thierry Lefèvre, Massy, France

Endpoints

Primary endpoint

  • In-Stent Late Lumen Loss (LLL) at 9 months

Secondary clinical endpoints (selected)

  • Target Lesion Failure (TLF)
  • Definite stent thrombosis

Intra vascular imaging subgroups

  • OCT at baseline and at 9 months (n = 65)
  • IVUS at baseline and at 9 months (n = 66)

Patients

Inclusion of up two de novo lesions with a maximal length of 26mm each

 

Primary endpoint results 

Cumulative frequency of in-stent late lumen loss at 9 months

 

 

 

 

 

 

 

Secondary clinical endpoint results
TLF rate out to 24 months

Clinical event rates were comparable between Orsiro and Xience Prime up to 24 months

 

Target Lesion Failure (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.

 

All subject stent thrombosis results at 24 months

  • No definite stent thrombosis occurred in either arm through 24 months
  • One diabetic subject in the Xience Prime arm had a very late possible stent thrombosis

 

Intra vascular imaging subgroups
OCT imaging was performed in a pre-specified subgroup to assess strut coverage at 9 months

Download:
BIOFLOW-II Study Flyer

 

 

 

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