SORT OUT VII

SORT OUT VII

NCT01879358

BIOTRONIK Sirolimus-eluting Orsiro stent vs Terumo biolimus-eluting Nobori Stent

Conclusion

  • One year data from large (n = 2,525) industry independent SORT OUT VII trial presented at EuroPCR 2015 demonstrate Orsiro is non-inferior to Nobori stent
  • At one year, the primary endpoint target lesion failure (TLF) occurred in 3.8 % of Orsiro patients vs. 4.6 % of those treated with Nobori DES (p non-inferiority < 0.0001)
  • Patients in the Orsiro arm demonstrated a significantly lower rate of definite stent thrombosis: only 0.4 % of Orsiro patients compared with 1.2 % of patients in the Nobori arm (p = 0.03)
  • These highly encouraging results reconfirm those of BIOSCIENCE, the large independent comparison between Orsiro and Xience Prime presented at ESC 2014 and published in The Lancet

Patient and lesion characteristics

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Patient characteristics
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Lesion characteristics

Study Design

  • All-comers, multi-center, randomized, non-inferiority design
  • Principal Investigators: Prof. Lisette Okkels Jensen, Odense, Denmark and Dr. Per Thayssen, Odense, Denmark
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Picture shows study design

Primary endpoint results

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Primary endpoint graph

Stent thrombosis1 results at 12 months

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Definite stent thrombosis
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Definite stent thrombosis

Downloads


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Orsiro Image

Vascular Intervention

Drug-Eluting Stent

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Orsiro Image

Vascular Intervention

Clinical Study


Source
Presentation, Lisette Okkels Jensen, EuroPCR 2015

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


1 Definite and probable stent thrombosis according to ARC definition and adjudicated by independent clinical events committee

2 Primary endpoint: Target Lesion Failure composite of cardiac death, myocardial infarction or target lesion revascularization