SORT OUT VII

SORT OUT VII

NCT01879358

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

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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

Patient characteristics
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
Picture shows study design

Primary endpoint results

Primary endpoint graph

Stent thrombosis1 results at 12 months

Definite stent thrombosis
Definite stent thrombosis

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SORT OUT VII Clinical Study Flyer
Orsiro Image

Vascular Intervention

Orsiro

Drug-Eluting Stent

Orsiro Image

Vascular Intervention

BIO-RESORT

Clinical Study

Source
Presentation, Lisette Okkels Jensen, EuroPCR 2015

Disclaimer
© BIOTRONIK AGAll 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