ORIENT

ORIENT RCT

NCT01826552

Comparison of the angiographic result of the Orsiro stent with Resolute Integrity stent

Conclusion

  • In this 375 patient randomized trial with an angiographic primary endpoint of late lumen loss (LLL) at 9 months, Orsiro demonstrated non-inferiority to Resolute Integrity. (Orsiro 0.10 ± 0.35 mm, Resolute Integrity 0.16 ± 0.39 mm, p for non-inferiority <0.001).
  • Orsiro, with its ultrathin struts and bioabsorbable polymer, additionally showed numerically better results for the secondary clinical endpoint, target lesion failure (TLF) out to 12 months. (Orsiro 2.4 %, Resolute Integrity 3.3 %, p = 0.0623).
  • This study confirms the good performance profile of Orsiro

Study Design

  • A prospective, multi-center, randomized, controlled trial comparing the Orsiro hybrid DES to Resolute Integrity
  • Principal Investigator: Prof. Tae-Jin Youn, Seoul National University Bundang Hospital, South Korea
  • Primary endpoint: In-stent Late Lumen Loss (LLL) at 9 months
  • Secondary endpoints (selected): TLF defined as composite of cardiac death, TLR and target vessel-related MI, All-cause and cardiac deaths, Clinically-driven TLR, MI (target or non-target vessel-related), Definite or probable stent thrombosis (ST)
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Picture shows study design

Primary endpoint results

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Primary endpoint results graph

Secondary endpoint results

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Secondary endpoint graph

Downloads


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Orsiro Image

Vascular Intervention

Drug-Eluting Stent

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Orsiro Image

Vascular Intervention

Clinical Study


Source
Kang S. EuroPCR 2016. Oral presentation.

Disclaimer
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1 von Birgelen C et al. BIO-RESORT (TWENTE III). A Prospective, Randomized Three-Arm Trial Comparing Orsiro, Synergy and Resolute Integrity in an All-Comers Population. TCT 2016. Oral presentation.

2 von Birgelen C et al. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial. Lancet 2016. Online publication (10.1016. S0140-6736(16); 31920-1).