BIO-RESORT

BIO-RESORT RCT

NCT01674803

Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population

Conclusion

  • In this 3514 patient large, randomized, investigator-initiated, all-comers trial, Orsiro proves non-inferiority to Resolute Integrity whilst performing equally well as Synergy (primary endpoint TVF at 12 months: Orsiro 4.7%, Synergy 4.7%, Resolute Integrity 5.4%, p non-inferiority < 0.0001)
  • Orsiro, with its ultrathin struts and bioabsorbable polymer, additionally showed safety with a definite stent thrombosis rate of 0.3 % at 12 months, which was equally low in the other study arms.
  • These convincing results reconfirm those of previous Orsiro trials and adds to the solid foundation of clinical evidence that supports the use of Orsiro across a broad range of applications.

Study Design

  • All-comers, multi-center, assessor and patient-blinded, randomized, non-inferiority design
  • Principal Investigator: Prof. Clemens von Birgelen, Enschede, Netherlands
  • Primary endpoint: Target Vessel Failure (TVF) at 12 months defined as the composite of cardiac death, target vessel-related Myocardial Infarction (MI), or Target Vessel Revascularization (TVR)
  • Prespecified secondary endpoints: Components of the primary endpoint, All-cause mortality, Any Myocardial Infarction, Clinically indicated TLR, Stent thrombosis
圖片
Picture shows study design

Primary endpoint results

Target vessel failure1,2

圖片
Primary endpoint results graph

Downloads


Orsiro Image

Vascular Intervention

Drug-Eluting Stent

Orsiro Image

Vascular Intervention

Clinical Study


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


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).