Comparison of Biomatrix and Orsiro Drug Eluting Stent
Condition: Coronary Artery Disease; Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro
      drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have
      biodegradable polymer for the treatment of all-comers' coronary artery diseases.
    

Detailed description: 
      The rate of in-stent restenosis after percutaneous coronary intervention (PCI) has decreased
      since the launching of drug-eluting stents (DES). However, restenosis still remains a problem
      since PCI is being performed on more complex, calcified, tortuous and tough lesions.
      Furthermore, there is still a controversy on whether these DES are more thrombogenic than
      bare metal stent (BMS) because of inflammation related to the polymer coating and delayed
      vessel healing due to the eluted drug despite of reduced restenosis. Therefore, works aiming
      to reduce both restenosis and thrombotic event are still on-going in the field of
      interventional cardiology, and there has been a rush of various third generation DES with
      "biodegradable polymer". Recently, Orsiro hybrid DES (Biotronik AG, Bulach, Switzeland) has
      been developed. The Orsiro DES incorporated optimally combined two kind of polymer onto
      thinner cobalt-chromium backbone (60um) compared with earlier type of DES. The BIOlute®
      active component is a bioabsorbable polymer matrix combined with an anti-proliferative drug,
      sirolimus, that is released in a controlled manner leaving only the PROBIO® coated stent in
      the long-term. The PROBIO® passive coating encapsulates the stent and eliminates interaction
      between the metal stent and the surrounding tissue. To date, Orsiro stent showed excellent
      results in terms of late lumen loss at 9 months in first-in-man single arm trial comparing
      the historical results of other DES (BIOFLOW-I trial), and RCT with non-inferiority design,
      comparing late lumen loss at 9 months of Orsiro versus everolimus-eluting stent (Xience
      prime®) is ongoing (BIOFLOW-II trial). However, there have been no trials comparing the
      Orsiro stent versus the Biomatrix stent (Biosensors Inc, Newport Beach, CA, USA).

      This multicenter, randomized, open label, parallel arm study will evaluate whether the
      innovative newer generation stent, Orsiro hybrid DES, is non-inferior to the third generation
      stent, Biomatrix stent, in terms of 18 months late lumen loss.
    

Intervention name(s): Orsiro drug eluting stent; Biomatrix drug eluting stent
Intervention type(s): Device; Drug
Intervention description(s): Orsiro Hybrid drug eluting stent; Biomatrix Flex drug eluting stent
Other intervention name(s): Orsiro drug eluting stent (Biotronik AG, Bulach, Switzeland); Biomatrix drug eluting stent (Biosensors,Newport Beach,USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biomatrix drug eluting stent; Orsiro drug eluting stent; Coronary artery disease