Sinomed has announced results from the HT Supreme healing-targeted drug-eluting stent (DES), in complex patients compared to the Xience (Abbott Cardiovascular) or Promus (Boston Scientific) family of DES. One-year results were presented at the 2021 EuroPCR annual congress (18–20 May, virtual), showing that the devices have similar clinical safety and effectiveness.
The PIONEER III study enrolled 1,629 patients (randomised 2:1 experimental to control) from North America, Europe and Japan, where the complex patient subgroup showed similar rates of target lesion failure (TLF) at one-year. Patients were considered complex based on AHA/ACC B2/C-criteria.
HT Supreme had a TLF of 5.8% compared to 5.9% in the control arm, with no statistical difference. Additionally, long lesions, severe calcification and severe tortuosity showed no difference between the two arms.
“The one-year target lesion failure rates of the HT Supreme are very low and compared favourably to current best-in-class devices,” said Andreas Baumbach from Queen Mary University of London, London, United Kingdom, and European co-primary investigator of the PIONEER III trial. “It is important for clinicians to understand how new devices perform in more complex lesion; as this is a reflection of the patients we treat day-to-day.”
“As we progress our clinical programme and continue to see the same, safe and consistent data from trial to trial, we are convinced that our healing-targeted stent is the right approach,” said Jianhua Sun, chairman and chief executive officer of Sinomed. “Ensuing that all patient types have another safe option is a true benefit.”