Sinomed has announced the presentation of data from its inter-continental PIONEER III study comparing the safety and efficacy of the Supreme HT (healing-targeted) drug-eluting stent (DES), to the Xience (Abbott) or Promus durable polymer stent (Boston Scientific). One-year results were presented during a late-breaking trial session at the American Heart Association 2020 scientific sessions (AHA 2020, 13–17 November, virtual). The data showed equivalent clinical performance of the Supreme HT to the market-leading DES and will be used to support US Food and Drug Administration (FDA) and Japanese regulatory approvals.
The PIONEER III study enrolled 1,629 patients (randomised 2:1 experimental to control) from North America, Europe and Japan and had a primary composite endpoint of target lesion failure (TLF) at one-year. The TLF outcomes showed that the Supreme HT met the non-inferiority endpoint at 5.4% compared to 5.1% from the durable polymer DES (p=0.002). A grouped analysis of secondary endpoints showed a numerically better result for Supreme HT in cardiac death or target-vessel myocardial infarction (TV MI) with 3.5% in the Supreme HT arm compared to 4.6% in the control arm (p=0.27). Lower late stent thrombosis data (Supreme HT 0.1% compared to DP DES 0.4%, p=0.22) also suggested exceptional safety for the HT DES. A powered, landmark TLF analysis evaluating the healing superiority of Supreme HT between one and five years is ongoing.
“I am very pleased that Japanese patients will benefit from the most advanced DES in the US, Europe and Japan,” said Shigeru Saito, Shonan Kamakura General, Kamakura, Japan and primary investigator of the Japanese cohort of the PIONEER III study . “The results combined with the safety measurement of cardiac death, target vessel MI and late stent thrombosis favour the Supreme HT, supporting the early endothelial healing concept.”
The Supreme HT development was based on the “wound-healing window” concept originally proposed in 2013 and represents a novel class of DES that highlight the importance of early, timely healing, Sinomed said in a press release.
“We are very grateful to the extraordinary group of medical professionals and all the patients who have endured through this difficult pandemic and completed this study milestone in such a timely and professional manor,” said Jianhua Sun, chairman & chief executive officer of Sinomed. “The results have been extremely encouraging and if we reach superiority in the landmark analysis, we could revolutionise the understanding of healing and the future of implantable devices.”