News | Stents | November 24, 2020

Biodegradable Drug Eluting Coronary Stent Noninferior to Xience or Promus Durable Polymer Stents

PIONEER III Trial data presented at AHA 2020 for Sinomed Supreme HT stent will be used for FDA review

One-year results off the PIONEER III study comparing the safety and efficacy of the Supreme HT drug-eluting stent (DES), to the Xience or Promus Durable Polymer DES showed it was equivalent in clinical performance to the market-leading DES. The results were presented at the 2020 American Heart Association (AHA) Scientific Session. #AHA2020 #AHA20 #AHA

One-year results off the PIONEER III study comparing the safety and efficacy of the Supreme HT drug-eluting stent (DES), to the Xience or Promus Durable Polymer DES showed it was equivalent in clinical performance to the market-leading DES. The results were presented at the 2020 American Heart Association (AHA) Scientific Session.

November 24, 2020 — One-year results off the PIONEER III study comparing the safety and efficacy of the Supreme HT (Healing-Targeted) drug-eluting stent (DES), to the Xience or Promus Durable Polymer Drug-Eluting Stent (DP DES) showed it was equivalent in clinical performance to the market-leading DES. The results were presented at the 2020 American Heart Association (AHA) Scientific Session. 

The data were presented by Alexandra Lansky, M.D., FACC, FAHA, FSCAI, FESC, director of the Yale Heart and Vascular Clinical Research Program and the Cardiovascular Research Group. The study will be used to support U.S. Food and Drug Administration (FDA) and Japanese regulatory approvals.

The HT-DES is designed to actively restore endothelial function after stent delivery using a combination of rapid sirolimus delivery and a bioresorbable PLGA drug carrier polymer that dissolves after four to six weeks and leaves behind a bare metal stent. The thin-strut sent is 80 microns and includes layer of inert eG coating that promotes endothelial growth and help avoid hyperplasia.

Supreme HT Drug-Eluting Stent Trial

The PIONEER III study enrolled 1,629 patients (randomized 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 DP 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 1 and 5 years is ongoing.

"I am very pleased that Japanese patients will benefit from the most advanced DES in the U.S., Europe and Japan," said Shigeru Saito, M.D., Shonan Kamakura General, 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 favor the Supreme HT, supporting the early endothelial healing concept."

Contemporary DES have emphasized delay healing through prolonged drug delivery to suppress the body's response to injury, hypersensitivity, or progression of disease.  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.  Through patented designs and proprietary processes, the Supreme HT was tailored to help patients accelerate their wound-healing process and restore their natural endothelial function.  This healing-targeted mechanism may help overcome the long-standing problem of tradition-DES implantation, allowing for safer long-term results.

"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, Ph.D., chairman and chief executive officer of Sinomed. "The results have been extremely encouraging and if we reach superiority in the landmark analysis, we could revolutionize the understanding of healing and the future of implantable devices,"

The trial was started in 2017. The device is based on the Sinomed BuMA Supreme stent, which originally offered the bioresorbables drug carrier polymer. The Supreme HT has the edition of the inert eG coating. 

China-based Sino Medical Science Technology Inc. (Sinomed) is a global medical device company engaged in research, development, production, and commercial distribution of interventional devices. 

For more information: www.sinomed.com

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