SINOMED, a leading international medical device company, announced that the clinical trial results for its HT Supreme® Drug-Eluting Stent (DES) System has been published in Circulation. The article described results from the PIONEER III trial where investigators demonstrated equivalence in safety and effectiveness between the HT Supreme and best-in-class DES.
“This trial was performed in the USA, Europe and Japan and the enrolled patients reflect a broad spectrum of disease treated. The HT Supreme performed very well and showed results non-inferior to the current market leading stent,” said Prof. Andreas Baumbach from St. Bartholomew’s Hospital, London, England, and European Co-Principal Investigator. “I am now looking forward to see whether the novel design of the stent platform and drug delivery system will result in superior outcomes in future long-term follow-up out to five years.”
The PIONEER III study enrolled 1,629 patients from centres in Belgium, Canada, France, Germany, Japan, Netherlands, Spain, Switzerland, U.K., and the U.S.A. This tri-continent trial had a primary composite endpoint of target lesion failure (TLF) at one-year. The TLF outcomes showed that the HT Supreme met the non-inferiority endpoint at 5.4% compared to 5.1% from the control arm (p=0.002) of Xience and Promus devices (DP DES).
A grouped analysis of secondary endpoints showed a numerically better result for HT Supreme in cardiac death or target-vessel myocardial infarction (TV MI) with 3.5% in the HT Supreme arm compared to 4.6% in the control arm (p=0.27). Lower late stent thrombosis data (0.1% compared to 0.4%, p=0.22) also suggested exceptional safety for the HT Supreme.
“PIONEER III is the cornerstone of our extensive, international clinical trial program and I am very grateful for the support we have had from investigators around the world,” said Dr. Jianhua Sun, PhD., chairman and chief executive officer of SINOMED. “Now is a very exciting time for us as we are in the early stage of product launch where we are putting our clinical learnings towards real-life clinical experience. ”
A powered, landmark TLF analysis evaluating the healing superiority of HT Supreme between 1 and 5 years is ongoing. Data from this trail will be submitted to the U.S. Food and Drug Administration (FDA) for approval in the U.S.A. and the and Pharmaceuticals and Medical Devices Agency (PMDA) for approval in Japan.
The HT Supreme represents a novel class of stents that highlights the importance of early, timely healing. Through patented designs and proprietary processes, the HT Supreme is tailored to help patients accelerate their wound-healing process and restore their naturally protective vessel function. The HT Supreme was launched this summer in Europe and China.
More information on the PIONEER III study is available at www.clinicaltrials.gov, identifier: NCT03168776.
SINOMED is a global medical device company engaged in research, development, production, and commercial distribution of interventional devices. We are focused on developing breakthrough technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to expose more patients to the benefits of our medical innovations, increasing patient longevity and quality of life. For more information visit www.sinomed.com.