Sinomed’s HT Supreme DES Demonstrates Noninferiority to Best-in-Class Devices in Published PIONEER III Trial

October 27, 2021—Sinomed, a Tianjin, China–based developer of neuro- and cardiovascular technologies, announced the publication of results from the PIONEER III clinical trial of the company’s HT Supreme drug-eluting stent (DES) system. The HT Supreme was recently launched in Europe and China.

According to the company, the findings demonstrated equivalence in safety and effectiveness between the HT Supreme and the control arm of best-in-class DES (Xience [Abbott] and Promus [Boston Scientific Corporation] durable polymer DES).

The PIONEER III study results were published by Alexandra J. Lansky, MD, et al in Circulation (2021;143:2143–2154). In November 2020, Prof. Lansky presented the 1-year results as a late-breaking trial at the American Heart Association Scientific Sessions 2020, which was held as a virtual meeting.

“This trial was performed in the United States, Europe, and Japan and the enrolled patients reflect a broad spectrum of disease treated,” commented Professor Andreas Baumbach, MD, in Sinomed’s press release. “The HT Supreme performed very well and showed results noninferior to the current market leading stent.”

Prof. Baumbach, who is with St. Bartholomew’s Hospital in London, England, and served as European Coprincipal Investigator in PIONEER III, continued, “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 5 years.”

According to Sinomed, the PIONEER III study enrolled 1,629 patients from centers in Belgium, Canada, France, Germany, Japan, the Netherlands, Spain, Switzerland, the United Kingdom, and the United States. The primary composite endpoint was target lesion failure (TLF) at 1 year.

The HT Supreme met the noninferiority TLF endpoint compared to the control arm (5.4% vs 5.1%; P = .002).

Additionally, the company reported that a grouped analysis of secondary endpoints showed a numerically better result for HT Supreme in cardiac death or target-vessel myocardial infarction compared to the control arm (3.5% vs 4.6%; P = .27). Lower late stent thrombosis data also suggested the safety of the HT Supreme compared to the control arm (0.1% vs 0.4%; P = .22).

Sinomed advised that a powered, landmark TLF analysis evaluating the healing superiority of HT Supreme between 1 and 5 years is ongoing.

The data will be submitted to the FDA for approval in the United States and the Pharmaceuticals and Medical Devices Agency for approval in Japan.