November 17, 2020
PIONEER III Findings Presented for Sinomed’s Supreme HT DES
November 17, 2020—Sino Medical Sciences Technology Inc. (Sinomed), a Tianjin, China–based developer of neuro- and cardiovascular technologies, announced data from the randomized, global PIONEER III study evaluating the safety and efficacy of the Supreme HT healing-targeted drug-eluting stent (DES).
The trial showed equivalent clinical performance of the Supreme HT compared to the Xience (Abbott) or Promus (Boston Scientific Corporation) durable polymer (DP) DES. The findings will be used to support regulatory approvals in the United States and Japan. Professor Alexandra Lansky, MD, presented the 1-year results as a late-breaking trial at the American Heart Association Scientific Sessions 2020 held as a virtual meeting on November 13-17.
According to Sinomed, the PIONEER III study enrolled 1,629 patients in North America, Europe, and Japan. Patients were randomized 2:1 to experimental or control groups. The study’s primary composite endpoint was target lesion failure (TLF) at 1 year. In July, the company announced the completion of 1-year follow-up in the trial.
Prof. Lansky reported the following:
- For Supreme HT versus the control arm of DP DES, the noninferiority endpoint of TLF was met (5.4% vs 5.1%; P = .002).
- In a grouped analysis of secondary endpoints, Supreme HT showed a numerically better result in cardiac death or target vessel myocardial infarction (3.5% vs 4.6%; P = .27).
- Lower late stent thrombosis data suggested exceptional safety for the Supreme HT versus DP DES (0.1% vs 0.4%; P = .22).
- A powered, landmark TLF analysis evaluating the healing superiority of Supreme HT between 1 and 5 years is ongoing.
Shigeru Saito, MD, from Shonan Kamakura General in Kamakura, Japan, served as Primary Investigator of the Japanese cohort of the PIONEER III study. “I am very pleased that Japanese patients will benefit from the most advanced DES in the United States, Europe, and Japan,” commented Dr. Saito in the company’s press release. “The results combined with the safety measurement of cardiac death, target vessel myocardial infarction, and late stent thrombosis favor the Supreme HT, supporting the early endothelial healing concept.”
The Supreme HT development was based on the “wound-healing window” concept that highlights early, timely healing, whereas contemporary DESs have emphasized delayed healing through prolonged drug delivery to suppress the body’s response to injury, hypersensitivity, or progression of disease.
The company’s designs and processes were used to tailor Supreme HT to help accelerate a patient’s wound-healing process and restore natural endothelial function. This healing-targeted mechanism may help overcome the problem of traditional DES implantation, allowing for safer long-term results, stated Sinomed.