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EuroPCR 25: BIOADAPTOR RCT 3Y Outcomes
Published: 22 May 2025
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EuroPCR25 - Novel DynamX Bioadaptor demonstrates a sustained reduction of device-related events from six-month to three-year follow-up compared to drug-eluting stents (DES).
We are joined by Dr Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, JP) to discuss key findings from the BIOADAPTOR RCT trial (NCT04192747). This prospective, randomised controlled trial compared the ELX1805J (DynamX Bioadaptor) with the Resolute Onyx zotarolimus-eluting stent in 445 patients requiring treatment of up to two de novo coronary lesions in vessels measuring 2.25-4.0mm in diameter and ≤34mm in length, with Target Lesion Failure (TLF) as the primary endpoint.
Findings showed a significant reduction in TLF with the Novel DynamX Bioadapter at three-year follow-up compared to DES, as well as a reduction in cardiac death and clinically driven revascularisation. Furthermore, a significant treatment benefit was observed in left anterior descending artery lesions at three years.
Interview Questions:
1. What was the rationale for developing a bioadaptor approach compared to conventional drug-eluting stents?
2. Could you describe the study design and patient population in the BIOADAPTOR-RCT trial?
3. What were the key findings from the 3-year outcomes data?
4. What are the clinical implications of these results for patients requiring percutaneous coronary intervention?
5. What further research is needed, and what are the next steps for bioadaptor technology?
Recorded at EuroPCR 2025, Paris, France.
Editors: Yazmin Sadik, Jordan Rance
Videographer: Dan Brent, Mike Knight
Support: This is an independent interview produced by Radcliffe Cardiology.
Dr Shigeru Saito
Okay, I'm Dr Saito coming from Japan, and I'm working in the big hospital in Japan.
What was the rationale for developing a bioadaptor approach compared to conventional drug-eluting stents?
So after the development of bare-metal stent, you know power was increased, improved by introducing drug-eluting stent. However, now we know that after the drug-eluting stent implantation to the lesions, we have an annual increase of adverse effects. So that's why we have to go to the next step that is Bioadaptor.
Could you describe the study design and patient population in the BIOADAPTOR-RCT trial?
Yes, this was a randomised clinical trial and the observation period was three years. And we had initially 445 patients and it was randomised into Bioadaptor or Resolute Onyx.
What were the key findings from the 3-year outcomes data?
Three-year data clearly tells that after the drug-eluting stent, the three-year adverse event rate was 7.2%; however, the Bioadaptor case, this was 2.7%. So clearly, that was statistically significant, you know, Bioadapter had a very nice result.
What are the clinical implications of these results for patients requiring percutaneous coronary intervention?
After the Bioadapter implantation, we can reduce the adverse event rate compared to the drug-eluting stent.
What further research is needed, and what are the next steps for bioadaptor technology?
So Bioadapter clearly showed the better result compared to drug-eluting stent. Our question is, you know, we want to have the more big case numbers. First, we have to get approval from the PMDA — that is my task.
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