The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.
The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm to assess the leave-nothing behind approach. The study addresses a critical unmet need, as patients with diabetes continue to experience higher rates of stent failure despite advances in DES technology1.
“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. “By combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested to see the impact on restenosis and long-term vessel health in patients with diabetes.”
The DUBSTENT DIABETES trial will enroll 120 diabetes patients across high-volume centers in Ireland. Participants will be randomized to receive either:
- A combination of the Pantera™ Lux™ DCB Catheter (which is part of the Lux™ family of Paclitaxel-coated balloons) and the Orsiro™ Mission™ DES
- The Pantera™ Lux™ DCB Catheter alone
- The Orsiro™ Mission™ DES alone
The primary endpoint is percentage diameter stenosis at six months, assessed by quantitative coronary angiography. Secondary endpoints include death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and quality of life up to five years.
“We are committed to advancing evidence-based solutions for complex patient populations,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs for Vascular Intervention at Teleflex. “We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.”
