First Patient Enrolled in DUBSTENT DIABETES Trial

Teleflex Incorporated has enrolled the first patient in the DUBSTENT DIABETES trial, a randomized, investigator-initiated clinical study that will assess a dual-device strategy for percutaneous coronary intervention (PCI) in diabetes mellitus patients.

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 Freesolve 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 technology.¹

“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne,* the study’s coordinating principal investigator and director of Cardiology at Mater Private Network in 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 at high-volume centers in Ireland. Participants will be randomized to receive either:

• A combination of the Pantera Lux DCB Catheter (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.”

As a global provider of medical technologies, Teleflex offers solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck.

Not all products may be available in all countries. The Pantera Lux Drug-Coated Balloon Catheter is not approved in United States and the Freesolve Resorbable Magnesium Scaffold (RMS) is limited to investigational use in the United States.

* Professor Byrne is a paid consultant of Teleflex Incorporated or its affiliates.

Reference
¹ https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013302