Teleflex Initiates DUBSTENT DIABETES Trial Testing Dual-Device Strategy for Diabetic Patients Undergoing PCI

Key Insights

• Teleflex has enrolled the first patient in the DUBSTENT DIABETES trial, a randomized study evaluating a dual-device approach combining drug-coated balloons with drug-eluting stents for percutaneous coronary intervention in diabetic patients.
• The 120-patient trial addresses the critical unmet need of higher stent failure rates in diabetic patients despite advances in drug-eluting stent technology.
• The study will compare the combination therapy against single-device strategies using either drug-coated balloons alone or drug-eluting stents alone, with the primary endpoint being percentage diameter stenosis at six months.

Teleflex Incorporated has announced the enrollment of the first patient in the DUBSTENT DIABETES trial, a randomized investigator-initiated clinical study that will evaluate a novel dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. The study addresses a critical unmet medical need, as patients with diabetes continue to experience higher rates of stent failure despite advances in drug-eluting stent technology.

Trial Design and Patient Population

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 in diabetic patients with de novo coronary artery lesions. The study will enroll 120 diabetes patients across high-volume centers in Ireland.

Participants will be randomized into three treatment arms:

• A combination of the Pantera™ Lux™ DCB Catheter and the Orsiro™ Mission™ DES
• The Pantera™ Lux™ DCB Catheter alone
• The Orsiro™ Mission™ DES alone

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.

Clinical Rationale and Expert Perspective

"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 Pantera™ Lux™ DCB Catheter is part of the Lux™ family of Paclitaxel-coated balloons, designed to deliver anti-proliferative medication directly to the vessel wall during balloon inflation.

Study Endpoints and Follow-up

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 measures tracked up to five years.

Company Commitment to Complex Patient Populations

"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."

Regulatory Status and Availability

The Pantera™ Lux™ Drug-Coated Balloon Catheter is not approved in the United States, and the Freesolve™ Resorbable Magnesium Scaffold (RMS) is limited to investigational use in the United States. Product availability and indications for use may vary by geographic location.