A 120-patient randomized trial in Ireland will compare a hybrid percutaneous coronary intervention strategy—drug-coated balloon angioplasty followed by drug-eluting stent implantation—against single-device approaches in diabetics with de novo coronary lesions. The primary endpoint is the percent diameter stenosis at six months, as measured by quantitative coronary angiography. Clinical outcomes, including death, myocardial infarction, target lesion revascularization, thrombosis, target vessel revascularization, and quality of life, will be tracked over five years. The DCB arm allows a bail-out with a resorbable magnesium scaffold to preserve a leave-nothing-behind option.
Teleflex disclosed first-patient enrollment in the investigator-initiated DUBSTENT DIABETES study, which tests the Pantera Lux paclitaxel-coated balloon and the Orsiro Mission sirolimus-eluting stent either in combination or alone. The design directly targets a persistent weak spot in contemporary PCI: higher failure and restenosis rates in patients with diabetes despite iterative stent advances. By randomizing against both monotherapy arms, the study aims to clarify whether a combined drug-delivery and scaffolding strategy can close the performance gap without locking operators into permanent metal in every segment.
Strategically, the trial is a calculated bet on two converging narratives in interventional cardiology: hybrid PCI and the “leave-nothing-behind” approach. The combination arm tests whether front-loading antiproliferative drug delivery with a DCB can blunt neointimal hyperplasia while the stent provides mechanical security only where needed. The allowance for a resorbable scaffold in the DCB-only arm hedges procedural risk and keeps the “no permanent implant” pathway viable in diffuse diabetic disease. Teleflex’s support aligns with its DCB and resorbable scaffold ambitions and positions the company to shape usage patterns in a high-risk subset where differentiation still matters. The choice of a six-month angiographic surrogate reflects a hypothesis-generating posture more than a guideline-changing agenda; it is a pragmatic first step that could de-risk a larger outcomes-powered program.
For sites, the protocol introduces operational complexity that will test workflow discipline: device sequencing, standardized lesion preparation, and adherence to core lab QCA requirements. Centers will also need clear antiplatelet strategies, given dual local drug exposures in the combination arm and the potential interaction with scaffold resorption kinetics in bail-out cases. CROs and sponsors watching from the sidelines should note the interpretability trade-off embedded in the DCB-only arm’s bail-out option, which enhances patient safety and realism but risks diluting pure DCB signals. Vendors will read this as a validation exercise for DCBs in de novo diabetic lesions and as a cautiously reimagined role for resorbable platforms after prior generation setbacks. Regulators are likely to view any positive angiographic signal as a doorway to outcomes trials rather than an endpoint for labeling shifts, particularly in markets where de novo DCB use remains constrained.
The near-term milestone is the six-month QCA readout, which, assuming steady enrollment, could be achieved within the next 18 to 24 months. Two operational variables will be worth tracking: the frequency of bail-out scaffold use in the DCB arm, which will influence the credibility of a leave-nothing-behind narrative, and lesion complexity metrics typical of diabetes, including diffuse disease and calcification, which will stress-test the strategy’s generalizability. If the combination arm shows a clinically meaningful reduction in restenosis without safety trade-offs, expect a larger, MACE-powered multicountry RCT and growing pressure to standardize hybrid PCI protocols. Conversely, a neutral result would reinforce the simplicity of single-device approaches and sharpen questions about cost, procedure time, and DAPT management that hybrid approaches must overcome to move beyond niche adoption.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
