Combining a drug-coated balloon and a drug-eluting stent for people with diabetes and new coronary artery blockages

Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus

This trial tests whether using a drug-coated balloon together with a drug-eluting stent works better than using either device alone for adults with diabetes who have new (de novo) coronary artery lesions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal College of Surgeons, Ireland (Academic / other)
• Locations: 1 site (Dublin, County Dublin)
• Trial ID: NCT07303439 on ClinicalTrials.gov

What this trial studies

DUBSTENT-DIABETES is a prospective, randomized, multicenter, assessor-blind trial enrolling 120 adults with diabetes undergoing PCI for de novo native coronary lesions. Participants are randomized 1:1:1 to receive Pantera® Lux paclitaxel drug-coated balloon combined with Orsiro® drug-eluting stent, Pantera® Lux DCB alone, or Orsiro DES alone. The trial compares safety and efficacy outcomes, including target lesion failure and restenosis, with standardized angiographic entry criteria and clinical follow-up. Procedures are done at participating centers with follow-up visits to monitor clinical outcomes and device-related events.

Who should consider this trial

Good fit: Adults (≥18) with diabetes undergoing PCI for de novo obstructive lesions in native coronary arteries who can give informed consent and meet angiographic criteria are ideal candidates.

Not a fit: Patients with left main disease, STEMI at presentation, acute cardiogenic shock, severe renal impairment, prior stented (non‑de novo) lesions, or lesions unsuitable for balloon pre-dilation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combined approach could lower restenosis and target lesion failure, reducing repeat procedures and improving longer-term outcomes for people with diabetes.

How similar studies have performed: Drug-coated balloons and drug-eluting stents have established evidence individually, but using them together in people with diabetes is a novel approach that has not been tested in randomized trials.

Eligibility criteria

Inclusion Criteria:

1. Patients with acute or chronic coronary syndrome
2. Diagnosis of diabetes
3. Patients undergoing PCI for de novo lesions in native coronary arteries
4. Patients able and willing to provide written informed consent
5. Age ≥ 18 years.
6. Patients able and willing to comply with the study procedures and follow-up.
7. All angiographic inclusion criteria fulfilled:

   1. the lesion has been deemed treatable
   2. the guidewire has crossed the lesion
   3. the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \>2, and there is no evidence of flow-limiting dissection is seen.

Exclusion Criteria:

1. Lesions located at the left main coronary artery.
2. Patient presents with a ST-elevation myocardial infarction (STEMI).
3. Patient with acute cardiac decompensation or acute cardiogenic shock.
4. Patient with impaired renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
5. Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.
6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
8. Patients unable to take dual antiplatelet therapy for 6-12 months
9. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
11. Anticipated difficulties to complete the angiographic surveillance.
12. Patient with a life expectancy of less than 12 months.
13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
14. The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited

Where this trial is running

Dublin, County Dublin

• Mater Private Hospital — Dublin, County Dublin, Ireland (Recruiting)

Study contacts

• Study coordinator: Amy Carswell, MSc.

Conditions Diabetes Mellitus; Coronary Arterial Disease; de Novo Coronary Lesions; De Novo Stenosis; Coronary Artery Disease; Drug-coated Balloon; Drug-Eluting Stent; Target Vessel Failure