DCB for CAD With Type 2 Diabetes

Official title

Long-Term Efficacy and Safety of Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease and Type 2 Diabetes: A Multicenter, Prospective, Randomized Controlled Trial

Overview

Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.

Detailed description

Coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often coexist, and the long-term hyperglycemic state and metabolic disorders in diabetic patients contribute to endothelial dysfunction and accelerated atherosclerosis. As a result, coronary lesions in T2DM patients tend to be more diffuse and complex, posing greater challenges to percutaneous coronary intervention (PCI). Although drug-eluting stents (DES) have significantly improved clinical outcomes, diabetic patients remain at higher risk for in-stent restenosis (ISR) and target lesion revascularization (TLR), negatively impacting long-term prognosis.

Drug-coated balloons (DCBs), a novel PCI technique, allow for rapid and effective delivery of anti-proliferative agents (e.g. paclitaxel or sirolimus) to the vessel wall without leaving behind a permanent implant. This "leave nothing behind" approach reduces the risk of chronic inflammation and stent-related complications. DCBs have shown promising results in non-diabetic populations, particularly in small vessel disease and bifurcation lesions. However, evidence supporting their use in T2DM patients remains limited, especially from prospective, randomized controlled trials. As such, whether DCBs can serve as a viable alternative to DES in this high-risk group remains an open question.

This study aims to evaluate the efficacy and safety of DCB angioplasty in patients with CAD and T2DM through a prospective, randomized controlled design. The study will focus on restenosis rates, improvement in angina symptoms, incidence of major adverse cardiovascular events (MACE), and patient-reported quality of life outcomes, providing a more individualized and evidence-based treatment approach for this challenging patient population.

Interventions

• Device Drug-Coated Balloon (DCB)
  Following lesion preparation (usually with a standard balloon), a drug-coated balloon is advanced to the target lesion. The balloon is inflated and maintained to allow effective drug transfer to the vessel wall.
• Device Drug-Eluting Stent (DES) implantation
  After coronary angiography identifies the target lesion, a DES is selected based on the vessel size. Post-deployment angiography is performed to confirm the result and check for complications.

Primary outcome measures

• Target Lesion Diameter Stenosis Rate [Time frame: At 12 months after intervention]

Secondary outcome measures (4)

• Major Adverse Cardiovascular Events (MACE) [Time frame: At 12 months after intervention]
• Angina Symptom Improvement [Time frame: At baseline, 1, 3, 6 and 12 months after intervention]
• Changes in glycemic indices including glycated hemoglobin (HbA1c) [Time frame: At 3, 6 and 12 months after intervention]
• Glycemic indices [Time frame: At 3, 6 and 12 months after intervention]

Eligibility criteria

Inclusion criteria

• Age ≥18 years
• Diagnosed CAD with ≥70% stenosis in ≥1 coronary artery confirmed by coronary angiography
• Diagnosed type 2 diabetes (per WHO criteria)
• Target lesion suitable for DCB (diameter 2.0-4.0 mm, length ≤40 mm)
• Informed consent provided

Exclusion criteria

• Prior coronary artery bypass surgery or PCI with complications
• STEMI within 24 hours
• Severe hepatic/renal dysfunction
• Active bleeding or uncontrolled anticoagulation
• Allergy to DCB components
• Pregnancy or lactation
• Psychiatric conditions limiting compliance

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 6 centers

• Huaihe Hospital of Henan University — Kaifeng
• Luoyang Central Hospital Affiliated to Zhengzhou University — Luoyang
• The First Affiliated Hospital of Zhengzhou Uninversity — Zhengzhou
• Shanghai Tenth People's Hospital — Shanghai
• The Second People's Hospital of Yibin — Yibin
• Ninghai First Hospital — Ningbo

Identifiers

NCT: NCT07009938 · DCBinT2DM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗