DCB for CAD With Type 2 Diabetes

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Target Lesion Diameter Stenosis Rate — At 12 months after intervention
  Target Lesion Diameter Stenosis Rate refers to the percentage of narrowing at the target coronary lesion, calculated by comparing the minimal lumen diameter (MLD) at the lesion site with the reference vessel diameter (RVD), which was measured based on coronary angiography.

Trial sites (6)

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