STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)

Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study

This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.

A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.

Inclusion Criteria:

• Patients with significant multivessel coronary artery disease requiring revascularization
• Any De novo lesions (reference vessel diameter of 2.25mm~4.0mm) suitable for DCB angioplasty
• Lesion suitable for intravascular imagings
• Written informed consent

Exclusion Criteria:

• Hemodynamically unstable or cardiogenic shock
• Left main stenotic lesion or graft vessel lesion
• Visible angiographic thrombus, not resolved by balloon angioplasty
• Pregnancy or breastfeeding
• Comorbidities with life expectancy < 12 months
• Severe coronary calcification or tortuosity, hindering timely DCB delivery