The VaSecure Paclitaxel Drug Coated Balloon Clinical Trial: One Year Outcomes

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Endovascular Therapy

Background:

• Randomized controlled trials (RCTs) indicate similar short-term outcomes for drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with chronic limb-threatening ischemia (CLTI) affecting femoropopliteal lesions.
• The VaSecure paclitaxel DCB is a novel device for treating femoropopliteal CLTI.

Purpose of the Study:

• To evaluate the one-year safety and efficacy of the VaSecure paclitaxel DCB compared to PTA in patients with femoropopliteal CLTI.
• To assess outcomes including freedom from clinically driven target lesion revascularisation (CD-TLR), amputation, and all-cause death.

Main Methods:

• A prospective, multicentre randomized controlled trial (RCT) involving 199 subjects with CLTI.
• Participants were randomized 1:1 to receive either DCB angioplasty or PTA.
• One-year follow-up included assessments of CD-TLR, amputation rates, all-cause death, and ankle-brachial index.

Main Results:

• No statistically significant differences were observed in all-cause death or amputation rates between the DCB and PTA groups.
• The DCB group showed significantly better primary patency (72.7% vs. 50.0%) and lower rates of re-stenosis (8.1% vs. 19.0%) at 12 months.
• The DCB group also demonstrated significantly lower rates of major adverse events (MAEs) (7.5% vs. 19.0%) and CD-TLR/CD-TVR (5.1% vs. 15.0%) compared to the PTA group.

Conclusions:

• The VaSecure paclitaxel DCB angioplasty is safe and effective for treating femoropopliteal CLTI, showing comparable safety outcomes to PTA.
• DCB angioplasty demonstrated superior effectiveness in terms of primary patency, reduced re-stenosis, and fewer re-interventions compared to PTA at one year.
• Further long-term outcomes (two and five years) from this trial are anticipated.