The use of drub coated balloons (DCB) in the treatment of femoropopliteal artery disease has grown. Studies on first generation high dose DCB (HD-DCB) have shown benefits, which has led to their recommendation by current guidelines. However, there have been reports of secondary effects caused by paclitaxel and its excipients.
Second generation low dose DCB (LD-DCB) were looked into by the COMPARE trial (Compare I Pilot Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease), which showed similar primary patency at 2 years vs. HD-DCB. However, due to design limitations, the study was not able to establish comparisons against more complex real world populations.
The aim of this multicenter prospective study was to compare LD-DCB and HD-DCB outcomes in patients with femoropopliteal artery disease in a real world population.
Primary end point was primary patency at one year (restenosis free). Secondary end point included residual stenosis, slow flow or no reflow, rescue stent, post-procedural complications, clinically driven target lesion revascularization (CD-TLR) at 1 year, major amputation, major adverse limb related events (including a combination of CD-TLR and major amputation) and mortality.
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581 patients were included in the study, 370 treated with LD-DCB and 211 with HD-DCB. After propensity score matching for homogeneous sampling, the study compared 358 patients treated with LD-DCB vs 163 treated with HD-DCB.
The LD-DCB group had fewer men (62.4% vs 71.1%; P = 0.043), older on average (76 vs 74 years; P = 0.018), with a higher rate of anticoagulant use (23.5% vs 14.7%; P = 0.015), and higher prevalence of critical ischemia (47.9% vs 34.1%; P = 0.010), a lower ankle-brachial index (0.53 vs 0.60; P = 0.016), a more compromised popliteal artery (55.7% vs 26.0%; P < 0.001), smaller reference diameter (5.3 mm vs 5.5 mm; P = 0.011) and longer lesions (20.6 cm vs 17.5 cm; P = 0.001).
As regards primary end outcomes, primary patency at 1 year resulted 87% for LD-DCB patients and 81.3% for HD-DCB, with no statistically significant differences (HR: 0.93; 95% CI: 0.55-1.59; P = 0.79). Neither were there significant differences in secondary end outcomes.
Conclusion
LD-DCB showed efficacy and safety comparable to HD-DCB’s in a real world population, which suggests the use of LD-DCB might be a viable option to treat femoropopliteal lesions.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease PROSPECT MONSTER Study Outcomes.
Reference: Tatsuya Nakama, MD et al J Am Coll Cardiol Intv 2023.
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