Treatment of Femoropopliteal Lesions with Low-Dose vs. High-Dose Drug-Coated Balloons

The use of drug-covered balloons (DCBs) has increased significantly for the endovascular treatment of femoropopliteal arterial disease. Previous studies on first-generation high-dose DCB (HD-DCB) have validated its benefits, thus supporting its recommendation in current clinical guidelines. However, there have been reports of adverse effects associated with paclitaxel and its excipients.

Acceso retrógrado mediante la arteria tibial para el tratamiento de oclusiones en territorio femoropoplíteo: ¿es una estrategia segura?

Second-generation, lower-dose DCBs (LD-DCB) have been studied in the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) Study, revealing similar primary patency at 2 years for LD-DCB and HD-DCB. However, due to the design of that study, there cannot be an adequate comparison between devices, as the population studied is less complex than real-world population.

The aim of this prospective, multicenter study was to contrast the results of LD-DCB and HD-DCB in patients with femoropopliteal disease in a real-world population. 

The primary endpoint (PEP) focused on primary patency at 1 year (restenosis-free). The secondary endpoint (SEP) encompassed residual stenosis, slow flow or no reflow, rescue stent, post-procedural complications, freedom from clinically-driven target-lesion revascularization (CD-TLR) at 1 year, major amputation, limb-associated major adverse events (including a composite of CD-TLR and major amputation), and mortality.

Read also: Use of Intravascular Lithotripsy in Left Main.

The study included a total of 581 patients; 370 were treated with LD-DCB and 211 with HD-DCB. After propensity score matching to homogenize the samples, researchers compared 358 samples from the LD-DCB group and 163 from the HD-DCB group.

The LD-DCB group had a lower prevalence of men (62.4% vs. 71.1%; P = 0.043), older age (76 years vs. 74 years; P = 0.018), a higher rate of anticoagulant use (23.5% vs. 14.7%; P = 0.015), 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), greater involvement of the popliteal artery (55.7% vs. 26.0%; P < 0.001), smaller reference diameter (5.3 mm vs. 5.5 mm; P = 0.011), and more extensive lesions (20.6 cm vs. 17.5 cm; P = 0.001).

Regarding the PEP, the primary patency rate at 1 year was 87% in the LD-DCB group and 81.3% in the HD-DCB group, with no statistically significant differences (hazard ratio [HR]: 0.93; 95% confidence interval [CI]: 0.55-1.59; P = 0.79). There were also no statistically significant differences in the SEP.

Conclusion

In conclusion, LD-DCBs demonstrated comparable efficacy and safety with HD-DCBs in a real-world population, suggesting the feasibility of using LD-DCB in the treatment of 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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