The development of new devices and techniques has expanded the range of patients who benefit from endovascular treatment of femoropopliteal lesions. Paclitaxel-eluting devices have improved clinical results and treated-vessel patency at follow-up compared with conventional angioplasty. Currently, devices with different doses of paclitaxel are available in the market.
The COMPARE (Compare I Pilot Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease) study compared low-dose (Ranger) vs. high-dose (IN-PACT) paclitaxel-coated balloons, showing that the former were non-inferior in terms of efficacy and safety after 1 year.
The aim of this prospective, multicenter study was to evaluate efficacy and safety results after 2 years.
The primary endpoint was absence of clinically guided treated-vessel revascularization or restenosis assessed by a Doppler study. Additionally, researchers analyzed a safety endpoint and clinical results.
This study analyzed 414 patients randomized between the low-dose arm and the high-dose arm. Mean patient age was 68 years old, and most subjects were male. The most frequent clinical presentation was Rutherford class III. There were no differences between groups in terms of the characteristics of treated lesions (lesion length, chronic occlusion %, and calcification level). Technical and procedural success rates were also similar.
After 2 years, the patency rate was 70% for the low-dose arm, and 71% for the high-dose arm (p = 0.96). There was no difference in all-cause mortality or clinically guided revascularization.
Conclusion
This study has shown a sustained and comparable effect regarding the treatment of femoropopliteal lesions between balloons coated with low and high doses of paclitaxel in terms of treated-vessel patency and need for revascularization after 2 years.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions 2-Year Results From the COMPARE Trial.
Reference: Sabine Steiner, MD et al J Am Coll Cardiol Intv 2022.
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