Low- and High-Dose Paclitaxel-Coated Balloons Have Similar 2-Year Outcomes

Treatment with low- or high-dose paclitaxel-coated balloons has favorable 2-year outcomes in patients with femoropopliteal lesions.

Both low- and high-dose paclitaxel-coated balloons for femoropopliteal interventions have favorable 2-year outcomes. These findings were published in JACC: Cardiovascular Interventions.

The COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial was a prospective, multicenter, clinical study that recruited patients with symptomatic femoropopliteal lesions. Patients (N=414) were randomly assigned in a 1:1 ratio to receive endovascular treatment with either low-dose (2.0 μg/mm2; n=207) or high-dose (3.5 μg/mm2; n=207) paclitaxel-coated balloons. This study evaluated 2-year safety and clinical outcomes.

The low- and high-dose cohorts included patients with a mean age of 68.2 (SD, 10.0) years and 68.4 (SD, 9.3) years, 38.2% and 36.2% were women, 84.1% and 78.7% were Rutherford class 3, target limb ankle brachial index was 0.65 (SD, 0.24) and 0.63 (SD, 0.26), 87% and 90.8% had hypertension, and 30.6% and 36.9% had diabetes mellitus, respectively.

The low- and high-dose groups were well-balanced for baseline lesion and procedural characteristics. Most patients (88.4%-91.8%) had de novo lesions, the average lesion length was 123.9 to 128.3 mm in length, the stenosis diameter was 84.2%, 40.6% to 43% were total occlusions, and a minority of lesions (17.1%-17.7%) had grade 4 calcification.

The COMPARE study demonstrated a sustained and comparable treatment effect of both low-dose and high-dose PCBs with respect to primary patency and TLR through 24 months for femoropopliteal interventions, including a wide range of lesion complexity.

Technical success of the endovascular treatment occurred among 96.6% of both groups and procedural success among 96.1% of the low-dose and 95.7% of the high-dose groups. Bailout stenting was required by 30.0% of the low-dose cohort and 25.6% of the high-dose cohort.

The event-free survival rates were 87.6% and 88.7% at 1 year and 70.6% and 71.4% at 2 years among the low- and high-dose cohorts (P =.96), respectively.

At month 24, the primary composite safety outcome of freedom from device- and procedure-related death, target limb major amputation, and clinically driven target lesion revascularization occurred among 80.1% and 85.1% of the low- and high-dose groups (P =.13), respectively. Numerically fewer deaths occurred among high-dose paclitaxel-coated balloon recipients (1.1% vs 3.6%; P =.55) compared with the low-dose paclitaxel-coated balloon recipients, respectively. Stratified by individual events, no safety signals differed significantly between groups.

Stratified by lesion size, 13.2% of patients with 10 cm or less sized lesions (n=121), 15.5% of those with larger than 10 to 20 or less cm lesions (n=123), and 17.7% of those with larger than 20 to ≤30 or less cm lesions (n=17.7%) received target lesion revascularization. More of the cohort with the largest lesions had proximal (P <.001) and mid (P =.002) superficial femoral artery involvement compared with the other cohorts. No group differences were observed for procedural characteristics or technical success rates.

This study may have been limited, as double blinding is not possible due to the difference in paclitaxel-coated balloon appearance.

“The COMPARE study demonstrated a sustained and comparable treatment effect of both low-dose and high-dose PCBs [paclitaxel-coated balloons] with respect to primary patency and TLR [target lesion revascularization] through 24 months for femoropopliteal interventions, including a wide range of lesion complexity,” the study authors wrote.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

References:

Steiner S, Schmidt A, Zeller T, et al. Low-dose vs high-dose paclitaxel-coated balloons for femoropopliteal lesions: 2-Year results from the COMPARE trial. JACC Cardiovasc Interv. Published online September 28, 2022. doi:10.1016/j.jcin.2022.08.004