Sirolimus-eluting balloon for the treatment of peripheral artery disease: SUCCESS PTA real-world single-arm study

Background Outcomes with sirolimus-coated drug-eluting balloons (DEB) have been positive for the treatment of femoropopliteal arterial lesions but have not been studied in a broader patient population. Objectives Collect real-world safety and effectiveness data on the SELUTION SLR DEB in patients with claudication and chronic limb-threatening ischemia (CLTI). Methods This international multi-center, prospective, single-arm, post-market study (SUCCESS PTA) enrolled 723 patients at 27 sites. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) after 1 year. Results Median age was 71.0 [63.0–79.0] years, 65% were male, 25.7% had CLTI. In total, 822 lesions were included; median lesion length was 100.0 mm [50.0–190.0] with 42.1% chronic total occlusions and 36.4% moderate-to-severe calcification. At 12 months, freedom from CD-TLR was 91.1%, 95% CI [88.6–93.1] and 52.1% of patients were asymptomatic. Median EQ-VAS score and ankle-brachial pressure index improved significantly from baseline to 12 months (65.0 [50.0–80.0] vs. 75.0 [60.0–85.0] ( p < 0.0001)) and (0.6 [0.5–0.8] vs. 0.9 [0.8–1.0] ( p < 0.0001)), respectively. At 12 months, outcomes in CLTI patients included major target limb amputation, 5.8%; major cardiac event rate, 4.3%; and death, 11.3%. Respective outcomes for those with claudication were 0.0%, 2.2% and 1.2%. Conclusions This real-world single-arm study is the largest assessment of a sirolimus DEB for treatment in claudication and CLTI. The outcomes were consistent with those reported for paclitaxel-coated balloons and support this DEB platform as a promising alternative, particularly in CLTI patients. Level of evidence Level 3.