Sirolimus-eluting balloon for the treatment of peripheral artery disease: SUCCESS PTA real-world single-arm study
Michael Lichtenberg1, Thomas Zeller2, Ashish Patel3
1Arnsberg Vascular Center, Alexianer Klinikum Hochsauerland, Stolte Ley 5, Arnsberg, 59759, Germany. klichte@gmx.net.
Insights
The SELUTION SLR drug-eluting balloon (DEB) shows promising real-world effectiveness for femoropopliteal arterial lesions in patients with claudication and chronic limb-threatening ischemia (CLTI). One-year results demonstrate high freedom from revascularization and significant symptom improvement.
Area of Science:
- Vascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Sirolimus-coated drug-eluting balloons (DEB) have shown positive outcomes for femoropopliteal arterial lesions.
- Previous studies have not extensively evaluated DEB in a broad patient population, including those with chronic limb-threatening ischemia (CLTI).
Purpose of the Study:
- To gather real-world safety and effectiveness data for the SELUTION SLR DEB.
- To assess outcomes in patients experiencing claudication and CLTI.
Main Methods:
- A prospective, single-arm, post-market study (SUCCESS PTA) involving 723 patients across 27 international sites.
- The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at one year.
- Data collected included patient demographics, lesion characteristics, and clinical outcomes.
Main Results:
- At 12 months, freedom from CD-TLR was 91.1%.
- Significant improvements were observed in EQ-VAS scores and ankle-brachial pressure index.
- In CLTI patients, 12-month outcomes included a 5.8% major target limb amputation rate, 4.3% major cardiac event rate, and 11.3% death rate. For claudication patients, these rates were 0.0%, 2.2%, and 1.2%, respectively.
Conclusions:
- This study represents the largest assessment of a sirolimus DEB for claudication and CLTI.
- Outcomes align with those of paclitaxel-coated balloons, supporting sirolimus DEB as a viable alternative, especially for CLTI patients.
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.
