Author: Dr. Edward Choke
Institution: Vascular Surgery Department, Sengkang General Hospital, Singapore & Associate Professor at DUKE-NUS Medical School
Summary
This report covers the latest updates from the XTOSI trial and HOPE registry, focusing on the application of Sirolimus-Coated Balloons (SCB) in patients with complex peripheral arterial disease (PAD). The XTOSI trial evaluates the long-term clinical outcomes of SCBs in the femoropopliteal and below-the-knee (BTK) arteries, while the HOPE registry provides real-world data comparing SCBs with standard balloons. Results indicate that SCBs significantly reduce target lesion revascularization (TLR) and major amputation rates.
XTOSI Trial Update
•Background: The XTOSI trial is a single-arm study assessing the efficacy of MagicTouch Sirolimus-Coated Balloons in 50 patients, 20 with femoropopliteal lesions and 30 with BTK lesions.
•Results: At 3 years, the TLR-free rate was 92.9% for femoropopliteal lesions and 77.8% for BTK lesions. The overall limb salvage rate was 63.3%, with 70% in the femoropopliteal group and 58.6% in the BTK group. All patients maintained ulcer healing at 3 years.
•Conclusion: The XTOSI trial demonstrates the significant efficacy of SCBs in treating complex femoropopliteal and BTK lesions, with positive 3-year outcomes in reducing restenosis and major amputations.
HOPE Registry Update
•Study Design: The HOPE registry is a prospective, single-center study comparing SCBs to standard balloons in real-world applications. Patients included were classified as Rutherford 4-6 with primary stenotic lesions.
•Results: At 2 years, the SCB group showed superior outcomes, with a lower TLR rate (p=0.037) and higher amputation-free survival (p=0.007) compared to the standard balloon group. The TLR-free rate was 75.2% for the SCB group versus 66.2% for the standard balloon group, with a significantly higher limb salvage rate for SCBs.
Conclusion
1.Both the XTOSI trial and HOPE registry suggest that Sirolimus-Coated Balloons are highly effective and safe for treating complex PAD.
2.SCBs outperform standard balloons in reducing restenosis and improving limb salvage, making them suitable for high-risk and complex lesions.
3.While real-world data demonstrates their effectiveness, future large-scale randomized controlled trials are needed to confirm long-term safety and outcomes.
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