Author: Prof. Dr. Ramon L. Varcoe

Institution: University of New South Wales and Prince of Wales Hospital, Australia

Summary

This presentation provides an overview of recent advancements in Sirolimus-eluting technology for coronary and lower extremity arteries. Prof. Varcoe examines current clinical trial data and future research directions, highlighting the significant advantages of Sirolimus-eluting technology for both below-the-knee and above-the-knee applications. Studies demonstrate that Sirolimus, as a cytostatic drug, offers superior anti-proliferative properties, making it suitable for coronary and peripheral artery treatments.

Pharmacological Properties and Mechanism of Sirolimus

•Drug Characteristics: Sirolimus is an mTOR inhibitor with anti-proliferative effects, effectively inhibiting smooth muscle cell migration and reducing neointimal hyperplasia. It is well-suited for anti-restenosis treatments in coronary stents and below-the-knee venous stents.

Key Clinical Trials and Study Data

• Ongoing Clinical Trials: Numerous RCTs are evaluating the effectiveness of Sirolimus-coated balloons (SCB) in above-the-knee and below-the-knee arteries. Notable studies include SIRONA (Germany, Austria), FUTURE SFA (Asia), and SELUTION4SFA (global). Early findings indicate promising therapeutic potential for SCBs in lower extremity arteries.

• Device and Technology Innovation: New Sirolimus-coated devices like the Sundance™ DCB utilize uniform drug coating and hydrophobic layers to ensure consistent drug release at the lesion site and enhance adaptability in complex anatomical structures.

Future Outlook for Sirolimus Stents

• Bioabsorbable Stents: Companies like R3 Vascular and REVA Medical are developing fully bioabsorbable stents. Sirolimus-coated stents not only prevent restenosis but also gradually absorb within months, reducing the risks associated with long-term implants.

Conclusion

1. Due to its superior anti-proliferative properties, Sirolimus has become a preferred drug for coronary and lower extremity stents.

2. Early clinical data show promising results for Sirolimus-coated balloons in both above-the-knee and below-the-knee arteries, with ongoing RCTs expected to further validate its efficacy.

3. Bioabsorbable stents with Sirolimus coatings show tremendous potential in peripheral artery treatment, with promising prospects for future development.

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