BEST-BTK: 12-Month Data Of the Use Of the Biotronik Absorbable Metal Stent Below the Knee

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Marc Bosiers, MD¹, Patrick Peeters, MD², Koen Deloose, MD¹, Jürgen Verbist, MD².
¹AZ St-Blasius, Dendermonde, Belgium, ²Imelda Hospital, Bonheiden, Belgium.

Background:
The study was designed to evaluate the safety and performance of a new metal absorbable metal stent for the treatment of infrapopliteal occlusive disease. The use of absorbable material during stenting removes the trigger for neo-intima hyperplasia and therefore potentially lowers in-stent restenosis.
Methods:
From December 2003 to January 2004, 20 patients with chronic CLI caused by infrapopliteal occlusive disease were prospectively identified and included in a Phase I clinical trial. Patients were followed for adverse events with comprehensive laboratory analysis and clinical exam. Surveillance of stent performance was investigated by CFDU and MRA. 6-month limb salvage defined the primary endpoint.
Results:
All stents are deployed successfully as confirmed by intra-operative angiography and IVUS. The alloy shows to be MRA-compatible, allowing MRA for vessel control. The 1-month CFDU and MRA confirm the start of the stent absorption process. Six months after implantation limb salvage is achieved in 94.7% of the patients and CFDU shows a primary patency rate of 78.9%. Serum and blood analysis reveals no systemic toxicity from the implanted metal alloy. 12-month data regarding mid-term limb salvage and vessel patency will be available at the time of the meeting.
Conclusion:
This study is the first to report the implantation of a metal bio-absorbable stents in man for the treatment of arterial occlusive disease. Immediate results show good bio- and MRA-compatibility of the absorbable metal stents, while 6-month data confirm the excellent expected limb salvage.