| back to overview |
23rd Annual Congress ot the European Society of Cardiology (ESC), September 2001, Stockholm, Sweden
- Prevention of nickle release does not prevent in-stent restenosis
- S. Silber, I. Krischke, N. Schoen, S. Tourlakidou, N. Seidel
- Cath Lab, Dr. Müller Hospital, Munich, Germany
- Eur Heart J 22, Abstract suppl., 281, (2001)
The release of nickle from coronary stents was recently related to the development of in-stent restenosis. Therefore a new stent with a biometallic surface (BMS) was developed, implanting tantalum as biometallic atoms into the surface of a stainless steel stent, carved with a high precision laser system under vacuum conditions. Edges, ends and struts are rounded using a special finishing procedure to protect the vascular wall from possible damage. No ions - including nickle compounds - are released into the surrounding tissues and corrosive currents are lower than with the conventional 316L stents. In this first clinical study, 120 consecutive pats with de-novo lesions were enrolled. Mean age was 62±11 y, height 169±8 cm and weight 79±12 kg.
Results: All stents (premounted) could be implanted as planned. The average length of stents implanted was 17.5±5 mm with a mean stent diameter of 3.1±.2 mm at 11± 3 bar. There was no acute or subacute stent thrombosis. Angiographic follow-up was obtained at 169±39 days after stent implantation:
restenosis < 20%: 42.3% restenosis = 20 - 49%: 15.5% restenosis = 50%: 7.0% restenosis = 51-74%: 9.9% restenosis = 75-99%: 19.7% occlusion: 5.6%
The angiographic restenosis rate (> 50%) was 35.2% and target vessel revascularization (TVR) 26.1%.
Conclusion: This newly developed, vacuum-produced high-tech stent did not prove to lead to clinical and/or angiographic restenosis rates lower than known for conventional stents. It may be concluded that the prevention of nickle release as well as the reduction of corrosive currents do not contribute to a reduction of in-stent restenosis.
