[Initial results and 6 month clinical follow-up after implantation of a silicon carbide coated coronary stent].

Abstract

INTRODUCTION AND OBJECTIVES:

To present the initial Spanish experience with the Tenax coronary stent, a laser sculpted from high-precision 316L stainless steel coated with hydrogen rich amorphous silicon carbide that reduces thrombogenecity and improves biocompatibility.

PATIENTS AND METHODS:

From July 1998 to July 1999, 206 patients (62 +/- 5 years) underwent implantation of 231 Tenax stents in 9 centers as the only revascularization procedure. The most frequent clinical indication was unstable angina (66%), and most of the lesions were complex (class B2 and C). The target vessels were the left anterior descending (51%) and right coronary arteries (36%). The ejection fraction was < 0.5 in 19% cases.

RESULTS:

Revascularization was complete in 70%, elective in 80%, and the implantation was direct in 25% of the cases. The procedure was successful in all the lesions, reducing stenosis from 62 +/- 16 to 16 +/- 10% and increasing the minimal luminal diameter from 0.81 +/- 0.40 to 2.61 +/- 0.59 mm. The TIMI flow was reduced in 30%, but normalized after the stent in all but one case. The incidence of cardiac events was minimal: 1 acute thrombosis (0.5%) resolved by a new angioplasty and 1 non-Q myocardial infarction (0.5%). At the 6-month clinical follow-up 10% of the patients presented complaints of angina greater than class II, and a new angioplasty was carried out in 1.9% of these cases.

CONCLUSION:

Clinical and angiographic data suggest that the hydrogenated silicon carbide coating of the Tenax coronary stent may indeed play a beneficial role in patient outcome, and should therefore be evaluated by prospective clinical trials.

• Authors: J A Fournier, J Calabuig, A Merchán, J M Augé, R Melgares, T Colman, R Martín De Dios, L Insag, I Santos
• Journal: Revista espanola de cardiologia (Rev Esp Cardiol) Vol. 54 Issue 5 Pg. 567-72 (May 2001) ISSN: 0300-8932 [Print] Spain
• Vernacular Title: Resultados iniciales y seguimiento clínico a 6 meses tras el implante de un stent coronario recubierto de carburo de silicio.
• PMID: 11412747 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Biocompatible Materials
• Carbon Compounds, Inorganic
• Silicon Compounds
• silicon carbide

Topics

• Angina, Unstable (therapy)
• Biocompatible Materials
• Carbon Compounds, Inorganic
• Coronary Disease (complications, surgery)
• Follow-Up Studies
• Humans
• Myocardial Revascularization
• Prosthesis Implantation
• Registries
• Silicon Compounds
• Stents (adverse effects)
• Treatment Outcome