Key result
Implantation of the Tenax coronary stent resulted in a 95.4% clinical success rate, with a 1-year target lesion revascularization rate of 7.1% and a major adverse cardiac event rate of 15.8%.
Observational (n=241)
Yes
The Tenax coronary stent demonstrated high procedural success and acceptable 1-year rates of target lesion revascularization and major adverse cardiac events in a cohort with a high proportion of complex lesions.
Supports feasibility in complex lesions; leaves open comparative efficacy versus contemporary stents in randomized trials.
The Tenax coronary stent is laser sculpted from high precision 316 L stainless steel using advanced production procedures. An a-SiC: H (hydrogen-rich amorphous silicon carbide) coating reduces its thrombogenicity and improves its biocompatibility. From April to July 1998, 266 stents were implanted in 241 patients (aged 62.7 +/- 10.5 years) in five centers. The clinical indication for intervention was unstable angina (33.2%) and recent myocardial infarction (29.5%) in many cases. Most lesions (53.8%) had complex characteristics (Class B2 or C). The target vessel was the LAD in 42.5% and the right coronary artery in 36.8% of all cases. Four primary stent deployment failures occurred and implantation was successful in 259 (97.4%) of 266 stents. No death and no Q-wave myocardial infarction or emergency CABG occurred during hospital stay. Clinical success, defined as successful deployment without procedural or clinical event, was achieved in 230 (95.4%) of 241 patients. One-year clinical follow-up shows a low need for target lesion revascularization (17/237 [7.1%] patients) and a 15.8% rate of major adverse cardiac events (36/237 patients). The clinical and angiographic outcomes of our study suggest that the hybrid, amorphous hydrogenated silicon carbide coated design is promising and merits further evaluation in larger clinical trials.
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Carrié et al. (2001) conducted an observational in Coronary artery disease (unstable angina, recent myocardial infarction) (n=241). Tenax coronary stent was evaluated on Major adverse cardiac events at 1 year. Implantation of the Tenax coronary stent resulted in a 95.4% clinical success rate, with a 1-year target lesion revascularization rate of 7.1% and a major adverse cardiac event rate of 15.8%.
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