Endeavor: Opening a new era of drug-eluting stents
Release date: 2008-04-28
Endeavor: Opening a new era of drug-eluting stents
At the recent China Interventional Cardiology Congress in 2008, cardiovascular disease experts paid extensive attention to the new FDA-approved next-generation drug stent Endeavor, which is considered to be a milestone in the field of coronary artery disease treatment. The advent of a new era of drug-eluting stents.
"The advent of drug stents solves the problem of high rate of restenosis of bare metal stents, so the effect is outstanding. The Endeavor stent not only has outstanding curative effect, but also solves the problem that the drug stent has a higher thrombosis rate than the bare metal stent. It is a drug. Another breakthrough in the stent." Yang Yuejin, vice president of Beijing Fuwai Hospital pointed out.
The Endeavor Stent is the first drug-eluting stent approved by the FDA since 2004. In the analysis of the safety summary data submitted to the FDA, patients with the Endeavor stent showed less than 1% of stent thrombosis within one year after surgery, and the incidence of stent thrombosis was lower in the second to third years. 0.08%. The report also shows the cumulative safety of the 3-year follow-up study: stent thrombosis was 0.7%, myocardial infarction was 2.7%, and cardiogenic death was 1%. The incidence of cardiac death and myocardial infarction in patients with bare metal stents was 6.6%, indicating that Endeavor performed better than bare metal stents in terms of safety performance.
The clinical effectiveness of the Endeavor stent is the same as that of the current mainstream drug-eluting stents in the US market. The Endeavor Stage IV randomized controlled trial reached the primary endpoint compared to the Taxus stent. In terms of primary endpoint target vessel failure rate (TVF), the Endeavor stent was 6.6% at 9 months and the Taxus stent was 7.2%. In all of the lesions analyzed, the results were similar, and the difference in the incidence of target lesion revascularization (TLR) was not statistically significant. Phase II trials showed that Endeavor stents had a TLR incidence of more than 61% at 9 months compared with bare metal stents, and this treatment was sustainable, with a 7.3% reintervention rate throughout the 3-year follow-up study. .
Endeavor uses a cobalt alloy stent that combines a drug that prevents cell growth, Zotarolimus, and a biocompatible polymer PC coating. This polymer mimics the surface of red blood cells and covers the cobalt alloy scaffold. This structure makes the stem of the scaffold extremely smooth and thin, allowing the scaffold to be safely wrapped in the arterial wall to be separated from the blood flow.
——Shanghai Medical Device Industry Association
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