The low profile stent is designed to minimize damage to the vessel wall during interventional procedures. This type of stent has a smaller outer diameter and cross-sectional area, making it easier to navigate through narrow or small blood vessels, thereby reducing surgical trauma and the risk of complications. The purpose of the ZEPHYR registry study is to evaluate the mid-term therapeutic effects and safety of the low profile Zenith Alpha stent in a real-world clinical setting. The 2-year results were published online on March 13, 2024, in the European Journal of Vascular & Endovascular Surgery journal website[1].Clinic门诊Endovascular
Research MethodsThe ZEPHYR registry study is a physician-initiated, multicenter, non-randomized, core laboratory-controlled prospective registry study. Inclusion criteria were patients with non-ruptured abdominal aortic aneurysms with a maximum diameter of ≥50 mm or an increase of more than 5 mm within 6 months, and a reported infrarenal aortic neck length of ≥10 mm, who intended to selectively implant the Zenith Alpha abdominal aortic stent. The study included patients from 14 centers in Germany, Belgium, and the Netherlands. The primary endpoint was treatment success, defined as both technical success and clinical success. Technical success was defined as successful delivery and deployment of the stent to the intended position without inadvertently covering the iliac or renal arteries, and successful removal of the delivery system. Clinical success was defined as no aneurysm sac enlargement greater than 5 mm, no type I or III endoleaks, no aneurysm rupture, no stent migration greater than 10 mm, no conversion to open surgery, and no stent occlusion.
Research Results
A total of 347 patients were included in the ZEPHYR registry study. The median clinical follow-up time was 743 days (IQR 657–806 days), and the median imaging follow-up time was 725 days (IQR 408–788 days). The treatment success rates at 6 months, 1 year, and 2 years were 92.5%, 90.4%, and 85.3%, respectively. The rates of freedom from reintervention were 94.3%, 93.4%, and 86.9%, respectively. The main reason for reintervention was limb complications. The rates of freedom from limb occlusion (per patient) at 6 months, 1 year, and 2 years were 97.2%, 95.8%, and 92.5%, respectively. Univariate and multivariate Cox regression analyses failed to identify any independent predictors of limb complications.Conclusion
Although the treatment success rate of the Zenith Alpha stent is similar to that of other commercially available stents, the incidence of limb complications within two years is concerning. Strict adherence to the instructions for use is necessary. Further research is needed to explore the underlying reasons for the increased incidence of limb complications associated with the Zenith Alpha stent.
References
[1] Hatzl J, van Basten Batenburg M, Yeung KK, Fioole B, Verhoeven E, Lauwers G, Kölbel T, Wever JJ, Scheinert D, Van den Eynde W, Rouhani G, Mees BME, Vermassen F, Schelzig H, Böckler D, Cuypers PWM, ZEPHYR Study Group Collaborators Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry, European Journal of Vascular & Endovascular Surgery (2024), doi: https://doi.org/10.1016/j.ejvs.2024.03.004.
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