Minneapolis Heart Institute and Foundation, 920 E. 28th Street, Suite 600, Minneapolis, MN 55407.
Circ Cardiovasc Interv. 2008 Oct;1(2):143-53. doi: 10.1161/CIRCINTERVENTIONS.108.789974.
Coronary drug-eluting stents are commonplace in clinical practice with acceptable safety and efficacy. Preclinical evaluation of novel drug-eluting stent technologies has great importance for understanding safety and possibly efficacy of these technologies, and well-defined preclinical testing methods clearly benefit multiple communities within the developmental, testing, and clinical evaluation chain. An earlier consensus publication enjoyed widespread adoption but is in need of updating. This publication is an update, presenting an integrated view for testing drug-eluting technologies in preclinical models, including novel devices such as bioabsorbable coatings, totally bioabsorbable stents, bifurcation stents, and stent-free balloon-based drug delivery. This consensus document was produced by preclinical and translational scientists and investigators engaged in interventional technology community. The United States Food and Drug Administration (USFDA) recently issued a Draft Guidance for Industry Document for Drug-Eluting Stents. This expert consensus document is consistent with the Food and Drug Administration guidance. The dynamic nature of this field mandates future modifications and additions that will be added over time.
冠状动脉药物洗脱支架在临床实践中已广泛应用，其安全性和疗效得到了认可。新型药物洗脱支架技术的临床前评估对于了解这些技术的安全性和可能的疗效具有重要意义，明确的临床前测试方法显然使研发、测试和临床评估链中的多个领域受益。之前的共识文件得到了广泛采用，但需要更新。本出版物是对该共识文件的更新，为药物洗脱技术在临床前模型中的测试提供了综合观点，包括生物可吸收涂层等新型器械、完全生物可吸收支架、分叉支架和无支架球囊药物输送。本共识文件由从事介入技术研究的临床前和转化科学家及研究人员共同撰写。美国食品和药物管理局（FDA）最近发布了一份《药物洗脱支架行业指南草案》。本专家共识文件与 FDA 指南一致。该领域的动态性质要求随着时间的推移进行未来的修改和补充。
