Design Criteria for the Ideal Drug-Eluting Stent
Section snippets
Deliverability
Stent deliverability is one of the most under-recognized requirements for intracoronary stent technology4 and as such represents one of the key properties necessary for the ideal DES. Stents can perform their function only after deployment in target lesions. The first-generation DESs, with insufficient deliverability and lesion accessibility of their balloon-expandable delivery systems, may occasionally be limited in providing optimal clinical benefit. The serious procedural complications
Efficacy
The primary objective in the design of first-generation DESs was to decrease the neointimal formation seen with BMSs while maintaining an effective luminal dimension. Were it the case that stent dimensions remained static after deployment, the efficacy of the DES could be measured by the degree of inhibition of neointimal growth. The efficacy of the next-generation DES systems—biodegradable, for example, or based on platforms with thinner struts—may be influenced as well by the degree of
Safety
As clinical experience and longer term follow-up have accumulated, safety has emerged as an important issue with the DES. Several reports have emphasized the possible increase in the frequency of late stent thrombosis,1, 2, 3 occurring >1 year after stent implantation.
Addressed from the perspective of optimizing stent design, safety is a challenging issue. First, there are no established animal models that can reliably predict the safety profile of the DES in humans. Second, the recent
Conclusion
Current approaches to DES development were reviewed in this report. Although first-generation DESs placed great emphasis on efficacy, long-term safety issues have arisen, making the DES stand in an exquisite balance among the occasionally conflicting key properties of deliverability, efficacy, and safety. A careful reexamination of research findings, as well as a redefinition of safe and effective outcomes, will lead future stent technology in the optimal direction. There is no doubt that the
Author Disclosures
The authors who contributed to this article have disclosed the following industry relationships.
Junya Ako, MD, has no financial arrangement or affiliation with a corporate organization or a manufacturer of a product discussed in this supplement.
Heidi N. Bonneau, RN, MS, has received honoraria from Medtronic, Inc. and Boston Scientific.
Peter J. Fitzgerald, MD, PhD, has served as a consultant for Cordis Corporation, Boston Scientific, Abbott Vascular, Medtronic, Inc., CardioMind, Inc., REVA
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Statement of author disclosure: Please see the Author Disclosures section at the end of this article.