来自哥伦比亚大学医学中心的Martin B. Leon教授指出，药物释放支架的使用在07年有所下降，而今年的用量则有所回升。Leon说：“在使用数量上已经处于了稳定状态，PCI或诊断性介入的数量的确有所减少，约为10%，但没有继续下滑的趋势。但是，还没有回到业界两年以前的状态和数量。”

Leon的统计显示，诊断性介入检查增加了1.3%，但PCI治疗手术则在2006到2008年间降低了13.1%。另外，药物释放支架的用量从去年起有了少量回升。

他说：“药物释放支架的回升比较温和，特别在美国，但很难达到前期的高峰水平，这一回升主要源于对药物释放支架安全性数据的再确认和近期对死亡率和心梗率数据的披露.”

Leon称从2007年8月到2008年8月，美国药物释放支架的使用量增加了10.5%，类似的，欧洲增加了4.6%。同期，共有22个新型药物释放支架获得了CE认证。那些知名品牌，如雅培的Xience V，Cypher（Cordis），波科的Taxus以及美敦力的Endeavor支架占据了95%的市场，其他品牌只有5%的份额。

Leon还展示了TCTMD医生调查问卷的结果，共有490名来自全球的医生接受了对这四种为美国FDA批准的药物释放支架的调研。结果显示这些医生认为Endeavor（42%）和Cypher（27%）是最安全的。Cypher（60%）支架被认为是最有效的，而Xience V则被认为是传输性最好的（47%）。超过70%的医生称药物释放支架之间也存在巨大的差异，37%希望在未来6个月内能看到更新的产品问世。

报销与保险也在深刻的影响着药物释放支架的使用和市场推广。Leon引用英国国家临床评价研究所（NICE）的标准，即靶血管小于3mm，靶病变长度超过15mm，且药物释放支架与裸支架的价格差未超过300英镑，则可以被报销。

他说：“尽管美国还未接受这一标准，但Medicare和Medicaid应尽早对这些标准进行评估，适应越来越多的人群希望接受药物释放支架治疗的愿望，以给出最经济、最有效的报销策略，并使所有患者受益。”

Soft Rebound in DES Use This Year  

By TCT Daily Staff

The use of DES decreased during 2007, with current trends indicating a soft rebound this year, according to Martin B. Leon, MD, professor of medicine at Columbia University Medical Center and chairman emeritus of the Cardiovascular Research Foundation in New York.

"You can see that things have essentially stabilized, that the hemorrhaging has stopped, and that the reduction we saw — about a 10% absolute reduction in PCI and diagnostic catheterizations — has stabilized," Leon said during this year’s Drug-eluting Stent Summit. "However, we have not fully rebounded to the levels where we were two years ago."

Leon reported a 1.3% increase in diagnostic procedures and a 13.1% decrease in PCI procedures between 2006 and 2008 (see Figure). There was also a slight rebound in market penetration for DES.

"DES penetration has shown a slow-to-moderate rebound, especially in the U.S., but it is unlikely to ever recapture previous peak levels," Leon said. "This rebound is due largely to reassuring DES safety data and especially some of the more recent death and MI data."

Leon reported a 10.5% increase in DES penetration and a 7.1% increase in market penetration from August 2007 to August 2008 in the U.S. This contrasts with a 4.6% increase in Europe, where 22 DES have received CE mark approval and are available.

DES other than Xience V (Abbott Vascular), Cypher (Cordis), Taxus (Boston Scientific), and Endeavor (Medtronic) represent only 5% of the market share.

Leon also presented data from the TCTMD Physician Survey, which asked 490 physicians worldwide about their use of the four currently approved DES on the U.S. market. Survey data indicated that physicians consider the Endeavor (42%) and Cypher (27%) stents the safest. The Cypher (60%) stent was identified as the most efficacious and the Xience V as most deliverable (47%). Over 70% said there are important differences between DES; 37% anticipate additional DES use in their practices within the next six months.

The emerging influence and complexity of reimbursement structures also was identified as a factor in DES use and market penetration in both the U.S. and Europe. Leon cited the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) Final Appraisal Determination as an example. The NICE reimbursement structure allows for reimbursement if the target artery is ,3 mm, the target lesion length is .15 mm, and the price difference between a DES and BMS does not exceed £300.

"Although we have been somewhat impervious to this in the U.S., we are particularly vulnerable and will be in the future as the Centers for Medicare and Medicaid Services adopts an increasing role in trying to regulate the use of medical devices in an attempt to cut costs and provide cost-effective benefits for patients," Leon said.

Disclosures:

• Dr. Leon is on the scientific advisory board of Medtronic Vascular, Abbott Vascular, and Boston Scientific.