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在糖尿病患者中TAXUS支架的再次干预率更低
Natick, MA and Chicago IL （2006年11月14日）今天，波士顿科学公司（NYSE: BSX）迎来了Joost Daemen博士和Patrick Serruys博士所作的一项报告，题为“雷帕霉素洗脱支架（SES）和紫杉醇洗脱支架（PES）与金属裸支架（BMS）相比较在糖尿病患者中的长期疗效”。报告的相关数据来自T-SEARCH/RESEARCH研究，一项由荷兰鹿特丹Erasmus大学医疗中心Thoraxcenter进行的、包含了708例患者的现实世界注册研究。研究结果显示，与Cypher®支架（SES）和金属裸支架（BMS）相比，TAXUS®支架（PES）的再次干预率更低，死亡或心脏性死亡率相同或者更低。该结果是在芝加哥举行的美国心脏协会（AHA）2006年年会科学研讨会上公布的。
该研究2年的结果显示，在靶血管血运重建（TVR）和主要不良心脏事件（MACE）发生率方面，TAXUS支架都要优于Cypher支架和BMS。TAXUS支架的2年TVR发生率为9.7％，而Cypher支架和BMS分别为15.3％（PES比SES，p=0.06）和19.5％（PES比BMS，p=0.0034）。Cypher支架和BMS的TVR发生率无显著差异（SES比BMS，p=0.97）。TAXUS支架的2年MACE发生率为21.2％，而Cypher支架和BMS分别为28.9％（PES比SES，p=0.058）和29.7％（PES比BMS，p=0.04）。报告者总结说，研究中的MACE数据显示在该研究的患者群中，SES与BMS相比并无益处，而PES则具有更好的TVR结果。.
2年累积死亡率在3种不同的支架组间是可比的，TAXUS支架为11.5％，Cypher支架为13.3％，BMS为9.8％。TAXUS支架的2年支架内血栓发生率低于Cypher支架（2.4％比4.4％），但未达到显著性差异（p=0.29）。BMS的支架内血栓发生率为0.8％，与TAXUS支架无显著性差异（p=0.18）。而Cypher支架的2年支架内血栓发生率则明显高于BMS（p=0.015）。
“该研究为TAXUS支架在糖尿病患者中的优异表现提供了进一步的资料，使得在这类难治性患者群中的TAXUS支架数据更加完善”，波士顿科学的首席执行官Paul LaViolette说道，“这一结果十分引人注目，因为这代表了多支血管复杂病变——现实世界中医生们每天都在治疗的一类病变。 我们很高兴地看到研究结果证实了TAXUS支架的安全性能与金属裸支架相似或者更好。”
糖尿病患者的长期并发症比一般的心脏介入治疗患者要来得多，在对支架总体性能进行评价时，从合并糖尿病的心脏病患者中得出的结论更值得关注。目前，这类重要的并不断增长的糖尿病患者群占全美所有冠状动脉介入治疗患者的四分之一。
目前，波士顿公司正在收集相关的临床资料，用以支持向美国食品和药品管理局递交的一份有关进一步扩大TAXUS支架在美国使用适应证的申请，希望将糖尿病患者纳入其中。TAXUS Express™支架的安全性和有效性在糖尿病患者中尚未得到确认。
STUDY FAVORS TAXUS® STENT OVER CYPHER® STENT AND BARE-METAL STENTS IN DIABETIC PATIENTS
Lower re-intervention rates for the TAXUS Stent in diabetic patients
Natick, MA and Chicago IL (November 14, 2006) – Boston Scientific Corporation (NYSE: BSX) today welcomed a presentation by Joost Daemen, M.D., and Patrick Serruys, M.D., entitled “The Long Term Efficacy of Sirolimus-eluting (SES) and Paclitaxel-eluting stents (PES) as Compared to Bare Metal Stents (BMS) in Patients With Diabetes Mellitus.” Data were presented from the T-SEARCH/RESEARCH study, a 708-patient, real-world registry managed from the Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands. The study reports that the TAXUS® Stent (PES) exhibited a lower re-intervention rate and equal or lower instances of death or heart attack than the Cypher® Stent (SES) and bare-metal stents (BMS). The data were presented at the annual American Heart Association (AHA) Scientific Sessions in Chicago.
The study reported two-year results, which trended in favor of the TAXUS Stent compared to the Cypher Stent and BMS in both target vessel revascularization (TVR) and major adverse cardiac events (MACE) rates. The TVR rate for the TAXUS Stent was 9.7 percent compared to 15.3 percent for the Cypher Stent (p=0.06) and 19.5 percent for BMS (p=0.0034). Rates of TVR for the Cypher Stent and BMS were comparable (p=0.97). The study also reported rates of MACE with the TAXUS Stent of 21.2 percent compared to 28.9 percent for the Cypher Stent (p=0.058 PES vs. SES) and 29.7 percent for BMS (p=0.04 PES vs. BMS). The presenter concluded that the MACE data showed no benefit to SES as compared to BMS in the study’s patient population, and that there was a trend toward better TVR outcomes with PES.
Two-year cumulative incidence of mortality was comparable among the three stent groups, with rates of 11.5 percent for the TAXUS Stent, 13.3 percent for the Cypher Stent and 9.8 percent for BMS. The two-year stent thrombosis rate for the TAXUS Stent was lower than that of the Cypher Stent (2.4 percent versus 4.4 percent), however, the difference was not statistically significant (p=0.29). Stent thrombosis for BMS was 0.8 percent, which was not significantly different from TAXUS (p=0.18). Stent thrombosis for Cypher at two years was significantly higher compared to BMS (p=0.015).
“This study provides further insight into the strong performance of the TAXUS Stent in diabetic patients and adds to the growing body of TAXUS Stent data in this difficult-to-treat patient population,” said Paul LaViolette, Chief Operating Officer of Boston Scientific. “These results are particularly compelling because they represent patients with multiple complexities, the kind physicians treat every day in real-world settings. We are also pleased that the data demonstrated that the safety profile of the TAXUS Stent was comparable to -- or better than -- that of bare-metal stents.”
Diabetic patients generally have more long-term complications than interventional cardiology patients as a whole, making results in diabetic patients with heart disease worthy of note when evaluating overall stent performance. The important and growing diabetic patient subset accounts for more than one-quarter of all coronary interventional procedures in the United States.
The Company is currently sponsoring the collection of clinical data to support an application to the U.S. Food and Drug Administration to expand the TAXUS Stent’s labeled indications for use in the United States to include diabetic patients. The safety and effectiveness of the TAXUS Express™ Stent have not been established in patients with diabetes.