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[TCT2008]ZEST-AMI试验

发布于:2008-10-17 09:46    

ZEST-AMI试验:STEMI中不同的DES在12个月的MACE相近


要点:
      Cypher, Taxus Libertè和Endeavor DES三种洗脱支架对照试验8个月的随访结果。通过比较三种药物洗脱支架发现,在病人PCI初期,Cypher sirolimus比紫杉醇和Endeavor zotarolimus的洗脱支架晚期丢失率和发生在狭窄率低。


      Cheol Whan Lee和他的同事随机选取328名STEMI病人分别置入Cypher (n=110)、Taxus (n=110)或Endeavor (n=108)支架。在八个月的随访中发现,Cypher支架和另外两种支架相比支架内和结段内的晚期丢失率是最低的。

 

 Lee说:“在12个月时,三种支架的MACE末端没有明显的差异(Cypher, 9.1%; Taxus Liberté, 9.1%; and Endeavor, 11%; P=0.804),并且死亡率和MI率也相近。Cypher组、Taxus Liberté组和Endeavor组发生支架血栓的病例数分别为4(3.6%)、3(2.7%)和0(P=0.169),说明Endeavor没有明显的优势。”


      Christian Spaulding说:“必须指出的是,在这样一个小病例模板的条件下,没有得出支架血栓率的结论是很可能的。我不想让人们得出这样一个错误的结论,AMI病人当你选择一种特定类型的支架,就可以降低支架血栓的发生,这是不正确的。AMI病人不论选择哪种类型的支架,支架血栓的发生率都是很高的。”

 

 Lee说:“最初计划选取1482例病人进行这项试验,但是由于随机、前瞻性和单盲试验的人员选取缓慢,所以人员招募在早期就停止了。”

 

(医心评论:朱婧 译 陆卫 校)

 

Key Points:

  • Eight-month follow-up results reported on comparison trial of Cypher, Taxus Libertè and Endeavor DES.

 

By TCT Daily Staff

 

In a comparison of three drug-eluting stents, the Cypher sirolimus-eluting stent demonstrated less late loss and a lower rate of restenosis than the Taxus paclitaxel-eluting or Endeavor zotarolimus-eluting stents in patients undergoing primary PCI.

 

Cheol Whan Lee, MD, PhD, of Asan Medical Center, Seoul, South Korea, and colleagues randomized 328 STEMI patients to receive Cypher (n=110), Taxus (n=110), or Endeavor (n=108). At eight-month follow-up, the Cypher stent had the lowest rate of in-stent and in-segment late loss compared with the other two DES (see Figure).

 

At 12 months, there was no difference in the primary endpoint of MACE among the three stents (Cypher, 9.1%; Taxus Liberté, 9.1%; and Endeavor, 11%; P=.804). Death and recurrent MI rates also were similar at 12 months, Lee said.

 

There were four stent thromboses in the Cypher group (3.6%), three in the Taxus Liberté group (2.7%), and none in the Endeavor group (P=.169), suggesting a nonsignificant trend favoring Endeavor, Lee said.

 

"It’s important to note that no conclusion of stent thrombosis rate is possible in such a small sample," commented Christian Spaulding, MD, PhD, of the cardiology department of Cochin Hospital, Paris Descartes University.

 

"I wouldn’t want people to come out of this room with the wrong message … that if you choose a certain type of stent in an AMI, you can actually reduce stent thrombosis. … Stent thrombosis rates are high in AMI patients regardless of the stent."

 

A sample size of 1,482 was originally planned for the trial, but recruitment was stopped early due to slow enrollment in the randomized, prospective, single blind trial, Lee said.

 

Disclosures:

  • Dr. Lee reports no relevant conflicts of interest.
  • Dr. Spaulding reports receiving grant and research support from the French Health Ministry and receiving consulting fees/honoraria from Cordis, Abbott, Eli Lilly, and Pfizer.

 

(source:www.tctmd.com



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