ENDEAVOR IV: 2年时Taxus、Endeavor的TLR, TVR 率相似

ENDEAVOR IV: TLR, TVR Rates Similar Between Taxus, Endeavor at Two Years

ENDEAVOR IV研究显示，靶病变血运重建（TLR）和靶血管血运重建(TVR)在Endeavor支架和Taxus支架间具有可比性，而Endeavor的MI率更低。哥伦比亚大学医学中心、CRF主席Martin B. Leon教授在周二说，两种支架的TLR和TVR率相似，即使是再狭窄高风险的患者（如糖尿病患者）也是如此。

ENDEAVOR试验

ENDEAVOR IV试验从美国80个中心入选1548名单支原发冠脉病变患者。患者随机分组置入ENDEAVOR支架或者Taxus支架。随访24个月后，全因死亡、心性死亡、支架血栓、主要不良心脏事件，TVR和TLR率，两组都相等。而ENDEAVOR组患者由于非Q波心梗降低其MI率较低。

与Taxus紫杉醇洗脱支架相比，Zotarolimus洗脱支架ENDEAVOR可以降低极晚期支架血栓风险（事件发生率6：1，P=0.0690）。这些安全数据的发现与更大型ENDEAVOR试验综合分析相一致，Leon说。

需要进行更大规模的试验

克里夫兰医院的Stephen Ellis教授，提出了其他关于ENDEAVOR IV结果的观点。Ellis说需要进行入选更多患者的更大型试验，来更好地分析ENDEAVOR Zotarolimus洗脱支架的有效性和安全性。尽管12～14个月随访期间，ENDEAVOR洗脱支架支架血栓率似乎比Taxus更低，但是这些差别在6～12个月随访期间并不明显。

“我们仍然不清楚双重抗血小板药物治疗的最佳持续时间，”Ellis说，“虽然可以去判断一个患者是否能服用一个月以上的氯吡格雷，但不容易判断患者能否持续服用6到12个月以上。ENDEAVOR可能更适合需要在6个月后停用氯吡格雷的患者。”

（《医心评论》编辑 刘瑞琦 翻译 马秀芹 校对）

（来源：www.tctmd.com）

ENDEAVOR IV: TLR, TVR Rates Similar Between Taxus, Endeavor at Two Years 
   
Key Points:

Risk of MI and very late stent thrombosis lower in patients treated with the Endeavor stent.

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By TCT Daily Staff

Two-year results from the ENDEAVOR IV study show that rates of target lesion revascularization and target vessel revascularization are comparable between the Endeavor and Taxus stents, while rates of MI are lower with Endeavor.

Martin B. Leon, MD, from Columbia University Medical Center and chairman emeritus of the Cardiovascular Research Foundation in New York, said Tuesday that the similar rates of TLR and TVR between the two DES were observed even in patients with high restenosis risk, such as those with diabetes.

ENDEAVOR trial

The ENDEAVOR IV trial included 1,548 patients with single de novo coronary lesions at 80 sites in the United States. Patients were randomized to treatment with either an Endeavor or Taxus stent.

After 24 months of follow-up, all-cause mortality, cardiac mortality, stent thrombosis, major adverse cardiac events, TVR, and TLR were all equivalent between the two groups, while MI occurred in fewer Endeavor patients, driven by a reduction in non-Q-wave MI (see Figure).

The Endeavor zotarolimus-eluting stent was associated with a reduced risk of very late stent thrombosis when compared with the Taxus paclitaxel-eluting stent (one vs. six events, respectively; P=.069). These safety findings were consistent with the larger pooled analysis of Endeavor studies, Leon said.

Larger trials needed

Stephen Ellis, MD, from The Cleveland Clinic, provided additional perspective about the ENDEAVOR IV results. Ellis said larger studies with more patients are needed to better analyze the efficacy and safety of the Endeavor zotarolimus-eluting stent. Although stent thrombosis rates with Endeavor stents seemed lower than with Taxus in the12- to 24-month follow-up period, these differences were not apparent in the six- to 12-month follow-up.

"We still don’t know optimal duration of dual antiplatelet treatment for first generation DES," Ellis said. "While it may be reasonable to judge if a patient can or cannot take clopidogrel for more than one month, it is more difficult to judge if they can take it for more than six to 12 months. Endeavor may be preferred for patients who may need to stop clopidogrel after six months."

Disclosures:

Dr. Leon reports that he has held positions on the scientific advisory boards of Abbott, Boston Scientific, and Medtronic.
Dr. Ellis reports that he has been a paid consultant for Abbott, Boston Scientific, and Cordis.
 
（source：www.tctmd.com）