ENDEAVOR IV: No Difference in TVF　Between Endeavor And Taxus

　　ENDEAVOR支架与TAXUS支架相比，二者有相似的死亡率和靶血管重建率（TVF）。

　　ENDEAVOR IV试验的最新结果表明：ENDEAVOR zotarolimuse药物洗脱支架与TAXUS紫杉醇药物洗脱支架在总的死亡率、心肌梗死发生率、靶血管重建率上没有差别。

　　ENDEAVOR支架置入后30天非Q波心肌梗死发生率明显低于TAXUS组，但8个月造影晚期管腔丢失要高于后者。  支架置入后9个月临床随访，主要终点TVF ENDEAVER支架组与TAXUS支架组分别为6.6%和7.2%，二者无统计学差别，这一结果一直持续到12个月（图 1）。

 　　与TAXUS支架组相比，Endeavor支架组在支架置入后30天心肌梗死发生率（0.8% vs. 2.3%）、非Q波心肌梗死(0.5% vs. 2.2%)及MACE发生率(1.2% vs. 3%)均明显低于后者。但在支架置入后9个月在死亡、支架内血栓、靶病变重建（TLR）和靶血管重建（TVR）两组没有统计学差别，支架置入后12个月时死亡和心肌梗死二组结果相似。但8个月造影随访，Endeavor组支架内晚期管腔丢失高于TAXUS组（图 2）。

 
　　大约30％入选ENDEAVOR IV试验的患者合并有糖尿病。研究者对这些患者进行了亚组分析。12个月临床随访两组TVF没有明显差别，分别为8.6%（Endeavor）和10.8%（TAXUS）。而TLR无论是否合并糖尿病两组均无差别。

　　Endeavor支架是更安全的支架

　　CRF主席Gregg Stone医生在先前的报告中指出：围绕DES支架内血栓问题的讨论已经日趋冷静，但是对更安全的支架的需求是永无止境的。

　　CRF名誉主席Martin Leon医生报道了ENDEAVOR IV的结果，他指出Endeavor支架的设计更安全。荷兰的Patrick Serruys医生针对Leon医生的演讲进行讨论时说，他所担心的是Edeavor支架节段内晚期管腔丢失的问题，是否节段内晚期管腔丢失在高危患者中也不差于TAXUS支架，这是一个有待证实的问题。”

　　ENDEAVOR IV试验仅是一项临床试验中的一部分，该试验包括25619例患者，而其中1548例患者随机分到Endeavor和TAXUS支架组。

　　（阜外心血管病医院 高立建 编译   陈纪林审校）

　　（医心网为独家授权网站，转载请注明出自医心网）

ENDEAVOR IV: No Difference in TVF　Between Endeavor And Taxus

Endeavor stent also had a similar mortality and　repeat procedure rate compared with Taxus.

Late-breaking results from the ENDEAVOR IV trial showed a similar overall clinical efficacy with equivalent rates of mortality, MI and repeat procedures between the Endeavor zotarolimuseluting stent and the Taxus paclitaxel-eluting stent.

In addition, Endeavor (Medtronic) showed a lower rate of non-Q-wave MI at 30 days, but a higher rate of angiographic late loss at eight months compared with Taxus (Boston Scientific).

At nine months, TVF was 6.6% with Endeavor and 7.2% with Taxus, which was statistically significant for noninferiority, meeting the study’s primary endpoint. At 12 months, TVF with Endeavor was still noninferior to that of Taxus

Treatment with Endeavor was associated with a lower rate of MI at 30 days (0.8% vs. 2.3%) driven by a significant reduction in non-Q-wave MI (0.5% vs. 2.2%). This reduction contributed to a significant difference in major adverse cardiac events at 30 days (1.2% vs. 3%), but there was no significant difference in death, stent thrombosis, TLR and TVR. By nine months, the differences in death and MI were not statistically significant, with similar findings at 12 months.

However, in the cohort of patients assigned to routine angiographic follow-up, several angiographic parameters including in-stent late loss were worse with Endeavor than with Taxus at 8 months (Figure 2).

Approximately 30% of the patients in ENDEAVOR IV had diabetes, and researchers performed a subgroup analysis of these patients. TVF in this patient population at 12 months was 8.6% with Endeavor and 10.8% with the Taxus stent, a non-significant difference.

TLR was not statistically different in Endeavor- vs. Taxus-treated patients, whether they were diabetic or not.
Toward a safer stent

In a presentation prior to the ENDEAVOR IV trial, Gregg Stone, MD, chairman of the Cardiovascular Research Foundation, said the firestorm surrounding DES and thrombosis is only now starting to abate, and the need for a safer stent has never been greater.

Martin Leon, MD, chairman emeritus of CRF, who presented the results of ENDEAVOR IV, said the Endeavor stent was designed for safety.

In a comment period following Leon’s presentation, Patrick Serruys, MD, professor of interventional cardiology at Erasmus University, said he was concerned about the rate of in-segment late loss.

“My concern is whether the failure of Endeavor IV to meet the noninferiority secondary endpoint of in-segment late loss may become even more evident in a high-risk patient cohort, but this has yet to be demonstrated,” Serruys said.

The ENDEAVOR IV trial was part of a clinical trial program that now includes 25,619 patients. The study enrolled 1,548 patients and randomly assigned them to either Endeavor or Taxus.