SORT OUT II研究18个月结果显示：Cypher 和Taxus支架无明显差别

Cypher and Taxus stents seemingly equivalent: 18-month results from SORT OUT II

　　SORT OUT II 研究18个月随访结果显示，对于急性心肌梗死，非ST段抬高型心肌梗死，稳定/不稳定型心绞痛患者，应用Cypher雷帕霉素和Taxus紫杉醇药物洗脱支架治疗，结果没有差别。研究者所入选的患者代表了丹麦行PCI术的患者，由于应用这两种支架的不良事件发生率低，说明药物洗脱支架对一般患者来说是安全的。

　　但是Anders M Galløe医生(丹麦，哥本哈根Gentofte医院)和同事们也承认，由于研究设计的不足，许多患者的主要心脏不良事件率（MACE）低于预期，明显限制了对这两组支架实际差别的研究。这些患者是从丹麦接受PCI治疗的患者中随机挑选出的，1065例患者进行CYPHER治疗，1033名患者进行TAXUS治疗。

　　SORT OUT II试验所示Cypher 和Taxus相同，“可能是由于临床实践中忽略了有效性和安全性的差异，但是也可能是因为研究力量不足”作者说道。

　　SORT OUT II 研究9个月结果在TCT2006公布，由heartwire报道。18个月结果在2008年1月30日JAMA发表。

　　18个月主要复合终点，包括心源性死亡，急性心肌梗死，靶病变重建（TLR）或靶血管重建（TVR），两组没有差别。分别对每位患者的临床终点、全因死亡率和支架血栓进行评估，Cypher 和Taxus治疗无差别。

　　SORT OUT II ：18个月结果

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终点 　　　　　　　　　　　　　Cypher  　　　　　　　Taxus  　　　　　　　　p

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主要心脏不良事件 　　　　　　　　10.0 　　　　　　　　11.6 　　　　　　　　0.21
心源性死亡 　　　　　　　　　　　1.7 　　　　　　　　　1.5　　　　　　　　 0.80
急性心肌梗死 　　　　　　　　　　4.2　　　　　　　　　 5.1　　　　　　　　 0.32
靶病变重建（TLR） 　　　　　　　4.5 　　　　　　　　　5.9　　　　　　　　 0.14
靶血管重建（TVR）　　　　　　　6.6 　　　　　　　　　7.8 　　　　　　　　0.25
全因死亡率　　　　　　　　　　　 3.8 　　　　　　　　　3.9 　　　　　　　　0.97
* 支架血栓率　　　　　　　　　　2.6 　　　　　　　　　2.8 　　　　　　　　0.70

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 * 根据学术研究协会的定义，明确或可能的

　　在随刊评论中，Debabrata Mukherjee 和David Moliterno医生（ Lexington，Kentucky大学）指出，有关DES安全性和有效性讨论的文献日益增多，令人困惑，Galløe等人应该“增加研究的确定性和相关性”。他们也指出SORT OUT II的几个局限：第一，从12 000例行PCI患者中挑选2100例患者，可能产生入选误差。其次，研究力量不足会掩盖两种支架的真正不同，因为至少在TLR方面，研究的绝对结果支持Cypher支架。第三，支架血栓率2.5%-2.9%，高于其他药物洗脱支架分析与研究的相关结果。

　　（刘瑞琦　编译　付世娜　审校）

　　（来源：www.theheart.org）

Cypher and Taxus stents seemingly equivalent: 18-month results from SORT OUT II

January 29, 2008 
Shelley Wood

Copenhagen, Denmark- Eighteen months of follow-up for patients participating in the SORT OUT II trial continue to show no differences in outcomes for patients treated with the Cypher sirolimus- or Taxus paclitaxel-eluting stent for AMI, non-ST elevation MI, or stable/unstable angina [1]. Authors say the patients represent a cross-section　of the Danish population undergoing PCI and, given the low rates of adverse events with both stents, say that drug-eluting stents (DES) are safe for the "general population."

But Dr Anders M Galløe (Gentofte Hospital, Copenhagen, Denmark) and colleagues also acknowledge that the patients in the study, designed with a study power of 80%, had many fewer major adverse cardiac events (MACE) than anticipated, significantly limiting the ability of the study to identify any true differences between the two stents. In all, 1065 patients were randomized to the Cypher stent and 1033 were randomized to the Taxus, but patients were selected for randomization from the almost-12 000 patients undergoing PCI in Denmark during the study period.

The equivalence seen between the Cypher and Taxus stents in SORT OUT II "may have resulted from a truly negligible difference in the effectiveness and safety of the stents in everyday clinical practice, but it also may be due to insufficient study power," the authors write.

Nine-month results from SORT OUT II were first presented at the TCT 2006 meeting, as reported by heartwire. The 18-month results are now published in the January 30, 2008 issue of the Journal of the American Medical Association.

Sorting out SORT OUT II

At 18 months, the primary composite end point, made up of cardiac death, AMI, target lesion revascularization (TLR) or target vessel revascularization (TVR), was no different between the two groups. Each of these individual end points evaluated separately, as well as all-cause death and stent thrombosis, were also no different between Cypher- and Taxus-treated patients.

SORT OUT II: 18-month outcomes
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End point 　　　　　　　　 Cypher  　　　Taxus 　　　　　　 p

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MACE 　　　　　　　　　　　10.0 　　　　11.6 　　　　　0.21
Cardiac death 　　　　　　　　1.7 　　　　1.5 　　　　　0.80
AMI 　　　　　　　　　　　　4.2 　　　　　5.1　　　　　 0.32
TLR 　　　　　　　　　　　　 4.5　　　　 5.9 　　　　　0.14
TVR 　　　　 　　　　　　　　6.6　　　　 7.8 　　　　　0.25
All-cause death　　  　　　　　3.8　　　　 3.9 　　　　　0.97
Stent thrombosis* 　　 　　　　2.6 　　　　2.8 　　　　　0.70

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*Definite or probable, by Academic Research Consortium definition

In an accompanying editorial, Drs Debabrata Mukherjee and David Moliterno (University of Kentucky, Lexington) state that Galløe et al’s study should "add clarity and relevance" in an increasingly confusing body of literature dealing with DES safety and efficacy [2]. But they also point to several limitations of SORT OUT II. For one, randomization of just 2100 patients out of 12 000 PCI-treated patients points to some type of unintended selection bias among physicians in Denmark. Second, the underpowered study may have masked　true differences between the two stent types, since absolute results numerically favored the Cypher stent, at least in terms of TLR. Third, the stent-thrombosis rates, at 2.5% to 2.9%, were somewhat higher than those seen in other DES analyses and trials.