ISAR-LEFT MAIN研究提示：治疗UPLM病变，Taxus与Cypher之间并无统计学差异

ISAR-LEFT MAIN: Taxus Noninferior to Cypher

      来自德国慕尼黑Technische大学内科的Julinda Mehilli副教授汇报的ISAR-LEFT MAIN研究2年随访结果显示：Taxus支架组TLR为9.2%，Cypher组为10.7%，P=0.47,在全因死亡，MI和再次介入率上两组差异无显著性 (RR=0.99; 95% CI, 0.69-1.42)。并且随访2年间，支架内血栓发生率都非常低，Taxus组明确的支架内血栓比例为0.3%，可能的支架内血栓比例为0，Cypher组这一比例分别为0.7%和0.3%；两组在死亡率上无统计学差异（见图1）

      ISAR-LEFT MAIN研究入选条件是：患者有缺血症状或者心肌缺血指征且病变部位狭窄程度在50%以上，入选患者中，有302例患者置入了Taxus支架，305例患者置入Cypher支架。

1年随访结果：
在主要联合终点MACE（含死亡、MI、中风和TLR）Taxus支架组与Cypher支架相比并无统计学差异（13.6% vs. 15.8%, RR=0.85; 95% CI, 0.56-1.29; P=0.001，在非劣效性上），死亡率、MI和中风亦无统计学差异，分别为（5.0% vs. 6.6%， P=0.39）、（ 5.0% vs. 4.6%，P=0.83）、（1.7% vs. 1.0%； P=0.47）；死亡联合MI (Taxus, 8.7% vs. Cypher, 9.5%； P=0.71)以及死亡+MI+中风 (Taxus, 9.6% vs. Cypher 10.2%; P=0.83)比例相似，次要终点（造影再狭窄率）为(Taxus, 9.2% vs. Cypher, 10.7%; P=0.47).

Mehilli说：“2年随访结果证实，对UPLM患者置入DES是可行的，并且安全而有效，无论是Cypher支架还是Taxus支架，其临床疗效和造影结果相似。”

    瑞士著名心脏介入学家Stephan Windecker教授说：“在ISAR-LEFT MAIN研究中支架内血栓发生率与其它研究相似。（见图2）研究中得出Taxus和Cypher支架相似的临床结果，我们应该对研究者表示祝贺。除此之外，该研究还表现了良好的短期安全性。”

（《医心评论》编辑 马秀芹 翻译 朱婧 校对）

（来源：www.tctmd.com）

ISAR-LEFT MAIN: Taxus Noninferior to Cypher       
 
By TCT Daily Staff

The Taxus paclitaxel-eluting stent was noninferior to the Cypher sirolimus-eluting stent in patients with unprotected left main coronary artery lesions according to two-year results reported from in the ISAR-LEFT MAIN trial Tuesday.

Julinda Mehilli, MD, associate professor of medicine at Technische Universität Munich in Germany, reported that two-year TLR was 9.2% in the Taxus group and 10.7% in the Cypher group (P=.47). Two-year follow-up of the composite of death, MI, or reintervention was comparable between treatment groups (RR=0.99; 95% CI, 0.69-1.42).

Two-year stent thrombosis rates were low overall for both Taxus (0.3% definite stent thrombosis, 0.0% probable stent thrombosis) and Cypher (0.7% definite stent thrombosis, 0.3% probable stent thrombosis).

Two-year mortality also was comparable between the Taxus and Cypher cohorts (see Figure 1).

Patients were included in ISAR-LEFT MAIN if they had ischemic symptoms or evidence of myocardial ischemia in the presence of >50% stenosis located in unprotected left main lesions. Three hundred and two patients received a Taxus stent and 305 received a Cypher stent.

One-year follow-up

Taxus was noninferior to Cypher at one year for the primary composite endpoint of MACE including death, MI, stroke, and TLR (13.6% vs. 15.8%, RR=0.85; 95% CI, 0.56-1.29; P,.001 for non-inferiority). One-year clinical outcomes for death (Taxus, 5.0% vs. Cypher, 6.6%; P=.39); MI (Taxus, 5.0% vs. Cypher, 4.6%; P=.83); and stroke (Taxus, 1.7% vs. Cypher, 1.0%; P=.47) were comparable between treatment groups.

One-year composites of death and MI (Taxus, 8.7% vs. Cypher, 9.5%; P=.71) and death, MI, and stroke (Taxus, 9.6% vs. Cypher 10.2%; P=.83) were similar, as was the secondary endpoint of angiographic restenosis (Taxus, 9.2% vs. Cypher, 10.7%; P=.47).

"Treatment of unprotected left main coronary artery lesions in unselected patients with DES is feasible, safe and effective for up to two years," Mehilli said. "Both Taxus and Cypher stents provide similar clinical and angiographic outcomes in this form of coronary artery disease."

Stephan Windecker, MD, professor of invasive cardiology at University Hospital in Bern, Switzerland, said that stent thrombosis rates in ISAR-LEFT MAIN are comparable to other trials and registries (see Figure 2).

"The investigators should be congratulated for having established noninferiority between Taxus and Cypher in this trial," Windecker said. "The trial, in addition, shows very favorable short-term safety."

Disclosures:

Dr. Mehilli reports no relevant conflicts of interest.
Dr. Windecker reports receiving consulting fees and honoraria from Abbott Vascular, Biotronik, Biosensors, Boston Scientific Corporation, Johnson & Johnson, and Medtronic.

（source：www.tctmd.com）