资料显示，与非糖尿病患者相比，糖尿病患者在Taxus组和CABG组的死亡率均显著增高

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根据周二报告的SYNTAX研究亚组分析资料，在糖尿病患者中，使用TAXUS进行经皮冠状动脉介入治疗较CABG有较高的主要不良心脏和脑血管事件（MACCE），主要是由于再次血运重建率的增高。

Keith D. Dawkins报告了SYNTAX研究中使用药物治疗的糖尿病患者随机接受CABG或TAXUS的12月结果。

波士顿科学公司（Boston Scientific Corporation）的Dawkins表示，研究发现植入TAXUS是糖尿病(HR=2.72; P<.001)和非糖尿病(HR=1.46; P=.03)患者发生MACCE的有意义的预测因素。

SYNTAX研究中511例患者有糖尿病，在这些患者中，452例接受药物治疗者进行了亚组分析。在这组患者中，57％有代谢综合征，48％的患者HbA1c>7%。另外，71％的接受药物治疗的糖尿病患者有三支血管病变，29％有不同程度的左主干病变，而无糖尿病的患者中64.1％有三支血管病变，35.9％有左主干病变。

1年的临床结果

1年时，接受药物治疗的糖尿病患者植入TAXUS者26％发生MACCE,而接受CABG者MACCE的发生率为14.2％（p=0.003）。研究者报道在非糖尿病患者中，TAXUS组和CABG组MACCE的发生率差异无统计学意义(15.1% 比11.8%; P=.08)。

Dawkins表示，“无糖尿病的患者较糖尿病患者的MACCE发生率低，但糖尿病患者中发生MACCE的量不成比例，主要是由于再次血运重建率的增加”（见表1）

任何血管的再次血运重建率在接受TAXUS治疗的糖尿病患者中（20.3％）高于接受CABG治疗者（11.1％；P<.001）。在CABG组，糖尿病患者和非糖尿病患者的再次血运重建率是相似的（糖尿病患者，6.4％；非糖尿病患者5.7％；P＝0.74）。

无论哪种治疗方法，糖尿病和非糖尿病患者死亡/CVA/MI的发生率是相似的（图2）。

据Dawkins表示，SYNTAX资料提示与无糖尿病的患者相比，CABG组和TAXUS组的糖尿病患者的死亡率均是显著增高的。

TAXUS组中药物治疗的糖尿病患者的全因死亡率高于非糖尿病患者（8.4%比3.0%; P<.001）

糖尿病治疗的影响

SYNTAX研究者还报告了使用不同类型的糖尿病药物者的临床结果

在452例接受药物治疗的糖尿病患者中，270例使用口服药物（CABG组128例，TAXUS组142例），182使用胰岛素（CABG组93例，TAXUS组89例）

Dawkins表示，在胰岛素依赖的糖尿病患者中，较CABG组相比，1年随访TAXUS组有较高的再次血运重建发生率（20.5％比9.2％，P=0.04）、死亡/CVA/MI（14.8％比8％；P=0.16）和全因死亡（12.5％比5.7％，P=0.12）。另外，胰岛素治疗组的死亡/CVA/MI（14.8％）和全因死亡（12.5％）高于口服降糖药组（分别为7.2％和5.8％）。

信息披露：
 
• Dawkins报告他是波士顿科学公司的雇员和股票持有者

SYNTAX: Increased MACCE Driven by Revascularization in Patients with Diabetes 

Key Points:

• Data reveal significantly increased mortality compared with nondiabetics with both Taxus and CABG.

By TCT Daily Staff

Percutaneous coronary intervention with the Taxus stent is associated with higher rates of major adverse cardiac and cerebrovascular events than CABG in patients with diabetes, driven mainly by higher revascularization rates, according to data from a SYNTAX subanalysis presented Tuesday.

Keith D. Dawkins, MD, presented 12-month outcome data on a subgroup of SYNTAX patients with medically treated diabetes who were randomized to CABG or Taxus.

Taxus implantation was found to be a significant predictor of MACCE in both diabetic (HR=2.72; P<.001) and nondiabetic patients (HR=1.46; P=.03), said Dawkins, of Boston Scientific Corporation.

A total of 511 patients in SYNTAX had diabetes. Of those, 452 were medically treated and were the focus of the subset analysis. Among that group, 57% had metabolic syndrome and 48% had HbA1c >7%. Additionally, 71% of patients with medically treated diabetes had three-vessel disease and 29% had any degree of left main disease, compared with 64.1% and 35.9% of patients without diabetes, respectively.

One-year outcome data

At one year, 26% of patients with medically treated diabetes assigned to Taxus had MACCE, compared with 14.2% of those assigned to CABG (P=.003). The researchers reported a nonsignificant difference in MACCE with Taxus compared with CABG in nondiabetic patients (15.1% vs. 11.8%; P=.08).

"MACCE in the nondiabetic was lower than in the diabetic. But in the diabetic patient there was a disproportionate amount of MACCE, which was driven by revascularization," Dawkins said (see Figure 1).

Revascularization rates of any vessel were higher among patients with diabetes assigned to Taxus (20.3%) compared with CABG (11.1%; P<.001). In the CABG group, revascularization rates in diabetics and nondiabetics were similar (diabetes, 6.4%; no diabetes, 5.7%; P=.74).

The outcome of death/CVA/MI was similar between patients with and without diabetes regardless of therapy (see Figure 2).

SYNTAX data reveal significantly increased mortality in patients with diabetes compared with patients without diabetes in both the CABG and Taxus groups, according to Dawkins.

The rate of all-cause death among patients with medically treated diabetes assigned to Taxus was higher than nondiabetics assigned to Taxus (8.4% vs. 3.0%; P<.001).

Effect of diabetes therapy

SYNTAX researchers also presented outcomes data based on type of diabetes medication.

Of 452 medically treated patients with diabetes, 270 were using oral agents (CABG, n=128; Taxus, n=142) and 182 were using insulin (CABG, n=93; Taxus, n=89).

Insulin-dependent patients with diabetes assigned to Taxus had higher rates of revascularization (20.5% vs. 9.2%; P=.04), death/CVA/MI (14.8% vs. 8%; P=.16), and all-cause death (12.5% vs. 5.7%; P=.12) at one year compared with insulin-dependent patients assigned to CABG. In addition, insulin therapy was associated with more death/CVA/MI (14.8%) and all-cause death (12.5%) compared with oral hypoglycemic agents (7.2% and 5.8%), Dawkins said.

Disclosures:
• Dr. Dawkins reports that he is a Boston Scientific employee and stockholder.