Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
Eur J Cardiothorac Surg. 2013 May;43(5):1006-13. doi: 10.1093/ejcts/ezt017. Epub 2013 Feb 14.
This prespecified subgroup analysis examined the effect of diabetes on left main coronary disease (LM) and/or three-vessel disease (3VD) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the SYNTAX trial.
Patients (n = 1800) with LM and/or 3VD were randomized to receive either PCI with TAXUS Express paclitaxel-eluting stents or CABG. Five-year outcomes in subgroups with (n = 452) or without (n = 1348) diabetes were examined: major adverse cardiac or cerebrovascular events (MACCE), the composite safety end-point of all-cause death/stroke/myocardial infarction (MI) and individual MACCE components death, stroke, MI and repeat revascularization. Event rates were estimated with Kaplan-Meier analyses.
In diabetic patients, 5-year rates were significantly higher for PCI vs CABG for MACCE (PCI: 46.5% vs CABG: 29.0%; P < 0.001) and repeat revascularization (PCI: 35.3% vs CABG: 14.6%; P < 0.001). There was no difference in the composite of all-cause death/stroke/MI (PCI: 23.9% vs CABG: 19.1%; P = 0.26) or individual components all-cause death (PCI: 19.5% vs CABG: 12.9%; P = 0.065), stroke (PCI: 3.0% vs CABG: 4.7%; P = 0.34) or MI (PCI: 9.0% vs CABG: 5.4%; P = 0.20). In non-diabetic patients, rates with PCI were also higher for MACCE (PCI: 34.1% vs CABG: 26.3%; P = 0.002) and repeat revascularization (PCI: 22.8% vs CABG: 13.4%; P < 0.001), but not for the composite end-point of all-cause death/stroke/MI (PCI: 19.8% vs CABG: 15.9%; P = 0.069). There were no differences in all-cause death (PCI: 12.0% vs CABG: 10.9%; P = 0.48) or stroke (PCI: 2.2% vs CABG: 3.5%; P = 0.15), but rates of MI (PCI: 9.9% vs CABG: 3.4%; P < 0.001) were significantly increased in the PCI arm in non-diabetic patients.
In both diabetic and non-diabetic patients, PCI resulted in higher rates of MACCE and repeat revascularization at 5 years. Although PCI is a potential treatment option in patients with less-complex lesions, CABG should be the revascularization option of choice for patients with more-complex anatomic disease, especially with concurrent diabetes.
本预先设定的亚组分析检查了糖尿病对接受经皮冠状动脉介入治疗(PCI)或冠状动脉旁路移植术(CABG)的患者的左主干冠状动脉疾病(LM)和/或三血管疾病(3VD)的影响。
1800 名 LM 和/或 3VD 患者被随机分为接受 TAXUS Express 紫杉醇洗脱支架 PCI 或 CABG。检查亚组(n=452)或无糖尿病(n=1348)患者的 5 年结局:主要不良心脑血管事件(MACCE)、全因死亡/中风/心肌梗死(MI)的复合安全性终点和单独的 MACCE 成分死亡、中风、MI 和再次血运重建。用 Kaplan-Meier 分析估计事件发生率。
在糖尿病患者中,PCI 与 CABG 的 5 年 MACCE 发生率(PCI:46.5% vs CABG:29.0%;P <0.001)和再次血运重建(PCI:35.3% vs CABG:14.6%;P <0.001)的差异有统计学意义。全因死亡/中风/MI 的复合终点(PCI:23.9% vs CABG:19.1%;P=0.26)或全因死亡(PCI:19.5% vs CABG:12.9%;P=0.065)、中风(PCI:3.0% vs CABG:4.7%;P=0.34)或 MI(PCI:9.0% vs CABG:5.4%;P=0.20)的差异无统计学意义。在非糖尿病患者中,PCI 的 MACCE(PCI:34.1% vs CABG:26.3%;P=0.002)和再次血运重建(PCI:22.8% vs CABG:13.4%;P<0.001)的发生率也更高,但全因死亡/中风/MI 的复合终点(PCI:19.8% vs CABG:15.9%;P=0.069)的差异无统计学意义。全因死亡(PCI:12.0% vs CABG:10.9%;P=0.48)或中风(PCI:2.2% vs CABG:3.5%;P=0.15)的差异无统计学意义,但非糖尿病患者的 PCI 组 MI(PCI:9.9% vs CABG:3.4%;P<0.001)的发生率显著升高。
在糖尿病和非糖尿病患者中,PCI 在 5 年时导致更高的 MACCE 和再次血运重建发生率。尽管 PCI 是治疗病变较少患者的潜在治疗选择,但对于解剖病变较复杂的患者,CABG 应是血运重建的首选方法,尤其是合并糖尿病的患者。