London Chest Hospital, Barts and The London NHS Trust, Imperial College, London, England.
J Am Coll Cardiol. 2010 Feb 2;55(5):432-40. doi: 10.1016/j.jacc.2009.10.014.
The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease.
CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization.
The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available.
At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively.
The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154).
本研究旨在比较经皮冠状动脉介入治疗（PCI）加支架与冠状动脉旁路移植术（CABG）治疗糖尿病合并多支血管病变患者的安全性和疗效。
CABG 是糖尿病合并多支血管病变患者的常规血运重建方法，但随着 PCI 的进展，CABG 是否仍是首选血运重建方法尚不确定。
主要终点是全因死亡率、心肌梗死（MI）和卒中的复合终点，主要次要终点包括将再次血运重建加入主要终点事件。共有来自 24 个中心的 510 例糖尿病合并多支血管或复杂单支血管病变患者被随机分为 PCI 加支架（和常规使用阿昔单抗）或 CABG 组。主要比较采用非劣效性方法，95%置信区间（CI）上限不超过 1.3，以宣告 PCI 不劣效。最初使用裸金属支架，但当 Cypher（西罗莫司药物洗脱）支架（Cordis，Johnson & Johnson，Bridgewater，新泽西州）可用时，将其转换为 Cypher 支架。
在 1 年随访时，CABG 组的复合死亡率、MI 和卒中发生率为 10.5%，PCI 组为 13.0%（风险比[HR]：1.25，95%CI：0.75 至 2.09；p=0.39），全因死亡率分别为 3.2%和 3.2%，死亡率、MI、卒中和再次血运重建的发生率分别为 11.3%和 19.3%（HR：1.77，95%CI：1.11 至 2.82；p=0.02）。当将接受 CABG 的患者与接受药物洗脱支架的患者亚组（69%的患者）进行比较时，主要终点发生率分别为 12.4%和 11.6%（HR：0.93，95%CI：0.51 至 1.71；p=0.82）。
CARDia（糖尿病患者冠状动脉血运重建）试验是第一项糖尿病患者冠状动脉血运重建的随机试验，但 1 年结果并未表明 PCI 不劣效于 CABG。然而，CARDia 试验确实表明多支血管 PCI 对糖尿病患者是可行的，但需要更长时间的随访和来自其他试验的数据，以更准确地比较这两种血运重建策略的疗效。（冠状动脉血运重建在糖尿病中的试验；ISRCTN82506137）。
