Erasmus University Medical Center, Rotterdam, The Netherlands.
Herzzentrum Universität Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany.
Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.
AIMS: Coronary artery bypass grafting (CABG) has been considered the standard of care for patients with three-vessel disease (3VD), but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention (PCI) using drug-eluting stents (DES) remain limited. METHODS AND RESULTS: Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial. This pre-specified analysis presents the 5-year outcomes of patients with 3VD (n = 1095). The rate of major adverse cardiac and cerebrovascular events (MACCE) was significantly higher in patients with PCI compared with CABG (37.5 vs. 24.2%, respectively; P < 0.001). Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction (MI) (22.0 vs. 14.0%, respectively; P < 0.001), all-cause death (14.6 vs. 9.2%, respectively; P = 0.006), MI (9.2 vs. 4.0%, respectively; P = 0.001), and repeat revascularization (25.4 vs. 12.6%, respectively; P < 0.001); however, stroke was similar between groups at 5 years (3.0 vs. 3.5%, respectively; P = 0.66). Results were dependent on lesion complexity (P for interaction = 0.12); in patients with a low (0-22) SYNTAX score, PCI vs. CABG resulted in similar rates of MACCE (33.3% vs. 26.8%, respectively; P = 0.21) but significantly more repeat revascularization (25.4% vs. 12.6%, respectively; P = 0.038), while in intermediate (23-32) or high (≥ 33) SYNTAX score terciles, CABG demonstrated clear superiority in terms of MACCE, death, MI, and repeat revascularization. Differences in MACCE between PCI and CABG were larger in diabetics [hazard ratio (HR) = 2.30] than non-diabetics (HR = 1.51), although the P for interaction failed to reach significance for MACCE (P for interaction = 0.095) or any of the other endpoints. CONCLUSION: Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death, MI, and repeat revascularization, while stroke rates were similar. For patients with low SYNTAX scores, PCI is an acceptable revascularization strategy, although at a price of significantly higher rates of repeat revascularization. CLINICAL TRIAL REGISTRATION: NCT00114972.
目的：冠状动脉旁路移植术（CABG）一直被认为是治疗三支血管病变（3VD）患者的标准治疗方法，但 CABG 与药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）的长期随机试验比较结果仍然有限。
方法和结果：新诊断的 3VD 或左主干疾病患者在 SYNTAX 试验中被随机分配接受紫杉醇第一代支架的 PCI 或 CABG。这项预先指定的分析显示了 3VD 患者的 5 年结果（n = 1095）。与 CABG 相比，PCI 患者的主要不良心脏和脑血管事件（MACCE）发生率明显更高（分别为 37.5%和 24.2%；P < 0.001）。与 CABG 相比，PCI 导致死亡/卒中/心肌梗死（MI）复合终点的发生率显著更高（分别为 22.0%和 14.0%；P < 0.001），全因死亡率（分别为 14.6%和 9.2%；P = 0.006），MI（分别为 9.2%和 4.0%；P = 0.001）和再次血运重建（分别为 25.4%和 12.6%；P < 0.001）的发生率也明显更高；然而，5 年后两组的卒中发生率相似（分别为 3.0%和 3.5%；P = 0.66）。结果取决于病变的复杂性（P 交互 = 0.12）；在低（0-22）SYNTAX 评分的患者中，PCI 与 CABG 的 MACCE 发生率相似（分别为 33.3%和 26.8%；P = 0.21），但再次血运重建的发生率显著更高（分别为 25.4%和 12.6%；P = 0.038），而在中危（23-32）或高危（≥33）SYNTAX 评分 tertile 中，CABG 在 MACCE、死亡、MI 和再次血运重建方面具有明显优势。与 CABG 相比，糖尿病患者的 MACCE 差异更大（风险比[HR] = 2.30），而非糖尿病患者的差异较小（HR = 1.51），尽管 MACCE 的交互检验 P 值未达到显著水平（P 交互 = 0.095）或其他任何终点。
结论：接受第一代紫杉醇洗脱 DES 的 CABG 或 PCI 治疗的 3VD 患者 5 年结果表明，CABG 应继续作为标准治疗方法，因为它可显著降低死亡率、MI 和再次血运重建的发生率，而卒中发生率相似。对于低 SYNTAX 评分的患者，PCI 是一种可接受的血运重建策略，尽管其再次血运重建的发生率明显更高。
临床试验注册：NCT00114972。
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