From the Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de santé, Massy, France (M.-C.M.); Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands (P.W.S., A.P.K.); Evanston Hospital, Evanston, IL (T.E.F.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milan, Italy (A.C.); Medical City Hospital, Dallas, TX (M.J.M.); Mayo Clinic, Rochester, MN (D.R.H.); Baylor Heart and Vascular Hospital, Dallas, TX (J.W.C.); Institute of Cardiology, Warsaw, Poland (W.R., G.R.); Boston Scientific Corporation, Natick, MA (J.H., K.R., K.D.D.); University of Leipzig Heart Center, Leipzig, Germany (F.M.).
Circulation. 2014 Jun 10;129(23):2388-94. doi: 10.1161/CIRCULATIONAHA.113.006689. Epub 2014 Apr 3.
BACKGROUND: Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. METHODS AND RESULTS: The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95-1.59]; P=0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58-1.32]; P=0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12-0.92]; P=0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28-2.57]; P<0.01). Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores (≥33). CONCLUSIONS: At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.
背景：目前的指南建议对有明显新发左主干冠状动脉（LM）狭窄的患者进行冠状动脉旁路移植术（CABG）治疗；然而，对于特定患者的无保护 LM 疾病，经皮冠状动脉介入治疗（PCI）具有 IIa 类适应证。这项分析比较了 SYNTAX 试验中接受 PCI 和 CABG 治疗的 LM 患者的 5 年临床结局，这是该组迄今为止最大的试验。
方法和结果：SYNTAX 试验将 1800 名 LM 或 3 血管疾病患者随机分为 PCI（使用 TAXUS Express 紫杉醇洗脱支架）或 CABG 治疗组。无保护 LM 队列（N=705）是预先设定并具有统计学效力的。5 年时主要心脏和脑血管不良事件发生率在 PCI 组为 36.9%，在 CABG 组为 31.0%（风险比，1.23[95%置信区间，0.95-1.59]；P=0.12）。PCI 组和 CABG 组的死亡率分别为 12.8%和 14.6%（风险比，0.88[95%置信区间，0.58-1.32]；P=0.53）。CABG 组的卒中发生率显著升高（PCI 组为 1.5%，CABG 组为 4.3%；风险比，0.33[95%置信区间，0.12-0.92]；P=0.03），而 PCI 组的再次血运重建率较高（26.7%对 15.5%；风险比，1.82[95%置信区间，1.28-2.57]；P<0.01）。在低/中 SYNTAX 评分患者中，两组之间的主要心脏和脑血管不良事件无差异，但在高评分（≥33）患者中，PCI 组的发生率更高。
结论：5 年时，两组之间在总体主要心脏和脑血管不良事件方面无差异。与 CABG 相比，PCI 治疗患者的卒中发生率较低，但血运重建率较高。这些结果表明，这两种治疗方法都是 LM 患者的有效选择。在选择手术和 PCI 之间时，应考虑疾病的严重程度，因为与较低三分位数的患者相比，高 SYNTAX 评分的患者似乎从手术中获益更多。
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