Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
JACC Cardiovasc Interv. 2012 Jun;5(6):618-25. doi: 10.1016/j.jcin.2012.02.013.
The aim of this study was to evaluate the use of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in "real-world" patients unsuitable for the alternative treatment.
No data are available on the risk profile and outcomes of patients that can only undergo PCI or CABG.
In the SYNTAX (Synergy between PCI with TAXUS and Cardiac Surgery) trial, a multidisciplinary Heart Team reached a consensus on whether PCI and CABG could result in clinical equipoise; if so, the patient was randomized. If not, the patient was enrolled in a CABG-ineligible PCI registry or PCI-ineligible CABG registry. A proportion (60%) of patients in the CABG registry was randomly assigned to be followed up for 5 years. No statistical comparisons were performed between randomized and registry patients. Major adverse cardiac or cerebrovascular event (MACCE) rates are presented as observational only.
A total of 3,075 patients were treated in the SYNTAX trial; 198 (6.4%) and 1,077 (35.0%) patients were included in PCI and CABG registries, respectively. The main reason for inclusion in the CABG registry was too complex coronary anatomy (70.9%), and the main reason for inclusion in the PCI registry was too high-risk for surgery (70.7%). Three-year MACCE was 38.0% after PCI and 16.4% after CABG. Stratification by SYNTAX score terciles demonstrated a step-wise increase of MACCE rates in both PCI and CABG registries.
The SYNTAX Heart Team concluded that PCI and CABG remained the only treatment options for 6.4% and 35.0% of patients, respectively. Inoperable patients with major comorbidities that underwent PCI had high MACCE rates. In patients not suitable for PCI, surgical results were excellent. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries, NCT00114972).
本研究旨在评估经皮冠状动脉介入治疗（PCI）和冠状动脉旁路移植术（CABG）在不适合替代治疗的“真实世界”患者中的应用。
尚无关于仅行 PCI 或 CABG 治疗患者的风险特征和结局的数据。
在 SYNTAX（PCI 联合 Taxus 与心脏手术的协同作用）试验中，一个多学科心脏团队就 PCI 和 CABG 是否可能导致临床均势达成共识；如果是这样，患者将被随机分组。如果不是，则患者被纳入 CABG 不适合 PCI 登记处或 PCI 不适合 CABG 登记处。CABG 登记处中有一定比例（60%）的患者被随机分配进行 5 年随访。未对随机分组和登记处患者进行统计学比较。主要不良心脑血管事件（MACCE）发生率仅作为观察结果报告。
共有 3075 例患者在 SYNTAX 试验中接受治疗；198（6.4%）和 1077（35.0%）例患者分别被纳入 PCI 和 CABG 登记处。CABG 登记处纳入的主要原因是复杂的冠状动脉解剖结构（70.9%），PCI 登记处纳入的主要原因是手术风险太高（70.7%）。PCI 后 3 年 MACCE 发生率为 38.0%，CABG 后为 16.4%。按 SYNTAX 评分三分位数分层显示，PCI 和 CABG 登记处的 MACCE 发生率呈逐步上升趋势。
SYNTAX 心脏团队得出结论，PCI 和 CABG 分别仍然是 6.4%和 35.0%患者的唯一治疗选择。有重大合并症而无法手术的 PCI 患者 MACCE 发生率较高。对于不适合 PCI 的患者，手术效果极佳。（SYNTAX 研究：Taxus 药物洗脱支架与冠状动脉旁路移植术治疗狭窄动脉，NCT00114972）。
