Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
Division of Clinical and Experimental Medicine, Brighton and Sussex Medical School, Brighton, United Kingdom.
EuroIntervention. 2022 Jan 28;17(13):1081-1090. doi: 10.4244/EIJ-D-21-00338.
The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD).
We sought to determine whether these outcomes remained consistent regardless of geography of enrolment.
We performed a prespecified subgroup analysis based on regional enrolment.
Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (p=0.02).
In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.
EXCEL 试验报告称,经皮冠状动脉介入治疗(PCI)与冠状动脉旁路移植术(CABG)治疗阻塞性左主干冠状动脉疾病(LMCAD)的主要复合终点(死亡、心肌梗死[MI]或中风)的五年发生率相似。
我们旨在确定这些结果是否在入组地理位置不同的情况下仍然一致。
我们根据区域入组情况进行了预设的亚组分析。
在随机分配至 PCI(n=948)或 CABG(n=957)的 1905 例患者中,有 1075 例(56.4%)来自 52 个欧盟(EU)中心,752 例(39.5%)来自 67 个北美(NA)中心。EU 与 NA 患者在许多基线人口统计学、解剖学、药物治疗和程序特征方面存在差异。尽管如此,PCI 与 CABG 后主要终点的相对发生率在 30 天和 5 年时在 EU 与 NA 中心之间是一致的。然而,NA 患者 PCI 后缺血驱动的血运重建(IDR)的晚期发生率显著更高,主要是由于需要更多的靶血管和病变血运重建。这导致 5 年时死亡、MI、中风或 IDR 的次要复合终点的相对风险存在显著差异(p=0.02)。
在 EXCEL 试验中,PCI 与 CABG 后 30 天和 5 年的主要复合终点(死亡、MI 或中风)的相对风险与地理位置无关。然而,NA 中心 PCI 后 IDR 的 5 年发生率显著更高,心脏团队和患者在做出治疗决策时应考虑这一点。临床试验注册号:NCT01205776。