Heart Center, ZNA (Ziekenhuis Netwerk Antwerpen) Middelheim, Antwerp, Belgium; Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.
Heart Center, ZNA (Ziekenhuis Netwerk Antwerpen) Middelheim, Antwerp, Belgium.
Am J Cardiol. 2023 May 15;195:98-106. doi: 10.1016/j.amjcard.2023.01.024. Epub 2023 Feb 18.
The Evaluation of XIENCE versus EXCEL (Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial is the largest randomized study comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comer population of ULMD PCI would be eligible for the EXCEL trial and whether these patients show different long-term outcomes than the rest of the ULMD population. A total of 246 consecutive patients underwent ULMD PCI between January 2018 and December 2021 and were retrospectively analyzed. After application of the EXCEL trial inclusion and exclusion criteria, 98 patients (39%) were allocated to the "EXCEL-like" cohort and 148 to the "non-EXCEL-like." Baseline characteristics of the 2 groups were substantially comparable. The mean baseline SYNTAX score was lower in the EXCEL-like patients than the non-EXCEL-like group (20.1 ± 7.1 vs 23.0 ± 11.2, p = 0.025), with the latter also showing a higher degree of incomplete revascularization (residual SYNTAX score >8 : 11% vs 26%, p = 0.005). At 1 year, the cumulative major adverse cardiovascular and cerebral events rate was 7% for the EXCEL-like and 17% for the non-EXCEL-like patients, respectively (p = 0.03). At the last follow-up available, the significant difference in major adverse cardiovascular and cerebral events rate persisted (19% vs 37%, p = 0.02) and a significant difference in any unplanned revascularization was also shown (1.5% vs 13%, p = 0.04). In conclusion, in a contemporary real-world cohort of ULMD PCI, only a minority of patients could be enrolled in the EXCEL trial; the EXCEL-like patients, in our population, showed less clinical events at long-term follow-up than the cohort of patients who were ineligible for EXCEL, despite comparable baseline cardiovascular profiles; these findings may challenge a broad external applicability of the results of the EXCEL trial in routine clinical activity.
XIENCE 与 EXCEL（冠状动脉旁路移植术治疗左主干血运重建效果）试验是一项比较经皮冠状动脉介入治疗（PCI）与第二代药物洗脱支架和无保护左主干疾病（ULMD）旁路手术的最大规模随机研究。我们的目的是评估来自 ULMD PCI 的当代所有患者人群中，有多少比例的患者符合 EXCEL 试验的入选标准，以及这些患者的长期结果是否与 ULMD 人群的其余部分不同。共有 246 例连续 ULMD PCI 患者于 2018 年 1 月至 2021 年 12 月进行回顾性分析。在应用 EXCEL 试验的纳入和排除标准后，98 例（39%）患者被分配至“EXCEL 样”队列，148 例至“非 EXCEL 样”队列。两组患者的基线特征基本相当。EXCEL 样患者的基线 SYNTAX 评分低于非 EXCEL 样患者（20.1 ± 7.1 比 23.0 ± 11.2，p = 0.025），后者也显示出不完全血运重建的程度更高（残余 SYNTAX 评分>8：11%比 26%，p = 0.005）。在 1 年时，EXCEL 样患者的累积主要不良心血管和脑事件发生率为 7%，而非 EXCEL 样患者为 17%（p = 0.03）。在可获得的最后一次随访中，主要不良心血管和脑事件发生率的显著差异仍然存在（19%比 37%，p = 0.02），且未计划再次血运重建的发生率也有显著差异（1.5%比 13%，p = 0.04）。总之，在当代 ULMD PCI 的真实世界队列中，只有少数患者可以被纳入 EXCEL 试验；在我们的人群中，EXCEL 样患者的长期随访结果显示出比不符合 EXCEL 标准的患者队列更少的临床事件，尽管基线心血管特征相当；这些发现可能对 EXCEL 试验结果在常规临床活动中的广泛外推性提出挑战。
