Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Division of Biostatics, Center for Medical Research and Information, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.
Although target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease is not rare, its timing of occurrence and prognostic impact on long-term mortality is uncertain.
This study sought to investigate TLR incidence over time and its impact on mortality after PCI with drug-eluting stents (DES) for LMCA disease.
Using a pooled data from 4 multicenter observational registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents], IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization], MAIN-COMPARE [Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization], and PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease]), we evaluated 1,397 patients with LMCA disease treated with DES and available long-term mortality data. The association between TLR and the 10-year risk of mortality was examined by multivariable Cox proportional hazards regression, with TLR as a time-varying covariate.
During maximum follow-up of 10 years (median 6.8 years), TLR occurred in 118 patients and its 10-year cumulative incidence was 10.8%. TLR mostly occurred within 2 years after initial PCI and decreased over time: early-stage TLR (within 2 years) in 73 (61.9%) patients and late-stage TLR (beyond 2 years) in 45 (38.1%) patients. Among all TLR patients, 23 patients underwent coronary artery bypass grafting and 95 underwent repeat PCI. In the time-varying multivariable Cox model, the presence of TLR was not significantly associated with an increased risk of mortality (adjusted HR: 0.90; 95% CI: 0.50-1.63; P = 0.73).
Although the incidence of ischemia-driven TLR was mostly common within 2 years after left main PCI, TLR occurred steadily during the 10-year follow-up period. However, given that such patients were optimally revascularized, the prognostic impact of TLR on mortality was not substantial. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133; Observational Study for Left Main Disease Treatment [IRIS-MAIN]; NCT01341327; Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN COMPARE]; NCT02791412; Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).
尽管经皮冠状动脉介入治疗（PCI）治疗无保护左主干冠状动脉（LMCA）疾病后的靶病变血运重建（TLR）并不罕见，但它的发生时间及其对长期死亡率的预后影响尚不确定。
本研究旨在探讨经药物洗脱支架（DES）治疗 LMCA 疾病后 TLR 的发生率及其对死亡率的影响随时间的变化。
利用来自 4 个多中心观察性注册研究（IRIS-DES[介入心脏病学研究协会-药物洗脱支架]、IRIS-MAIN[介入心脏病学研究协会-左主干再血管化]、MAIN-COMPARE[未保护左主干冠状动脉狭窄的血运重建：经皮冠状动脉介入治疗与冠状动脉旁路移植术的随机比较]和 PRECOMBAT[左主干冠状动脉疾病患者中使用药物洗脱支架的旁路手术与血管成形术的 PREmier 随机比较]）的数据，我们评估了 1397 例接受 DES 治疗的 LMCA 疾病患者，并获得了长期死亡率数据。采用多变量 Cox 比例风险回归分析 TLR 与 10 年死亡率风险之间的关系，将 TLR 作为随时间变化的协变量。
在最长 10 年的随访期间（中位随访时间 6.8 年），118 例患者发生 TLR，其 10 年累积发生率为 10.8%。TLR 主要发生在初始 PCI 后 2 年内，并随时间逐渐减少：早期 TLR（2 年内）73 例（61.9%），晚期 TLR（2 年后）45 例（38.1%）。在所有 TLR 患者中，23 例患者接受了冠状动脉旁路移植术，95 例患者接受了重复 PCI。在时间变化的多变量 Cox 模型中，TLR 的存在与死亡率增加无显著相关性（调整后的 HR：0.90；95%CI：0.50-1.63；P=0.73）。
尽管左主干 PCI 后缺血驱动的 TLR 发生率主要在 2 年内较高，但在 10 年随访期间 TLR 仍持续发生。然而，鉴于这些患者得到了最佳的血运重建，TLR 对死亡率的预后影响并不显著。（常规临床实践中第一代、第二代和新药洗脱支架的评估 [IRIS-DES]；NCT01186133；左主干疾病治疗的观察性研究 [IRIS-MAIN]；NCT01341327；药物洗脱支架与冠状动脉旁路移植术治疗左主干冠状动脉疾病的 10 年结果 [MAIN COMPARE]；NCT02791412；左主干冠状动脉疾病患者使用西罗莫司洗脱支架的旁路手术与血管成形术 [PRECOMBAT]；NCT00422968）。
