Oh Young Soo, Lee Hyun Jong, Lee Juneyoung, Choi Young Jin, Choi Rak Kyeung, Yu Cheol Woong, Park Jinsik, Choi Jin-Oh, Kim Je Sang, Kim Tae-Hoon, Jang Ho-Jun, Park Seung Woo, Lee Sang Hoon
Department of Internal Medicine, Division of Cardiology, Sejong General Hospital, Bucheon.
Departments of Biostatistics.
Coron Artery Dis. 2019 Jun;30(4):239-248. doi: 10.1097/MCA.0000000000000718.
Major randomized clinical trials assessing clinical outcomes in patients who underwent a percutaneous coronary intervention (PCI) for left main coronary artery disease excluded some high-risk subsets. Whether the effectiveness and safety of a percutaneous approach in this group of patients are comparable with those observed in clinical trials is unclear. We aimed to explore the long-term outcomes of contemporary drug-eluting stent (DES)-based revascularization for left main coronary artery disease in patients presenting with one or more clinical or angiographic characteristics who would have precluded inclusion in randomized trials.
Between April 2003 and December 2011, 340 consecutive patients with unprotected left main coronary artery stenosis of at least 50% who underwent successful PCI with DES at Sejong General Hospital (Bucheon, Republic of Korea) were included in this retrospective study. Patients were classified into the exclusion group (group E; n=120) and the inclusion group (group I; n=220) according to the prespecified inclusion and exclusion criteria utilized in clinical trials.
During the median follow-up of 86 (52-114) months, major adverse cardiac or cerebrovascular events occurred in 69 (31.4%) patients in group I and 46 (38.3%) patients in group E (P=0.155). In the propensity score-matched population, group E was not associated with a higher incidence of major adverse cardiac or cerebrovascular events (hazard ratio: 1.42, 95% confidence interval: 0.76-2.65, P=0.758). Definite or probable stent thrombosis occurred in five patients of group I, with no cases in group E.
In our real-world registry, about a third of patients who underwent PCI for unprotected left main coronary artery stenosis had one or more high-risk characteristics or comorbid conditions that represent exclusion criteria of previous randomized trials. PCI using DES is feasible in these patients.
评估接受经皮冠状动脉介入治疗（PCI）的左主干冠状动脉疾病患者临床结局的主要随机临床试验排除了一些高危亚组。在这组患者中，经皮治疗方法的有效性和安全性是否与临床试验中观察到的相当尚不清楚。我们旨在探讨当代药物洗脱支架（DES）为基础的血运重建术治疗左主干冠状动脉疾病在那些因具有一项或多项临床或血管造影特征而被排除在随机试验之外的患者中的长期结局。
在2003年4月至2011年12月期间，340例在世宗总医院（韩国富川）接受DES成功PCI治疗的无保护左主干冠状动脉狭窄至少50%的连续患者被纳入这项回顾性研究。根据临床试验中预先设定的纳入和排除标准，患者被分为排除组（E组；n = 120）和纳入组（I组；n = 220）。
在中位随访86（52 - 114）个月期间，I组69例（31.4%）患者和E组46例（38.3%）患者发生了主要不良心脏或脑血管事件（P = 0.155）。在倾向评分匹配人群中，E组与主要不良心脏或脑血管事件的较高发生率无关（风险比：1.42，95%置信区间：0.76 - 2.65，P = 0.758）。I组有5例患者发生明确或可能的支架血栓形成，E组无病例。
在我们的真实世界注册研究中，接受无保护左主干冠状动脉狭窄PCI治疗的患者中约三分之一具有一项或多项高危特征或合并症，这些代表了既往随机试验的排除标准。使用DES进行PCI在这些患者中是可行的。
