Piedmont Heart Institute, Atlanta, Georgia.
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.
Catheter Cardiovasc Interv. 2019 Oct 1;94(4):509-515. doi: 10.1002/ccd.28436. Epub 2019 Aug 24.
Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents.
Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined.
Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization.
In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.
有限的研究详细说明了在多个应用现代技术和新一代药物洗脱支架的中心进行慢性完全闭塞（CTO）血运重建的晚期安全性和疗效。
在 20 个中心中，222 名接受依维莫司洗脱支架（EES）治疗的 XIENCE 冠状动脉支架、性能和技术（EXPERT）CTO 试验患者接受了 CTO 经皮冠状动脉介入治疗（PCI）。通过计划的 4 年随访，确定了主要复合终点（MACE；死亡、心肌梗死[MI]和靶病变血运重建）和各个终点和支架血栓形成的发生率。
人口统计学、病变和程序特征包括先前的旁路手术，9.9%；糖尿病，40.1%；病变长度，36.1±18.5mm；支架长度，51.7±27.2mm。4 年后，根据预先指定的 ARC 和方案定义，MACE 发生率分别为 31.6%和 22.4%。4 年后临床指示的靶病变血运重建率为 11.3%。在血管重建后第一年以外的事件的里程碑分析中，靶血管相关 MI 和临床指示的靶病变血运重建的年化发生率分别为 0.53%和 1.3%。4 年内，明确/可能的支架血栓形成累积发生率为 1.7%，索引血运重建后初始年无事件发生。
在一项代表当代技术和 EES 的多中心注册试验中，这些结果表明 EES 在 CTO 经皮血运重建中的长期安全性和有效性持续存在，并可用于告知考虑 CTO PCI 的患者的决策，以了解晚期安全性和血管通畅性。
