Anadol Remzi, Mühlenhaus Annika, Trieb Ann-Kristin, Polimeni Alberto, Münzel Thomas, Gori Tommaso
Kardiologie I, Zentrum für Kardiologie, University Medical Center Mainz and Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main 55131 Mainz, Germany.
Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, 88100 Catanzaro, Italy.
J Clin Med. 2020 Mar 20;9(3):847. doi: 10.3390/jcm9030847.
We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events.
Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641-2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan-Meier and Cox regression analysis.
512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second-third year, and 0.6% in the fourth-fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. Procedural parameters (vessel size, scaffold footprint) and the technique used at implantation (including predilation, parameters of sizing, and postdilation) were predictors of ScT and TLF in the first three years after implantation. In contrast, only diabetes was predictive of events between 4-5 years (HR 6.21(1.99-19.40), = 0.002).
After device resorption, the incidence of very late adverse events in lesions/patients implanted with a BRS decreases. Procedural and device-related parameters are not predictors of events anymore.
我们报告了接受冠状动脉生物可吸收支架治疗长达5年的患者的预后数据，并研究不良事件的预测因素。
纳入2012年5月至2014年5月期间在我们中心接受至少一枚冠状动脉生物可吸收支架（BRS，美国雅培血管公司，圣克拉拉）治疗的连续患者。收集1868（1641 - 2024）天的临床/手术特征及预后数据。采用Kaplan-Meier法和Cox回归分析研究支架血栓形成（ScT）、再狭窄（ScR）和靶病变失败（TLF）的发生率及其预测因素。
数据库纳入512例连续患者及598处病变。共报告30例ScT、42例ScR和92例TLF。植入后第一年ScT发生率为3.6%，第二至三年为2.2%，第四至五年为0.6%。ScR的相应发生率分别为2.5%、5.7%和1.1%。TLF的相应发生率分别为8.8%、8.0%、3.8%。手术参数（血管大小、支架覆盖面积）及植入时使用的技术（包括预扩张）、尺寸参数和后扩张）是植入后前三年ScT和TLF的预测因素。相比之下，只有糖尿病是4至5年期间事件的预测因素（HR 6.21(1.99 - 19.40)，P = 0.002）。
在器械吸收后，植入BRS的病变/患者中极晚期不良事件的发生率降低。手术和器械相关参数不再是事件的预测因素。
