Tyczyński Maciej, Kern Adam, Buller Patryk, Wańha Wojciech, Gil Robert J, Bil Jacek
Department of Invasive Cardiology, Center of Postgraduate Medical Education, 02-508 Warsaw, Poland.
Department of Cardiology and Internal Medicine, School of Medicine, Collegium Medicum, University of Warmia and Mazury, 10-082 Olsztyn, Poland.
J Clin Med. 2023 Aug 15;12(16):5313. doi: 10.3390/jcm12165313.
We aimed to characterize the performance and safety of percutaneous coronary intervention (PCI) in complex, high-risk indicated procedure (CHIP) and high-bleeding-risk (HBR) patients at a 4-year follow up. We included all consecutive patients who underwent PCI with the sirolimus-eluting coronary stent Alex Plus (Balton, Poland) between July 2015 and March 2016. We analyzed various baseline demographic and clinical characteristics, laboratory data, and clinical outcomes. We enrolled 232 patients in whom 282 stents were implanted, including 81 patients meeting the CHIP criteria and 76 patients meeting the HBR criteria. In the whole population, the mean age was 68 ± 11 years, and 23.7% were females. Most procedures were performed from radial access (83.2%) using a 6F guiding catheter (95.7%). The lesions were mostly predilated (61.6%), and postdilatation was performed in 37.9%. The device success was 99.6% (in one case, a second stent was required due to heavy calcifications). Additional stents were deployed in 39% of cases due to edge dissection (6.9%), side branch stenting (5.2%), or diffuse disease (26.9%). Myocardial infarction (MI) type 4a was revealed in 2.2% of cases. At 4 years, the MACE rates for the whole population and for CHIP and HBR patients were 23.3%, 29.6%, and 27.6%, respectively. CHIP patients had a higher risk of MACEs (29.6% vs. 19.9%, HR 1.69, = 0.032) and cardiac death (11.1% vs. 4.6%, HR 2.50, = 0.048). There were no differences for MI (7.4% vs. 6.6%, = 0.826) and TLR (18.5% vs. 12.6%, = 0.150). HBR patients were also characterized by a higher risk of MACEs (27.6% vs. 21.2%, HR 1.84, = 0.049) and cardiac death (17.1% vs. 1.9%, HR 9.61, < 0.001). There were no differences for MI (7.9% vs. 6.4%, = 0.669) and TLR (11.8% vs. 16.0%, = 0.991). PCI in CHIP and HBR patients is feasible with a low rate of periprocedural complications. Nevertheless, CHIP and HBR patients are at a high risk of future adverse events and require strict surveillance to improve outcomes.
我们旨在对复杂、高风险指定手术（CHIP）和高出血风险（HBR）患者经皮冠状动脉介入治疗（PCI）的4年随访期内的疗效和安全性进行特征描述。我们纳入了2015年7月至2016年3月期间所有连续接受西罗莫司洗脱冠状动脉支架Alex Plus（波兰Balton公司）PCI治疗的患者。我们分析了各种基线人口统计学和临床特征、实验室数据及临床结局。我们纳入了232例患者，共植入282枚支架，其中81例符合CHIP标准，76例符合HBR标准。在总体人群中，平均年龄为68±11岁，女性占23.7%。大多数手术通过桡动脉途径（83.2%）使用6F引导导管（95.7%）进行。病变大多进行了预扩张（61.6%），37.9%进行了后扩张。手术成功率为99.6%（1例因严重钙化需要植入第二枚支架）。39%的病例因边缘夹层（6.9%）、分支支架置入（5.2%）或弥漫性病变（26.9%）而额外植入了支架。2.2%的病例出现4a型心肌梗死（MI）。4年时，总体人群以及CHIP和HBR患者的主要不良心血管事件（MACE）发生率分别为23.3%、29.6%和27.6%。CHIP患者发生MACE的风险更高（29.6%对19.9%，HR 1.69，P = 0.032），心脏死亡风险也更高（11.1%对4.6%，HR 2.50，P = 0.048）。MI（7.4%对6.6%，P = 0.826）和靶病变血运重建（TLR，18.5%对
12.6%，P = 0.150）方面无差异。HBR患者发生MACE（27.6%对21.2%，HR
1.84，P = 0.049）和心脏死亡（17.1%对1.9%，HR 9.61，P < 0.001）的风险也更高。MI（7.9%对6.4%，P = 0.669）和TLR（11.8%对16.0%，P = 0.991）方面无差异。CHIP和HBR患者的PCI治疗可行，围手术期并发症发生率低。然而，CHIP和HBR患者未来发生不良事件的风险较高，需要严格监测以改善结局。
