Meraj Perwaiz M, Patel Krunalkumar, Patel Amitkumar, Doshi Rajkumar, Srinivas Guruprasad, Jauhar Rajiv, Kaplan Barry, Garzon Ruby, Sharma Anurag, Cao Yijian, Diaz Molina Ferney, Sharma Rajiv
Department of Cardiology, Northwell Health, Manhasset, New York.
Department of Radiation Medicine, Northwell Health, Manhasset, New York.
Catheter Cardiovasc Interv. 2021 Jan 1;97(1):41-46. doi: 10.1002/ccd.28708. Epub 2020 Jan 13.
The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES).
ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater.
A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke.
A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI.
ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.
本研究旨在报告药物洗脱支架(DES)患者冠状动脉内近距离放射治疗(ICBT)治疗再狭窄(ISR)后的安全性、短期和长期临床疗效。
ICBT是治疗裸金属支架(BMS)ISR的有效方法,但由于DES的出现,其应用已减少。DES后的ISR发生率为8%或更高。
对2011年1月至2016年10月期间在机构审查委员会(IRB)批准的方案下接受ICBT治疗DES ISR的患者进行回顾性分析。所有患者均随访24个月,观察手术并发症、死亡率、临床ISR/靶病变血运重建(TLR)和中风情况。
共纳入290例患者,平均年龄66.6岁。他们均有较高的典型冠状动脉疾病危险因素发生率。我们的主要结局,即住院死亡率、心肌梗死(MI)、安全结局和手术失败的综合情况,在1例发生MI的患者中出现(0.3%)。住院期间未观察到其他次要结局。在1年随访时,12.4%的患者发生ISR,1.7%的患者死亡,1例(0.3%)发生缺血性中风。在2年时,14.7%的患者发生ISR,共有6例(2.1%)患者发生MI。
ICBT在治疗、安全性和2年无复发性临床ISR方面显示出优异的技术成功率和合理疗效。本研究代表了迄今为止在非常复杂的病变亚组中DES ISR的最大ICBT数据,然而,需要更多的前瞻性数据来确定最佳治疗患者。