Rapamycin-eluting stents for unprotected left main coronary artery stenosis in coronary atherosclerosis in the older adults: study protocol for a prospective, non-randomized, controlled trial and preliminary results
- VernacularTitle:雷帕霉素药物洗脱支架治疗老年退行性冠状动脉粥样硬化性心脏病无保护左主干病变:前瞻性、非随机、对照临床试验方案及预试验结果
- Author:
Wei CHEN
1
;
Zhi-Cheng FANG
;
Xiang ZHENG
;
Bo-Yi LIU
;
Ji-Xian ZHAO
;
Ying-Ying LIAO
Author Information
1. 十堰市太和医院重症医学科(湖北医药学院附属医院)
- From:
Chinese Journal of Tissue Engineering Research
2018;22(18):2890-2895
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: Coronary artery bypass grafting (CABG) is the gold standard therapy for unprotected left main coronary artery (ULMCA) stenosis in coronary atherosclerosis. However, the treatment of ULMCA stenosis using drug-eluting stents has recently been reported to lead to a relatively low incidence of cardiovascular events.Thus,drug-eluting stents are a potential surrogate for CABG,and could become the new gold standard treatment for ULMCA stenosis; however, this issue remains controversial. OBJECTIVE: To explore the safety and efficacy of CABG versus rapamycin-eluting stents for ULMCA stenosis in older adult patients with degenerative coronary atherosclerosis. METHODS: The proposed prospective, non-randomized, controlled trial will include 224 older adult patients with degenerative coronary atherosclerosis with ULMCA stenosis being treated at the Department of Cardiology at Taihe Hospital and Renmin Hospital of Shiyan, China. Patients will be divided into two groups in accordance with each patient’s treatment choice and indications (n=112/group): the stent group will receive rapamycin-eluting stents, while the CABG group will undergo CABG.All patients will be followed up at 9, 12, 24, and 36 months postoperatively. The primary outcome measure will be the rate of repeat revascularizations in the target lesion at 36 months postoperatively.The secondary outcome measures will be the rates of repeat revascularizations in the target lesion at 9, 12, and 24 months postoperatively, the rate of restenosis, mortality, causes of death, and survival at 9, 12, 24, and 36 months postoperatively, and the angiographic appearance of the diseased vessels preoperatively and at 9, 12, 24, and 36 months postoperatively. The safety indicator will be the incidence of major adverse cardiac and cerebrovascular events at 9, 12, 24, and 36 months postoperatively. Eighty-six older adult patients with degenerative coronary atherosclerosis who underwent treatment of ULMCA stenosis between January 2016 and December 2017 were included in a pilot study. Pilot study results showed that the stent group (n=48) had a significantly reduced waiting time for surgery, hospitalization time, and rate of complete revascularizations in the target lesion compared with the CABG group (n=38) (P ＜ 0.05). At 6 months postoperatively, there were no significant differences between the two groups in mortality, and incidences of myocardial infarction, repeat revascularizations in the target lesion, and cardiovascular events. The trial was approved by the Ethics Committee of Taihe Hospital (approval No. TH005X) in July 2017 and by the Ethics Committee of Renmin Hospital of Shiyan (approval No. RM011X) in July 2017. All the patients will provide written informed consent with the premise of fully understanding the treatment plan. The study protocol will follow the relevant laws and regulations of the Declaration of Helsinki and relevant hospital’s ethical principles. Design of the trial was completed in January 2018. Recruitment will be initiated in August 2018 and it is expected to be completed in August 2019. Data analysis will be conducted in October 2022 and the trial will be completed in December 2022. The results of the study will be disseminated through presentations at scientific meetings and/or in peer-reviewed publications. The trial has been registered with the Chinese Clinical Trial Registry (registration No. ChiCTR1800016413) and the version number is 1.0 DISCUSSION: The results of this study will indicate the medium-and long-term efficacy and safety of rapamycin-eluting stents versus CABG in older adult patients with ULMCA stenosis, and then identify which of these two treatments has better prognosis, thereby screening out the optimal strategy for treating ULMCA.
