Rapamycin-eluting stents for unprotected left main coronary artery stenosis in older adult patients with coronary atherosclerosis: study protocol for a prospective, non-randomized, controlled trial and preliminary results

Background and objectives: Coronary artery bypass grafting (CABG) is the gold standard therapy for unprotected left main coronary artery (ULMCA) stenosis in coronary atherosclerosis. However, ULMCA stenosis has recently been successfully treated with drug-eluting stents. The present study aims to compare 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 Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) and Renmin Hospital Affiliated to Hubei University of Medicine, 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. Outcome measures and preliminary results: 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. 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. 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. Ethics and dissemination: This study was approved by Medical Ethics Committee, Taihe Hospital (approval No. TH0058X), and Shiyan Renmin Hospital (approval No. RM011X), China in July 2017. This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from each patient. The study protocol was designed in January 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2022. The study will end in December 2022. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016413). Protocol version: 1.0