Restenosis is a serious complication for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI). In this prospective clinical study, we aimed to investigate the effects of Radix Salviae decoction (RSD) on coronary stenosis and restenosis in CHD patients.
Methods
We conducted this study at Guangdong Hospital of Traditional Chinese Medicine (registration No. BF2022-052) and enrolled 60 patients diagnosed with CHD for PCI surgery. The patients were divided into a control group and an RSD treatment group of 30 cases each. The primary outcome was restenosis after PCI, and the secondary outcome was newly increased stenosis (neostenosis).
Results
Fifty-eight of the 60 enrolled patients completed follow-up and were included in the final analysis, with 28 in the control and 30 in the RSD group. A baseline comparison of stenosis location, stenosis degree, and the number of vessels in stenosis before PCI showed comparable results (p > 0.05). Comparison of implanted stents showed similar features in stent diameter and stent length during PCI between the two groups (p > 0.05). For the primary outcome, there was no significant difference in restenosis percentage (p > 0.05) or the number of vessels in restenosis (p > 0.05) of the three arteries between groups. For the secondary outcome, neither the number of nonculprit vessels in neostenosis after PCI nor the percentage of neostenosis of the three arteries showed significant differences between groups (p > 0.05). Although multifactor logistic regression analysis for the incidence of restenosis did not find any statistically significant factors (p > 0.05), the diagnosis of MI/angina (p = 0.031), average stent length (p = 0.010), and alanine transaminase (p = 0.027) were found to be significantly associated with neostenosis occurrence. Safety index measurement indicated that RSD had a good safety profile in clinical treatment.
Conclusions
This study was designed to test the additional efficacy of RSD plus conventional treatment for coronary artery restenosis and neostenosis, compared with the conventional treatment given to the control group. Our data showed that although the addition of RSD for a short period did not significantly change restenosis and neostenosis occurrence after PCI, the diagnosis of MI/angina, average stent length, and ALT levels were significantly associated with neostenosis occurrence. This pilot study will provide preliminary evidence for designing further studies to investigate RSD effects to stenosis in the future.
Full text
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The study was recently published in the Journal of Exploratory Research in Pharmacology.
Journal of Exploratory Research in Pharmacology (JERP) publishes original innovative exploratory research articles, state-of-the-art reviews, editorials, short communications that focus on novel findings and the most recent advances in basic and clinical pharmacology, covering topics from drug research, drug development, clinical trials and application.
