A Clinical Study On Yixin Tongmai Tang To Treat And Prevent In-stent Restenosis After Percutaneous Coronary Intervention Applied To Diabetes Mellitus With Coronary Heart Disease

Objective To assess the effectiveness and safety of using Yixin Tongmai Tang to treat and prevent In-stent restenosis after PCI applied to diabetes mellitus(DM) with coronary heart disease(CHD),all the cases can be attributed to precordial stuffiness pain in traditional Chinese medicine (TCM),here we investigated the syndrome of Qi-deficiency and blood stasis and the syndrome of phlegm stagnation.Methods70patients suffered DM with CHD after coronary-arterial stent implantation were randomly assigned to treatment group(conventional western medicine therapy integrated with Yixin Tongmai Tang as treatment; n=35) and control group (single conventional western medicine therapy-, n=35).The treatment course was one year for both groups. The primary outcome was the ratio of restenosis in stent-implanted coronary artery in both groups before and at the end of1-year treatment; compare the RR period changes in ECG with Valsalva-test to assess the cardiac autonomic nerves situation; assess the condition by a rating scale of syndrome and symptom in TCM and observe the side-effects in both groups before and1-week,1-month,3-months,6-months and1-year during the treatment.Results1. Effectiveness assessments:70patients were enrolled in this clinical trial;68patients completed the treatment course. For the primary outcome, there was a significant (P<0.05) difference in the restenosis ratio at the end of1-year treatment between treatment group (8.82%) and control group (17.65%). There was a (P<0.05) difference in effectiveness ratio assessed by R-R period of ECG through Valsalva test between treatment group (73.53%) and control group (61.76%). There was also a significant (P<0.05) difference in the total effectiveness ratio assessed by syndrome and symptom in TCM between treatment group (88.24%) and control group (35.29%).2. Safety assessments:There was no obvious abnormality in both groups safety detection during the clinical study; also no side-effects produced by the treatment.Conclusion Yixin Tongmai Tang can decrease the ISR ratio after PCI applied to DM with CHD(attributed to Qi-deficiency and blood stasis syndrome and phlegm stagnation syndrome of precordial stuffiness pain in TCM); improve the cardiac autonomic nerves function, remarkably improve those patients’ living standards assessed by the rating scale of syndrome and symptom in TCM; possess safety with no obvious side-effects.