Efficacy And Safety Of Cardiac Shock Wave Therapy For Patients With Severe Coronary Artery Disease

Background:Cardiac shock wave therapy(CSWT)is a relatively new therapy used globally for coronary artery disease(CAD)patients.Previous single-arm studies proved the efficacy and safety for CAD patients who are not candidate forreperfusion therapy.Randomized control trials are limited.The method of control and the assessment of outcome is different in the previous RCTs.In this study,prseudo treatment is selected.We try to explore the efficacy and safety of CSWT for patients with severe CAD.In the second part of this study,we try to observe the long-term outcome and investigate the related risk factors of major adverse cardiovascular event(MACE).Methods:All patient were in-hospital patients who underwent coronary angiography and confirmed multi-vessle disease from January of 2017 to September of 2020 in our hospital.Patients had ischemia on myocardial perfusion imaging(MPI)were enrolled and randomly assigned to group A or group B.Group A received the real treatment first and then changed to pseudo-treatment.Group B received the pseudo-treatment first and followed the real treatment.Efficacy outcomes included clinical symptom,imaging outcomes,quality of life(QOL)and 6 minut walk test(6MWT).Blood pressure,heart rate(HR)and saturation of oxeyon(SO2)was recorded.Cardiac enzyme and brain natrium peptide(BNP)was checked after one week of the iniation of CSWT.In the part II study,patients who received CSWT in our hospital were enrolled from 2012.1-year MACE were analyzed.Risk factors associated with 1-year MACE were investigated.Results:In RCT part,40 patients were finally enrolled,with an average age of 70.3 years old.Male and female ratio was 29:11.Three-vessel disease patients accounted for 92.5%.In all the cormorbidities,hypertension and hyperlipidemia were the most common,with a ratio of 85%.Group A enrolled 25 patients and group B had 15 patients.At the first follow-up,CCS and NYHA classification were not significant between two groups.CCS classification significantly increased after treatment in group A(P=0.043).Nitroglycerin usage and 6MWT were not different between two groups.Nitroglycerin usage significantly decreased after treatmentin group A(P=0.03),while group B not.6MWT significantly increased after treatmentin group A(P<0.001),while group B not.5 domains of SAQ were not significant different between groups.Physical limitation(P=0.012),angina stability(P=0.029),angina frequence(P=0.011),treatment satisfaction(P=0.018)significantly improved after treatment in group A.Angina stability(P=0.01),angina frequence(P=0.003)and treatment satisfaction(P=0.04)and QOL(P=0.04)significantly improved after treatment in group B.8 domains of SF36 questionnaire were not different between groups.Physical function(P=0.037),body pain(P=0.032)and social function(P=0.046)significantly improved after treatment in group A.General health(P=0.012),vitality(P=0.005)and mental health(P=0.015)significantly improved in group B.MPI indicated that summed rest score(SRS),summed stress score,summed difference score(SDS)were not different between groups.SSS(P=0.014)and SDS(P=0.008)significantly decreasd in group A.SRS(P=0.016)significantly decreasd in group B.Regional stress score(P=0.001),regional reverse score(P<0.001)and regional stress ischemic area(P=0.001)and egional reverse ischemic area(P=0.01)significantly improved after treatment in group A.Regional reverse score(P=0.016)significantly improved in the group B.In the second follow-up,there were 24 patients in goup A and 12 patients in group B.CCS,NYHA classification,nitroglycerin usage and 6MWT were not different between groups.CCS classification significantly decreased after treatment in group A(P=0.021).Nitroglycerin usage significantly decreased after treatment in group A(P<0.001),while group B not.6MWT significantly increased after treatment in both group A(P=0.004)and group B(P<0.001).5 domains of SAQ were not significant different between groups.Physical limitation(P=0.007),angina stability(P=0.002).angina frequence(P=0.011)and treatment satisfaction(P=0.019)and QOL(P=0.033)all significantly improved after treatment ingroup A.Only Physical limitation(P=0.008)improved after treatment in group B.SF-36 questionnaire showed that only physical role(P=0.007)significantly improved after treatment in group A.MPI indicated that SRS(P<0.001),SSS(P<0.001)and SDS(P=0.033)significantly decreased after treatment in group A.SRS(P=0.016)significantly increased after treatment in group B.Regional reverse score in group A was significantly higher that group B before(P=0.006)and after treatment(P=0.008).Regional stress score(P=0.019)and regional reverse score(P=0.001)significantly decreased after treatment in group A.Regional rest score(P=0.02)significantly increased after treatment and regional reverse score(P=0.003)significantly decreased after treatment in group B.In terms of adverse effect,8 patients reported mild pain and 5 patients had skin redness.2 patients reported non-related SAE.During the treatment,HR.BP and SO2 were not different between two group or after treatment.Serum TNT and BNP did not change after treatment.CKMB showed significantly increased after treatment in group B,but the value was with in the normal range.In the long-term observational period,the incidence of 1-year MACE were 8(10.95%).Binary Logistic regression analysis showed that Syntax ? PCI score was the independent risk factor for 1-year MACE(OR=1.131,95%CI 1.012-1.265,P=0.030).Conclusions:Our study indicate:1.CSWT could effectively alleviate angina,increase exertional capacity and inprove QOL in patients with severe CAD who are not candidate for reperfusion therapy.2.CSWT may improve the degree and area of ischemia by MPI evaluation.3.CSWT is a safe treatment for those patients who are not appropriate for reperfusion therapy.4.Syntax ? PCI score may be the independent risk factor of 1-year MACE for those patients.