Comparative Analysis on the Efficacy of Sustained-release Isosorbide Dinitrate and Isosorbide Mononitrate in Patients With Residual Ischemia After Percutaneous Coronary Intervention or Borderline Coronary Stenosis
Objectives:To compare the effectiveness and safety of sustained-release isosorbide dinitrate(ISDN)or isosorbide mononitrate(ISMN)in Chinese patients with residual ischemia after percutaneous coronary intervention(PCI)or borderline coronary stenosis.Methods:Patients with residual ischemia after PCI or borderline coronary stenosis were randomized to either ISDN(20 mg,twice daily,n=217)or ISMN(20 mg,twice daily,n=218)groups.The patients were treated for 3 months.Main analysis included changes in the Seattle Angina Questionnaire(SAQ),major adverse cardiac or cerebrovascular events(MACCE,including all causes of death,myocardial infarction,revascularization,stroke),and drug-related adverse effects between baseline and 1,2,and 3 months after therapy.Results:After therapy,there was a significant increase in scores across all five SAQ domains in both groups(both Ptrend<0.001).The non-inferiority test did not reveal any distinction between the two groups.After three months,there was no statistically significant difference in MACCE between the two groups(1.4%vs.4.6%,P=0.067).Following therapy,both groups had negative medication effects such as headaches,hypotension was less common in the ISDN group than in ISMN group(0.9%vs.4.1%,P=0.033).There was no discernible difference in discontinuation rate between the two patient groups(3.2%vs.3.7%,P=0.916).Conclusions:Patients with residual ischemia after PCI or borderline coronary stenosis can significantly enhance their quality of life by taking sustained-release isosorbide dinitrate.The frequency of hypotension is less common in ISPN group,the therapeutic effectiveness,MACCE,and adverse medication effects are comparable between groups.