Endpoints
stress myocardial perfusion, chest pain, myocardial ischemia
ADVERSE EVENTS, SECONDARY, MYOCARDIAL ISCHEMIA
The primary endpoint was weekly use of nitroglycerin at 3 months after the therapy. The secondary endpoints included chest pain frequency, CCS class score, 6-min walking distance, stress myocardial perfusion imaging, echocardiography, cardiac MRI, and adverse events. Weekly use of nitroglycerin and chest pain frequency were recorded by individual patient in dedicated notebooks received after the registration, and at the follow-up period, collected by blinded clinical research coordinator (CRC). During the study period, the notebooks were reviewed monthly by the CRC to confirm their accuracy regarding chest symptoms and frequency of nitroglycerin use. CCS class score was recorded by another blinded cardiologist. Changes in walking distance of the 6-min walking distance from baseline to 84 days after the initial implementation of treatment were obtained. Changes of left ventricular ejection fraction and abnormal wall motion in the echocardiography and cardiac MRI from baseline to 84 days after the initial implementation of treatment were obtained. As an evaluation of myocardial ischemia by stress myocardial perfusion imaging, the summed difference score (SDS) of the treatment area and the change in the ischemic amount before and 3 months after the treatment were calculated. Ischemic area was determined by prior invasive functional evaluation or stress myocardial perfusion imaging, and the analysis area of the heart was divided into 17 segments, and only the treatment-targeted area was extracted and analyzed [