1.
Safety of Low-calcium Dialysate and its Effects on Coronary Artery Calcification in Patients Undergoing Maintenance Hemodialysis.
Wen, Y, Gan, H, Li, Z, Sun, X, Xiong, Y, Xia, Y
Scientific reports. 2018;(1):5941
Abstract
To determine the safety of low-calcium-dialysate in patients undergoing maintenance hemodialysis (MHD) and its effects on coronary artery calcification (CAC) and analyze clinical risk factors for CAC. A total of 174 MHD patients were recruited and randomly divided into two groups: high-calcium dialysate (HCD, 1.5 mmol/L Ca2+) and low-calcium dialysate (LCD, 1.25 mmol/L Ca2+). Changes in CAC score (CACS) and cardiac function were evaluated using spiral computed tomography and echocardiography, respectively. Clinical and laboratory parameters were measured. Intra-dialysis adverse reactions were recorded and compared between the two groups. CACS was significantly lower in the LCD group than in the HCD group by the end of the study. Cardiac E/Amax was significantly higher in the LCD group than in the HCD group by the end of the study. There was no significant difference in the frequency of any intra-dialysis adverse reactions between the two groups during the study. LCD is helpful in maintaining cardiac diastolic function and postponing CAC progression. LCD does not increase intra-dialysis adverse reactions. Age may be the most important factor impacting CAC in MHD patients.
2.
Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial.
Xu, B, Dou, K, Yang, Y, Lv, S, Wang, L, Wang, H, Li, Z, Wang, L, Chen, Y, Huo, Y, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2012;(7):796-802
Abstract
AIMS: This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions. METHODS AND RESULTS The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively). CONCLUSIONS The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).