Jun-Neng Roan1,2, Wei-Hung Lin3, Meng-Ta Tsai1, Te-Hui Kuo3, Ting-Wei Lin1,4, Di-Yung Chen1, Shih-Yuan Fang5, Ya-Ping Hsieh5, Chung-Yi Li6,7, Chen-Fuh Lam8,9. 1. Department of Surgery, Division of Cardiovascular Surgery. 2. Medical Device Innovation Center. 3. Department of Internal Medicine, Division of Nephrology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan. 4. Department of Surgery, Division of Cardiovascular Surgery, E-DA Hospital and College of Medicine, I-Shou University, Kaohsiung. 5. Department of Anesthesiology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University. 6. Department and Institute of Public Health, College of Medicine, National Cheng Kung University, Tainan. 7. Department of Public Health, College of Public Health, China Medical University, Taichung. 8. Department of Anesthesiology, E-Da Hospital. 9. School of Medicine, I-Shou University College of Medicine, Kaohsiung, Taiwan.
Abstract
BACKGROUND: Very limited therapeutic strategies exist to prevent the primary failure of arteriovenous (AV) fistulas in patients with diabetes. OBJECTIVES: To investigate whether rosuvastatin could improve the primary patency of AV fistulas in diabetic patients with stage 5 chronic kidney disease (CKD). METHODS: This was a double-blind randomized clinical trial. From July 2012 to September 2018, patients aged between 18 and 65 years with type 2 diabetes and stage 5 CKD were randomized to receive placebo or rosuvastatin (5 mg/day) for 7 days prior to the creation of an AV fistula on the forearm until the 21st day after surgery. Patients were followed up for 180 days after the operation. The primary composite endpoint was the development of fistula immaturity or stenosis. The secondary endpoints were changes in inflammatory markers, oxidative stress, and occurrence of postoperative complications. RESULTS: A total of 60 patients were enrolled in the study. Rosuvastatin resulted in a 20% reduction in total cholesterol from postoperative day 0 to 28 (p = .0006). The overall rate of AV fistula failure (immaturity or stenosis) was 30%, with no significant difference between patients receiving rosuvastatin and those receiving the placebo (33.3% vs. 26.7%, p = .5731). Although not statistically significant, the administration of rosuvastatin might have increased the incidence of postoperative complications (2.99 vs. 2.39 event rate per 1000 patient-days; odds ratio, 1.33; p = .5986). CONCLUSIONS: Rosuvastatin showed no significant beneficial effects on the primary patency of AV fistulas in diabetic patients with stage 5 CKD, but might have been associated with the risk of drug-related complications.
BACKGROUND: Very limited therapeutic strategies exist to prevent the primary failure of arteriovenous (AV) fistulas in patients with diabetes. OBJECTIVES: To investigate whether rosuvastatin could improve the primary patency of AV fistulas in diabetic patients with stage 5 chronic kidney disease (CKD). METHODS: This was a double-blind randomized clinical trial. From July 2012 to September 2018, patients aged between 18 and 65 years with type 2 diabetes and stage 5 CKD were randomized to receive placebo or rosuvastatin (5 mg/day) for 7 days prior to the creation of an AV fistula on the forearm until the 21st day after surgery. Patients were followed up for 180 days after the operation. The primary composite endpoint was the development of fistula immaturity or stenosis. The secondary endpoints were changes in inflammatory markers, oxidative stress, and occurrence of postoperative complications. RESULTS: A total of 60 patients were enrolled in the study. Rosuvastatin resulted in a 20% reduction in total cholesterol from postoperative day 0 to 28 (p = .0006). The overall rate of AV fistula failure (immaturity or stenosis) was 30%, with no significant difference between patients receiving rosuvastatin and those receiving the placebo (33.3% vs. 26.7%, p = .5731). Although not statistically significant, the administration of rosuvastatin might have increased the incidence of postoperative complications (2.99 vs. 2.39 event rate per 1000 patient-days; odds ratio, 1.33; p = .5986). CONCLUSIONS: Rosuvastatin showed no significant beneficial effects on the primary patency of AV fistulas in diabetic patients with stage 5 CKD, but might have been associated with the risk of drug-related complications.
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