Yaling Han1, Guoying Zhu2, Lixian Han3, Fengxia Hou4, Weijian Huang5, Huiliang Liu6, Jihong Gan7, Tiemin Jiang8, Xiaoyan Li9, Wei Wang10, Shifang Ding11, Shaobin Jia12, Weifeng Shen13, Dongmei Wang14, Ling Sun15, Jian Qiu16, Xiaozeng Wang17, Yi Li17, Jie Deng17, Jing Li17, Kai Xu17, Bo Xu18, Roxana Mehran19, Yong Huo20. 1. Department of Cardiology, Shenyang Northern Hospital, Shenyang, China. Electronic address: hanyl169@gmail.com. 2. Department of Cardiology, WuHan Asia Heart Hospital, Wuhan, China. 3. Department of Cardiology, CangZhou Central Hospital, CangZhou, China. 4. Department of Cardiology, Changchun Central Hospital, Changchun, China. 5. Department of Cardiology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China. 6. Department of Cardiology, General Hospital of Armed Police Forces, Beijing, China. 7. Department of Cardiology, Lanzhou Military WuluMuqi PLA Hospital, Wulumuqi, China. 8. Department of Cardiology, Affiliated Hospital of Medical College of Armed Police Forces, Tianjin, China. 9. Department of Cardiology, Jinan Military General Hospital, Jinan, China. 10. Department of Cardiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 11. Department of Cardiology, Wuhan General Hospital of Guangzhou Military, Wuhan, China. 12. Department of Cardiology, Affiliated Hospital of Ningxia Medical College, Yinchuan, China. 13. Department of Cardiology, Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University, Shanghai, China. 14. Department of Cardiology, Shijiazhuang International Peace Hospital, Shijiazhuang, China. 15. Department of Cardiology, Fushun Central Hospital, Fushun, China. 16. Department of Cardiology, General Hospital of Guangzhou Military Command of PLA, Guangzhou, China. 17. Department of Cardiology, Shenyang Northern Hospital, Shenyang, China. 18. Cardiac Catheterization Laboratory, Fuwai Hospital, Beijing, China. 19. Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 20. Department of Cardiology, First Hospital of Beijing University, Beijing, China.
Abstract
OBJECTIVES: This study sought to evaluate the safety and efficacy of rosuvastatin in preventing contrast-induced acute kidney injury (CI-AKI) in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). BACKGROUND: CI-AKI is an important complication after contrast medium injection. While small studies have shown positive results with statin therapy, the role of statin therapy in prevention of CI-AKI remains unknown. METHODS: We randomized 2,998 patients with type 2 DM and concomitant CKD who were undergoingcoronary/peripheral arterial angiography with or without percutaneous intervention to receive rosuvastatin, 10 mg/day (n = 1,498), for 5 days (2 days before, and 3 days after procedure) or standard-of-care (n = 1,500). Patients' renal function was assessed at baseline, 48 h, and 72 h after exposure to contrast medium. The primary endpoint of the study was the development of CI-AKI, which was defined as an increase in serum creatinine concentration ≥0.5 mg/dl (44.2 μmol/l) or 0.25% above baseline at 72 h after exposure to contrast medium. RESULTS: Patients randomized to the rosuvastatin group had a significantly lower incidence of CI-AKI than controls (2.3% vs. 3.9%, respectively; p = 0.01). During 30 days' follow-up, the rate of worsening heart failure was significantly lower in the patients treated with rosuvastatin than that in the control group (2.6% vs. 4.3%, respectively; p = 0.02). CONCLUSIONS:Rosuvastatin significantly reduced the risk of CI-AKI in patients with DM and CKD undergoing arterial contrast medium injection. (Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes [TRACK-D]; NCT00786136).
RCT Entities:
OBJECTIVES: This study sought to evaluate the safety and efficacy of rosuvastatin in preventing contrast-induced acute kidney injury (CI-AKI) in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). BACKGROUND: CI-AKI is an important complication after contrast medium injection. While small studies have shown positive results with statin therapy, the role of statin therapy in prevention of CI-AKI remains unknown. METHODS: We randomized 2,998 patients with type 2 DM and concomitant CKD who were undergoing coronary/peripheral arterial angiography with or without percutaneous intervention to receive rosuvastatin, 10 mg/day (n = 1,498), for 5 days (2 days before, and 3 days after procedure) or standard-of-care (n = 1,500). Patients' renal function was assessed at baseline, 48 h, and 72 h after exposure to contrast medium. The primary endpoint of the study was the development of CI-AKI, which was defined as an increase in serum creatinine concentration ≥0.5 mg/dl (44.2 μmol/l) or 0.25% above baseline at 72 h after exposure to contrast medium. RESULTS:Patients randomized to the rosuvastatin group had a significantly lower incidence of CI-AKI than controls (2.3% vs. 3.9%, respectively; p = 0.01). During 30 days' follow-up, the rate of worsening heart failure was significantly lower in the patients treated with rosuvastatin than that in the control group (2.6% vs. 4.3%, respectively; p = 0.02). CONCLUSIONS:Rosuvastatin significantly reduced the risk of CI-AKI in patients with DM and CKD undergoing arterial contrast medium injection. (Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes [TRACK-D]; NCT00786136).
Authors: David M Safley; Adam C Salisbury; Thomas T Tsai; Eric A Secemsky; Kevin F Kennedy; R Kevin Rogers; Faisal Latif; Nicolas W Shammas; Lawrence Garcia; Matthew A Cavender; Kenneth Rosenfield; Anand Prasad; John A Spertus Journal: JACC Cardiovasc Interv Date: 2021-02-08 Impact factor: 11.195
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