Table 1. Characteristics of the study, trial characteristics and protocols.
Trial (Year) | Patients number | Inclusion criteria | Definition of CIN | Medication Protocols | Contrast agent | Contrast volumes (mean), ml | Hydration protocols | |||
Statin (N = 2889) | Control (N = 2936) | Statin | Control | Statin | Control | |||||
PROMISS (2008) | 118 | 118 | CKD patients undergoing CAG or PCI, CrCl≤60 mL/min or SCr≥1.1 mg/dL | Increase of SCr≥0.5 mg/dL or ≥25% at 48 hours | Simvastatin 40 mg bid, 1 day pre-procedure and 1 day post-procedure | Placebo | Visipaque (iodixanol) | 173.3 | 190.9 | NS 1 mg/kg/h for 12 h before and 12 h after procedure |
Toso et al. (2009) | 152 | 152 | CKD patients undergoing CAG or PCI, CrCl<60 mL/min | Increase of SCr≥0.5 mg/dl within 5 days. | Atorvastatin 80 mg/day 2 days pre-procedure and 2 days post-procedure, NAC 1200 mg bid from 1 day before to 1 day post-procedure | Placebo + NAC 1200 mg bid from 1day before to 1 day post-procedure | Visipaque (iodixanol) | 151.0 | 164.0 | NS 1 ml/kg/h for 12 h before and after the procedure |
Xinwei et al. (2009) | 113 | 115 | ACS (UA/NSTEMI) including STEMI patients undergoing PCI | Increase of SCr≥0.5 mg/dL or ≥25% at 48 hours | Simvastatin 80 mg/day from admission to the day before, 20 mg/day after procedure | Simvastatin, 20 mg/day from admission to the end | Visipaque (iodixanol) for CKD, Omnipaque (iohexol) for non-CKD | 227.0 | 240.0 | NS 1 ml/kg/h for 6 to 12 h before and 12 h after procedure |
Zhou Xia et al. (2009) | 50 | 50 | Patients undergoing CAG or PCI | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Atorvastatin 80 mg/day before for 1day,10 mg/day for 6days after procedure | Atorvastatin 10 mg/day for 7 days | Iopamidol 370 mg/ml | 118.7 | 112.9 | NS 1000 mL infusion, for 12 h before and 12 h after intervention |
Acikel et al. (2010) | 80 | 80 | Patients undergoing elective CAG or PCI (excluding ACS), LDL≥70 mg/dl, eGFR≥60 ml/min/1.73 m2 | Increase of SCr≥0.5 mg/dL at 48 hours | Atorvastatin 40 mg/day 3 days pre-procedure and 2 days post-procedure | None | Omnipaque(iohexol) | 105.0 | 103.0 | NS 1 ml/kg/h starting 4 h before and continuing until 24 h after procedure |
Ozhan et al. (2010) | 60 | 70 | Patients undergoing CAG or PCI, eGFR≥70 ml/min/1.73 m2 or SCr≤1.5 mg/dL | Increase of SCr≥0.5 mg/dL or ≥25% at 48 hours | Atorvastatin 80 mg 1 day pre-procedure and 2 days post-procedure, NAC 600 mg bid pre-procedure | No statin pre-procedure, NAC 600 mg bid pre-procedure | Iopamidol | 97.0 | 93.0 | NS 1000 ml infusion during 6 h after procedure |
Hua et al. (2010) | 76 | 97 | Patients undergoing CAG or PCI | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Atorvastatin 80 mg/day pre-procedure | Atorvastatin 20 mg/day pre-procedure | Iopromide | 173.0 | 177.0 | NR |
ARMYDA-CIN (2011) | 120 | 121 | ACS (UA/NSTEMI) Patients undergoing CAG or PCI (excluding high-risk NSTEMI requiring emergency PCI), SCr≤3 mg/dl | Increase of SCr≥0.5 mg/dL or ≥25% at 48 hours | Atorvastatin 80 mg (12 h before) → 40 mg (2 h before), 40 mg for 2days after procedure | Placebo before procedure → Atorvastatin 40 mg for 2days after procedure | Xenetix (iobitridol) | 209.0 | 213.0 | For patients CrCl <60 ml/min, NS 1 ml/kg/h for 12 h before and 24 h after intervention |
Wei Li et al. (2012) | 78 | 83 | STEMI patients undergoing emergency PCI within 12 hours of symptom onset | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Atorvastatin 80 mg loading pre-procedure, long-term 40 mg/day after procedure | Placebo 801mg loading pre-procedure, long-term 40 mg/day after procedure | Ultravist 370 (iopromide) | 100.0 | 103.6 | NS 1 ml/kg/h before the procedure and for 12 h after the procedure |
NAPLES II (2012) | 202 | 208 | CKD patients undergoing CAG or PCI, eGFR<60 ml/min/1.73 m2 | Increase of Serum Cystatin C concentration ≥10% at 24 hours | Atorvastatin 80 mg before procedure, NAC 1200 mg bid the day before and the day of procedure | No statin pre-procedure, NAC 1200 mg bid the day before and the day of procedure | Visipaque (iodixanol) | 177.0 | 184.0 | Sodium bicarbonate solution (154 mEq/L), initial bolus of 3 mL/kg/h for 1 h before procedure, 1 mL/kg/h during and for 6 h after the procedure |
CAO et al. (2012) | 90 | 90 | Patients undergoing CAG or PCI | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Atorvastatin 40 mg/day from 3days before procedure, 20 mg/day after procedure | Atorvastatin 20 mg/day from 3days before procedure, 20 mg/day after procedure | NR | 162.3 | 158.9 | NR |
PRATO-ACS (2014) | 252 | 252 | ACS (UA/NSTEMI) patients undergoing CAG or PCI (excluding STEMI and high-risk NSTEMI requiring emergency PCI), SCr≤3 mg/dl | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Rosuvastatin 40 mg loading → 20 mg/day before procedure, Rosuvastatin 20 mg/day continued after procedure, NAC 1200 mg bid the day before and the day of procedure | No statin pre-procedure, Atorvastatin 40 mg/day after procedure, NAC 1200 mg bid the day before and the day of procedure | Visipaque (iodixanol) | 149.7 | 138.2 | NS 1 ml/kg/h for 12 h both before and after the procedure. Hydration rate was reduced to 0.5 ml/kg/h inboth arms for patients with LVEF <40% |
TRACK-D (2014) | 1498 | 1500 | Stage 2 or 3 CKD and type II DM patients undergoing CAG or PCI, eGFR ≥30 ml/min/1.73 m2 and <90 ml/min/1.73 m2 (excluded stage 0,1,4,5 CKD patients) | Increase of SCr≥0.5 mg/dL or ≥25% at 72 hours | Rosuvastatin 10 mg/day from 2 days before to 3 days after procedure → continued after procedure | No statin pre-procedure, Rosuvastatin 10 mg. day 3 days after procedure | Visipaque (iodixanol) | 120.0 | 110.0 | NS 1 ml/kg/h started 12 h before and continued for 24 h after procedure |
Abbreviations: ACS, acute coronary syndrome; CAG, coronary angiography; CIN, contrast induced nephropathy; CKD, chronic kidney disease; CrCl, creatinine clearance; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; LDL, low-density lipoprotein; LVEF, left ventricular ejection fraction; NAC, N-acetylcystein; NR, not reported; NS, normal saline (isotonic saline, 0.9%); NSTEMI, non ST-segment elevation myocardial infarction; PCI, percutaneous coronary intervention; SCr, serum creatinine; STEMI, ST-segment elevation myocardial infarction; UA, unstable angina.