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Young-Hak Kim, MD, PhD on behalf of the PREVENT investigators

P reventive Strategies of RE nal Insufficiency in Patients with Diabetes Undergoing Inter VENT ion or Arteriography: The PREVENT trial . Young-Hak Kim, MD, PhD on behalf of the PREVENT investigators. Department of Cardiology, University of Ulsan College of Medicine

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Young-Hak Kim, MD, PhD on behalf of the PREVENT investigators

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  1. Preventive Strategies of REnal Insufficiency in Patients with Diabetes Undergoing InterVENTion or Arteriography: The PREVENT trial Young-Hak Kim, MD, PhD on behalf of the PREVENT investigators Department of Cardiology, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea

  2. Conflict of Interest • Nothig to disclose

  3. Contrast-Induced Nephropathy (CIN): - Common cause of hospital acquired renal failure. - Occurs in less than 1% of general population. - Occurs in up to 50% of patients with chronic renal insufficiency, especially if diabetes is present. Diabetic nephropathy and chronic kidney disease are the most common risk factors for the development of CIN. Background

  4. Background • Recent small scale studies suggested that hydration with sodium bicarbonate may be more protective than sodium chloride alone in the prevention of CIN. • However, in the recent meta-analysis, the effectiveness of sodium bicarbonate treatment remains uncertain due to the heterogeneity in outcomes across studies. • Ann Intern Med. 2009;151:631 • In particular, there are a few data about its effectiveness for patients with diabetes mellitus.

  5. Objective • To determine if sodium bicarbonate is superior to sodium chloride for preventing CIN in diabetic patients with mild to moderate chronic kidney dysfunction who are undergoing coronary and/or endovascular intervention or angiography.

  6. Subjects 3569 Patients screened 3146 Excluded 423 Eligible 41 Denied 382 Randomized 189 Randomized to Saline 193 Randomized to Bicarbonate 187 Included in primary contrast-induced nephropathy analysis 2 Excluded because did not have laboratory data after angiography 189 Included in 30-day clinical FU 188 Included in 6-month clinical FU 188 Included in primary contrast-induced nephropathy analysis 5 Excluded because did not have laboratory data after angiography 193 Included in 30-day clinical FU 192 Included in 6-month clinical FU

  7. Study Protocol Clinical FU to 6 months Contrast Media Exposure Before After Preparation Saline Creatinine, GFR Electrolyte Bicarbonate 1 hr 12 hrs 12 hrs 24 hrs 48 hrs 6 hrs NAC NAC • 1:1 randomization, open label design • 9 cardiac centers in Korea • Independent event committee and data management • Sponsored by CardioVascular Research Foundation, Seoul, Korea

  8. Study Protocol • Bicarbonate group: Sodium bicarbonate 154mEq/L: 3 mL/kg for 1 hour prior, decreased to 1 mL/kg/hr during and 6 hours after the procedure. • Saline group: Isotonic saline 0.9% NaCl: 1 mL/kg/hr for 12 hours before and 12 hours after. • All patients received oral N-acetylcysteine 1200 mg twice daily for 2 days, prior to procedure. • If ejection fraction < 45%, hydration rate was reduced to 0.5mL/kg/hr in both arms.

  9. Study Protocol • Serum creatinine was measured on days 1 and 2 post angiography. • For all patients, creatinine levesls were assessed until any increase of renal resolved or reached a new baseline of renal function. • All patients who developed CIN were asked to return around 1 month for repeat measurement of creatinine. • All study participants received idixanol (Visipaque, 320mg iodine/mL, Amersham), a non-ionic, dimeric iso-osmolar contrast medium.

  10. Inclusion Criteria • Age>18 years, no upper limits, • Diabetes treated with insulin or oral hypoglycemic agents, • Serum creatinine ≥ 1.1mg/dL, and • resting estimated glomerular filtration rate (GFR) • < 60 ml/min per 1.73 m2 by Modification of Diet in Renal Disease formula (1.863 x serum creatinine level -1.154 x age -0.203 x [0.742 if female])

  11. Exclusion Criteria • Serum creatinine ≥ 8 mg/dL • Resting estimated GFR < 15 ml/min/1.73 m2 • End stage renal disease on hemodialysis • Multiple myeloma • Pulmonary edema • Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg) • Acute STEMI undergoing primary PCI • Emergent coronary angioplasty or angiography • Recent use of contrast agent within 2 days • Allergic reaction to contrast • Pregnancy • Allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine

  12. Primary Study Endpoint • Occurrence of CIN within 48 hours after contrast exposure. • CIN was defined as an increase of serum creatinine >25% or absolute increase of serum creatinine  0.5mg/dL within 48 hours after coronary and/or endovascular intervention or angioplasty

  13. Secondary Endpoints • Secondary Endpoint • : Death (all-cause) • : Myocardial infarction • : Stroke • : Dialysis including hemofiltration • at 30 days, between 1 month and 6 months, and 6 months after contrast exposure.

  14. Sample Size Estimation • Study sample size was calculated on the basis of a power analysis assuming that 10% of sodium chloride group and 2% of the sodium bicarbonate group would develop contrast induced nephropathy. • With a power of 90% and 2-sided α of 0.05, 368 patients with complete data would be required to detect a statistically significant difference.

  15. Statistical Analysis • The categorical variables were presented as number (percentage) and were compared using chi-square or Fisher exact test. • The continuous variables were presented as median (interquartile range) and were compared using Mann-Whitney U test. • To identify independent predictors of CIN, multivariate logistic regression test was performed with fixed 7 covariates.

  16. Results

  17. Baseline Characteristics IDDM, insulin dependent diabetes; NIDDM, non insulin dependent diabetes; OHA, oral hypoglycemic agent.

  18. Baseline Characteristics BMI, body mass index; BP, blood pressure; GFR, glomerular filtration rate.

  19. Baseline Characteristics AMI, acute myocardial infarction

  20. Procedures * High Contrast Load: >140 mL and > maximal contrast dose (5 X body weight/creatinine)

  21. Medications during Hospitalization ACE, angiotensin converting enzyme

  22. Changes in Renal Function * Wilcoxon signed rank test

  23. Effect of Bicarbonate

  24. Primary End Point- Occurrence of CIN - % P=0.17 % % 17/188 10/187

  25. Difference in Serum Creatinine mg/dL P=0.18 P=0.49 † Mann-Whitney U test

  26. Difference in Estimated GFR mL/min/1.73 ㎡ P=0.48 P=0.18 † Mann-Whitney U test

  27. Rates of Dialysis % P=0.69 2/187 4/188

  28. Effect of BicarbonateAccording to the Contrast Volume

  29. CIN according to Contrast Volume P=0.93 P=0.058 (2/137) (8/134) (8/50) (9/54) * HCL, High Contrast Load: >140 mL and > maximal contrast dose (5Xbody weight/creatinine)

  30. Dialysis according to Contrast Volume P=1.00 P=0.37 (1/50) (1/54) (3/134) (1/137) * HCL, High Contrast Load: >140 mL and > maximal contrast dose (5Xbody weight/creatinine)

  31. CIN according to Contrast Volume P=0.61 P=0.15 6/76 8/78 9/110 4/111

  32. Dialysis according to Contrast Volume P=1.00 P=1.00 (2/78) (2/110) (1/76) (1/110)

  33. Multivariate Predictors of CIN From 7 covariates including age, sex, contrast amount, procedural type, LV ejection fraction, randomization, and body mass index

  34. Clinical Outcomes

  35. Major Adverse Events at 1 Month P=1.00 P=1.00 P=1.00 1 1 1 1 2 * MAE: Cumulative major adverse events

  36. Major Adverse Events between 1 to 6 months P=0.11 P=0.45 P=0.25 2 5 3 2 8 * MAE: Cumulative major adverse events

  37. Major Adverse Events at 6 Months P=0.053 P=0.45 P=0.37 2 6 1 4 3 10 * MAE: Cumulative major adverse events

  38. Conclusion • In patients with diabetic nephropathy who received coronary or endovascular angiography or intervention, hydration with sodium bicarbonate before or after contrast exposure was not superior to hydration with sodium chloride for the prevention of CIN.

  39. Thank You!! www.summitMD.com

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