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Contrast Awareness: Why and When Do we Worry? Roxana Mehran, MD Professor of Medicine Contrast Awareness: Why and When Do we Worry? Roxana Mehran, MD Professor of Medicine (Cardiology) and Health Evidence Policy Director of Interventional Cardiovascular Research and Clinical Trials The Icahn School of Medicine at Mount Sinai, New York, NY Chief Scientific Officer Cardiovascular Research Foundation, New York, NY Cardiovascular Research Technology - CRT February 23 -26, 2013 Washington, DC

Roxana Mehran, MD Consulting: Astra. Zeneca, Johnson and Johnson, Merck and Company, Inc. , Roxana Mehran, MD Consulting: Astra. Zeneca, Johnson and Johnson, Merck and Company, Inc. , and Abbott Laboratories Grant Support: Bristol-Myers Squibb, Sanofi, The Medicines Company, Lilly and Daiichi Sankyo Honoraria: Regado Bio-Sciences

Contrast Media During CTO: What are the Issues? • CTO procedures are one of Contrast Media During CTO: What are the Issues? • CTO procedures are one of the most complex • • • and time consuming procedures in IC Most CTO procedures require dual injection for complete visualization of the vessel to enhance success Contrast volume in these procedures are usually twice or more than the routine PCI procedures Patients with CTO are usually more complex, with more co-morbidities which will increase the risk of contrast Induced- acute kidney injury (CI- AKI)

Contrast-induced Nephropathy: In-hospital Mortality % In-hospital Death P<0. 001 Mc. Cullough et al. Am Contrast-induced Nephropathy: In-hospital Mortality % In-hospital Death P<0. 001 Mc. Cullough et al. Am J Med. 1997; 103 -375.

Contrast-Induced Nephropathy: Resource Utilization Patients Endpoint (%) P-value With CIN Without CIN Hospital length Contrast-Induced Nephropathy: Resource Utilization Patients Endpoint (%) P-value With CIN Without CIN Hospital length of stay (days) 9. 6+7. 2 3. 2+6. 4 <0. 001 ICU length of stay (days) 2. 3+4. 4 0. 6+1. 8 <0. 0001 12 0 <0. 0001 Need for hemodialysis (%) Iakovou I et al. J Am Coll Cardiol. 2002; 39: 2 A.

How to Assess Renal Function? Abbreviated Modification of Diet in Renal Disease equations (MDRD) How to Assess Renal Function? Abbreviated Modification of Diet in Renal Disease equations (MDRD) equation: e. GFR, ml/min/1. 73 m 2= 186 x (Serum Creatinine [mg/d. L]) -1. 154 x (Age-0. 203 x (0. 742 if female) x (1. 210 if African American) Cockcroft-Gault equation: (140 - age) x Body Weight [kg]* Creatinine Clearance, ml/min = Serum Creatinine mg/d. L] x 72 * Multiple by 0. 8 in female

Contrast-Induced Nephropathy Definition • New onset or exacerbation of renal dysfunction after contrast administration Contrast-Induced Nephropathy Definition • New onset or exacerbation of renal dysfunction after contrast administration in the absence of other causes: increase by > 25% or absolute of > 0. 5 mg/d. L from baseline serum creatinine Occurs 24 to 48 hrs post–contrast exposure, with creatinine peaking 5 to 7 days later and normalizing within 7 to 10 days in most cases

Can we Prevent CIN? Can we Prevent CIN?

YES we Can!! Or at least try to… • Assess the patient’s risk status YES we Can!! Or at least try to… • Assess the patient’s risk status before the procedure

Scheme to Define CIN Risk Score Risk Factors Integer Score Hypotension 5 IABP 5 Scheme to Define CIN Risk Score Risk Factors Integer Score Hypotension 5 IABP 5 CHF 5 Age >75 years 4 Anemia 3 Diabetes 3 Contrast media volume Serum creatinine > 1. 5 mg/dl OR e. GFR <60 ml/min/1. 73 m 2 e. GFR < 60 ml/min/1. 73 m 2 = 186 x (SCr)-1. 154 x (Age)-0. 203 X (0. 742 if female) x (1. 210 if African American) 1 for each 100 cc 3 4 2 for 40 – 60 4 for 20 – 40 6 for < 20 Risk Score Dialysis ≤ 5 Calculate Risk of CIN Risk of 7. 5% 0. 04% 6 to 10 14. 0% 0. 12% 11 to 16 26. 1% 1. 09% ≥ 16 57. 3% 12. 6% Mehran et al. JACC. 2004; 44: 1393 -1399.

Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Hydrate all patients as tolerated for as long as possible but at least two- four hours before procedure- may require to bring the patient in the night before for careful/gentle hydration in those with CHF

Optimal Hydration 0. 9% NS vs 0. 45% NS 3 0. 9% Saline 0. Optimal Hydration 0. 9% NS vs 0. 45% NS 3 0. 9% Saline 0. 45% Sodium Chloride Incidence, % P=. 04 2 P=. 93 P=. 35 1 0 CN Mortality Mueller et al Arch Intern Med 2002 Vascular

Sodium Bicarbonate Hydration p = 0. 82 p = 0. 97 Brar S, et Sodium Bicarbonate Hydration p = 0. 82 p = 0. 97 Brar S, et al. JAMA 2009

Renal. Guard. TM for CI-AKI prevention is designed to: ¡ Create and maintain high Renal. Guard. TM for CI-AKI prevention is designed to: ¡ Create and maintain high urine output ¡ Prevent contrast agents from clogging tubules ¡ Limit toxin exposure in kidneys ¡ Automated matched fluid replacement in real-time to reduce side effects associated with over- or under-hydration US: Investigational device. Limited by Federal Law to investigational use. 23

MYTHOS Study Consecutive CKD patients (e. GFR<60 ml/min/1. 73 m 2) undergoing coronary angiography MYTHOS Study Consecutive CKD patients (e. GFR<60 ml/min/1. 73 m 2) undergoing coronary angiography between September 1, 2008 and September 15, 2010 Elective Procedures n= 94 Renal. Guard n=80 157 pts Urgent (<24 hrs) procedures (NSTEMI) n= 63 Standard i. v. hydration (1 ml/kg/hr) for 12 hrs before and after procedure n=77 Primary end point: CIN (>0. 5 mg/dl or >25% s. Cr increase during first 72 hrs) Secondary end points: In-hospital MACE (acute pulmonary edema, cardiogenic shock, MI, need for RRT, severe arrhythmias, and death) Bartorelli A. JACC Int. 2012.

 Incidence of CIN Controls P=0. 03 % P=0. 028 16% -69% Renal. Guard Incidence of CIN Controls P=0. 03 % P=0. 028 16% -69% Renal. Guard 25% -80% P NS -60% 10% 5% All patients 6% NSTEMI 4% Elective procedures

REMEDIAL II REnal Insufficiency Following Contrast MEDIA Administration II Tria. L Renal. Guard system REMEDIAL II REnal Insufficiency Following Contrast MEDIA Administration II Tria. L Renal. Guard system in high risk patients for contrast induced acute kidney injury Carlo Briguori, MD, Ph. D Laboratoy of Interventional Cardiology Clinica Mediterranea, Naples - Italy

Enrollement Assessed for eligibility (n=806) Exclusion (n=512) Not meeting inclusion/exclusion criteria (n=485 ) Refused Enrollement Assessed for eligibility (n=806) Exclusion (n=512) Not meeting inclusion/exclusion criteria (n=485 ) Refused to partecipate (n=27) Analysis Follow-up Allocation Randomized (n=294) üPatients allocated in the Renal. Guard group (n=147) üReceived allocated treatment (n=146) üDid not receive the allocated treatment (n=1) üPatients allocated in the Control group (n=147) üReceived allocated treatment (n=146) üDid not receive the allocated treatment (n=1) Patients lost at follow-up (n=0) Discontinued treatment (n=2) Patients lost at follow-up (n=0) Discontinued treatement (n=0) Patients analized (n=146) Patients excluded from analysis (n=0)

Primary endpoint 25 20 Odds ratio = 0. 47; 95% CI= 0. 24 -0. Primary endpoint 25 20 Odds ratio = 0. 47; 95% CI= 0. 24 -0. 92 p = 0. 025 20. 5% CI-AKI (%) 30/146 15 11% 10 16/146 5 0 Control group Renal. Guard group

A study to evaluate the safety and efficacy of the Renal. Guard System when A study to evaluate the safety and efficacy of the Renal. Guard System when compared with standard care in the prevention of contrast induced nephropathy in the catheterization laboratory RGS 001 D Version 4. 1 – 14 April 2011 © PLC Medical Systems, Inc.

STUDY PROCEDURES RENALGUARD CONTROL RANDOMIZATION Approx 90 min prior Approx 60 min prior During STUDY PROCEDURES RENALGUARD CONTROL RANDOMIZATION Approx 90 min prior Approx 60 min prior During Cath • Baseline Blood (prior to therapy) • Foley Cath • RG Match Hydration • Hydration Bolus (NS 100 -250 mls) • NAC per protocol • Lasix Dose (0. 3 mg/Kg) • RG Match Hydration • Visipaque or Isovue • Additional Lasix ( if needed) • RG Matched Hydration (for 4 hrs post last administration of contrast) • Blood Draw/urine post procedure (2 - 4 post last contrast) • Urine output monitoring ( from hour 4 to hour 6) • NAC per site protocol • Baseline Blood (prior to therapy) • NAC per protocol • 3 ml/Kg/hr Bicarb hydration (x 60 min prior to cath) • 1 ml/Kg/hr Bicarb hydration • Visipaque or Isovue • 1 ml/Kg/hr saline hydration (for 6 hours post cath) • Blood Draw/urine post procedure (2 - 4 post last contrast) • Patient monitoring • NAC per site protocol Approx 90 min prior Approx 60 min prior During Cath Post Catheterization © PLC Medical Systems, Inc,

Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Hydrate all patients as tolerated for as long as possible but at least two- four hours before procedure- may require to bring the patient in the night before for careful/gentle hydration in those with CHF • Choose low-osmolar contrast media and monitor the volume

CARE Design • DESIGN: Prospective, randomized, double-blind, parallel-group, multi-center clinical evaluation ipamidol-370 and iodixanol-320 CARE Design • DESIGN: Prospective, randomized, double-blind, parallel-group, multi-center clinical evaluation ipamidol-370 and iodixanol-320 • OBJECTIVE: To compare the incidence of CIN between iopamidol-370 and iodixanol-320 • PRIMARY ENDPOINT: Increase in SCr ≥ 0. 5 mg/d. L from baseline to 45 to 120 hours after administration 482 patients enrolled between July 2005 and June 2006 in 25 clinical site in North America 14 patients withdrew consent 468 assigned to a treatment arm 230 patients assigned to Iopamidol-370 26 excluded 204 evaluable patient 236 patients assigned to Iodixanol -320 26 excluded 210 evaluable patient Solomon RJ et al. Circulation. 2007; 115, 3189.

CARE p = 0. 39 p = 0. 44 p = 0. 15 CARE p = 0. 39 p = 0. 44 p = 0. 15

Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Hydrate all patients as tolerated for as long as possible but at least two- four hours before procedure- may require to bring the patient in the night before for careful/gentle hydration in those with CHF • Choose low-osmolar contrast media and monitor the volume!!

Columbia University CTO Experience N=390 (ml) Contrast Volume Min. 43 – Max. 1120 ml Columbia University CTO Experience N=390 (ml) Contrast Volume Min. 43 – Max. 1120 ml P=0. 68

Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Tips to Prevent CIN • Assess the patient’s risk status before the procedure • Hydrate all patients as tolerated for as long as possible but at least two- four hours before procedure- may require to bring the patient in the night before for careful/gentle hydration in those with CHF • Choose low-osmolar contrast media and monitor the volume!! • Follow the patient post procedure with repeat creat ( 24 hours, 48 -72 hrs with PMD) and continue hydration for 12 hours

Conclusions (1) • CTO procedures are usually in the most complex patients and are Conclusions (1) • CTO procedures are usually in the most complex patients and are the most time consuming and require the largest volume of contrast media than most coronary procedures. • CI- AKI remains a frequent source of acute renal failure and is associated with increased morbidity and mortality, and higher resource utilization • Several factors predispose patients to CIN • Preventive measures pre procedure, as well as careful post procedure management should be routine in all patients

 Conclusions (2) • • • Hydration pre-PCI (12 hours recommended) D/C nephrotoxic drugs Conclusions (2) • • • Hydration pre-PCI (12 hours recommended) D/C nephrotoxic drugs (NSAIDS, antibiotics, etc) NO ROLE for n-acetylcysteine !! No Role for IV Fenoldopam Sodium bicarbonate may be useful, but need more definitive data • Limit contrast agent volume • Low-osmolar agents are better than high-osmolar ¡ Within non-ionic contrast, the data are contradictory