Evolving Patterns Of Use Of Aldosterone Inhibition In Chronic Heart Failure; A Report From Get With The Guidelines HF

1. Evolving Patterns Of Use OfAldosterone Inhibition In Chronic Heart Failure;A Report From Get With The Guidelines HF Nancy M. Albert, Clyde W. Yancy, Li Liang, Adrian Hernandez, Gregg C. Fonarow, and the Get with the Guidelines Steering Committee and Hospitals

2. Presenter Disclosure InformationAHA Scientific Sessions Evolving Patterns Of Use OfAldosterone Inhibition In Chronic Heart Failure;A Report From Get With The Guidelines HF I willnotdiscuss off label or investigational use of drugs or devices in my presentation. I have financial relationships to disclose: Consultant and Speakers Bureau: GlaxoSmithKline Consultant: Medtronic GWTG-HF was sponsored in part by funding from GlaxoSmithKline to the American Heart Association

3. Background: Level B Evidence Aldosterone inhibition recommendations: Moderately severe-severe HF symptoms (i.e. hospitalized for HF) and Reduced LVEF Careful monitoring to preserve renal function and normal K+ Serum creatinine ≤ 2.5 mg/dL- men ≤ 2.0 mg/dL – women Serum potassium < 5.0 mEq/L Hunt SA, et al. ACC/AHA 2005 Practice Guidelines. Available at http://www.acc.org.

4. Background: Utilization Of Aldosterone Inhibitors OPTIMIZE-HF: Hospital Discharge 83 83 65.4 52.3 Eligible Patients Treated (%) 39.2 18 ACEI/ARB at Discharge (11,976/14,493) -Blocker at Discharge (13,032/15,675) Evidence-Based -Blocker (10,248/15,675) Aldosterone Antagonist (3,621/20,118) Statin (14,904/38,066) Warfarin (6,571/12,560) ACEI/ARB, -blocker, and aldosterone antagonist use in eligible patients with LVSD; statin in HF patients with a history of CAD, PVD, CVD and/or diabetes; and warfarin use in patients with HF and atrial fibrillation. Fonarow et al. JAMA 2007;297:61-70.

5. Background: Utilization Of Aldosterone Inhibitors IMPROVE-HF: Cardiology Outpatient Practices at Baseline Patients (%) (N = 11,271 / 14,167) (N = 12,039 / 14,058) (N = 3630 / 7169) (N = 9459 / 15,381) (N = 905 / 2505) (N = 528 / 1361) (N = 2450 / 3533) Fonarow GC, et al. Circ Heart Fail. 2008;1:98–106.

6. Background: Potential for Harm • Usage  since RALES1 • > 7 fold : 3% to 21.3%1 • > 4 fold : 34/1000 pts. (94) to 149/1000 pts (01) • 30.9% did not meet enrollment criteria1 • 22.8%, hyperkalemia; 14.1% Sr. Creatinine ≥ 2.5 mg/dL; 17.3%, eGFR < 30 ml/min • Discontinued in 7.2% (67/926 cases)3 • 49%, hyperkalemia; 51%, renal failure • Hospitalization for hyperkalemia2 • 2.4/1000 (1994) to 11.0/1000 (2001) • Mortality for hyperkalemia2 • 0.3/1000 (1994) to 2.0/1000 (2001) 1Masoudi FA, et al. Circulation 2005;112:39-47. 2 Juurlink DN, et al. NEJM 2004;351:543-551. 3Tamirisa KP et al. Am Heart J 2004;148:971-978.

7. Problem: It is unknown if HF patients in a quality of care hospital program receive aldosterone inhibitors more often and receive this therapy per recommendations Research Question: Has the appropriateness of aldosterone inhibitor usage among patients hospitalized for heart failure improved since 2005? PURPOSE

8. METHODS: Sample Get With the Guidelines-Heart Failure (GWTG-HF) National initiative of the AHA to improve guidelines adherence in patients hospitalized with HF Study Cohort 242 participating hospitals 45,322 patients hospitalized for HF Discharged home Without contraindications to aldosterone inh. January 1, 2005 – December 26, 2007

9. Patient Management Tool • Data was recorded using the Patient Management Tool™ (Outcome, Cambridge, MA), a Web-based interactive assessment and reporting system that tracks treatment and facilitates evidence- based medicine

10. METHODS: Definitions & Analysis Definitions • LV systolic dysfunction: EF ≤ 35% • Normal K+ level: ≤ 5.5 mmol/L • Normal serum creatinine: < 2.5 mg/dL • Opt Medical Tx: BB, ACEi/ARB or diuretic if indicated Analysis • Cochran-Mantel Haenzel general association statistics: Aldosterone in patient groups • Cochran-Mantel Haenzel- Row Mean scores: Aldosterone and time • Within hospital clustering was considered • Multivariable logistic regression analysis using Generalized Estimating Equations to account for pt & hosp characteristics and clustering within hospitals

11. RESULTS: Pt. Characteristics

12. RESULTS: Pt. Characteristics

13. RESULTS: Pt. Characteristics

14. RESULTS: Aldosterone Inh. Use

15. RESULTS: Aldosterone Inh. Use Over Time *, adjusted for within-hospital clustering

16. RESULTS: Trends in Compliance of Aldosterone Inhibitor Use Over Time *, adjusted for within-hospital clustering

17. Multivariable Modeling Logistic regression with GEE approach • Excluded cases with missing data. N=13,289 (67% of LVSD population) • Aldosterone use = 30.7%

18. LIMITATIONS • Data presented are dependent upon the accuracy and completeness of data abstraction from medical chart review • GWTG-HF hospitals are self selected • Rationale for decisions regarding therapy utilization may not be captured • These findings may not apply to practices that differ in patient characteristics or care patterns from GWTG-HF hospitals

19. CONCLUSIONS • These data are among the first to assess aldosterone inhibitor use in hospitalized patients and appropriateness since ~ 2005. • Within pts enrolled in GWTG HF, they demonstrate: • Appropriate use of aldosterone inhibitors increased modestly from 2005-2007 • Non-indicated use was low • Overall use of aldosterone inhibitors remains lower than expected • Users are more likely to have higher compliance on other performance and quality measures • Additional research is required to identify ongoing impediments to aldosterone inhibitorsuse.