Evolving Patterns Of Use Of Aldosterone Inhibition In Chronic Heart Failure; A Report From Get With...
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Transcript of Evolving Patterns Of Use Of Aldosterone Inhibition In Chronic Heart Failure; A Report From Get With...
Evolving Patterns Of Use Of Aldosterone 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
Presenter Disclosure Presenter Disclosure InformationInformation
AHA Scientific SessionsAHA Scientific SessionsEvolving Patterns Of Use Of Aldosterone
Inhibition In Chronic Heart Failure; A Report From Get With The Guidelines HF
I will not discuss 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
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.
Background: Utilization Of Aldosterone Inhibitors
83.0 83.0
65.4
39.2
18.0
52.3
0
20
40
60
80
100
Eli
gib
le P
atie
nts
Tre
ate
d (
%)
OPTIMIZE-HF: Hospital Discharge
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.
-Blocker at Discharge
(13,032/15,675)
Evidence-Based -Blocker
(10,248/15,675)
ACEI/ARB at Discharge
(11,976/14,493)
Aldosterone Antagonist
(3,621/20,118)
Statin (14,904/38,066)
Warfarin (6,571/12,560)
83 83
65.4
18
39.2
52.3
Background: Utilization Of Aldosterone Inhibitors
51
39
8086
36
6961
0
10
20
30
40
50
60
70
80
90
100
ACEI / ARB Beta-Blocker AldosteroneAntagonist
Anticoagulationfor Atrial
Fibrillation
CRT (CRT-D / CRT-P)
ICD / CRT-D HF Education
Pat
ien
ts (
%)
(N = 11,271 / 14,167)
(N = 12,039 / 14,058) (N = 905 / 2505)
(N = 2450 / 3533)(N = 528 / 1361)
(N = 3630 / 7169) (N = 9459 / 15,381)
IMPROVE-HF: Cardiology Outpatient Practices at Baseline
Fonarow GC, et al. Circ Heart Fail. 2008;1:98–106.
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.
PURPOSE 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?
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
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
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
indicatedAnalysis
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
RESULTS: Pt. Characteristics
Total N
No Aldo Inh.
Yes Aldo Inh. P value
Age, years; mean 70.2 71.1 66.4 <0.0001
Gender, male; % 51.5 50.7 57.7 <0.0001
Race, Caucasian; % 68.0 68.8 64.4 <0.0001
Hypertension; % 70.8 71.4 68.6 <0.0001
Prior MI, % 13.7 13.1 16.2 <0.0001
Smoking Hx, % 80.8 81.6 77.2 <0.0001
Renal Insuff. (SCr > 2.0) 16.4 17.1 13.5 <0.0001
Non-Ischemic HF 47.8 47.7 47.9 <0.0001
RESULTS: Pt. Characteristics
Status: Mean valuesTotal
N
No Aldo Inh.
Yes Aldo Inh. P value
Adm. SBP, mmHg 141.7 143.6 133.6 <0.0001
Adm. HR, bpm 85.0 84.8 86.0 <0.0001
Adm. BNP, pg/mL 1306 1275 1434 <0.0001
Adm. Sr Creat., mg/dL 1.86 1.94 1.52 <0.0001
Adm. BUN, mg/dL 28.5 29.0 26.7 <0.0001
Ejection Fraction, % 38.41 40.41 30.02 <0.0001
RESULTS: Pt. Characteristics
Therapies; Mean valuesTotal
N
No Aldo Inh.
Yes Aldo Inh. P value
Disch home after education x 6 instructions
81.8 80.2 85.7 <0.0001
Disch LVSD + ACEi/ARB Tx 87.6 86.2 91.1 <0.0001Disch LVSD + BB Tx 89.6 88.4 92.8 <0.0001Disch Smoking cessation 91.5 90.7 94.2 <0.0001ICD, % 10.4 8.3 19.6 <0.0001CRT/ICD, % 9.3 8.5 12.9 <0.0001Dialysis, % 3.7 4.5 0.5 <0.0001
RESULTS: Aldosterone Inh. Use
Use of Aldosterone Inhibitor %Overall 18.9EF ≤ 35% 28.9LVSD + Sr Creat < 2.5 mg/dL 31.8LVSD + Cr Clearance > 30 ml min 32.6LVSD + Sr K+ ≤ 5.5 mmol/L 30.5LVSD + optimal medical Tx when not contraindicated
29.4
ACC/AHA guidelines (EF ≤ 35%) 33.8
RESULTS: Aldosterone Inh. Use
Over Time
Group
Aldo Inh. Use
Trends in Aldosterone Inhibitor Use Over Time
P value*
Jan-Jun 05
Jul-Dec 05
Jan-Jun 06
Jul-Dec 06
Jan-Jun 07
Jul-Dec 07
Overall Use 8,564 17.25 18.90 19.36 20.23 17.70 19.09 <.0001
LVSD 5,735 25.3 28.34 29.58 31.08 27.49 29.53 <.0001
No LVSD 2,050 9.68 11.10 11.45 11.60 9.64 10.44 .140
Core HF drugs 5,619 25.61 28.85 30.12 31.54 28.03 29.89 <.0001
Class I guideline criteria
3,687 29.62 33.95 33.44 36.03 32.93 .0004
*, adjusted for within-hospital clustering
RESULTS: Trends in Compliance of Aldosterone Inhibitor Use Over Time
Aldosterone Inh. Users (n / N)
Trends in COMPLIANCE of Aldosterone Inhibitor Use Over Time
P value*
Jan-Jun 05
Jul-Dec 05
Jan-Jun 06
Jul-Dec 06
Jan-Jun 07
Jul-Dec 07
S.Cr < 2.5 mg/dl (5149 / 5388)
93.78 95.37 96.81 95.47 94.70 96.29 .88
CrCl > 30 ml/m (4580 / 5077)
88.40 88.44 90.45 90.64 91.03 90.70 .88
K+ ≤ 5.5 mEq/L (4509 / 4523)
100.0 99.72 99.89 99.52 99.67 99.49 .11
*, adjusted for within-hospital clustering
Multivariable ModelingLogistic regression with GEE approach Excluded cases with missing data. N=13,289 (67% of LVSD population) Aldosterone use = 30.7%
VariableAdjuste
d ORLower 95% CI
Upper 95% CI
P value
Age per 10 years 0.85 0.82 0.88 <0.0001
SBP per 10 units 0.90 0.89 0.92 <0.0001
Hx ICD 1.52 1.37 1.68 <0.0001
Hx Chronic dialysis
0.16 0.08 0.32 <0.0001
Adm. Sr Creat <2.5
2.22 1.81 2.73 <0.0001
Optimal Medical Tx
2.35 1.64 3.38 <0.0001
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
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 inhibitors use.