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Acute Heart Failure
- 1. Randall C. Starling, M.D., M.P.H., F.A.C.C. Section of Heart Failure and Cardiac Transplant Medicine Department of Cardiovascular Medicine Kaufman Center for Heart Failure Acute Heart Failure
- 4. Fonarow GC. Rev Cardiovasc Med. 2003; 4 (Suppl. 7): 21 Cleland JG et al. Eur Heart J. 2003; 24: 442 The Major Reason for Heart Failure Hospitalizations Worsening chronic heart failure (75%) De novo heart failure (23%) Advanced/ end-stage heart failure (2%)
- 5. Outcomes in Patients Hospitalized With HF Fonarow, GC. Rev Cardiovasc Med. 2002 ;3(suppl 4):S3 Jong P et al. Arch Intern Med. 2002 ;162:1689 0 25 50 75 100 20% 50% 30 Days 6 Months Hospital Readmissions 0 25 50 75 100 12% 50% 30 Days 12 Months Mortality 33% 5 Years Mean LOS: 6.5 days
- 6. Most Common IV Medications All Enrolled Discharges (n=105,388) October 2001-January 2004 0 10 20 30 40 50 60 70 80 90 100 Patients (%) IV Diuretic Dobutamine Dopamine Milrinone Nesiritide Nitroglycerin Nitroprusside IV Vasoactive Meds 88% 6% 6% 10% 3% 1% 10%
- 7. ADHERE ® CART: Predictors of Mortality Highest to Lowest Risk Cohort OR 12.9 (95% CI 10.4-15.9) Reference: Fonarow GC, et al. Risk stratification for in-hospital mortality in heart failure using classification and regression tree (CART) methodology. JAMA . 2005;293:572-580. YES YES YES SYS >BP 115 n=24,933 SYS >BP 115 n=7,150 6.41% n=5,102 15.28% N=2,048 21.94% n=620 12.42% n=1,425 5.49% n=4,099 2.14% n=20,834 BUN 43 N=33,324 Greater than Less than 2.68% n=25,122 8.98% n=7,202 Cr <2.75 2,045
- 8. Baseline BUN Predictive of 60 day Outcomes ACTIV trial Filappatos GJ Cardiac Fail 2007;13:360e364 N=319
- 9. Klein L. Circ Heart Fail. 2008;1:25-33. N=949
- 10. Mullens W et al. Am J Cardiol 2008;101:1297–1302 N=513
- 11. Mullens W et al. Am J Cardiol 2008;101:1297–1302 N=513
- 12. Copyright ©2008 American College of Cardiology Foundation. Restrictions may apply. Abraham, W. T. et al. J Am Coll Cardiol 2008;52:347-356 In-Hospital Mortality by SCr and SBP From OPTIMIZE HF Registry
- 14. In-Hospital Mortality According to Troponin I or Troponin T Quartile Peacock WF 4th et al. N Engl J Med 2008;358:2117-2126
- 15. Mortality According to Type of Treatment and Troponin Status Peacock WF 4th et al. N Engl J Med 2008;358:2117-2126
- 18. VMAC: Primary End Point VMAC Investigators. JAMA. 2002;187:1531–1540. Dyspnea at 3 Hours – 10 0 10 20 30 40 50 60 70 80 90 100 Nesiritide Placebo Nitroglycerin Improved (%) Worsened (%) P = 0.034 P = 0.191 P values are based on van Elteren test with 7-point ordinal scale
- 20. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Adrian F. Hernandez, MD On behalf of the ASCEND-HF Committees, Investigators and Study Coordinators
- 21. International Steering Committee Study organization >800 Investigators and Study Coordinators at 398 Sites Clinical Event Committee Chair: John McMurray Executive Committee Chair: Rob Califf Chris O’Connor (Co-PI), Randy Starling (Co-PI) Paul Armstrong, Kenneth Dickstein, Michel Komajda, Barry Massie, John McMurray, Markku Nieminen, Jean Rouleau, Karl Swedberg, Vic Hasselblad Sponsor Scios Inc. Independent DSMB Chair: Sidney Goldstein Salim Yusuf, David DeMets, Milton Packer, John Kjekshus North America Academic Consortium: (DCRI, C5, Jefferson, Henry Ford, Canadian VIGOUR Centre) ROW: Johnson & Johnson Global Clinical Operations Coordinating center: DCRI Adrian Hernandez, Craig Reist, Gretchen Heizer
- 28. Enrollment North America = 45% 214 sites Latin America = 9% 39 sites Asia-Pacific = 25% 62 sites Central Europe = 14% 48 sites Western Europe = 7% 35 sites 7141 patients 30 Countries & 398 Sites >800 Investigators and Study Coordinators
- 30. Baseline characteristics Continuous variables as median (IQR 25 th , 75 th ); MITT population Placebo (n=3511) Nesiritide (n=3496) Age (yrs) 67 (56, 76) 67 (56, 76) Female (%) 34.9 33.4 Black or African American 15.0 14.7 Systolic Blood Pressure (mmHg) 124 (110, 140) 123 (110, 140) Heart rate (beats/min) 82 (72, 95) 82 (72, 95) Respiratory rate (breaths/min) 24 (21,26) 23 (21, 26) Medical History (%) Ischemic heart disease 60.8 59.5 Hypertension 72.6 71.8 Atrial fibrillation 37.7 37.4 Chronic respiratory disease 16.6 16.3 Diabetes 42.9 42.3 LVEF <40% 79.5 80.8
- 31. Baseline characteristics Continuous variables as median (IQR 25 th , 75 th ); MITT population Placebo (n=3511) Nesiritide (n=3496) Labs/Studies BNP (pg/mL) 989 (544, 1782) 994 (549, 1925) NT pro-BNP (pg/mL) 4461 (2123, 9217) 4508 (2076, 9174) Creatinine (mg/dL) 1.2 (1.0, 1.6) 1.2 (1.0, 1.5) Pre-randomization treatment (%) Loop diuretics 95.3 94.9 Inotropes 4.4 4.3 Vasodilators 14.1 15.7
- 32. Co-Primary outcome: 30-day all-cause mortality or HF rehospitalization Placebo Nesiritide HF Rehospitalization 30-day Death/HF Rehospitalization 30-day Death 0 2 4 6 8 10 12 Risk Diff (95 % CI) -0.7 (-2.1; 0.7) -0.4 (-1.3; 0.5) -0.1 (-1.2; 1.0) % 10.1 4.0 6.1 P=0.31 9.4 3.6 6.0
- 33. Regional variation in outcomes
- 34. Regional variation in outcomes
- 35. 30 day death/HF readmission subgroups Difference (%) and 95% Confidence Interval Risk Difference <0: Favors Nesiritide; Risk Difference >0: Favors Placebo All-Cause Death/HF Rehosp Day 30 N=6836 Sex Female Male N=1192 N=2221 Age ≤ 64 65-74 ≥ 75 N=1514 N=871 N=1028 Race White Black or African American Asian Other N=1913 N=512 N=834 N=154 Region North America Latin America Asia-Pacific Central Europe Western Europe N=1547 N=324 N=837 N=474 N=231
- 36. 30 day death/HF readmission subgroups Difference (%) and 95% Confidence Interval Risk Difference <0: Favors Nesiritide; Risk Difference >0: Favors Placebo All-Cause Death/HF Rehosp Day 30 N=6836 Baseline SBP (mmHg) < 123 ≥ 123 N=1646 N=1767 Baseline Ejection Fraction (%) <40 ≥ 40 N=2179 N=604 Renal function- MDRD GFR (mL/min/m 2 ) <60 ≥ 60 N=1704 N=1534 History of CAD No Yes N=1525 N=1887 History of Diabetes Mellitus No Yes N=1949 N=1464
- 37. 30 day death/HF readmission subgroups Difference (%) and 95% Confidence Interval Risk Difference <0: Favors Nesiritide; Risk Difference >0: Favors Placebo All-Cause Death/HF Rehosp Day 30 N=6836 Inotrope Use at Randomization No Yes N=3272 N=141 Vasodilators None Any IV Vasodilators No IV Nitroglycerin IV Nitroglycerin N=2962 N=448 N=2987 N=425 Diuretic Use from Hosp through Rand No Yes N=329 N=3084 Study Drug Bolus No Yes N=1310 N=2103
- 38. Co-Primary Endpoint: 6 and 24 hour dyspnea 70 60 50 40 30 20 10 0 10 20 30 40 % Subjects 24 Hours Markedly Better Minimally Worse Moderately Better Moderately Worse Minimally Better Markedly Worse No Change 70 60 50 40 30 20 10 0 10 20 30 40 % Subjects 50 60 6 Hours 42.1% 44.5% 66.1% 68.2% 3444 Placebo 13.4 28.7 34.1 21.7 P=0.030 3416 Nesiritide 15.0 29.5 32.8 20.3 3398 Placebo 27.5 38.6 22.1 9.5 3371 Nesiritide 30.4 37.8 21.2 P=0.007 8.6
- 39. Secondary endpoints *Combined response for moderately/markedly better Placebo (n= 3511 ) Nesiritide (n=3496) Difference (95% CI) P-value Persistent or worsening HF or all-cause mortality through discharge 4.8% (165) 4.2% (147) -0.5 (-1.5 to 0.5) 0.30 Days alive and outside of hospital through Day 30 20.7 20.9 0.2 (-0.13 to 0.53) 0.16 CV death or CV rehosp through Day 30 11.8% (402) 10.9% (372) -0.9 (-2.4 to 0.6) 0.24 Placebo (n=3511) Nesiritide (n=3496) P-value Well Being at 6 hours* 40.3% 41.4% 0.32 Well Being at 24 hours* 63.7% 65.7% 0.02
- 40. 30-day mortality meta-analysis 1 10 0.1 Odds ratio (95% CI) Mills (311) Colluci/Efficacy (325) Comparative (326) PRECEDENT (329) VMAC (339) PROACTION (341) ASCEND-HF COMBINED 30 day w/out ASCEND COMBINED with ASCEND Odds Ratio (95% CI) 0.38 (0.05, 2.74) 1.24 (0.23, 6.59) 1.43 (0.50, 4.09) 0.59 (0.18, 2.01) 1.63 (0.77, 3.44) 6.93 (0.89, 53.91) 0.89 (0.69, 1.14) 1.28 (0.73, 2.25) 1.00 (0.76, 1.30)
Editor's Notes
- Congestive heart failure (CHF) afflicts nearly 5 million persons in the United States. An estimated 550,000 new cases of heart failure are diagnosed annually. 1 Roughly equal numbers of men and women have CHF. The incidence of heart failure is approximately 1 per 100 for persons older than 65 years. 2 Heart failure results in a tremendous economic burden. CHF now represents the most common discharge diagnosis in patients older than 65 years. 3 The prognosis of this condition in the absence of optimal treatment remains poor. Only 50% of CHF patients survive for 5 years after diagnosis. 4 References: Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2001. American College of Cardiology Web site. Available at: http://acc.org/clinical/guidelines/failure/hf_index.htm. Accessed December 2002. American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, TX: American Heart Association; 2001. Graves EJ, Gillum BS. 1994 Summary: National Hospital Discharge Survey: Advance Data From Vital and Health Statistics. No. 278. Hyattsville, MD: National Center for Health Statistics; 1996. Dargie HJ, McMurray JJ, McDonagh TA. Heart failure—implications of the true size of the problem. J Intern Med. 1996;239:309–315.
- Heart failure currently affects 4.79 million persons in the United States alone, 1 and this number is expected to rise to 10 million by 2037. 2 Approximately 550,000 new cases of heart failure are diagnosed each year. One reason for the increase in heart failure is old age. Risk of sudden cardiac death is 6 to 9 times higher in the heart failure population. 1 The prevalence of heart failure increases with age, affecting 10% of persons aged 70 years and older. 3 References: American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, TX: American Heart Association; 2001. Croft JB, Giles WH, Pollard RA, et al. National trends in the initial hospitalization for heart failure. J Am Geriatr Soc. 1997;45:279–275. National Heart, Lung, and Blood Institute. Congestive Heart Failure Data Fact Sheet. Available at: http://www.nhlbi.nih.gov/health/public/heart/other/CHF.htm. Accessed December 2002.
- Data from the Acute Decompensated Heart Failure Registry (ADHERE) and Euro Heart Failure Survey in over 120,000 consecutive patients showed that over 75% of the admissions for heart failure are due to worsening of chronic heart failure. About 20% of the admissions are due to newly diagnosed heart failure cases (e.g., post-MI, hypertensive episode on a non-compliant ventricle, etc.) and only 2% of admissions are seen in patients with low output state (or advanced/end-stage heart failure). This is extremely important, as many clinicians believe that a low output state is a very common reason for admissions. Although these patients comprise only 2% of the population, they are often extremely sick and this is the population the heart failure specialists are being consulted on, contributing to the biased view that these patients represent the majority of admissions, when in fact they are a distinct minority.
- Most Common IV Medications All Enrolled Discharges (N = 105,388) October 2001 –January 2004 The use of IV vasoactive medications is shown on this slide. IV diuretics are used in 88% of patients admitted with ADHF. Data on file, Scios Inc.
- Figure 2. In-Hospital Mortality According to Troponin I or Troponin T Quartile. P<0.001 by the chi-square test for all comparisons.
- Figure 3. Mortality According to Type of Treatment and Troponin Status. P<0.001 by the chi-square test for the association between troponin status and mortality within the vasodilator and inotrope groups.
- In VMAC, the beneficial effect of nesiritide on dyspnea at 3 hours was significant compared with placebo, in all subjects ( P = 0.034) as well as in the catheterized stratum ( P = 0.030).