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STOP-HF Investigators St. Vincent’s / St. Michael’s Hospitals and Collaborative GP Group Dublin, Ireland

The Saint Vincents Screening To Prevent Heart Failure (STOP-HF) Study A Multicentre, Prospective, Randomised, Controlled Trial of Natriuretic Peptide Based Screening And Collaborative Care To Reduce The Prevalence of Left Ventricular Dysfunction and Heart Failure . STOP-HF Investigators

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STOP-HF Investigators St. Vincent’s / St. Michael’s Hospitals and Collaborative GP Group Dublin, Ireland

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  1. The Saint Vincents Screening To Prevent Heart Failure (STOP-HF) Study A Multicentre, Prospective, Randomised, Controlled Trial of Natriuretic Peptide Based Screening And Collaborative Care To Reduce The Prevalence of Left Ventricular Dysfunction and Heart Failure STOP-HF Investigators St. Vincent’s / St. Michael’s Hospitals and Collaborative GP Group Dublin, Ireland

  2. STOP-HF: Background • Prevention of heart failure is a “Holy Grail” of cardiovascular care • Present approaches are suboptimal • Risk differentiation based on clinical criteria may be limited • Biomarkers may help to focus care to where it is most needed

  3. Individualizing Risk with NP Framingham Cohort, Wang et al. NEJM 2004 NP predicts HF and CV Risk • Peptide secreted in response to • Pressure / Volume Overload • Ischemia • Fibro-inflammation • Adds to routine risk prediction • NP reflects established CV insult rather than risk of CV damage

  4. STOP-HF Hypothesis • NP-driven screening and targeted collaborative care in the general at-risk population will decrease the prevalence of LVD and HF • 39 collaborating primary care practices, intervention provided in a single referral center

  5. STOP-HF Inclusion / Exclusion • Excluded • Known LVSD or HF • Life-threatening illness • Refusal / inability to give informed consent • Entry Criteria (> 40yrs) with • Hypertension • Hyperlipidemia • Diabetes • Vascular disease • Arrhythmia • Obesity • Primary End Point • Prevalence of heart failure (hospitalized) and asymptomatic left ventricular dysfunction • Systolic Dysfunction: LVEF < 50% • Diastolic Dysfunction: E / e prime > 15 • Secondary End Point • Hospitalization for Cardiovascular Events (Time to event and Event rate) • Heart Failure, Arrhythmia, Myocardial Infarction, Unstable angina, CVA, TIA, Peripheral Thrombosis, PE

  6. Study Flow n=3,123 n=1,374 n=677 n=697 Lost to follow up n=69 Withdrew consent n=132 Death n=37 Lost to follow up n=70 Withdrew consent n=92 Death n=35 Intention to treat analysis

  7. STOP-HF Intervention NP-directed care In addition to routine PCP care • Annual BNP in all If BNP >50pg/ml at any time • Shared-care • Cardiology review • Echo-Doppler • Other CV investigations • CV nurse coaching • Regular Cardiology follow-up Routine PCP care • Annual BNP not available to clinicians • At least annual review by PCP • Cardiology review only if requested by PCP

  8. Demographics

  9. Demographics

  10. Primary Endpoint – HF and LVD OR 0.46 [0.27, 0.77], p=0.003 N=44 OR 0.59 [0.38, 0.90], p=0.01 N=25 N=59 N=39 Any BNP > 50 pg/ml Total Population

  11. Endpoint – Time to First MACE OR 0.67 [0.46,0.98] p=0.04 OR 0.70 [0.47,1.03] p=0.07 Intervention Control Any BNP > 50 pg/ml Total Population

  12. Endpoint – MACE Event Rate Event Rate OR 0.54 p=0.001 vs. Control N=71 (10.5%) N=51 (7.3%)

  13. Therapies and Risk Factors SBP (mmHg) -9.2 -9.9 HR (bpm) 0.0 -1.2 LDL-C (mg/dL) 0.0 -2.9 P=0.02 • BP significantly reduced within both groups (p<0.001) from baseline • Increased use of RAAS modifying therapies in intervention group • Trend to lower HR (p=0.09) and LDL-C (p=0.06) in high BNP subsets • 75% of primary end-point in control group had BNP > 50pg/mL Baseline (%) 42 43 25 27 52 53

  14. Limitations • One geographical region in one health system • Self-selected PCP • Unblinded study • Multifactorial intervention • Only included documented hospitalization events in MACE

  15. STOP-HF Conclusion • Natriuretic peptide-based screening and collaborative care targeted 4 in 10 at-risk patients • Reduced the rates of left ventricular dysfunction, heart failure, and emergency hospitalizations for major cardiovascular events.

  16. STOP-HF Investigators Principal Investigators: Kenneth McDonald, MD Mark Ledwidge, PhD Co-investigators: Joseph Gallagher, MB Carmel Conlon, PhD Elaine Tallon, PGDip Eoin O Connell, MSc Ian Dawkins, PhD Chris Watson, PhD Rory O Hanlon, MD Margaret Bermingham,BPharm Anil Patle, MBA Mallikarjuna R Badabhagni, BSE Gillian Murtagh, MD Victor Voon, MB Laura McDonald Brian Maurer, MD Funding Sources Heartbeat Trust Registered Charity CHY 15398 European Commission Framework Programme 7 Grant 261409 MEDIA Department of Health of Irish Government Health Services Executive St Vincent’s University Healthcare Group

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