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C oordinating study evaluating O utcomes of A dvising and C ounseling in H eart failure Tiny Jaarsma RN PhD, Dirk J van Veldhuisen MD PhD University Medical.

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Presentation on theme: "C oordinating study evaluating O utcomes of A dvising and C ounseling in H eart failure Tiny Jaarsma RN PhD, Dirk J van Veldhuisen MD PhD University Medical."— Presentation transcript:

1 C oordinating study evaluating O utcomes of A dvising and C ounseling in H eart failure Tiny Jaarsma RN PhD, Dirk J van Veldhuisen MD PhD University Medical Center Groningen, the Netherlands on behalf of the COACH investigators

2 Funded by the Netherlands Heart Foundation: Program grant 2000Z003 Unrestricted grants from Novartis, Biosite and Roche

3 Objective COACH main study To determine the effect of 2 levels of intensity in nurse-led heart failure care compared to a control group in an adequately powered study To study underlying mechanisms of heart failure disease management programs Jaarsma et al. Eur J Heart Fail 2004

4 Objective subgroup analyses To determine possible heterogeneity in the effect nurse-led heart failure care with regard to prespecified baseline variables

5 Basic Nurse led Advising + Counseling Intensive Nurse led Advising + Counseling Control (cardiologist only) R Hospital admission 18 months COACH - methods: Design Discharge Jaarsma et al. Eur J Heart Fail 2004

6 COACH - methods Intervention contacts in 18 months Visits to cardiologist Visits to HF nurse Home visit Multidisciplinary advice

7 Inclusion and exclusion criteria Inclusion - Hospital admission for symptomatic CHF (NYHA II-IV) - Evidence of structural underlying heart disease - Age > 18 years Exclusion - Participating in other research trials - Invasive intervention previous 6 months/planned in 3 months - Evaluation for heart transplantation

8 Major Endpoints Primary endpoint – Time to first event (all cause mortality + HF readmission) – Number of unfavorable days (number of days in hospital or dead) Major Secondary endpoints – Individual components of primary endpoint All cause mortality All cause mortality HF readmission HF readmission

9 Statistical analysis Primary endpoints - Two-sided log-rank test (Kaplan Meyer curves) - Mann-Whitney-U tests Interaction - Interaction tests for endpoints using baseline demographics (treatment x subgroup interaction) - Cox proportional hazards models Subgroups - Baseline demographic and clinical variables

10 Results: Baseline TotalN=1,023ControlN=339 Basic A&C N=340 Intensive A&C N=344 Age (yrs) Female gender 7138%7240%7134%7039% NYHA II at discharge NYHA III/IV at discharge 50%50%54%46%50%50%52%52% LVEF (%) ≤ 40% ≤ 40% >40% >40%3473%27%3470%30%3472%28%3375%25% Medication at discharge - ACE/AII - B-Blocker - Diuretics 83%66%95%82%65%96%85%70%97%81%63%95% BNP (pg/ml) Depressive symptoms 39%37%39%42%

11 Extra contacts % + 40% + 10%

12 Primary endpoint: All cause mortality and HF readmission

13 Co-primary endpoint: Unfavorable days 6,229 days = 15% decrease, ns 40,000 30,000 20,000 10,000

14 Secondary endpoint: All cause mortality

15 Secondary endpoint: HF readmission

16 Male Female Depressed Not depressed Subgroup analysis: Primary endpoint Age >65 Age ≤ 65 pg/ml BNP ≤ 500 pg/ml pg/ml BNP > 500 pg/ml NYHA II NYHA III/IV LVEF ≤ 40 LVEF > P value for interaction Favors interventionFavors controlHazard Ratio

17 Male Female Depressed Not depressed Subgroup analysis: Mortality Age >65 Age ≤ 65 pg/ml BNP ≤ 500 pg/ml pg/ml BNP > 500 pg/ml NYHA II NYHA III/IV LVEF ≤ 40 LVEF > P value for interaction Favors intervention Favors control Hazard Ratio

18 Conclusion subgroup analysis No significant treatment x subgroup interaction was found except for an interaction between depression and all cause mortality No significant treatment x subgroup interaction was found except for an interaction between depression and all cause mortality The power to analyses each subgroup was limited The power to analyses each subgroup was limited

19 Conclusion (2) Nurse-led education and counseling independent of intensity (on top of treatment by a cardiologist) did not reduce the combined endpoint of time to HF hospitalization or death in an unselected HF population. Nurse-led education and counseling independent of intensity (on top of treatment by a cardiologist) did not reduce the combined endpoint of time to HF hospitalization or death in an unselected HF population. Nurse-led advising and counseling is associated with a relevant but statistically not significant 15% decrease of unfavorable days, driven by a 15% (ns) decrease in all cause mortality but not in hospitalizations. Nurse-led advising and counseling is associated with a relevant but statistically not significant 15% decrease of unfavorable days, driven by a 15% (ns) decrease in all cause mortality but not in hospitalizations.

20 Implications Close intensive nurse-led advising and counseling in chronic heart failure patients might decrease mortality at the ‘cost’ of more – shorter – hospitalizations Close intensive nurse-led advising and counseling in chronic heart failure patients might decrease mortality at the ‘cost’ of more – shorter – hospitalizations No clear subgroups x treatment interaction was found, suggesting that further studies to determine the most optimal model for heart failure disease management are needed No clear subgroups x treatment interaction was found, suggesting that further studies to determine the most optimal model for heart failure disease management are needed

21 Steering committee Prof. Dr. D.J. van Veldhuisen Prof. Dr. D.J. van Veldhuisen Dr. T. Jaarsma Dr. T. Jaarsma Dr. P.H.J.M. Dunselman Dr. P.H.J.M. Dunselman Prof. Dr. W.H. van Gilst Prof. Dr. W.H. van Gilst Dr. H.L. Hillege Dr. H.L. Hillege Prof. Dr. A.W. Hoes Prof. Dr. A.W. Hoes Prof. Dr. K.I. Lie Prof. Dr. K.I. Lie D.J.A. Lok D.J.A. Lok Prof. Dr. R. Sanderman Prof. Dr. R. Sanderman Prof. Dr. J.G.P. Tijssen Prof. Dr. J.G.P. Tijssen Dr. M.C.M. Senten Dr. M.C.M. Senten I. Kamerling I. Kamerling Endpoint adjudication committee Dr. C.M.H.B. Lucas (chair) Dr. C.M.H.B. Lucas (chair) Dr. J.H. Cornel Dr. J.H. Cornel Dr. R.W.M.M. Jansen Dr. R.W.M.M. Jansen Dr. F.H. Rutten Dr. F.H. Rutten Dr. F. van den Berg Dr. F. van den Berg Safety analysis Prof. Dr. J.J.V. McMurray, Glasgow, UK. Prof. Dr. J.J.V. McMurray, Glasgow, UK. Researchers Dr. M.H.L. van der Wal Dr. M.L.A. Luttik Dr. J. Hogenhuis I. Lesman

22 Investigators and HF nurses Investigators and HF nurses University Medical Center Groningen: D. J. van Veldhuisen, A.A. Voors, A. Koops, A. Klungel, K. van Dijk, G. Westra, University Medical Center Amsterdam: W. Kok, L.M. Konst, J. van der Sloot, T. Veelenturf, R. Zwart, S. de Vries, University Medical Center St. Radboud, Nijmegen: F. Verheugt, L. Bellersen, L. Knubben, L. Baltussen, Medical Center Leeuwarden: C.J. de Vries, R. Breedveld, A. Obbema, A. Rijenga, D. van der Woude, J. de Bruin, Twenteborg Hospital, Almelo: G.C.M Linssen, E. Rodijk, M. Samsen, B. Beverdam, L. Bogemann, Atrium Medical Center Heerlen: J.A. Kragten, T. Thuis, I. Kremer, V. Post, S. Jongen, Jeroen Bosch Hospital Den Bosch: M.C.G. Daniëls, D. Jaftoran, V. van Zonsbeek, A. Berkhout, Rijnstate Hospital, Arnhem: F.F. Willems, M. Rolfes, P. Nienaber, Amphia Hospital,, Breda P.H.J.M. Dunselman, N. Creemer, I. Lauwerijssen, C. Paes, Refaja Hospital, Stadskanaal: L. van Wijk, K. de Vries, D. Thoma, R. Niewold, M. Wijbenga, Tweesteden Hospital,, Tilburg: J. Widdershoven E. Hendriks, H. Broers, Streekziekenhuis Midden Twente, Hengelo: A. Derks, L. Odink, P. ter Horst, W. Wolters, L. Navis, Scheper Hospital, Emmen: M.J. Nagelsmit, A. Bakker, W. Veenstra, J.W. van Brakel, Medisch Spectrum Twente, Enschede: P. van der Burgh, J. Roukema, H. Glazenburg, J. Grooters, Wilhelmina Hospital Assen: M.L. Pentinga, R. Aardema, J. Veninga, Deventer Hospital, Deventer: D.J.A. Lok J. Burger, D. Pruijsers, Oosterschelde Ziekenhuis, Goes: A.H. Liem, J. Witkam, A. Roelse, E. Salawanei


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