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Hot topics from the Heart F ailure Congress in Belgrade

Hot topics from the Heart F ailure Congress in Belgrade. May 23rd, 2012. Our presenters today. The program. 10’. 10’. 15’. The new 2012 ESC Guidelines for management of heart failure. Prof S. Anker. The new 2012 ESC Guidelines for acute and chronic heart failure.

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Hot topics from the Heart F ailure Congress in Belgrade

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  1. Hot topicsfrom the Heart Failure Congressin Belgrade May 23rd, 2012

  2. Our presenters today

  3. The program 10’ 10’ 15’

  4. The new 2012 ESC Guidelines for management of heartfailure Prof S. Anker

  5. The new 2012 ESC Guidelines for acute and chronic heart failure • 26 Task Force Members • Avaivable online www.escardio.org

  6. The principal changes from the 2008 guidelines An expansion of the indication for mineralocorticoid receptor antagonists (MRAs) A new indication for the sinus node inhibitor ivabradine An expanded indication for cardiac resynchronization therapy (CRT) New information on the role of coronary revascularization in HF Recognition of the growing use of ventricular assist devices The emergence of transcatheter valve interventions Addition of MR-proANP to biomarkers for HF diagnosis

  7. Diagnostic flowchart for patients with suspected heart failure—showing alternative ‘echocardiography first’ (blue) or ‘natriuretic peptide first’ (red) approaches.

  8. Pharmacological therapy for CHF patients

  9. Update on pharmacological therapy: expansion of the indication for MRA

  10. Update on pharmacological therapy: a new indication for ivabradine for patients with CHF

  11. Further treatment options for patients with CHF

  12. Update on implanted devices: an expanded indication for CRT

  13. New information on the role of coronary revascularization in systolic HF

  14. Lack of robust evidence for most lifestyle, non-pharmacological interventions RCT of “low” vs. “normal” sodium diet in systolic CHF 6 deaths 9 hospitalisations 15 deaths 30 hospitalisations

  15. Lifestyle and non-pharmacological interventions

  16. Management programmes for patients with heart failure

  17. New evidence from thetrial Presentations at Late Breaking Trials and Rapid Fire sessions Prof M. Komajda

  18. Primary objective of the main trial To evaluate whether the If inhibitor ivabradine improves cardiovascular outcomes in patients with 1. Moderate to severe chronic heart failure 2. Left ventricular ejection fraction 35% 3. Heart rate 70 bpm and in sinus rhythm 4. Recommended therapy

  19. Main study results: effect of ivabradine on major outcomes Hazard ratio p value Primary composite endpoint 0.82 <0.0001 All cause mortality 0.90 0.092 Cardiovascular death 0.91 0.128 Death from HF 0.74 0.014 All-cause hospital admission 0.89 0.003 Hospitalization for HF 0.74 <0.0001 Any CV hospitalization 0.85 0.0002 CV death/hospitalization for HF 0.82 <0.0001 or non-fatal MI 0.5 0.9 0.6 0.7 0.8 1.1 1.0 Swedberg K, et al. Lancet 2010;376: 875-885.

  20. Systolic Heart failure treatment withthe Ifinhibitor ivabradine Trial New findings: Ivabradine reduces mortality and other major outcomes in chronic systolic heart failure: analysis in high risk patients with HR ≥ 75 bpm Presentation at Rapid Fire Session, Sunday 20 May 2012

  21. Rationale • SHIFT and other heart failure studies showed a continuous increase in risk with increasing heart rate • 64% of the patients enrolled in SHIFT had a heart rate ≥ 75 bpm • A cut-off of ≥75 bpm was chosen by the EMA for the approval of ivabradine in chronic heart failure

  22. Effect of ivabradine on major outcomes in patients with HR 75 bpm 95% CI P Hazard ratio Primary composite end point Cardiovascular mortality Hospitalization for worsening HF Death from HF All-cause mortality All-cause hospitalization Any cardiovascular hospitalization 0.76 0.68-0.85 0.83 0.71-0.97 0.70 0.61-0.80 0.61 0.46-0.81 0.83 0.72-0.96 0.82 0.75-0.90 0.79 0.71-0.88 <0.0001 0.0166 <0.0001 0.0006 0.0109 <0.0001 <0.0001 0.20 0.40 0.60 0.80 1.00 1.20 Favors ivabradine Favors placebo Böhm M, et al. Clin Res Cardiol. Online 11 May 2012.

  23. Effect of ivabradine on outcomes according to HR achieved at 28 days Patients withprimary composite end point (%)  75 bpm 70 to <75 bpm 65 to <70 bpm 60 to <65 bpm <60 bpm 40 30 20 10 0 0 Day 28 6 12 18 24 Time (months) Böhm M, et al. Clin Res Cardiol. Online 11 May 2012.

  24. Effect of ivabradine on outcomes according to magnitude of HR reduction Patients withprimary composite end point (%) 40  0 bpm -10 to <0 bpm < -10 bpm 30 20 10 0 0 Day 28 6 12 18 24 Time (months) Böhm M, et al. Clin Res Cardiol. Online 11 May 2012.

  25. Available online now

  26. Systolic Heart failure treatment withthe Ifinhibitor ivabradine Trial New findings: Heart rate reduction, not dose of beta-blocker, key to ivabradine success in heart failure Presentation at Late Breaking Trials, Sunday 20 May 2012

  27. Subgroups by beta-blocker dose and heart rate Five patient categories according to beta-blocker status: • No BB / <25 % / 25-49 / 50-74 / 75-99 / > 100 % target dose Five patient categories, according to baseline heart rate: • <72 bpm / 72 - 74 / 75 - 79 / 80 – 86 / ≥ 87 bpm Swedberg K, et al. J Am Coll Cardiol2012; 59:1938-1945

  28. Clinical characteristics Swedberg K, et al. J Am Coll Cardiol2012; 59:1938-1945

  29. HR reduction according toon beta-blocker and HR category HR reduction from baseline to 28 days with ivabradine* (bpm) Baseline HR category (bpm) ≥87 80 to <87 75 to <80 72 to <75 Impact of baseline HR on HR reduction with ivabradine <72 No BB BB<25% BB 25-50% BB 50-100% BB ≥100% Beta-blocker category *Placebo corrected No impact of BB dose on HR reduction with ivabradine Swedberg K, et al. J Am Coll Cardiol2012; 59:1938-1945

  30. Effect of ivabradine on outcomes by beta-blocker doses Swedberg K, et al. J Am Coll Cardiol2012; 59:1938-1945

  31. Available online now Swedberg K, et al. J Am Coll Cardiol2012; 59:1938-1945

  32. Systolic Heart failure treatment withthe Ifinhibitor ivabradine Trial New findings: The effect of ivabradine on outcomes in patients with or without aldosterone antagonists

  33. Chronic HF background treatment Patients (%) 100 91 91 90 89 90 Ivabradine 84 83 80 Placebo 70 61 59 60 50 40 30 22 22 20 10 4 3 0 Beta-blockers ACEIs and/or Diuretics Aldosterone Digitalis ICD/CRT ARBs antagonists Swedberg K, et al. Lancet. 2010;376:875-885.

  34. Type and dose of aldosterone antagonists 3922 patients had aldosterone antagonist (AA) at baseline: • Spironolactone: 3783 patients (mean dose = 34.7 mg) • Eplerenone: 100 patients (mean dose = 28.8 mg) • Other: 39 patients  Komajda et al. Late breaking trial. Heart Failure 2012

  35. Baseline characteristics Komajda et al. Late breaking trial. Heart Failure 2012

  36. Event rate in placebo group Patients (%) Patients with AA (n=1941) 50 Patients without AA (n=1323) 40 HR=1.40* 33 30 23 20 23 HR=1.35** 19 18 HR=1.40** 17 HR=1.50* 13 11 10 HF Hosp. 6 All-cause mortality Primary endpoint CV death HR=1.41*** 0 3 Death from HF P<0.0001; ** P=0.0004; *** P=0.0667 Komajda et al. Late breaking trial. Heart Failure 2012

  37. Effect of ivabradine on major outcomes ratio* Ivabradine Placebo Hazard P interaction Primaryendpoint (%) 28 33 0.82 With AA, n=3922 0.916 19 23 0.81 Without AA, n=2583 Cardiovasculardeath (%) 0.88 With AA 16 18 0.279 1.02 Without AA 11 11 Hospitalization for HF (%) 0.77 With AA 19 23 0.304 0.67 Without AA 11 17 Deathfromany cause (%) With AA 0.88 17 19 0.366 Without AA 0.99 13 13 Deathfrom HF (%) 0.73 With AA 4 6 0.723 0.80 Without AA 3 3 0.8 1.4 0.4 0.6 1.0 1.2 1.6 Favors ivabradine Favors placebo Komajda et al. Late breaking trial. Heart Failure 2012

  38. Conclusion The results of new analysis are consistent with the main results of SHIFT, demonstrating that HR reduction with ivabradine prevents adverse CV outcomes In patients with HR ≥75 bpm, ivabradine significantly reduces all major outcomes, including all-cause death and CV death The magnitude of the effect is similar in patients taking or not aldosterone antagonists The magnitude of HR reduction with ivabradine, not the dose of beta-blockers, determines improvement of outcome

  39. Ivabradine in the management of systolic CHF: new ESC Guideline

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