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| |  BNP-Guided Therapy Demonstrates Significant Effects on Disease-Specific Outcome Versus Symptom-Guided Therapy: Presented at ESC By Chris Berrie MUNICH, Germany -- September 2, 2008 -- Although intensified (brain natriuretic peptide [BNP]-guided) therapy is not more effective than standard (symptom-guided) therapy for survival free of any hospitalisation in elderly patients with congestive heart failure, significant effects are seen for the more disease-specific outcome of survival free of heart-failure hospitalisation. Furthermore, the results of this randomised trial presented here on August 3 at the European Society of Cardiology 2008 Congress (ESC) demonstrated different responses to therapy between age groups, with BNP-guided therapy significantly more effective in younger patients for reduced mortality and survival free of heart-failure hospitalisations. Trial leader Hans-Peter Brunner-La Rocca, MD, Heart Failure Services, University Hospital, Basel, Switzerland, presented this study on behalf of the TIME-HF study (Trial of Intensified [BNP-Guided] Versus Standard [Symptom-Guided] Medical Therapy in Elderly Patients With Congestive Heart Failure). According to Dr. Brunner-La Rocca, "Previous smaller studies have suggested that BNP-guided therapy may improve outcome in chronic heart failure, and this concept may be particularly attractive in elderly patients who are physically less active and in whom symptoms are less reliable." Furthermore, although elderly subjects represent the majority of the heart failure population, they remain relatively under-represented in randomised trials. The aim of the trial was to compare intensified BNP-guided therapy with standard, symptom-guided therapy while assessing differences in these therapies in patients aged 75 years and older compared with those aged 60 to 74 years. Criteria for inclusion were aged 60 years or older with symptomatic heart failure (New York Heart Association [NYHA] class >=2, despite therapy), left ventricular ejection fraction (LVEF) <=45%, and hospitalisation within the last year. The N-terminal (NT)-pro-BNP levels were set for >2 times the upper limit of normal, as >400 pg/mL for patients aged 60 to 74 years and >800 pg/mL for patients aged 75 years or older. There was also a relevant range of exclusion criteria. The intensified BNP-guided therapy was based on the NT-pro-BNP levels and NYHA class, with standard therapy based solely on NYHA class and blinded to NT-BNP results. The primary endpoint was for survival free of any hospitalisation and quality of life; the secondary endpoint was more disease specific -- survival free of heart-failure hospitalisation. Following randomisation according to treatment strategy, the patient baseline characteristics showed no significant differences. When stratified according to age, as 60 to 74 years (mean, 69 years) versus 75 years and older (mean, 89 years), there were significant differences in gender (25% vs 41% female; P < .001); main cause of disease (P < .001); LVEF (28% vs 31%; P < .001); NYHA class >=2 (66% vs 81%; P = .001); NT-pro-BNP (2,998 vs 5,053 pg/mL; P < .001); C-reactive peptide (111 vs 121 mcmol/L; P = .004); heart rate (74 vs 77 bpm; P = .03); systolic blood pressure (117 vs 120 mm Hg; P = .04); kidney disease (45% vs 63%; P < .001); and >=2 comorbidities (64% vs 79%; P < .001). Similarly, some quality-of-life measures significantly favoured the younger patients, who were also on significantly more medication with beta-blockers (84% vs 75%; P = .02) and mineralocorticoid antagonists (47% vs 36%; P = .02). For the primary endpoint, there were no significant differences between treatment-guiding modes, although the more disease-specific secondary endpoint showed benefit for intensive BNP-guided therapy (hazard ratio, 0.66; 95% confidence interval, 0.49-0.90; P = .008). The subgroup analyses showed significant effects related to patient age, body mass index, and comorbidities (P < .05). For the endpoints across the different age groups, Dr. Brunner-La Rocca noted, "There was a significant reduction in mortality and improvements in survival free [of] heart-failure hospitalisation with intensified therapy in the younger patients and also a strong trend in the primary endpoint, although it was not statistically significant." Finally, Dr. Brunner-La Rocca noted that while these guided therapies showed no effects on quality of life in the younger patient group, in comparison with the standard symptom-guided therapy, patients aged 75 years and older under intensified BNP-guided therapy experienced significantly lower quality-of-life improvements (P < .05). Funding for this study was provided by unrestricted grants from AstraZeneca, Novartis, Menarini, Pfizer, Servier, Roche Diagnostics, Roche, and Merck.
[Presentation title: Trial of Intensified (BNP-Guided) Versus Standard (Symptom-Guided) Medical Therapy in Elderly Patients With Congestive Heart Failure: TIME-CHF. Abstract 230]
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