© 2005 European Society of Cardiology
Clinical trials update from the American College of Cardiology meeting: CARE-HF and the Remission of Heart Failure, Women's Health Study, TNT, COMPASS-HF, VERITAS, CANPAP, PEECH and PREMIER
a Department of Cardiology, University of Hull Castle Hill Hospital, Cottingham, Kingston-upon-Hull, HU15 5JQ, UK
b Department of Primary Care and General Practice University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK
* Corresponding author. Tel.: +44 1482 624086; fax: +44 1482 624085. E-mial address: a.p.coletta{at}hull.ac.uk
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Abstract |
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 Top Abstract 1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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This article provides information and a commentary on landmark trials presented at the American College of Cardiology meeting held in March 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. CARE-HF showed that Cardiac Re-synchronisation Therapy, administered in addition to expert pharmacological management, reduced all cause mortality and CV hospitalisation in patients with moderate or severe heart failure and cardiac dyssynchrony. The Women's Health Study showed no benefit of vitamin E supplementation or aspirin in the primary prevention of CV disease. The TNT study showed that reducing LDL cholesterol to levels lower than currently recommended, produced a 22% reduction in the incidence of major cardiovascular events. In COMPASS, an implantable device that continuously monitors intra-cardiac pressures was shown to be safe and to improve care in patients with chronic heart failure. Tezosentan failed to show benefit in patients with acute heart failure in the VERITAS study. The CANPAP study failed to show a benefit of continuous positive airway pressure on mortality and heart transplantation in heart failure patients with central sleep apnoea. EECP therapy improved exercise capacity but had no effect on peak VO2 in heart failure patients in the PEECH study. In the PREMIER study the matrix metalloproteinase inhibitor PG-116800 failed to prevent LV remodelling following myocardial infarction.
Key Words: CARE-HF and the Remission of Heart Failure • Women's Health Study • TNT • COMPASS-HF • VERITAS • CANPAP • PEECH • PREMIER
Received April 7, 2005; Accepted April 18, 2005
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1. CARE-HF (CArdiac REsynchronisation in Heart Failure] |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by John GF Cleland from Castle Hill Hospital, Kingston-upon-Hull, UK.
Cardiac dyssynchrony is common in patients with heart failure due to left ventricular systolic dysfunction (LVSD). Cardiac resynchronisation therapy (CRT) improves symptoms, quality of life and exercise capacity in these patients; however, effects on hospitalisation and mortality remain uncertain [1].
The aim of the CARE-HF study was to assess the effect of adding CRT to optimal medical therapy in patients with NYHA class III–IV heart failure due to LVSD and evidence of cardiac dyssynchrony. The primary endpoint was all cause mortality or unplanned CV hospitalisation.
The study randomised 813 patients and followed them for a mean duration of 29.4 months, with all patients followed for at least 18 months, and some patients followed for almost 4 years. The study design, baseline characteristics and results have been published [2–4]. In summary, 159 patients in the CRT group reached the primary end point compared with 224 patients in the control group (HR 0.63, p<0.001). The secondary endpoint of all-cause mortality also showed a reduction for patients in the CRT group compared with the control group (HR 0.64, p=0.0019). It was concluded in light of these findings that CRT should be considered routinely, in addition to pharmacological therapy, for the management of patients with moderate to severe heart failure with evidence of cardiac dyssynchrony.
Remarkably, 255 patients randomised to CRT had complete or near-complete resolution of their symptoms and left ventricular ejection fraction had increased above 40% in 57 CRT patients by 18 months. Just as remission of cancer means the resolution of symptoms, signs and evidence of the disease by imaging, this also constitutes remission of heart failure (Fig. 1) as these patients no longer have symptoms, signs or imaging criteria for heart failure. Beta-blockers were probably the first class of agent to cause remission of heart failure in a substantial number of patients and CRT is now the second proven intervention. These two treatments probably cause remission of heart failure in 15–20% of patients.
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The results of CARE-HF are consistent with the CRT-only arm of the COMPANION study [5] and prove that the non-significant trend to reduced mortality in COMPANION was a real effect. CRT reduced deaths due to worsening heart failure and due to sudden death in CARE-HF. The COMPANION study failed to show that the effects of CRT and CRT-D (CRT combined with a defibrillator) on mortality were different (average follow up in COMPANION <17 months). Accordingly, CRT may be the intervention of choice for the majority of patients with cardiac dyssynchrony. A meta-analysis of data from the CARE-HF study and from the CRT versus control arms in the COMPANION study, showing a clear effect of CRT on mortality, is shown in Fig. 2.
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2. Women's Health Study |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by Julie E Buring and Paul M Ridker from Brigham and Women's Hospital, Boston, USA.
The use of aspirin for the primary prevention of cardiovascular (CV) disease remains controversial and requires further investigation. Vitamin E has anti-oxidant properties which may reduce the risk of cardiovascular disease; however results from secondary prevention trials have been disappointing.
The aim of the Women's Health Study was to evaluate the effects of low dose aspirin (100 mg) and vitamin E (600 IU) administered on alternate days, for the primary prevention of cardiovascular disease in women. The study, which was double-blind and placebo controlled, randomised 39,876 women aged 
45 years, to treatment with either; aspirin plus vitamin E, aspirin plus placebo, placebo plus vitamin E or placebo plus placebo. Subjects were followed-up using annual postal questionnaires, and all reported cardiovascular end-points were checked against medical records. The primary endpoint was first major cardiovascular event (non-fatal MI, non-fatal stroke or CV death). The mean duration of follow-up was 10.1 years.
There was no difference in the incidence of the primary endpoint in the vitamin E group compared with the placebo group p=0.26 (Table 1). Analysis of data for stroke, MI, and all-cause mortality showed no difference between the treatment groups, but the incidence of cardiovascular death was slightly lower in the vitamin E group (p=0.03). It was concluded that vitamin E supplementation offers no benefit in the primary prevention of CV disease in well nourished women, but the observed effect on CV mortality requires further investigation.
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The recently reported HOPE-TOO study [6] represents an additional 2.6 years of follow-up of patients from the HOPE study. HOPE-TOO included 7030 patients in the vitamin E arm, half of whom were randomized to placebo. After a mean 7.2 years of follow-up, vitamin E did not significantly reduce the relative risk of total cancer incidence, cancer death, or the composite of cardiovascular events (relative risk 1.05; p=0.31). The vitamin-E associated increased risk of heart failure and heart-failure hospitalisation persisted, however, with relative risks of 1.13 (p=0.03) and 1.40 (p=0.002) respectively, after 7 years. These data require confirmation from other data-sets [7]. A recent meta-analysis showed increased mortality in trials using high-dose vitamin E, as reported by Heartwire [8].
The results of the aspirin part of the Women's Health Study have been published [9]. In summary, there was no difference in effect between aspirin and placebo on the primary endpoint and no effect on most major secondary outcomes. There was a reduction in the incidence of stroke in the aspirin group compared with placebo (Table 1, p<0.04) but this has not been observed in other primary prevention studies, neither is there good evidence that aspirin reduces stroke disability in secondary prevention studies [10].
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3. TNT (Treating to New Targets) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by John LaRosa from SUNY Downstate Medical Center, New York, USA.
The association between coronary heart disease (CHD) and low density lipoprotein (LDL) cholesterol levels is well documented. However, there is still considerable debate over the optimal target LDL level to minimise CV risk. Data from the PROVE-IT study [11] suggested additional benefit from reducing LDL levels below the currently recommended target level of 100 mg/dl (2.59 mMol L–1). The aim of the TNT study was therefore to evaluate whether reducing LDL levels below 100 mg/dl (target 75 mg/dl; 1.94 mMol L–1) in patients with coronary heart disease, could further reduce the incidence of coronary events.
All patients were initially treated with atorvastatin 10 mg for a run-in period of 8 weeks. Only patients with a LDL cholesterol level <130 mg/dl at the end of the run-in phase (n=10,001) were then randomised to double-blind treatment with either atorvastatin 10 mg or 80 mg per day. The primary end point was the first occurrence of a major CV event. The mean duration of follow-up was 4.9 years. Mean LDL levels were 77 mg/dl in the 80 mg atorvastatin group and 101 mg/dl in the 10 mg group.
The results of the TNT study have been published [12]. In summary, the study showed a 22% reduction in the incidence of major cardiovascular events in the high dose atorvastatin group compared with the low dose (p=0.0002). The 80 mg dose had a significant effect on all major primary and secondary endpoints including hospitalisation for heart failure. However, all-cause mortality was virtually identical in the two groups. The IDEAL study, comparing a target of 80 mg atorvastatin with 20 mg simvastatin (increased to 40 mg at 24 weeks in resistant patients) should report later this year.
The implication of these findings for patients with heart failure is questionable. Low serum cholesterol values predict a worse outcome in heart failure patients [13], although observational data suggests a beneficial effect of statins in heart failure [14,15]. Two definitive, randomised controlled trial of statin therapy in patients with heart failure, GISSI-CHF [16] and CORONA are ongoing.
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4. COMPASS-HF (Chronicle® Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by Robert C Bourge from University of Alabama School of Medicine, USA.
The Chronicle® device is an implantable haemodynamic monitor which is about the size of a pacemaker. The aim of this study was to show that continuous ambulatory monitoring of intra-cardiac pressures using the Chronicle® device could improve outcome in patients with chronic NYHA class III–IV heart failure.
All patients recruited into the study (n=274) were implanted with the device. Patients were stratified according to LVEF and then randomised into two groups. In one group the device transmitted haemodynamic data to the physician, in the other group data were not transmitted. Patients were blinded to their treatment allocation. Data from the device were transmitted weekly via a home based monitor. Patients were then defined as either hypervolaemic, euvolaemic or hypovolaemic and treatment modifications were made as appropriate. Patients were assessed at 1, 3 and 6 months. After 6 months the device was switched on in all patients. The primary endpoint was hospitalisation or emergency treatment requiring IV therapy for HF in the first 6 months.
The mean age of patients recruited was 58 years and 35% were female. There was a trend for fewer HF related events with the intervention compared to the control group (22% reduction; p=0.27) (Table 2) and a 21% reduction in the risk of first HF-related hospitalisation (p=0.029). Patients were also evaluated using a clinical composite score as either "improved" "no change" or "worsened", which favoured the device group (p=0.035) (Table 2). A subgroup analysis of data from patients with NYHA class III HF showed a 41% reduction in HF related events compared to the control group (p=0.03) and a significant reduction in the risk of first HF hospitalisation (p=0.023). As in other studies, changing outcome in NYHA class IV patients may be difficult, either because they are less amenable to therapy or because the imperative to treat means that treatment allocation cannot be maintained, resulting in both groups receiving the same treatment [17]. All study safety objectives were met.
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It was concluded that the Chronicle® system appeared safe and effective for the management of heart failure patients and that further studies and development were required, probably in conjunction with a CRT device. A study is currently underway to evaluate this concept.
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5. VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Studies) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by John JV McMurray from University of Glasgow, UK and John Teerlink, from San Francisco VA Medical Centre, USA.
Endothelin is a potent vasoconstrictor which may be deleterious in heart failure. Previous studies of the endothelin antagonist tezosentan failed to show any clinical benefit despite haemodynamic effects, in patients with acute decompensated heart failure [18].
The aim of the VERITAS study was to evaluate the effect of tezosentan on dyspnoea over 24 h and the incidence of death or worsening heart failure at 7 and 30 days in patients presenting with acute heart failure. Dyspnoea was assessed using a visual analogue scale at 3, 6 and 24 h.
This was a randomised, double-blind, placebo controlled study. Tezosentan and placebo were administered as 5 mg/h for 30 min and then 1 mg/h for 23.5 to 72 h. The study was stopped for futility in November 2004 by the Data Safety and Monitoring Board after 1435 patients had been enrolled. The mean age of patients was 70 years and 59% were male. The mean ejection fraction was 29% and the median duration of exposure to the study treatment drug was 30 h. Most patients had a history of hypertension and/or heart failure and about half had had a prior myocardial infarction.
Dyspnoea improved rapidly and similarly over 24 h in both the tezosentan and placebo groups. There was no difference in the incidence of death or worsening heart failure or adverse events between the treatment groups at 7 or 30 days (Table 3). Subgroup analyses showed no benefit of tezosentan over placebo and no heterogeneity of effect. However, a sub-study showed that tezosentan had haemodynamic effects.
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In this, the largest study of acute heart failure to date, it was concluded that tezosentan was safe but showed no clinical benefit in the treatment of acute heart failure. The study suggests that the needs of the majority of patients for the relief of breathlessness, as defined and measured in this study, are adequately met by existing therapy. New treatments for acute heart failure must seek better ways of defining the unmet needs of patients with respect to breathlessness, or find a different target for therapy or define a smaller population more resistant to existing therapy.
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6. CANPAP (CANadian continuous Positive Airway Pressure trial for congestive heart failure patients with central sleep apnoea) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by Douglas Bradley, University of Toronto, Canada.
Central sleep apnoea occurs in 30–40% of patients with heart failure and is associated with increased mortality. The aim of the CANPAP study was to evaluate whether treatment of sleep apnoea with continuous positive airway pressure (CPAP) could improve outcomes in these patients. The primary endpoint in this multicentre, randomised, controlled trial was all-cause mortality and heart transplantation. Secondary endpoints included severity of sleep apnoea, LV volumes and function, submaximal exercise capacity, quality of life and hospital admissions. The study design has been published [19].
The study aimed to recruit 408 patients with NYHA class II to IV heart failure, LVEF <40%, central sleep apnoea (mean apnoeas 15 per hour) and receiving optimal medical therapy. Patients were randomised to optimal medical therapy plus CPAP or optimal medical therapy alone.
The study was stopped by the DSMB after only 258 patients had been recruited, due to a reduction in the expected event rate, which meant that the study was no longer powered to detect a difference between the treatments. It was suggested that the fall in event rate was due to the increased use of beta-blockers in response to the results of clinical trials published after the CANPAP study had started.
The mean age of patients was 63 years and the majority (96%) were male; the mean LVEF was 24%. The mean duration of follow-up was 24 months (maximum 64 months). Thirty-two patients died or had heart transplantation in each treatment group. However, patients in the CPAP group showed improved LV function and exercise tolerance, a reduction in sympathetic activation and an improvement in symptoms attributed to sleep apnoea. The presenters concluded that these improvements in physiological and symptomatic outcomes should be explored further, either to ascertain whether CPAP should be deployed solely as a therapy for symptoms or to identify subgroups of patients who benefit (which would require confirmation in further trials).
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7. PEECH (Prospective evaluation of EECP in Congestive Heart Failure) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by Arthur Feldman, from Jefferson Medical College, Philadelphia, USA.
Enhanced External Counterpulsation (EECP) is a non-invasive therapy which uses a series of inflatable cuffs placed around the patients legs. Inflation and deflation of the cuffs is synchronised with the patient's ECG to provide an effect similar to intra-aortic balloon counter-pulsation. It improves coronary flow and reduces afterload.
Patients in the PEECH study were randomised to treatment with either EECP plus optimal pharmacological therapy or optimal pharmacological therapy alone for a period of 7 weeks. Patients with stable, NYHA class II–III heart failure, with an LV ejection fraction 
35% and an ability to exercise for at least 3 min were included [20]. The primary endpoint was the percentage of patients with a 60 s increase in exercise duration or with at least 1.25 ml/min/kg increase in peak VO2, at 6 months. Investigators who performed the patient evaluations were blinded to the treatment allocation. The patients were not blinded to their treatment group.
Baseline characteristics were similar in the two treatment groups, 76% of patients were male, mean age was 63 years and mean LVEF was 26%. After 6 months, significantly more patients in the EECP group had an increased exercise duration (35.4%) compared with placebo (25.3%) p=0.016. However there was no difference in effect on peak VO2. Quality of life and NYHA class also improved in the intervention group. There was no difference in adverse events between the treatment groups.
The presenters suggested that EECP provides useful adjunctive therapy in heart failure patients receiving optimal pharmacological therapy, with effects lasting for up to 6 months. However, the lack of difference between treatment groups in the most objective marker of benefit, the peak oxygen consumption, in an unblinded trial means that the results should be treated with caution. Further research is warranted before the benefits of EECP on symptoms and exercise capacity are considered conclusive.
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8. PREMIER (PREvention of MI Early Remodelling) |
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TopAbstract1. CARE-HF (CArdiac...2. Women's Health Study3. TNT (Treating to...4. COMPASS-HF (Chronicle(R)...5. VERITAS (Value of...6. CANPAP (CANadian continuous...7. PEECH (Prospective evaluation...8. PREMIER (PREvention of...References |
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Presented by Douglas Weaver from the Henry Ford Hospital, Detroit, Michigan, USA.
Matrix metalloproteinases are proteolytic enzymes which are thought to be involved in the process of cardiac remodelling following myocardial infarction. Early experimental studies have shown the matrix metalloproteinase inhibitor (MMPi) PG-116800 to be effective in reversing the LV remodelling process which may ultimately lead to heart failure.
The PREMIER study randomised 253 patients within 48 h of their first MI, to double-blind treatment with either MMPi or placebo in addition to usual care. LV function was assessed by echocardiography.
The investigators reported that although the treatment was safe and well tolerated, there was no difference in effect between PG-116800 and placebo on LV remodelling at 90 days.
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