Improvement in the management of chronic heart failure since the publication of the updated guidelines of the European Society of Cardiology
The Impact-Reco Programme
1 Pôle de Cardiologie et Maladies Vasculaires, CHRU de Lille, Université de Lille 2, France
2 Department of Cardiology, Université Pierre et Marie Curie–Paris VI, AP-HP, Pitie Salpetriere Hospital, 75651 Paris Cedex 13, France
3 Orgamétrie, Roubaix, France
4 Service de Cardiologie, Hôpital Bichat, AP-HP, Université Denis Diderot, Paris VII, Paris, France
5 Fédération des Services de Cardiologie, CHU Rangueil, Toulouse, France
6 Services de Cardiologie, Hôpital Saint Antoine, Paris, France
7 Astra-Zeneca, Rueil-Malmaison, France
8 Institut Cœur Effort Santé, Paris, France
9 Centre Alfred Kastler, Sarcelles, France
* Corresponding author. Tel: +33 1 4216 3003, Fax: +33 1 4216 3020, Email: michel.komajda{at}psl.ap-hop-paris.fr
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Abstract |
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Aims: Recent studies have shown that prescription rates and doses of recommended drugs for chronic heart failure (CHF) are not optimal in daily practice. The aim of the Impact-Reco programme was to analyse prescription rates of CHF drugs in stable outpatients with CHF related to left ventricular (LV) systolic dysfunction in two similar surveys in France.
Methods and results: The two surveys, which included 1917 and 1974 patients, were performed between September 2004 to March 2005 and September 2005 to May 2006, respectively. Prescription rates of angiotensin-converting enzyme-inhibitors (ACE-I) remained stable (71 vs. 68%, respectively), whereas the proportion of patients receiving angiotensin receptor blockers (21 vs. 30%, P < 0.0001) and beta-blockers (65 vs. 70% P < 0.0001) increased significantly. Doses of ACE-I and beta-blockers increased significantly between the two surveys. However, the improvement was of lesser magnitude in some subgroups of patients, such as elderly patients or patients with renal failure.
Conclusion: The Impact-Reco programme found an improvement in prescription rates and in the dosage of neurohumoral antagonists in French outpatients with stable CHF. However, there is still room for improvement, especially regarding the doses of medications and the treatment of some subgroups of patients such as the elderly and patients with renal failure.
Key Words: Chronic heart failure • Drug prescription • Angiotensin-converting enzyme-inhibitors • Beta-blockers • Angiotensin 2 receptor blockers • Guidelines
Received February 4, 2008; Revised August 17, 2008; Accepted August 22, 2008
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Introduction |
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Chronic heart failure (CHF) is a major public health concern with growing prevalence, particularly in the elderly. The social burden of this condition is important.1,2 The European Society of Cardiology guidelines for the management of CHF related to left ventricular (LV) systolic dysfunction are regularly updated and endorsed by national societies.3 These guidelines emphasize in particular the beneficial effects of angiotensin-converting enzyme-inhibitors (ACE-I), beta-blockers, angiotensin II receptor blockers (ARB), and aldosterone antagonists on mortality and morbidity, based on large outcome trials.4–8 Despite major advances in the management of CHF, mortality and morbidity remain high.9–12 One reason for this could be that this condition remains under-diagnosed and under-treated.13–17 Under-treatment may mean either under use of modern recommended treatments or prescription of low doses of these drugs.13,18,19 The EuroHeart Failure Survey I, conducted in 2001, demonstrated that in France, prescription rates of ACE-I and of beta-blockers did not exceed 63% and 30%, respectively.20,21 Moreover, prescribed doses of recommended drugs were usually low. Previous studies have demonstrated that drug compliance by patients and adherence to guidelines by physicians are independent predictors of outcome in CHF.22,23 The Impact-Reco programme was designed to analyse the management of CHF patients by private cardiologists in France before and after the publication of the updated European guidelines.3
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Methods |
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Two observational surveys were conducted in a randomly selected sample of private cardiologists in France. The first survey was carried out from September 2004 to March 2005 before the publication of the updated European guidelines and results have been already published.24 We demonstrated in the first survey that prescription rates of CHF drugs, particularly of beta-blockers, were higher than previously reported in similar studies. However, doses prescribed remained lower than in the recommended guidelines. The second survey was conducted from September 2005 to May 2006, after the publication of the updated version of CHF guidelines. For each survey, 1000 cardiologists were selected by drawing lots in the national database of cardiologists and were asked to participate in the study. The recruitment process for each study ended when 600 physicians agreed to participate. All physicians participating in the programme received an updated copy of the European guidelines translated into French. A significant number of them (320 of the 600 cardiologists participating in the second survey) participated in regional educational meetings. Physicians were instructed about the updated guidelines with special emphasis on differences with prior recommendations.
For each survey, cardiologists were asked to include four consecutive outpatients, who met the inclusion criteria defined below. At least one of these patients had to have been hospitalized for worsening heart failure within the previous 6 months. The inclusion criteria were similar for each survey: age 
18 years, with stable and symptomatic heart failure [New York Heart Association (NYHA) class II–IV] related to LV systolic dysfunction, defined as a left ventricular ejection fraction (LVEF) less than 40%, and measured within 12 months prior to inclusion. Key demographic data were collected including medical history, NYHA class, LVEF, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), or renal failure (defined as creatinine 220 µmol/L), clinical, and ECG data. Ongoing medical treatment for CHF and cardiovascular drugs and dosages were recorded.
Statistics
Results are presented as mean ± SD for continuous variables and as number and percentage for categorical variables. Group comparisons were made using t-test or 
2 test. All tests were two-sided and the alpha risk was set at 0.05. For each recommended treatment, the dose was classified based on the guidelines of the European Society of Cardiology: maximal recommended target doses and 50% of target doses were considered (see Appendix).25 The influence of demographic and clinical variables (age, gender, body mass index, history of hypertension, ischaemic cardiopathy, renal failure, diabetes mellitus, history of pulmonary disease, history of ACE intolerance, recent hospitalization for worsening CHF, NYHA functional classification, LVEF) as well as of the cardiologist's profile on the probability of prescription of each therapeutic class was modelled by logistic regression. The survey number (first or second) was also added in the model in order to test whether the probability of prescription was different between the two surveys when comparisons were multi-adjusted. The analysis was conducted using the forward stepwise option. The quality of models was assessed by the C criterion and the Hosmer–Lemeshow test. Statistical analyses were performed using SAS 9.1 software (SAS Institute, Cary, NC, USA). A quality control, focused on clinical characteristics of the patients and on the CHF treatment was performed randomly in 10% of centres. There was no disagreement between results reported by cardiologists and medical records in all the centres analysed.
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Five hundred and fifteen and 539 private cardiologists, respectively, participated in the first and the second surveys of the Impact-Reco programme, allowing the inclusion of 2068 and 2144 patients, respectively. We excluded from the analyses 151 and 170 patients, respectively, for violation of the inclusion criteria. Therefore, analyses were performed on 1917 and 1974 patients. Despite the fact that no patient participated in both the surveys, patient's key demographic data were similar. Clinical characteristics of the patients are summarized in Table 1. Almost one-third of the patients had been hospitalized within the previous 6 months [691 (36%) and 661 (33%) in each survey, respectively] and an history of intolerance to ACE-I was reported in 26%. LVEF, measured in most instances by echocardiography, was reduced and was <30% in 23% of patients in each survey.
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Prescription rates of main CHF drugs
Prescription rates of the main CHF drugs in the two surveys are presented in Figure 1. The prescription rate of renin–angiotensin inhibitors increased slightly between the two surveys (91–93%, P = 0.02). Although prescription rate of ACE-I remained stable (71 vs. 68%), the proportion of patients treated with an ARB increased significantly (21–30%, P < 0.0001), as did the proportion of patients on beta-blockers (65–70%, P < 0.0001). Of the 475 patients from the second survey treated with an ARB and not receiving an ACE-I, 416 (88%) had a previous history of intolerance to ACE-I. The combined prescription of an ACE-I and/or ARB and a beta-blocker was significantly more frequent in the second survey (66 vs. 61%, P = 0.0002), because of the higher prescription of both beta-blockers and ARBs. Dual-inhibition of the renin–angiotensin system with ACE-I and ARB was prescribed in 40 patients (2.1%) in the first survey and in 117 patients (6%, P < 0.0001) in the second survey. Patients receiving a combination of ACE-I and ARB in the second survey had a more severe NYHA functional class (65% in NYHA class III–IV vs. 51% in patients receiving either ACE-I or ARB, P < 0.001). The prescription of both drugs was not associated with a lower prescription of beta-blockers. Most of the prescribed ACE-I (93 and 94% in the first and second survey, respectively) and of the prescribed beta-blockers (88 and 92%, P < 0.0001) were those recommended by the ESC guidelines. Prescription rates of spironolactone and diuretics remained stable. Anti-platelet agents, such as aspirin or clopidogrel, were more frequently given in the second survey (43 vs. 48%, P = 0.002), as were statins (45 vs. 50%, P = 0.002).
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Physicians were asked about reasons for not prescribing ACE-I, ARBs, or beta-blockers. Reported side effects like cough with ACE-I and bradycardia, asthenia or impotence with beta-blockers were the most frequent answers as were contraindications or comorbid conditions, such as renal failure for ACE-I or ARB, and asthma or COPD for beta-blockers. For these different classes of drugs, orthostatic hypotension was cited in around 10% of patients and in around 25% of cases, the physician did not give any answer to the question. Moreover, for 12% of patients they answered that beta-blockers were not useful suggesting that the recommendations were not fully understood.
Predictors of chronic heart failure drugs prescription
For these analyses, patients from the two surveys were combined. In order to analyse the temporal impact, the sequence of the study was introduced in the multi-adjusted logistic regression model. Results are presented in Table 2. The probability of prescription of renin–angiotensin inhibitors or beta-blockers appeared to be higher in the second survey with an OR reaching 1.63 (95% CI 1.23–2.15) for renin–angiotensin inhibitors and 1.30 (95% CI 1.10–1.52) for beta-blockers. Age was a predictor of under-prescription of CHF drugs. Renal failure was a predictor of non-prescription of renin–angiotensin inhibitors and spironolactone, but a predictor of diuretic prescription. Beta-blockers were more often given to patients with ischaemic cardiomyopathy, but less often when LV dysfunction or NYHA functional class were more severe. History of asthma or COPD was the most powerful predictor of under-prescription of beta-blockers.
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Doses of chronic heart failure drugs
Figure 2 presents percentages of patients receiving target doses and 50% of target doses of ACE-I, beta-blockers, and ARB in each survey. The main reason for not reaching the target doses was safety concerns (59%) but in around 20% of patients, no reason was given. The combined prescription of ACE-I and ARB was not associated with lower doses: 78% of these patients reached at least 50% of the target dose of ACE-I and 28% received at least 50% of the target dose of ARB (vs. 58% and 15% in patients receiving either ACE-I or ARB).
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Prescription rates of chronic heart failure drugs in specific subgroups
Prescription rates and doses improved in the second survey in some subgroups of interest (Tables 3 and 4). In elderly patients, renin–angiotensin inhibitors were more often prescribed in the second survey than in the first one (from 84% to 89%, P = 0.006) and doses of ACE-I increased. Prescription rates for beta-blockers did not change but doses prescribed were higher. In NYHA class III patients, prescription rates of ACE-I, ARBs, and beta-blockers increased, as did the doses of ACE-I and beta-blockers. In diabetic patients, prescription rate of beta-blockers increased from 66% to 72% (P = 0.04) and doses of ACE-I and beta-blockers were higher. No significant change was observed in patients with renal failure or in patients with a history of asthma/COPD. ARB prescription was higher in the second survey in several subgroups of patients: older patients (22–29%, P = 0.002), patients with recent hospitalization for worsening CHF (17–28%, P < 0.001), NYHA class III patients (20–32%, P < 0.001), diabetic patients (20–33%, P < 0.001), patients with renal failure (22–33%, P = 0.01), ischaemic patients (22–32%, P < 0.001), and patients with pulmonary diseases (22–33%, P = 0.002).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionFundingAppendixReferences |
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The main objective of the Impact-Reco programme was to analyse prescription rates of CHF drugs in two observational surveys performed before and after the publication of the updated European CHF guidelines for the management of stable CHF. The results of the present study identify an improvement in prescription rates for some neurohumoural antagonists. Moreover, doses of ACE-I and beta-blockers also improved between the two surveys. Although the improvement in prescription rates of CHF drugs was significant in 1 year, there is still some room for improvement, especially regarding doses of renin–angiotensin inhibitors and beta-blockers.
Recommended chronic heart failure drugs
A number of observational studies have demonstrated that a large proportion of patients with CHF do not receive recommended drugs.13,15 Dissimilarity between patients enrolled in clinical trials and those encountered in daily practice only partly explains this situation.18 Other reasons may be patient-related (such as contraindications, intolerance, compliance), or prescriber-related (such as focusing on symptom relief rather than on prognosis, lack of awareness of the disease, and of treatment objectives or even a reluctance to prescribe or to up-titrate recommended medications). Prescription of beta-blockers and ARBs increased significantly between the two surveys, however, the situation remained suboptimal for these drugs. Our multivariate analyses clearly demonstrate that the timing of the survey was an independent predictor for the prescription of both renin inhibitors and beta-blockers. However, we did not find any change in the prescription rate of spironolactone (35%), despite a significant proportion of NYHA class III–IV patients (46% and 52% in each survey). Prescription of spironolactone was lower in patients with renal failure, which is probably explained by the fear of renal complications and particularly hyperkalaemia.26 The proportion of patients receiving at least 50% of target doses increased between the two surveys, even though the situation could be further optimized. The analysis of the reasons for non-prescription of recommended CHF drugs or for not reaching target doses suggested that contraindications/comorbidities (renal failure for ACE-I, COPD/asthma for beta-blockers) or side effects played a major role. However, in a significant proportion of patients, the physician was unable to give any specific reason suggesting that educational programmes might improve the situation.
Prescription of angiotensin receptor blockers
European guidelines recommend ARBs in patients intolerant to ACE-I.3,7 The proportion of patients receiving ARBs substantially increased between the two surveys, mainly in ACE-I-intolerant patients. Indeed, in 475 patients receiving ARB and not ACE-I, 416 (88%) had a history of poor tolerability with ACE-I.
The introduction of an ARB in ACE-I-treated patients who remain symptomatic is one of the major modifications in the 2005 version of the ESC guidelines.3 The combination of an ACE-I and an ARB remained limited but increased substantially between the two surveys (from 1.7% to 6%), suggesting that in severely symptomatic patients, the ESC guidelines were taken into consideration. Interestingly, in the present study patients receiving both an ACE-I and an ARB had more severe CHF and overall ARBs were given in combination with an ACE-I and beta-blockers at higher doses.
Subgroup analyses
Our results are in accordance with previous studies and suggest that prescription of neurohumoural antagonists in CHF is reduced in some subgroups of patients, namely elderly patients, and patients with respiratory disease or with renal failure.19,20,27–29 However, our results show a trend for an improvement in the therapeutic management of some subgroups of patients: diabetic patients and patients with ischaemic cardiomyopathy were more likely to receive renin–angiotensin inhibitors and beta-blockers at high doses.
CHF is a complex condition occurring frequently in aged and frail patients and treatment strategies can therefore be complicated. Cardiologists adherence to guidelines is a predictor of outcome in CHF.22 Thus, programmes increasing the awareness of physicians are likely to help implementation of guidelines in daily clinical practice. French cardiologists participating in the study were informed about the updated guidelines through medical journals or scientific meetings. The improvement in therapeutic behaviour was the result of a global process of education, which included medical journals, congresses, and local meetings. These results are encouraging, particularly the fact that this improvement was significant in a short period, and clearly indicate that educational efforts have to be pursued.
Study limitations
Our study has some limitations. First, despite quality control of the data via an audit of 10% of the centres, data were self-reported by the physician. However, patient profiles were remarkably constant in the two surveys. Secondly, it is possible that physicians who agreed to participate in the study were more interested by CHF than physicians who did not. The ongoing IMPROVE-HF registry might address this issue in the near future.30 Similarly, some investigators, but not all, participated in educational meetings. The impact of the selection of participating investigators on the therapeutic management of CHF patients could not be assessed in the present study. Finally, we could not eliminate the fact that up-titration of CHF drugs was in progress in some patients at the time of the study. Indeed, in patients recently hospitalized, doses of ARB and beta-blockers were lower than in more stable patients.
Conclusions
The Impact-Reco programme was divided into two observational surveys carried out before and immediately after the publication of the updated European CHF guidelines and demonstrate an improvement in prescription rates of neurohumoural antagonists in stable CHF outpatients by private cardiologists in France. However, there is still some room for improvement, especially regarding the doses of medications and the treatment of some subgroups of interest, such as elderly patients or patients with renal failure.
Conflict of interest: The authors have received honoraria for the conduct and the independent scientific supervision of the study from AstraZeneca France.
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The study was made possible by an unrestricted grant from AstraZeneca France.
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Appendix |
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Recommended doses of angiotensin-converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARBs), and beta-blockers based on the European Society of Cardiology guidelines for chronic heart failure
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