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European Journal of Heart Failure 2007 9(12):1205-1211; doi:10.1016/j.ejheart.2007.09.008
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© 2007 European Society of Cardiology

Is the gap between guidelines and clinical practice in heart failure treatment being filled? Insights from the IMPACT RECO survey

P. de Grootea,*, R. Isnardb, P. Assyagc, P. Clersond, A. Ducardonnete, M. Galinierf, G. Jondeaug, I. Leursh, J.-F. Thébauti and M. Komajdab

a Service de Cardiologie C, Hôpital Cardiologique CHRU, Bd du Pr Jules Leclercq, 59037 Lille Cedex, France
b Département de Cardiologie, Hôpital Pitié-Salpêtrière & Université Pierre et Marie Curie Paris, France
c Service Cardiologie, Hôpital Saint Antoine Paris, France
d Orgametrie Roubaix, France
e Institut Cœur Effort Santé Paris, France
f Fédération des Services de Cardiologie CHU Rangueil, Toulouse, France
g Service de Cardiologie, Hôpital Ambroise Paré Boulogne, France
h AstraZeneca Rueil-Malmaison, France
i Centre Alfred Kassler Sarcelles, France

* Corresponding author. Tel.: +33 3 20445045; fax: +33 3 20444881. pdegroote{at}chru-lille.fr (P. de Groote).


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
Background: Recent registries have shown that recommended drugs for the treatment of chronic heart failure (CHF) are under-prescribed in daily practice.

Aims: To determine prescription rates of CHF drugs, and to assess predictive factors for drug prescription using data from a large panel of French cardiologists.

Methods and results: We included 1919 outpatients, with NYHA class II–IV heart failure and a left ventricular ejection fraction <40%. The most frequently prescribed drugs were diuretics (83%), angiotensin converting enzyme inhibitors (ACE-I) (71%), beta-blockers (65%), spironolactone (35%) and angiotensin receptor blockers (ARB) (21%); 61% of patients received a combination of a beta-blocker and an ACE-I or ARB. Target doses were reached in 49% of the patients for ACE-I, but in only 18% for beta-blockers and in 9% for ARBs. Multivariate analyses showed that age >75 years was an independent factor associated with under-prescription of ACE-I-ARBs, beta-blockers or spironolactone. Renal failure was associated with a lower prescription of ACE-I-ARB and spironolactone, and asthma was a predictor of under-prescription of beta-blockers.

Conclusions: In this contemporary survey, prescription rates of CHF drugs were higher than previously reported. However, dosages were lower than those recommended in guidelines. Age remained an independent predictor of under-prescription of CHF drugs.

Key Words: Chronic heart failure • Drug prescription • Angiotensin converting enzyme inhibitors • Beta-blockers • Angiotensin 2 receptor blockers

Received March 12, 2007; Revised July 9, 2007; Accepted September 25, 2007


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
In western countries, chronic heart failure (CHF) is a growing health problem, which is in part related to increased life expectancy. Several large randomised controlled morbi-mortality trials have clearly demonstrated an improvement in survival in patients with CHF due to left ventricular systolic dysfunction, following treatment with angiotensin converting enzyme inhibitors (ACE-I), angiotensin-2 receptor blockers (ARB), beta-blockers and aldosterone antagonists [1-6]. Several guidelines for the treatment of heart failure have been published by international societies and these are regularly up-dated [7-9]. However, several registries from different countries have shown that effective drugs for CHF patients are under prescribed. In the EuroHeart Failure Survey, which was conducted in European hospitals in 2000-2001, prescription rates of ACE-I and beta-blockers were 62% and 37%, respectively, with a wide range of prescription rates in different countries [10]. For example, in France, prescription rates of ACE-I and beta-blockers were 63% and less than 30%, respectively. Similar rates of prescription were reported among European primary care physicians [11]. In 1999, a national survey in 600 French outpatients with stable CHF reported a prescription rate of 54% for ACE-I and of 14% for beta-blockers [12]. Moreover, most of these registries have also shown that prescribed doses were significantly lower than those used in landmark morbi-mortality trials [11,13].

The main objectives of this study were therefore to describe the therapeutic management of stable CHF outpatients by French private cardiologists in 2005 and to try to determine independent predictors of drug prescription prior to publication of the most recent European CHF guidelines [8].


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusions
 References
 
One thousand French private cardiologists, randomly selected from the French national database, were asked to participate in the study. The selection was complete when 600 cardiologists had agreed to participate in the study. Each cardiologist was asked to include the first 4 consecutive outpatients who met the study inclusion criteria, at least one of these 4 patients had to be hospitalised within the 6 previous months for decompensated heart failure. Inclusion criteria were: age≥18 years, with NYHA class II-IV stable chronic CHF with left ventricular systolic dysfunction defined as a left ventricular ejection fraction (LVEF)<40%. Key demographic data were collected including medical history, NYHA class, LVEF (measured within the last 12 months), co-morbidities such as asthma, chronic obstructive pulmonary disease (COPD) or renal failure (defined as plasma creatinine≥220 µmol/l). Results of the clinical examination and ECG had to be reported. Particular attention was paid to the patient's ongoing medical treatment for heart failure and dosage, including beta-blockers, ACE-I, ARB, loop or thiazide diuretics and spironolactone. The dose of ACE-I was classified according to the guidelines of the European Society of Cardiology; maximal recommended target doses and 50% of target doses were defined [7,8].

Results are presented as mean±standard deviation for continuous variables and as number and percentage for dichotomous variables. Group comparisons were made using t-test or chi-square test. All tests were two-sided and the alpha risk was set at 0.05. The influence of demographic and clinical variables, as well as the characteristics of each cardiologist for the probability of prescribing each therapeutic class was modelled by logistic regression. The analysis was conducted using the forward stepwise option. The quality of the models was assessed by the c criterion and the Hosmer-Lemeshow test. Statistical analyses were performed using SAS 8.2 software (SAS Institute, Cary, NC, USA).


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusions
 References
 
3.1. Study population
Between September 2004 and March 2005, 519 cardiologists included 2068 patients; 151 patients who did not meet the inclusion criteria were excluded from analysis. Therefore, results are given for 1917 patients including 691 patients (36%) who had been hospitalised for decompensated heart failure within the previous six months. Clinical characteristics of the study population are summarized in Table 1. The sex ratio was unbalanced, 74% of patients were male. Mean age was 70±11 years and 17% of patients were aged over 80 years. LVEF was determined by echocardiography (90%), angiography (8%), and scintigraphy (2%).


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  		Table 1 Clinical characteristics of the study population (n=1917)

 
3.2. Prescription rates of CHF treatment
The most frequently prescribed drugs were loop or thiazide diuretics (83%), ACE-I (71%), beta-blockers (65%), spironolactone (35%), and ARB (21%). Treatments were often associated: 61% of the patients received a dual combination of a beta-blocker and a renin angiotensin system inhibitor (ACE-I or ARB) and 51% received a triple combination of diuretics, beta-blockers and ACE-I or ARB. Although 91% of the patients received an ACE-I or an ARB, the dual inhibition of the renin angiotensin system by a combination of ACE-I and ARB was rare (1.7%). Other treatments were digoxin (21%), nitrates (19%), amiodarone (19%), oral anticoagulants (33%), and calcium channel blockers (9%); 43% of patients received aspirin or clopidogrel.

Ninety three percent of patients receiving ACE-I were treated with one of the 6 drugs recommended by the ESC guidelines (captopril, enalapril, lisinopril, perindopril, ramipril, trandolapril); 88% of patients prescribed a beta-blocker were receiving bisoprolol, carvedilol or metoprolol succinate, as recommended by the ESC guidelines.

3.3. Doses of CHF treatment
Of the 1266 patients treated with an ESC recommended ACE-I, 49% received the target dose and 81% received at least 50% of the target dose (Fig. 1). Among patients treated with an ESC recommended beta-blocker (n=1100), 18% received the target dose and 47% received at least 50% of the target dose [8]. All patients on spironolactone received at least 12.5 mg/day. ARBs were given at target doses in 9% of patients and 53% received at least 50% of the target dose. Interestingly, the average daily dose of each drug did not vary according to the number of CHF recommended drugs (Table 2).


Figure 01
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  		Fig. 1 Doses of recommended CHF treatments (ACE-I, ARB and BB). ACE-I: Angiotensin Converting Enzyme Inhibitors; ARB: Angiotensin II Receptor Blockers; BB: Beta-blockers.

 


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  		Table 2 Average daily doses of CHF treatment according to the number of recommended drugs (ACE-I/ARB, beta-blockers, spironolactone and diuretics)

 
3.4. Predictors of CHF treatment prescription
Univariate analyses of factors potentially associated with drug prescription are summarized in Table 3. Age, sex, body mass index, LVEF, renal failure, previous hospitalisation, asthma/COPD, previous history of cough with ACE-I, coronary disease, history of hypertension, duration of practitioner's professional activity, and whether the physician belonged to a CHF network or not, were entered in a multivariate model aimed at explaining the prescription of ACE-I, ARB, beta-blockers, spironolactone and diuretics. Results of these different analyses are presented in Table 4. Briefly, for ACE-I or ARB, the most important predictors of non-prescription were age and renal failure, whereas sex was not important. As expected, beta-blockers were more often prescribed in patients with coronary artery disease, and less prescribed in patients with asthma or COPD, and in NYHA III-IV patients. Again, age was a predictor of under-prescription of beta-blockers. Spironolactone was less often prescribed in patients over 75 years and in patients with renal failure or with ischaemic cardiomyopathy. In contrast, spironolactone was more often prescribed in patients with low LVEF. Our multivariate analyses showed that age was an important parameter explaining under-prescription of all CHF drugs except for diuretics. Diuretics were more often prescribed in patients with low LVEF, in NYHA class III/IV, in patients with a recent CHF hospitalisation, in patients with renal failure and in patients with a history of hypertension, asthma or COPD.


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  		Table 3 Ongoing treatments for heart failure in the whole population and in subgroups of patients according to clinical characteristics

 


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  		Table 4 Independent predictors explaining the prescription of the most important CHF treatments

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusions
 References
 
The results of the present study suggest an improvement in the therapeutic management of stable CHF outpatients in France. Most patients (91%) received a renin angiotensin system antagonist, ACE-I or ARB, and 65% a beta-blocker. However, these encouraging results are balanced by the fact that these drugs were prescribed at low doses, and that high-risk populations, such as elderly patients and patients with renal failure, were under-treated.

4.1. Prescription rate of CHF treatment
Previous registries and surveys performed between 1996 and 2001 have reported a stable prescription rate for ACE-I, of about 60% [10-12,14-17]. However, during this period, prescription rates of beta-blockers increased progressively, from less than 10% before 1998 to 53% in the MALHER study, which included patients from 2001 to 2002 [18]. Similarly, there was also an increase in the prescription rate of ARBs and of spironolactone. This suggests an improvement in the therapeutic management of CHF patients, probably related to a better knowledge of international guidelines [7,8] and of the results of large therapeutic trials [19-23]. In the Cardiovascular Health Study, the prescription rate of ACE-I in CHF patients increased from 26% in 1989-1990 to 36% in 1994-1995 [24]. However, the National Heart Care Project showed that in the United States of America from 1998 to 2001, the prescription rate of ACE-I remained stable, at close to 70% [15]. Similarly, ARBs were prescribed in 10% of the patients with no increase in prescription rate during this period. In the present study, we confirm the improvement in therapeutic practice in CHF outpatients. We found an increase in prescription rates of both ACE-I or ARB (currently 91%) and a marked increase in the rate of prescription of beta-blockers. The prescription rate of beta-blockers observed 5 years after the publication of mortality trials [4], is similar in this survey to that of ACE-I observed more than 10 years after the first mortality trial [1]. Moreover, the prescription rate for dual inhibition, i.e. ACE-I or ARB and beta-blocker, increased over time to 60% in the present study. When we compared our results to those of previous French registries conducted after 2000 (Fig. 2), we found a similar prescription rate for ACE-I, but an increase in prescription rates for beta-blockers (from 14% to 65%), for spironolactone (from 12% to 35%) and for ARB (from 5% to 21%). In a recent report from Spain, prescription rates of CHF drugs were compared during 3 periods (1991-1996; 1997-1999, 2000-2001), with close to 200 patients with a LVEF<50% per period [25]. Prescription rates of ACE-I increased significantly from 60% to 75%. Similar increases were found for beta-blockers (from 6% to 45%), ARBs (from 0% to 6%) and spironolactone (from 2% to 21%). Some studies have reported a higher prescription rate for ACE-I, of close to 75%, but these studies, like EPICAL, ETICS and EFFECT, enrolled patients on admission to hospital for decompensated CHF [26-28] and were performed at the beginning of the beta-blocker era.


Figure 02
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  		Fig. 2 Prescription rates of recommended CHF drugs in recent French surveys. Results are presented as % of patients ACE-I: Angiotensin Converting Enzyme Inhibitors; ARB: Angiotensin II Receptor Blockers; BB: beta-blockers [35,36].

 
4.2. Doses of CHF treatment
Although, prescription rates of recommended CHF drugs increased, only half of our patients were receiving target doses of ACE-I, and a minority were under target doses of beta-blockers. Except for the EPICAL study and the AUSTRIA survey [26,29], most registries have found that only half of patients are receiving recommended doses of ACE-I. For beta-blockers, the proportion of patients on target doses remained dramatically low. This is in line with previous studies such as the EuroHeart Failure Survey, in which only 6% of the MERIT-HF trial eligible patients received target doses of beta-blockers [13].

Interestingly, mean doses of the major recommended drugs were similar irrespective of blood pressure values (data not shown) and of the number of prescribed treatments (Table 2). This suggests that the low doses used by French cardiologists cannot totally be explained by combinations of CHF drugs and by the blood pressure effect of these combinations.

4.3. Reasons for CHF under treatment
Age was the most important factor limiting the prescription of CHF therapy. Older patients received less ACE-I/ARBs, beta-blockers and spironolactone, but more diuretics. These results are in agreement with previous reports [10,11,26,30-32]. In contrast, management of CHF was similar in men and in women unlike previous results [10,11,33].

The presence of renal failure was the most important parameter explaining the non-prescription of ACE-I/ARB. Renal dysfunction has been identified as an important parameter of ACE-I non-prescription in some previous studies [15,26,31], but not all [10,11].

As expected, and as demonstrated in previous studies [10,27], beta-blocker prescription was limited by a history of asthma or COPD. In contrast, patients with a history of CAD were more likely to receive beta-blockers. Despite the results of the COPERNICUS study [19], severe CHF, defined as NYHA class III-IV, was associated with a lower prescription rate of beta-blockers.

Spironolactone was less prescribed in older CHF patients and in patients with renal failure. The perception by the cardiologist of the risk of acute renal failure and hyperkalaemia probably explains these results [34]. On the contrary, low LVEF, but not NYHA classification, was associated with spironolactone prescription.

4.4. Study limitations
IMPACT-RECO was an observational cross-sectional survey performed in CHF outpatients followed by private cardiologists. Therefore, it does not provide an insight into the management of CHF by general practitioners. Moreover, although the cardiologists were randomly selected from the French database, we cannot exclude a selection bias with inclusion of a selected CHF population. However, most of the previous surveys from France and other countries have used the same methodology for the selection of practitioners. Data were self-reported by cardiologists but a quality control was performed randomly in 10% of centres. This quality control was focused on clinical characteristics of the patients and on the CHF treatment. There was no disagreement between reported results by cardiologists and medical records in all the centres analyzed. We included patients with a LVEF <40%. Therefore, our patients are not the same as those included in the large mortality trials (with a LVEF ≤35%). However, prescription rates of all CHF drugs, except for spironolactone, were similar in subgroups of patients divided according to LVEF (> or ≤35%) (data not shown).


   5. Conclusions
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusions
References
 
Our study suggests an improvement in the therapeutic management of CHF outpatients in 2005, with an increase in prescription rates of recommended CHF drugs, and particularly of beta-blockers and of the combination of ACE-I/ARB and beta-blockers. However, doses prescribed remain lower than the target doses used in large randomised controlled morbi-mortality trials. In addition, some populations, such as older patients and patients with renal failure, were under-treated. Continued education of cardiologists and general practitioners is required in order to improve the therapeutic management of CHF patients, with particular emphasis on the effective doses of drugs required.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 

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Filling the gap between guidelines and clinical practice in heart failure treatment -- Still a far cry from reality
Eur J Heart Fail, December 1, 2007; 9(12): 1143 - 1145.
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