Survival differences between heart failure in general practices and in hospitals.

OBJECTIVES: To compare the survival of patients thought to have heart failure in general practice (GP-HF) with that of patients with heart failure in hospital (hospital-HF), patients with heart disease but without heart failure (non-HF), and a control group without heart disease. DESIGN AND SETTING: Cross sectional study from general practice with a prospective follow up from 5.3 to 7.4 years. PARTICIPANTS: 2157 community participants, 1999 of whom lived outside nursing homes, were selected because they were registered with four general practitioners at entry. Study participants were divided into the four groups after a review of general practice case notes, questionnaires, and interviews. MAIN OUTCOME MEASURES: Five year survival and multivariate predictors of all cause mortality. RESULTS: Five year survival was 76% in the control group (n = 571, mean age at entry 74.1 years), 71% in non-HF patients (n = 218, 74.4 years), 61% in GP-HF patients (n = 67, 75.8 years), and 39% in hospital-HF patients (n = 33, 76.7 years). The median survival times were 6.8 years for GP-HF patients and 3.9 years for hospital-HF patients. Significant predictors of mortality in the multivariate Cox model of 1979 patients living outside nursing homes were hospital-HF (hazard ratio (HR) 2.1, p = 0.002), GP-HF (HR 1.7, p = 0.004), non-HF heart disease (HR 1.4, p = 0.03), previous myocardial infarction (HR 1.6, p = 0.04), no response to questionnaire (HR 2.0, p < 0.0001), higher age (for every 10 years, HR 2.4, p < 0.0001), and male sex (HR 2.1, p < 0.0001). Other factors such as atrial fibrillation, hypertension, and diabetes were not significant. CONCLUSION: Heart failure in general practice is associated with a worse survival than that seen in the control group but is better than for patients who have been treated at least once for heart failure in a hospital.

Different effects of calcium antagonist and beta-blocker therapy on left-ventricular diastolic function in ischemic heart disease. A direct comparison of the impact of mibefradil and atenolol.

OBJECTIVE: To compare the effect of a calcium antagonist and a beta-blocker on left-ventricular diastolic function in patients with ischemic heart disease. METHODS: 138 patients with chronic stable angina pectoris were randomized in a multicenter, double-blind trial to treatment with either mibefradil or atenolol for 6 weeks (50 mg once daily for 2 weeks followed by 100 mg once daily for 4 weeks). The ratio between early (E) and late (A) diastolic mitral flow velocities (E/A), the E wave deceleration time (DT) and the left ventricular isovolumetric relaxation time (IRT) were measured by Doppler echocardiography as parameters of left-ventricular diastolic function initially, after 4 and after 6 weeks of treatment. RESULTS: Mibefradil did not change the E/A ratio significantly (+4%, NS), while atenolol treatment resulted in a significant increase in the E/A ratio (+20%, p < 0.001). Mibefradil treatment, on the other hand, resulted in a significant decrease (-8%, p < 0.001) in IRT, while atenolol treatment did not change IRT. Neither mibefradil nor atenolol treatment changed DT significantly. CONCLUSIONS: Both mibefradil and atenolol treatment significantly improves echocardiographic indices of left-ventricular diastolic function in patients with chronic stable angina. However, they affect different parameters and thus apparently act through different mechanisms.

The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points.

BACKGROUND: A multicentre study permits rapid recruitment of a large number of patients. However, there is a risk of heterogeneities in end-point evaluations, as complex definitions of criteria are interpreted by several local investigators from different hospitals. Reports discussing end-point evaluation are sparse. The TRIM trial was a multicentre trial of a thrombin inhibitor in patients with unstable angina or non-Q myocardial infarction. In this study, an independent end-point committee evaluated all the reported events of death, acute myocardial infarction and refractory angina pectoris in order to obtain uniform judgements of major end-points. STUDY AIMS: To describe the work of the end-point committee, to analyse its possible effect on the final study results and to discuss the impact on the design of future trials. METHOD: The end-point committee consisted of four members, one from each participating country. After the data were processed by the study monitors, completed case record forms and patient files for patients with reported end-points were mailed to the national member of the end-point committee for judgement. The end-point committee met regularly and made final decisions about the end-points. The work of the end-point committee was documented on a separate case record form. RESULTS: The end-point committee assessed 246 events of death, acute myocardial infarction and refractory angina pectoris in 187 of the 1209 patients (15.5%) in the TRIM trial. Misinterpretation of the index event, an inclusion myocardial infarction, as an early cardiac event was found in 12 patients. After end-point committee judgements, the number of patients with acute myocardial infarction or refractory angina pectoris during 30 days of follow-up was reduced from 177 to 153 (13. 6% reduction). The classification of events was changed in 53 of 187 patients (28.3%) with death, acute myocardial infarction or refractory angina pectoris. The data assessed by the safety committee was significantly different from the final database after end-point committee judgements. CONCLUSION: The end-point committee corrected misinterpretations in such a high proportion of cases that the final results differed significantly from the preliminary results delivered to the safety committee. End-point judgements by an end-point committee should be performed in multicentre clinical trials to improve the quality and reliability of study results.

Prognostic value of echocardiography compared to other clinical findings. Multivariate analysis based on long-term survival in 456 patients.

The prognostic significance of conventional clinical and echocardiographic data in patients referred to echocardiography was retrospectively analyzed. 456 patients (206 females and 250 males) were studied in the department of cardiology in a district hospital. Survival after 3 years was 64%. By multivariate analysis five factors contained independent, significant, prognostic information (hazard ratios for death are given in parentheses): left ventricular wall motion score index (WMI) < or = 1.2 by echocardiography (2.5), status as inpatient (2.1), age > 65 years (1.7), clinical heart failure (1.9) and atrial fibrillation (1.5). A stepwise multivariate analysis was performed by entering variables into a model initially forced to contain information on age, hospitalization status, treatment of heart failure and heart rhythm. In this analysis, a poor WMI (< or = 1.2) and a dilated right ventricle contained further independent prognostic information. In conclusion, among conventional clinical and echocardiographic data, WMI was the most powerful predictor of long-term survival, and despite knowledge of major clinical features echocardiography provided further prognostic information.

Anipamil prevents ST depression in patients with stable angina pectoris.

The purpose of this study was to examine the 24-hour antiischemic efficacy of once-a-day anipamil compared to placebo in the treatment of patients with stable angina. The study was designed as a double-blind, placebo-controlled crossover study with an initial 3 week single-blind placebo period. The patients received anipamil 80 mg once daily, anipamil 160 mg once daily, and placebo in a randomized order. At the end of each treatment period the patients underwent 24-hour ambulatory ECG recording. Nineteen patients were included, all with typical stable angina pectoris for at least 2 months, exercise test with > or = 0.10 mV horizontal or down-sloping ST-segment depression and limited by angina pectoris, and at least 10 attacks of angina pectoris in the initial single-blind placebo period. During the placebo period, a total duration of transient myocardial ischemia > or = 0.10 mV during the 24-hour ambulatory ECG monitoring period was 2263 minutes, 75% of which were asymptomatic. Anipamil 80 mg and 160 mg significantly reduced the duration of episodes to 712 minutes (p < 0.001), with 87% asymptomatic, and to 913 minutes (p > 0.001), with 92% asymptomatic, respectively. In conclusion, anipamil given once a day is an effective 24-hour antiischemic drug in the treatment of transient myocardial ischemia.

A double-blind, parallel-group comparison of flosequinan and enalapril in the treatment of chronic heart failure.

The effects of flosequinan and enalapril on exercise capacity (bicycle exercise duration), quality-of-life symptomatology (visual analogue scales) and New York Heart Association (NYHA) grading, were compared in 61 patients with chronic heart failure (NYHA, grade III). Bicycle exercise duration improved similarly with flosequinan (+27%) and enalapril (+18%); in patients completing the study, flosequinan produced a significantly greater increase in exercise time at week 12, compared with enalapril (P = 0.02). Improvements in visual analogue scores relating to general health, energy and vitality, ability to perform physical activities and breathing performance, were equivalent for both drugs. Changes in NYHA classification showed that 27 (55%) of 49 patients completing the study had improved by at least one NYHA grade (15 (68%) patients on flosequinan; 12 (44%) on enalapril). The overall safety and tolerability of the two treatments was similar; 18 patients reported adverse effects while on flosequinan, compared with 19 patients on enalapril. Neither treatment was associated with any clinically important changes in haematological or biochemical variables, although some treatment-related effects were observed. This study confirms that flosequinan achieved similar efficacy to enalapril in the symptomatic relief of chronic heart failure. The effect of flosequinan on survival in chronic heart failure has not been tested; pending such studies, our data suggest that it may prove a useful alternative therapy in patients where ACE inhibitors are contraindicated or poorly tolerated.

The prognosis for patients admitted to a coronary care unit due to suspected acute myocardial infarction with and without confirmed diagnosis.

In a retrospective study the incidence of AMI and death after discharge from CCU have been recorded in 67 patients with and 93 without a diagnosis of AMI confirmed in the CCU. No statistically significant differences were found between the two groups in mortality rate during the first 3 years, 18.3% (non-AMI) and 22.4% (AMI), or in cardiac events, sudden death and AMI, 19.3% (non-AMI) and 24.9% (AMI), during the first 2 years after discharge. Non-AMI patients with either previous AMI, angina pectoris or ST-T abnormalities in the ECG accounted for the major part of cardiac events in this group. The mortality rates in the two groups, compared to a normal population matched for sex and age, were in the AMI group in the 1st year 13.4 and 2.6% (p less than 0.01), in the 2nd year 3.4 and 2.8% (p greater than 0.05), in the 3rd year 7.1 and 2.9% (p greater than 0.05) and in the non-AMI group in the 1st year 11.8 and 1.8% (p less than 0.01), in the 2nd year 3.7 and 2.0% (p greater than 0.05), in the 3rd year 3.8 and 2.1% (p greater than 0.05). It is concluded that the prognosis after discharge from the CCU is as unfavourable for patients without as for patients with AMI. The mortality is highest during the first 6-12 months after discharge.

The long-term prognosis for patients with sinoatrial block treated with permanent pacemaker.

Fifty patients with SA block have been treated with permanent pacing and followed up for 1-14 years. Survival after one, two, five and eight years was calculated to 94, 85, 64 and 48%, respectively. These figures indicate an excess yearly mortality in the first five years of 4-5% compared with a population of the same age and sex. Analysis of the survival curves shows that the excess mortality is caused by coexisting diseases, primarily coronary heart disease with previous myocardial infarction and valvular heart disease.