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A P Maggioni

Publications and source records attributed to A P Maggioni.

At least 19 recordsLinked to original sources

Very early administration of ACE-inhibitors in acute myocardial infarction.

Recent trials have shown that ACE-inhibitors are safe and can reduce mortality and the occurrence of severe left-ventricular dysfunction (LVD) (when started within the first day after acute myocardial infarction (MI) and continued for 4 to 6 weeks thereafter). GISSI-3, ISIS-4 and CCS-1 studies show that more than half of the lives are saved by ACE-inhibitor treatment within the first week of therapy. Although the benefit from ACE-inhibitor is larger in patients presenting with congestive heart failure (Killip class >1), the number of lives saved in patients at low risk, who represent the majority of the population, is relevant. This supports the approach of treating all hemodynamically stable MI patients. Treatment could be stopped after about 1 month in patients without evidences of LVD while those with LVD should be continued on ACE-inhibitors for a long period of time.

Angiotensin-Converting Enzyme Inhibitors

A comparison of the early outcome of acute myocardial infarction in women and men. The Third International Study of Infarct Survival Collaborative Group.

BACKGROUND: In previous studies, unadjusted comparisons of mortality and major morbidity after acute myocardial infarction have generally indicated that women have a poorer outcome than men. Much larger studies are needed, with more complete adjustment for coexisting conditions, to determine whether this difference is explained by the older age of the women studied or by the presence of other unfavorable prognostic factors, or both. METHODS: As part of the Third International Study of Infarct Survival (ISIS-3), information was collected on deaths during days 0 to 35 and on major clinical events during hospitalization up to day 35 for 9600 women and 26,480 men with suspected acute myocardial infarction who were considered to have a clear indication for fibrinolytic therapy. We compared the outcome among women and men, first without adjustment, then with adjustment for age, and finally with adjustment for other recorded baseline characteristics by means of multiple logistic regression. RESULTS: The unadjusted odds ratio for death among women as compared with men was 1.73 (95 percent confidence interval, 1.61 to 1.86). The women were significantly older than the men, and after adjustment for age the odds ratio was reduced markedly to 1.20 (95 percent confidence interval, 1.11 to 1.29). Adjustment for other differences in base-line clinical features further reduced the odds ratio to 1.14 (95 percent confidence interval, 1.05 to 1.23). Excesses in other major clinical events among women were generally reduced to a similar extent by adjustment. CONCLUSIONS: It seems likely that there is at most only a small independent association between female sex and early mortality and morbidity after suspected acute myocardial infarction.

Adult

Within-patient variability of hormone and cytokine concentrations in heart failure.

Several studies on disease and treatment effects on neurohormones have been conducted with small numbers of patients, using one blood sample as representative of their states. The aim of this study was to assess the within-patient variability of plasma concentrations of several hormones and cytokines of recent interest, in patients with moderate heart failure and controlled stable background therapy over 3 weeks. Blood for neurohormone and cytokine assays was sampled in duplicate from 18 patients with moderate heart failure. After an initial visit, the patients were kept on stable therapy until the second blood sampling 21 +/- 3 days later. The plasma concentrations of several neurohormones (endothelin, renin, angiotensin II, aldosterone, norepinephrine) and cytokines (interleukin-6 (IL-6), interleukin-13 (IL-13), ciliary neurotrophic factor (CNTF), leukemia inhibitory factor (LIF) and soluble receptor type I of tumour necrosis factor-alpha, (sTNF-RI) were measured with immunochemical methods. Some cytokines (IL-13, CNTF and LIF) were not detected. Despite clinically satisfactory ACE inhibition, circulating angiotensin II and aldosterone levels were still elevated in some patients, suggesting aldosterone escape. The between-visit agreement of plasma concentrations measured in duplicate was less than 35% for all circulating factors, except renin which showed a higher variability throughout the 3-week study period.

Aldosterone

Administration of thrombolytic therapy to 17,944 patients with acute myocardial infarction: the GISSI-3 database.

BACKGROUND: There is growing interest in assessing therapy for acute myocardial infarction. Because thrombolysis was not a study therapy in the GISSI-3 trial, the decision about thrombolysis was left to the responsible physicians. We evaluated the data on thrombolytic therapy among patients with acute myocardial infarction enrolled in the GISSI-3 trial to study the relation between rate of prescription and the characteristics of patients and participating coronary care units. METHODS: Complete clinical data were available for 17,944 patients randomized between June 1991 and July 1993 from 200 coronary care units in Italy. Demographic and clinical information were obtained for each patient, and each coronary care unit was classified according to patient volume, level of technology, and wide geographic area in which it was located. A multivariate logistic regression was performed with administration of thrombolytic therapy as the dependent variable and previously defined clinical and structural variables as independent variables. RESULTS: The most important factor in administration of thrombolytic therapy was that less than 6 hours elapse from symptom onset to hospital admission (odds ratio [OR] 14.05; 95% confidence interval [CI] 12.3 to 16.0). Next were location of coronary care unit in southern Italy (OR 1.81; 95% CI 1.62 to 2.01), presence of ST elevation at entrance electrocardiogram ECG (OR 1.47; 95% CI 1.35 to 1.61), absence of previous myocardial infarction (OR 1.35; 95% CI 1.22 to 1.49), and presence of catheterization laboratory or cardiac surgery program or both in the same hospital (OR 1.24; 95% CI 1.14 to 1.35). Coronary care units with high or low patient volume did not show different rates of administration of thrombolytic agents. CONCLUSIONS: The GISSI-3 experience confirmed a high rate of prescription of thrombolytic therapy to patients admitted within 6 hours of symptom onset and those with ST-segment elevation on entrance electrocardiogram. It demonstrated that patients admitted to coronary care units with catheterization laboratories or cardiac programs or both have higher chances of receiving thrombolytic treatment than those admitted to hospitals without these capabilities.

Adult

Clinical and epidemiological characteristics of juvenile myocardial infarction in Italy: the GISSI experience.

BACKGROUND: No clinical and epidemiological data are available about acute myocardial infarction (AMI) at a young age in large populations, due to the low prevalence of AMI in younger people. The aim of the present study is to analyze epidemiological and clinical characteristics of AMI among younger people in Italy, using the data bases of the three GISSI studies. METHODS: Analysis of epidemiological and clinical characteristics of AMI according to different age groups in the three GISSI studies that collected data from 1985 to 1993. RESULTS: In the GISSI-2 and GISSI-3 data bases, the prevalence of AMI at a young age (2 and 1.8% respectively; difference -0.2% with 95% CI from -0.4 to 0.3%), hospital mortality (2.3 and 1.9% respectively; difference -0.4% with 95% CI from -1.9 to 1.0%), and the rate of young female patients (8 and 7% respectively; difference -1% with 95% CI from -3.6 to 1.6%) are similar. In the GISSI-2 study, we observed that in comparison to elderly patients (> 70 years) young patients (< 40 years) are more frequently smokers (83.9 vs 21.0%; difference 62.9% with 95% CI from 58.5 to 67.3%) and have a higher rate of family history for CAD (42.1 vs 21.1%; difference 21.0% with 95% CI from 15.3 to 26.7%) and of hypercholesterolemia (28.3 vs 15.0%; difference 13.3% with 95% CI from 18.5 to 80.8%), but show a lower prevalence of hypertension (12.2 vs 44.3%; difference from -32.1% with 95% CI from -28.0 to -36.2%) and diabetes (2.9 vs 18.8%; difference -15.9% with 95% CI from -13.5 to -18.3%). AMI at a young age is generally the first event in ischemic heart disease; in comparison with older patients with previous AMI (6.4 vs 17.4%; difference -11.0% with 95% CI from -7.8 to -14.0%) and history of angina (23.2 vs 40.0%, difference -16.8% with 95% CI from -11.8 to -21.9%) this is less frequent. The rate of complications is lower in younger as opposed to older patients for both early (7.7 vs 31.2%; difference -23.5% with 95% CI from -20.0 to -26.9%) and late heart failure (2.9 vs 18.5%; difference -15.6% with 95% CI from -13.2 to -18.0%), as well as for angina (6.4 vs 10.5%; difference -4.1% with 95% CI from -1.1 to -7.1%), reinfarction (1.0 vs 3.3%; difference -2.3% with 95% Ci from -1.1 to -3.6%) and complete AV block (1.6 vs 6.6%; difference -5.0% with 95% CI from -3.3 to -6.7%). In young patients, we observed lower in-hospital (1.6 vs 21.1%; difference -19.5% with 95% CI to -21.6%) and six-month mortality (1.3 vs 8.1%; difference -6.8% with 95% CI from -5.0 to -8.5%). CONCLUSIONS: The incidence and mortality of AMI at a young age was steady during the period between 1988 and 1993. AMI at a young age is a clinical entity with specific characteristics that differ from those found in old patients. In addition, it has peculiar risk profile with a better short- and medium-term outcome.

Adult

Relevance of heart rate as a prognostic factor in patients with acute myocardial infarction: insights from the GISSI-2 study.

AIMS: It is as yet undefined whether simple indexes of autonomic balance such as heart rate (HR) may play a role in risk stratification in patients with acute myocardial infarction (MI). The aim of this study was to quantify the prognostic significance of HR from the surface ECG obtained both at entry and at discharge, in a large population of patients all treated with fibrinolysis during the acute phase and having confirmed acute MI. METHODS AND RESULTS: Surface ECGs obtained at entry and at discharge in patients with confirmed MI enrolled in the GISSI-2 study, a large multicentre trial of different thrombolytic agents, were retrieved. Heart rhythm was evaluated and HR was measured; these data were then added to the main database of GISSI-2 allowing a complete evaluation of the prognostic significance of HR. Patients not in sinus rhythm or with grade 2-3 atrioventricular block were excluded. The prognostic significance of HR (cut-offs predefined at 60, 80, 100 beats.min-1) at entry for in-hospital mortality and at discharge for 6-month mortality was evaluated in the general population and in predefined subgroups. Multivariate analyses were used to assess the independent prognostic value of HR. A total of 8915 patients (more than 70% of the original population) were suitable for the analysis. There was a progressive increase in mortality with increasing HR in the general population (from 7.1% for HR < 60 beats.min-1) to 23.4% for HR > 100 beats.min-1) and in the predefined subgroups. Multivariate analysis showed that HR exerted an independent prognostic significance. Data for analysis of HR at discharge were available for 7831 patients. Consistent with the data observed at entry, a progressive increase of 6-month mortality with increasing HR was present in the general population (from 0.8% for HR < 60 beats.min-1) to 14.3% for HR > 100 beats.min-1) and for the different predefined subgroups. Multivariate analysis confirmed the independent prognostic significance of HR. There was no relation between HR and the incidence of fatal and non-fatal reinfarction. CONCLUSION: The present study indicates that HR values from a standard 12-lead ECG independently predict mortality in patients with acute MI during the in-hospital phase and after discharge. This simple index appears very useful for risk stratification in clinical practice.

Aged

Effect of the ACE inhibitor lisinopril on mortality in diabetic patients with acute myocardial infarction: data from the GISSI-3 study.

BACKGROUND: Mortality of diabetic patients with acute myocardial infarction (MI) remains high despite recent improvement in their management. There is a need to evaluate efficacy and safety of novel treatments of MI in this high-risk population. We evaluated whether treatment with an ACE inhibitor begun within 24 hours from the onset of symptoms is able to decrease mortality and morbidity of diabetic patients with acute MI. METHODS AND RESULTS: A retrospective analysis of the data of the GISSI-3 study in patients with and without a history of diabetes was performed. Patients with suspected acute MI were randomized to treatment with lisinopril (2.5 to 5 up to 10 mg/d) with or without nitroglycerin (5 to 20 microg I.V. then 10 mg/d) begun within 24 hours and continued for 6 weeks. The main end point was mortality at 6 weeks, and the secondary end point was a combined evaluation of mortality and severe left ventricular dysfunction. Information on diabetic status was available for 18,131 patients (approximately 94% of the total population enrolled), of whom 2790 patients had a history of diabetes. Treatment with lisinopril was associated with a decreased 6-week mortality in diabetic patients (8.7% versus 12.4%; OR, 0.68; 95% CI, 0.53 to 0.86; 37+/-12 lives saved per 1000 treated patients), an effect that was significantly (P<.025) higher than that observed in nondiabetic patients. The survival benefit in diabetics was mostly maintained at 6 months despite withdrawal from treatment at 6 weeks (12.9% versus 16.1%; OR, 0.77; 95% CI, 0.62 to 0.95). CONCLUSIONS: Early treatment with the ACE inhibitor lisinopril in diabetic patients with acute MI is associated with a decreased 6-week mortality. This beneficial effect supports a widespread and early use of ACE inhibitors in diabetic patients with acute MI. The burden of mortality plus morbidity for ventricular dysfunction in diabetics remains clinically important and warrants further testing of novel therapeutic approaches.

Aged

Epidemiologic variables and outcome of 1972 young patients with acute myocardial infarction. Data from the GISSI-2 database. Investigators of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI-2).

BACKGROUND: Acute myocardial infarction in younger patients is uncommon, occurring mainly in men. The recent introduction of thrombolysis improved survival, left ventricular function, and infarct size. OBJECTIVE: To evaluate characteristics and clinical outcome of the patients younger than 50 years randomized in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico study. All patients received a thrombolytic treatment. METHODS: The 11483 patients were divided into 3 age subgroups: younger than 50 years (17.2%), between 50 and 70 years (60.2%), and older than 70 years (22.6%). All relations between variables were first determined by an unadjusted analysis. An adjusted analysis was performed by multiple logistic regression models for in-hospital and 6-month mortality. RESULTS: While older patients had a significantly higher rate of a history of hypercholesterolemia, diabetes, and hypertension, smoking and a positive family history were significantly more frequent in younger patients. Total in-hospital and 6-month mortality were significantly lower in patients younger than 50 years (2.7% and 1.2%, respectively) than in patients between 50 and 70 years old (6.9% and 2.7%) and those older than 70 years (21.1% and 8.4%). After multivariate analysis, the predictive value of age was confirmed. CONCLUSIONS: Our findings, based on a large group of patients who received thrombolytic treatment, suggest that younger age is a significant independent indicator of a favorable prognosis after acute myocardial infarction.

Age Factors

Pericardial involvement in acute myocardial infarction in the post-thrombolytic era: clinical meaning and value.

Pericardial involvement (PI) in acute myocardial infarction (AMI) is a complication usually considered benign and has therefore received less attention than those more severe. It may be easily missed because it presents few symptoms and signs, which in turn may be confused with those of AMI. Its pathophysiology, diagnosis, and pitfalls are discussed. The GISSI-1 trial revealed a marked reduction of PI in the group treated with thrombolysis. This unexpected finding was later confirmed by the GISSI-2 trial and by other studies, drawing attention to its meaning. Data from the GISSI as well as from other studies have been reviewed and seem to indicate that PI is associated with larger AMIs and with a significant increase in 6- and 12-month mortality. This may be attributed to the consequences of late remodeling of a large infarction. These findings lead to the conclusion that PI should be granted more attention, and that it might identify patients with a poorer long-term outcome.

Fibrinolytic Agents

Treatment of acute myocardial infarction today.

The management of acute myocardial infarction (AMI) has undergone major changes in the last decade. Today clinical practice can be based on sound evidence derived from a large number of well-conducted, randomized, large-scale clinical trials. Because of this, Scientific Societies, such as the European Society of Cardiology, have recently produced evidence-based guidelines for the treatment of AMI. This article summarizes the up-to-date, evidence-based treatments for patients with AMI, and their limitations in terms of uncertainty and transferability to real populations.

Adrenergic beta-Antagonists

Use of beta-blocking agents in secondary prevention after myocardial infarction: a case for evidence-based medicine? GISSI experience, 1984-1993. The Gruppo Italiano di Studio sulla Sopravvivenza nell'Infarto Miocardico (GISSI) Investigators.

AIMS: Many clinical trials conducted in the 1970s and early 1980s have shown that the long-term use of beta-blockers after an acute myocardial infarction significantly reduces mortality and reinfarction rates. This study assessed the impact of these findings in clinical practice. METHODS: We retrospectively analysed the beta-blocker prescriptions for 36,817 patients with acute myocardial infarction included in three large randomized clinical trials (Gruppo Italiano di Studio sulla Sopravvivenza nell'Infarto Miocardico--GISSI, 1, 2, and 3), conducted by a highly representative sample (about 75%) of Italian coronary care units in 1984-85, 1988-89 and 1991-93. RESULTS: The prescription of beta-blockers at discharge increased gradually from 8.5% in 1984-85 to 25.0% in 1988-89 and to 31.4% in 1991-93. A similar trend was apparent for beta-blocker prescriptions 6 months after acute myocardial infarction. The strongest predictors of beta-blocker prescription are the presence of post-infarctual angina and a history of arterial hypertension. Besides the classical contraindications, advanced age, transitory cardiac failure or arrhythmias in the acute phase of acute myocardial infarction are important predictors of nonprescription. CONCLUSION: The use of beta-blockers after acute myocardial infarction in Italy has increased more than three-fold in the last decade, but they are still prescribed to too few patients, especially those at higher risk, for whom the expected benefit is greater.

Adrenergic beta-Antagonists

Combination neurohormonal blockade with ACE inhibitors, angiotensin II antagonists and beta-blockers in patients with congestive heart failure: design of the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study.

BACKGROUND: The Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study is a trial of combination neurohormonal blockade using an angiotensin II antagonist (candesartan), an angiotensin-converting enzyme inhibitor (enalapril) and a beta-blocker (metoprolol) in patients with congestive heart failure (CHF). OBJECTIVES: Primary objectives of stage I are to determine the efficacy (via the 6 min walk test) and safety of candesartan alone, and in combination with enalapril, versus enalapril alone. Secondary objectives are to determine the effect of the above combinations on neurohormones, ventricular function, quality of life and symptoms. Stage II objectives are similar, evaluating the effect of the addition of metoprolol or placebo to the above medication(s). DESIGN: Randomized, two-stage trial consisting of a three-way comparison (stage I), followed by a 3 x 2 partial factorial design (stage II). SETTING: Sixty out-patient clinics in five countries. PATIENTS: Patients with symptoms of CHF (New York Heart Association functional classes II to IV), ejection fraction less than 40% and 6 min walk distance of 500 m or less. INTERVENTIONS: In stage I, 770 patients are randomized to receive candesartan alone, enalapril alone, or candesartan plus enalapril. After five months (end of stage I), patients are assessed for eligibility to be randomized in stage II. Those who are not candidates for randomization to beta-blocker or placebo are followed on their stage I medications until the end of the study. In stage II, patients are randomized to receive metoprolol or placebo for a further six months in addition to their stage I medications. Endpoints are measured at baseline, end of stage I (week 20) and end of stage II (week 46). STUDY STATUS: The study has recently completed follow-up in both stages. The findings from this study will be used to design a large scale mortality study that will help further define the role of neurohormonal blockade in patients with CHF.

Adrenergic beta-Antagonists

[Appropriateness of indicating aortocoronary bypass and coronary angioplasty: results of an observational prospective study in the Lombardy region. Gruppo Interdisciplinare Valutazione Appropriatezza Rivascolarizzazione Coronarica].

OBJECTIVE: Most studies on the appropriateness of cardiac revascularization procedures have been aimed at detecting "overuse" (ie when patients get a procedure without a clear indication), while little attention has been paid yet to "underuse" (when patients who could benefit from a procedure do not get it). This study was planned to assess the extent of over- and underuse of revascularization procedures in northern Italy. METHODS: A multidisciplinary panel of experts convened by the Italian Association of Hospital Cardiologists (ANMCO) rated the appropriateness of 898 "theoretical indications" for coronary artery by-pass grafting (CABG) and percutaneous transluminal angioplasty (PTCA) using the RAND Corporation methodology. Standardized information has been collected on a consecutive sample of patients in the Lombardy region and identified during performance of a coronary angiogram at one of the services belonging to the GISE (Gruppo Italiano Studi Emodinamica) network. Out of the 2718 consecutive patients undergoing a coronary angiogram during the recruitment period (February-May 1995), a total of 1821 (70%) were eligible for the appropriateness study. RESULTS: Indication for CABG were appropriate in 565 (80%) patients, uncertain in 111 (16%) and inappropriate in 25 (4%). Corresponding values for PTCA were: 40% (n = 262), 46% (n = 300) and 14% (n = 90). Among the 394 to whom a medical therapy was recommended after angiography, the indication was considered appropriated in only 14% (n = 57) and uncertain for 30% (n = 117). For the remaining 220, the indication was considered inappropriate, suggesting that according to the panel criteria, 56% of the patients should have received a revascularization procedure (either a CABG or PTCA) instead. CONCLUSIONS: These results suggest that underuse of revascularization procedures represents a substantial health care problem in Lombardy region, at least with reference to the period covered by this study. The study in itself does not make it possible to understand whether these results reflect a structural shortage of services (limited accessibility and/or unprioritized waiting lists) or a more general quality-of-care problem. The study protocol now foresees a follow-up for 9 months after the index angiogram to assess the eventual utilization pattern of CABG/PTCA.

Angioplasty, Balloon, Coronary

Diltiazem improves left ventricular systolic function following acute myocardial infarction treated with streptokinase. The Calcium Antagonist in Reperfusion Study (CARES) Group.

The role of diltiazem on left ventricular systolic function was analyzed in 101 patients with acute myocardial infarction treated with streptokinase, being obtained, for the total of the population, higher LV global ejection fraction (p = 0.022), LV regional shortening (p = 0.046) and LV global shortening (p = 0.064) for the treated group, relative to the placebo group; the p values were, respectively, 0.005, 0.009, and 0.012, for patients that achieved TIMI-3 antegrade coronary flow. It is concluded that diltiazem is useful as adjuvant to streptokinase, especially when antegrade coronary blood flow TIMI-3 is obtained.

Aged

Reproducibility of wall motion score and its correlation with left ventricular ejection fraction in patients with acute myocardial infarction.

The inter- and intraobserver variability, as well as the relation to left ventricular (LV) function indexes, of LV wall motion score calculated using the 16- and 11-segment models of LV segmentation were assessed in 105 patients with acute myocardial infarction who were examined at 36 +/- 7 hours from onset of symptoms. In these patients, the use of the 16-segment model of LV segmentation portends to a significantly higher inter- and intraobserver reproducibility of segmental wall motion score than the use of the 11-segment model. In addition, wall motion score assessed with the more detailed 16-segment model of LV segmentation showed a significantly higher correlation with LV ejection fraction than the wall motion score assessed using the 11-segment model.

Adult

Prognostic significance of heart rate variability in post-myocardial infarction patients in the fibrinolytic era. The GISSI-2 results. Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico.

BACKGROUND: Studies performed before the introduction of fibrinolysis showed that a low heart rate variability (HRV) is associated with higher mortality in post-myocardial infarction (MI) patients. We evaluated whether HRV adds information relevant to risk stratification in patients treated with fibrinolysis as well. METHODS AND RESULTS: From 24-hour ECG recordings obtained at discharge in patients treated with recombinant tissue-type plasminogen activator or streptokinase, we measured several time-domain indexes of HRV: standard deviation (SDNN), root-mean-square of successive differences (RMSSD), and number of RR interval increases > 50 ms ("NN50+"). The prognostic value of HRV for total and cardiovascular mortality was assessed. Of 567 patients with valid recordings, 52 (9.1%) died during the 1000 days of follow-up, 44 (7.8%) of cardiovascular causes. All indexes of low HRV were able to identify patients (16% to 18% of total population) with a higher total mortality (20.8% to 24.2% versus 6.0% to 6.8%, depending on index used). The independent predictive value of low HRV was confirmed by the adjusted analysis with the following relative risks: NN50+, 3.5 (95% CI, 1.9 to 6.7); SDNN, 3.0 (95% CI, 1.55 to 5.9); and RMSSD, 2.8 (95% CI, 1.5 to 5.3). Advanced age, previous MI, Killip class at entry, and use of digitalis were also independent predictors. Similar data were obtained for cardiovascular mortality. CONCLUSIONS: Time-domain indexes of HRV retain their independent prognostic significance even in post-MI patients of all ages treated with fibrinolysis.

Aged