Raffaele Griffo

Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction: Results of the GOSPEL Study, a Multicenter, Randomized Controlled Trial From the Italian Cardiac Rehabilitation Network

BACKGROUND Secondary prevention is not adequately implemented after myocardial infarction (MI). We assessed the effect on quality of care and prognosis of a long-term, relatively intensive rehabilitation strategy after MI. METHODS We conducted a multicenter, randomized controlled trial in patients following standard post-MI cardiac rehabilitation, comparing a long-term, reinforced, multifactorial educational and behavioral intervention with usual care. A total of 3241 patients with recent MI were randomized to a 3-year multifactorial continued educational and behavioral program (intervention group; n = 1620) or usual care (control group; n = 1621). The combination of cardiovascular (CV) mortality, nonfatal MI, nonfatal stroke, and hospitalization for angina pectoris, heart failure, or urgent revascularization procedure was the primary end point. Other end points were major CV events, major cardiac and cerebrovascular events, lifestyle habits, and drug prescriptions. RESULTS End point events occurred in 556 patients (17.2%). Compared with usual care, the intensive intervention did not decrease the primary end point significantly (16.1% vs 18.2%; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.74-1.04). However, the intensive intervention decreased several secondary end points: CV mortality plus nonfatal MI and stroke (3.2% vs 4.8%; HR, 0.67; 95% CI, 0.47-0.95), cardiac death plus nonfatal myocardial infarction (2.5% vs 4.0%; HR, 0.64; 95% CI, 0.43-0.94), and nonfatal MI (1.4% vs 2.7%; HR, 0.52; 95% CI, 0.31-0.86). A marked improvement in lifestyle habits (ie, exercise, diet, psychosocial stress, less deterioration of body weight control) and in prescription of drugs for secondary prevention was seen in the intervention group. CONCLUSION The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial, continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes, particularly nonfatal MI, although the overall effect is small. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00421876.

Effective secondary prevention through cardiac rehabilitation after coronary revascularization and predictors of poor adherence to lifestyle modification and medication. Results of the ICAROS Survey

BACKGROUND AND AIM Secondary prevention is a priority after coronary revascularization. We investigate the impact of a cardiac rehabilitation (CR) program on lifestyle, risk factors and medication modifications and analyze predictors of poor behavioral changes and events in patients after coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS Multicenter (n=62), prospective, longitudinal survey in post-CABG or -PCI consecutive patients after a comprehensive CR program. Cardiac risk factors, lifestyle habits, medication and 1 year cardiovascular events were collected. Logistic regression analyzed the association between risk factors, events and predictors of non-adherence to treatment and lifestyle. RESULTS At 1 year, of the 1262 patients (66 ± 10 years, CABG 69%, PCI 31%), 94% were taking antiplatelet agents (vs. 91.8% at CR admission and 91.7% at CR discharge, p=ns), 87% statins (vs. 67.5%, p<.0001, and 86.3%, p=ns), 80.7% beta-blockers (vs. 67.4%, p<.0001, and 88.8%, p=ns), and 81.1% ACE inhibitors (vs. 57.5% p<.0001, and 77.7%, p=ns). 89.9% of the patients showed good adherence to treatment, 72% adhered to diet and 51% to exercise recommendations; 74% of smokers stopped smoking. Younger age was predictive of smoking resumption (OR 8.9, CI 3.5-22.8). Pre-event sedentary lifestyle (OR 3.3, CI 1.3-8.7) was predictive of poor diet. Older patients with comorbidity (OR 3.1; CI, 1.8-5.2) tended to persist in sedentary lifestyle and discontinue therapy and diet recommendations. Age, diabetes, smoking and PCI indication were predictors of recurrent CV events which occurred in 142 patients. CONCLUSION Participation in CR results in excellent treatment after revascularization, as well as a good lifestyle and medication adherence at 1 year and provides further confirmation of the benefit of secondary prevention. Several clinical characteristics may predict poor behavioral changes.

Cardiac Rehabilitation in Very Old Patients: Data From the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)—Official Report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology

BACKGROUND Using data from the Italian SurveY on carDiac rEhabilitation-2008 (ISYDE-2008), this study provides insight into the level of implementation of cardiac rehabilitation (CR) in very old cardiac patients. METHODS Data from 165 CR units were collected online from January 28 to February 10, 2008. RESULTS The study cohort consisted of 2,281 patients (66.9 ± 11.8 years): 1,714 (62.4 ± 9.6 years, 78% male) aged<75 years and 567 aged ≥ 75 years (80.8 ± 4.5 years, 59% male). Compared with adults, a higher percentage of older patients were referred to CR programs after cardiac surgery or acute heart failure and showed more acute phase complications and comorbidity. Older patients were less likely discharged to home, more likely transferred to nursing homes, or discharged with social networks activation. Older patients had higher death rate during CR programs (odds ratio = 4.6; 95% confidence interval = 1.6-12.9; p = .004). CONCLUSION The ISYDE-2008 survey provided a detailed snapshot of CR in very old cardiac patients.

GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction: the GOSPEL study. A trial from the Italian Cardiac Rehabilitation Network: rationale and design.

Background Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction (GOSPEL) study investigates the benefits of a programme of continued educational and behavioural interventions to achieve optimal long-term secondary prevention goals. Design This will be a multicentre, randomized, controlled study carried out in 78 Italian cardiac rehabilitation centres. Methods After completion of an initial cardiac rehabilitation programme, patients with recent (<3 months) myocardial infarction were randomized to either a long-lasting (over 3 years) multifactorial continued educational and behavioural programme (intensive approach) or usual care (control) group. Intensive approach patients participated in extensive cardiac rehabilitation sessions, monthly from months 1 to 6, then every 6 months for 3 years. Each session consisted of aerobic exercise, comprehensive lifestyle and risk factor counselling, and clinical assessment Usual care patients returned to their family physicians’ care, and attended the reference centre only for the 6-month and then annual scheduled assessment. The efficacy of the two different strategies will be evaluated in terms of morbidity and mortality as primary endpoint. Results From January 2001 through December 2002, 3241 patients were enrolled. Results will be available in mid 2006. Conclusions The GOSPEL trial, the rationale and design of which we present here, was designed to test a new strategy of secondary prevention delivery and to raise standards of long-term secondary prevention in Italy. With a cohort of over 3200 patients, GOSPEL is the largest randomized, multifactorial lifestyle and risk factor intervention trial after myocardial infarction conducted so far.

Late postoperative atrial fibrillation after cardiac surgery: A national survey within the cardiac rehabilitation setting

Aims The aims of this study were to determine the incidence and clinical predictors of new-onset and recurrent late postoperative atrial fibrillation (POPAF) in a large cohort of patients who underwent cardiac rehabilitation programs (CRPs) after discharge from surgery units, and the association between late POPAF and cardiovascular morbidity and mortality in the medium term. Methods The ISYDE and ICAROS registries were two multicenter, prospective studies carried out by the Italian Association for Cardiovascular Prevention, Rehabilitation and Epidemiology (IACPR-GICR), providing clinical information on consecutive patients completing CRP in 165 facilities. Patients following cardiac surgery were considered, with the exclusion of those with persistent POPAF at discharge from the surgery units. A total of 2256 patients following cardiac surgery were enrolled (isolated coronary surgery 62.9%, valve interventions 16%, combined surgery 21.1%). Results The mean age of patients was 67 ± 10 years, and the observation period 13 ± 20 days. During CRP, POPAF occurred in 241 (10.7%) patients, with 4.4% new-onset and 6.3% recurrent cases, respectively. In the logistic regression model, valve surgery (P < 0.05), a history of early POPAF (P < 0.001), and the presence of postoperative ventricular arrhythmias (P < 0.05) independently predicted the occurrence of late POPAF. Lack of prescription of cardioprotective drugs was not associated with late POPAF. Late POPAF increased the 1-year risk of cardiovascular events after CRP, mainly episodes of decompensated heart failure. Conclusion A high level of suspicion for late POPAF, after discharge from surgery units, should be maintained due to the risk of occurrence, the low antiarrhythmic effect of common cardioprotective drugs and the impact on cardiovascular prognosis.

ANMCO/ISS/AMD/ANCE/ARCA/FADOI/GICR-IACPR/SICI-GISE/SIBioC/SIC/SICOA/SID/SIF/SIMEU/SIMG/SIMI/SISA Joint Consensus Document on cholesterol and cardiovascular risk: diagnostic-therapeutic pathway in Italy

Abstract Atherosclerotic cardiovascular disease still represents the leading cause of death in Western countries. A wealth of scientific evidence demonstrates that increased blood cholesterol levels have a major impact on the outbreak and progression of atherosclerotic plaques. Moreover, several cholesterol-lowering pharmacological agents, including statins and ezetimibe, have proved effective in improving clinical outcomes. This document focuses on the clinical management of hypercholesterolaemia and has been conceived by 16 Italian medical associations with the support of the Italian National Institute of Health. The authors discuss in detail the role of hypercholesterolaemia in the genesis of atherosclerotic cardiovascular disease. In addition, the implications for high cholesterol levels in the definition of the individual cardiovascular risk profile have been carefully analysed, while all available therapeutic options for blood cholesterol reduction and cardiovascular risk mitigation have been explored. Finally, this document outlines the diagnostic and therapeutic pathways for the clinical management of patients with hypercholesterolaemia.

Frequent coexistence of chronic heart failure and chronic obstructive pulmonary disease in respiratory and cardiac outpatients: Evidence from SUSPIRIUM, a multicentre Italian survey

Background Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) frequently coexist but concurrent COPD + CHF has been little investigated. Design This multicentre survey (SUSPIRIUM) was designed to evaluate: the prevalence of COPD in stable CHF and CHF in stable COPD; diagnostic/therapeutic work-up for concurrent COPD + CHF; clinical profile of patients with COPD + CHF; predictors of COPD in CHF and CHF in COPD. Methods A 5-month-long cross-sectional prospective observational survey was conducted in 10 cardiac and 10 respiratory connected outpatient units. Results The prevalence of CHF in the 378 surveyed COPD patients was 11.9% (95% confidence interval 8.8–16.6) and the prevalence of COPD in 375 CHF patients was 31.5% (95% confidence interval 26.8–36.4). Diagnostic tests for suspected comorbidity were prescribed in 21.6% and 22.9% of COPD and CHF patients, respectively. Patients with coexisting CHF + COPD had a higher incidence of hypertension, physical inactivity and more frequently a GOLD score of 3 or greater. Compared to CHF only, CHF + COPD patients were significantly older, more frequently smokers, at worse respiratory risk and in a higher New York Heart Association class. Conversely, hypercholesterolaemia, a family history of ischaemic heart disease, fluid retention and comorbidities were more frequent in COPD + CHF than COPD-only patients. At multivariate analysis, a GOLD score of 3 or greater in CHF strongly predicted coexistent COPD (odds ratio 8.985, P < 0.0001) as did a history of other respiratory diseases (5.184, P < 0.0001). A history of ischaemic heart disease (4.868, P < 0.0001), atrial fibrillation (3.302, P < 0.0001) and sedentary lifestyle (2.814, P < 0.004) predicted coexistent CHF in COPD. Conclusion The high prevalence of COPD + CHF calls for integrated disease management between cardiologists and pulmonologists. SUSPIRIUM identifies which cardiac/pulmonary outpatients should be screened for the respective comorbidity.

Clinical characteristics and course of patients with diabetes entering cardiac rehabilitation

BACKGROUND Using data from the Italian SurveY on carDiac rEhabilitation (ISYDE-2008), this study provides insight into the level of implementation of Cardiac Rehabilitation (CR) in patients with diabetes. METHODS Data from 165 CR units were collected online from January 28th to February 10th, 2008. RESULTS The study cohort consisted of 2281 patients (66.9 ± 12 yrs); 475 (69.7 ± 10 yrs, 74% male) patients with diabetes and 1806 (66.2 ± 12 yrs, 72% male) non-diabetic patients. Compared to non-diabetic patients, patients with diabetes were older and showed more comorbidity [myocardial infarction (32% vs. 19%, p < 0.0001), peripheral artery disease (10% vs. 5%, p < 0.0001), chronic obstructive pulmonary disease (20% vs. 11%, p < 0.0001), chronic kidney disease (20% vs. 6%, p < 0.0001), and cognitive impairment (5% vs. 2%, p = 0.0009), respectively], and complications during CR [re-infarction (3% vs. 1%, p = 0.04), acute renal failure (9% vs. 4%, p < 0.0001), sternal revision (3% vs. 1%, p = 0.01), inotropic support/mechanical assistance (7% vs. 4%, p = 0.01), respectively]; a more complex clinical course and interventions with less functional evaluation and a different pattern of drug therapy at hospital discharge. Notably, in 51 (3%) and in 104 (6%) of the non-diabetic cohort, insulin and hypoglycemic agents were prescribed, respectively, at hospital discharge from CR suggesting a careful evaluation of the glycemic metabolism during CR program, independent of the diagnosis at the admission. Mortality was similar among diabetic compared to non-diabetic patients (1% vs. 0.5%, p = 0.23). CONCLUSIONS This survey provided a detailed overview of the clinical characteristics, complexity and more severe clinical course of diabetic patients admitted to CR.

Gender differences in cardiac rehabilitation programs from the Italian survey on cardiac rehabilitation (ISYDE-2008)

PURPOSE In recent years epidemiological and clinical evidence has shown gender disparities in several aspects of cardiovascular disease. Aim of this study was to identify gender differences in the clinical profile and management of patients admitted to cardiac rehabilitation (CR) programs. POPULATION Patients enrolled in the ISYDE-2008 survey were considered. RESULTS The ISYDE-2008 survey enrolled 2281 patients; 604 (26.5%) were women. Compared to men, women were older (mean age 70.8 ± 11.5 versus mens 65.6 ± 11.5 years), had less traditional risk factors (low cardiovascular risk profile in 45.3% of women and 38.0% of men, p=0.003), were more frequently admitted after valvular surgery and heart failure, but less for post-acute myocardial infarction and post-by-pass procedure. Women were more frequently admitted to an in-hospital rehabilitation program. Women showed a more complicated acute and rehabilitative course, with 63.2% of them having at least one complication during acute-phase, compared to 52.5% of men, and 48.3% during rehabilitation, compared to 35.0% of men (p<0.0001). During rehabilitation, women underwent exercise tests less frequently, except for the 6-minute walking test. At discharge, women received ACE-inhibitors/ARBs, β-blockers, statins, omega-3 fatty acids, antiplatelet agents less frequently, but more frequently digoxin, amiodarone, diuretics, oral anticoagulants, insulin and anti-depressive drugs. The duration of the rehabilitation program was longer for women. Mortality was very low in the entire population. CONCLUSIONS Women are less frequently admitted to CR than men. They are older and show a greater cardiovascular burden. Women are more likely to be enrolled in CR after valvular surgery and heart failure than men.

Cardiac rehabilitation in chronic heart failure: data from the Italian SurveY on carDiac rEhabilitation (ISYDE-2008).

Background Using data from the Italian SurveY on carDiac rEhabilitation (ISYDE-2008), this study provides insight into the level of implementation of cardiac rehabilitation in patients with chronic heart failure (CHF). Methods Data from 165 Italian cardiac rehabilitation units were collected online from 28 January to 10 February 2008. Results The study cohort consisted of 2281 patients (66.9 ± 11.8 years): 285 (71.3 ± 12.2 years, 66% male) CHF patients and 1996 (66.3 ± 11.6 years, 74% male) non-CHF patients. Compared with non-CHF, CHF patients were older, showed more comorbidity, had lower left ventricular (LV) ejection fraction and reduced access to functional evaluation, underwent more complications during cardiac rehabilitation, and had longer length of in-hospital stay. CHF patients were also more likely to be transferred to ICU (9 versus 3%, P < 0.0001), and less likely to be discharged home (85 versus 92%, respectively, P < 0.0001). Also, discharge prescriptions were significantly different from those of non-CHF patients. Finally, CHF patients had higher mortality during cardiac rehabilitation (1.7 versus 0.5%, P = 0.01). After adjusting for age, ejection fraction, comorbidity, previous interventions and complications during cardiac rehabilitation, multivariate logistic analysis showed that not performing any of the physical performance tests [odds ratio (OR) = 7.0, 95% confidence interval (CI), 1.9–25.8, P = 0.003], acute respiratory failure (OR = 2.3, 95% CI, 1.3–4.1, P = 0.002), acute kidney insufficiency or worsening of chronic kidney disease (OR = 2.9, 95% CI, 1.5–5.6, P = 0.001) and worsening of cognitive impairment (OR = 3.7, 95% CI, 2.0–6.7, P < 0.001) were significant predictors of death in CHF patients. Conclusion The ISYDE-2008 survey provided a detailed snapshot of cardiac rehabilitation in CHF patients, and confirmed the complexity and the more severe clinical course of these patients during cardiac rehabilitation.