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

Giannuzzi, Pantaleo; Temporelli, Pier Luigi; Maggioni, Aldo P.; Ceci, Vincenzo; Chieffo, Carmine; Gattone, Marinella; Griffo, Raffaele; Marchioli, Roberto; Schweiger, Carlo; Tavazzi, Luigi; Urbinati, Stefano; Valagussa, Franco

doi:10.1097/00149831-200512000-00007

Cited by 102 publications

(171 citation statements)

References 15 publications

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“…Excluding the by far largest trial by Giannuzzi et al [16] from meta-analysis yielded slightly larger differences at 4 to 6 and 8 to 12 months but a non-significant negative effect at 18 to 24 months. Egger's test indicated significant (p=0.048) funnel plot asymmetry; when the trial by Giannuzzi et al [16] was excluded, the test became non-significant (p=0.43). The intensity of the intervention and study quality (lower risk of bias) did not have a major influence on study findings (Table 5).…”

Section: Study Resultsmentioning

confidence: 82%

“…Seven [13,22,25,30,40,41,44] of the 13 trials testing lifestyle interventions with moderate or high intensity and three [16,20,35] of the 13 trials with low or very low intensity interventions reported significant improvement in self-reported risk behavior regarding to at least two of the three key aspects of diet, physical activity, and stress management.…”

Section: Study Resultsmentioning

confidence: 99%

“…Of these, 61 did not meet the inclusion criteria leaving 41 publications, reporting 25 studies (see Table 1) with a total of 26 relevant comparisons (the three-armed trial by Sundin et al [38] evaluated two slightly different interventions) and a total of 7,703 participants. The study by Giannuzzi et al was by far the largest trial with 3,241 participants [16]. One publication [46] reported two separate studies (a primary and a secondary prevention study).…”

Section: General Description Of Included Trialsmentioning

confidence: 99%

“…Diabetes studies typically recruited patients from diabetes registers; one study included newly diagnosed patients [14]. Patients with manifest coronary artery disease were recruited after having experienced a recent acute myocardial infarction [16,32,37], after percutaneous coronary intervention [21], after coronary artery surgery [28], after any of these events [33,38,44,49], or more generally if their diagnosis was proven diagnostically [10,23,25,30,40,46]. Nine studies were done in Europe [11,15,19,24,32,33,38,44,47], seven in the USA [10,13,14,17,31,39,41], two in Canada [46], one in India [23], Hong Kong [48], South Korea [20], Australia [28], Thailand [45], and Japan [35], respectively (Table 1).…”

Section: General Description Of Included Trialsmentioning

confidence: 99%

“…Only four trials [14,16,20,46] reported both an adequate method for generating the randomization sequence and for concealment of allocation, while in the majority of publications, these details were not described. According to our predefined approach, we considered the risk of bias in the measurement of laboratory parameters and "hard" endpoints as low, and with two exceptions all studies reported at least some laboratory data.…”

Section: Assessment Of Risk Of Bias and Study Qualitymentioning

confidence: 99%

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Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials

2010

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This systematic review aims to summarize the available randomized trials of multifactorial lifestyle interventions in the primary and secondary prevention of coronary heart disease and type 2 diabetes mellitus. Randomized trials investigating the effects of lifestyle interventions including the elements of diet, physical activity, and stress management in people at increased risk for or with manifest coronary heart disease or type 2 diabetes mellitus were searched for in five electronic database and by citation tracking. Quality was assessed using the Cochrane Collaboration's risk of bias tool. Exploratory effect size calculations were performed for a variety of laboratory and clinical outcome measures. Twenty-five trials including a total of 7,703 participants met the inclusion criteria. Fifteen trials were in patients with coronary heart disease, seven in patients with type 2 diabetes mellitus, and three on primary prevention. The interventions varied greatly regarding concept, intensity, and providers. Compared to participants in "usual care" control groups, there were no consistent effects on lipid levels and blood pressure and small effects on body mass index and glycated hemoglobin (HbA1c). Composite cardiac event rates were significantly less in the intervention groups of the few trials reporting these outcomes. Mortality was also lower in the intervention groups, but the difference was not statistically significant, and confidence intervals were wide. The evidence base for multifactorial lifestyle interventions is weak. Effects on surrogate measures seem minor, but there may be clinically relevant effects on major clinical endpoints.

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Section: Study Resultsmentioning

confidence: 82%

Section: Study Resultsmentioning

confidence: 99%

Section: General Description Of Included Trialsmentioning

confidence: 99%

Section: General Description Of Included Trialsmentioning

confidence: 99%

Section: Assessment Of Risk Of Bias and Study Qualitymentioning

confidence: 99%

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Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials

2010

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Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction

et al. 2008

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Background: Secondary prevention is not adequately implemented after myocardial infarction (MI). We assessed the effect on quality of care and prognosis of a longterm, 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 signifi-Author Affiliations are listed at the end of this article.

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The stroke east Saxony pilot project for organized post‐stroke care: a case–control study

et al. 2016

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BackgroundLow adherence to secondary prevention guidelines in stroke survivors may increase the risk for recurrent stroke and adversely impact quality of life. We aimed to determine the feasibility of a self‐developed standardized post‐stroke pathway and its impact on secondary stroke prevention and long‐term outcome in patients with acute stroke.MethodsConsecutive patients with acute stroke were prospectively included in a standardized post‐stroke pathway accomplished through a single certified CM (case manager), which comprised educational discussions and quarterly checkups for vascular risk factors and adherence to antithrombotic/anticoagulant medication in addition to usual care. At 12 months, we compared achieved target goals for secondary prevention, functional outcome, stroke recurrence, and vascular death with age‐ and gender‐matched controls that received only usual care after stroke.ResultsWe included 45 cases and 45 controls. The following target goals were more frequently achieved in CM‐patients than in controls: blood pressure (100% vs. 46.2%, P < 0.001), cholesterol (100% vs. 74.4%, P < 0.001), and body mass index (67.4% vs. 46.2%, P = 0.052). The CM‐intervention emerged as an independent predictor of favorable functional outcome (mRS ≤ 2) at 12 months after adjusting for stroke severity and systemic thrombolysis (OR: 4.27; 95%CI:1.2–15.21; P = 0.025). Quality of life was rated significantly higher in CM‐patients than in controls (P = 0.049). As opposed to controls, none of the cases experienced a recurrent stroke (0% vs. 13.3%; P = 0.026) or suffered from vascular death (0% vs. 6.7%; P = 0.242).ConclusionsOur pilot data suggest that organized post‐stroke care enhances achievement of secondary prevention goals. Its possible effect on stroke recurrence, long‐term disability, and quality of life is currently investigated in a prospective cohort study.

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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

Cited by 102 publications

References 15 publications

Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials

Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials

Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction

The stroke east Saxony pilot project for organized post‐stroke care: a case–control study

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