Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction - GOSPEL

Nov 18, 2008
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Società Prodotti Antibiotici
Date Published:
01/01/2008
Date Updated:
11/18/2008
Original Posted Date:
11/18/2008
References

Description:

The goal of the trial was to evaluate the effect of a comprehensive cardiac rehabilitation program centered on individualized risk factor modification and lifestyle management compared with usual care among patients with a recent acute myocardial infarction.

Hypothesis:

Comprehensive cardiac rehabilitation would be more effective than usual care in improving adverse cardiac outcomes.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patients Enrolled: 3,241
Mean Follow Up: 3 years
Mean Patient Age: 58 years
Female: 14%
Mean Ejection Fraction: 53%

Patient Populations:

  • Patients within 3 months of an acute myocardial infarction who were referred to a cardiac rehabilitation center

Exclusions:

  • Age greater than 75 years
  • Shortened life span or any systemic illness that would limit participation in an exercise program

Primary Endpoints:

  • Cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for angina pectoris, heart failure, or urgent revascularization procedure

Secondary Endpoints:

  • Major cardiovascular events
  • Major cerebrovascular events
  • Lifestyle habits (diet, exercise, smoking)
  • Drug prescriptions

Drug/Procedures Used:

Patients with recent myocardial infarction were randomized to comprehensive cardiac rehabilitation (n = 1,620) versus usual care (n = 1,621). Patients in the cardiac rehabilitation group were encouraged to stop smoking, lose weight, exercise, and participate in a Mediterranean diet. Targets for risk factor modification were blood pressure <140/85 mm Hg (<130/80 mm Hg if diabetic), low-density lipoprotein cholesterol <100 mg/dl, and glycated hemoglobin <7%. Guideline-recommended medical therapies were also recommended, including aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins.

Concomitant Medications:

At baseline, the use of aspirin was 84.0%, beta-blockers 76.2%, ACE inhibitors 60.9%, and lipid-lowering agents 69.7%.

Principal Findings:

Overall, 3,241 patients were randomized. The median time from acute myocardial infarction to randomization was 61 days. There were 8.4% of participants older than 70 years, 15.4% had diabetes, 50.1% were overweight, mean ejection fraction was 52.7%, and percutaneous or surgical revascularization was performed in 67.3%.

The primary composite outcome occurred in 16.1% of the cardiac rehabilitation program versus 18.2% of the usual care group (p = 0.12). For individual outcomes: cardiovascular mortality was 1.1% versus 1.5% (p = 0.35), nonfatal myocardial infarction was 1.4% versus 2.7% (p = 0.01), nonfatal stroke was 0.7% versus 0.8% (p = 0.67), hospitalization for heart failure was 1.5% versus 2.0% (p = 0.22), and hospitalization for angina was 4.9% versus 5.6% (p = 0.39), respectively, for rehabilitation versus usual care.

For lifestyle and risk factor changes at 3 years: physical activity score (higher score indicates more physical activity) was 7.5% versus 7.1%, dietary habit score (higher score indicates a more Mediterranean-like diet) was 64.4% versus 56.1%, low-density lipoprotein cholesterol was 105 mg/dl versus 106 mg/dl, body mass index was 27.0 kg/m2 versus 27.4 kg/m2, glycated hemoglobin was 5.7% versus 5.7%, and smoking discontinuation was 75.3% versus 71.1%, respectively, for rehabilitation versus usual care.

Interpretation:

Among patients with recent acute myocardial infarction, the implementation of an integrated, multifactorial, and comprehensive cardiac rehabilitation program nonsignificantly reduces major adverse cardiac events over 3 years of follow-up compared with usual care. All individual adverse outcomes were nonsignificantly lower with cardiac rehabilitation; however, myocardial infarction was significantly reduced by this approach. While physical activity and dietary habits were improved at 3 years with cardiac rehabilitation, most risk factors (low-density lipoprotein cholesterol, body mass index, and glycated hemoglobin) were fairly similar between the groups. The rate of smoking discontinuation was slightly greater with cardiac rehabilitation at the extent of follow-up.

The cost and logistics of this program would be the biggest hurdle in widely recommending it to all patients after an acute myocardial infarction. Comprehensive cardiac rehabilitation should be especially considered to those at highest risk of adverse events and with numerous modifiable cardiac risk factors.

References:

Giannuzzi P, Temporelli PL, Marchioli R, et al. 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. Arch Intern Med 2008;168:2194-204.

Keywords: Myocardial Infarction, Stroke, Life Style, Behavior Therapy, Overweight, Blood Pressure, Risk Factors, Diet, Mediterranean, Smoking, Treatment Outcome, Lipoproteins, LDL, Glycated Hemoglobin A, Body Mass Index, Heart Failure, Motor Activity, Hospitalization, Diabetes Mellitus


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