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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00421876.
Giannuzzi
Pantaleo
P
Fondazione Salvatore Maugeri, Istituto di Ricovero e Cura a Carattere Scientifico, Veruno, Italy. pantaleo.giannuzzi@fsm.it
Temporelli
Pier Luigi
PL
Marchioli
Roberto
R
Maggioni
Aldo Pietro
AP
Balestroni
Gianluigi
G
Ceci
Vincenzo
V
Chieffo
Carmine
C
Gattone
Marinella
M
Griffo
Raffaele
R
Schweiger
Carlo
C
Tavazzi
Luigi
L
Urbinati
Stefano
S
Valagussa
Franco
F
Vanuzzo
Diego
D
D000787:Angina Pectoris / Q000209:etiology; D005260:Female; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control* / Q000534:rehabilitation; D009204:Myocardial Revascularization; D055502:Secondary Prevention; D013315:Stress, Psychological / Q000209:etiology; D020521:Stroke / Q000209:etiology