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Results of the GOSPEL Study, a Multicenter, Randomized Controlled Trial From the Italian Cardiac Rehabilitation Network

Pantaleo Giannuzzi, MD; Pier Luigi Temporelli, MD; Roberto Marchioli, MD; Aldo Pietro Maggioni, MD; Gianluigi Balestroni, PhD; Vincenzo Ceci, MD; Carmine Chieffo, MD; Marinella Gattone, MD; Raffaele Griffo, MD; Carlo Schweiger, MD; Luigi Tavazzi, MD; Stefano Urbinati, MD; Franco Valagussa, MD; Diego Vanuzzo, MD; for the GOSPEL Investigators

Arch Intern Med. 2008;168(20):2194-2204.

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

Author Affiliations: Fondazione Salvatore Maugeri, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Veruno, Italy (Drs Giannuzzi, Temporelli, Balestroni, and Gattone); Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy (Dr Marchioli); Centro Studi Associazione Nazionale Medici Cardiologi Ospedalieri, Firenze, Italy (Dr Maggioni); Ospedale Santo Spirito, Roma, Italy (Dr Ceci); Azienda Ospedaliera San Sebastiano, Caserta, Italy (Dr Chieffo); Ospedale La Colletta, Arenzano, Italy (Dr Griffo); Azienda Ospedaliera G. Salvini, Rho-Passirana, Italy (Dr Schweiger); Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (Dr Tavazzi); Ospedale Bellaria, Bologna, Italy (Dr Urbinati); Ospedale S. Gerardo, Monza, Italy (Dr Valagussa); and Centro per la Prevenzione Cardiovascolare, Udine, Italy (Dr Vanuzzo).
Died December 1, 2006.

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