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1. Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction

Author

Giannuzzi P., Temporelli P.L., Marchioli R., Maggioni A.P., Balestroni G., Ceci V., Chieffo C., Gattone M., Griffo R., Schweiger C., Tavazzi L., Urbinati S., Valagussa F., Vanuzzo D., Girardini D., Francesconi G., Vona M., Santoni R., Sarno C., Calisi P., Forzoni M., Boncompagni L., Tabouret G., Canci U., Rosato G., Stanco G., Gullace G., Carbone C., Gavazzi A., Mazzoleni D., Pinelli G., Frizzelli R., Tortelli O., Pantaleoni A., Mantovani E., Pettinati G., Storti G., Riccio C., Scrutinio D., Passantino A., Guiducci D., Zobbi G., Vanaria D., Barbanti P., Carini V., Coco R., Borrello G., Mazza M.L., Chiesa F., Sansoni C., Morbelli E., Rossi L., Ciglia C., Di Giovanni P., Cocchieri M., Dò V., Trudu A., Albonic D., Bendinelli S., Iori E., Balestra G., Giacometti N., Coppetti S., Priori S., Masotti G., Fattirolli F., Meniconi L., Paolucci P., Malinverni C., Quarenghi F., Fontanelli A., Marini R., Mandorla S., Provvidenza M., Giordano A., De Giuli F., Odoguardi L., Barsotti S., Moccetti T., Molteni A., Mauri F., Lecchi G., Bettini R., Bertoldi A., Zanettini R., Centeleghe P., Corallo S., Rainoldi M.L., Ferratini M., Tavanelli M., Leonetti G., Malfatto G., Pascotto P., Zanocco A., Buchberger R., Masaro G., Cobelli F., Sala L., Musca G., Cauteruccio M.A., Giallauria F., Mininni N., Morra P., Castello A., Sarullo F.M., Castelli D., Tramarin R., De Salvo M., Porcellati C., Giovagnoni F., Anniboletti P.F., Calisti M.G., Vergoni W., Iacopetti L., Zelaschi F., D'Cruz S., Lopizzo A., Caiazza M., Gigli G., Pastine J., Pulitanò G., Ruggeri A., Piovaccari G., Semprini P., Zavatteri G., Diaco T., Lumia F., Tamiz A.M., Oliva G., Galati A., Picelli A., Picelli F., Bosco R., Marcellini G., Zanchè E., Martin G., Masutti S., Milani L., Pizzolato G.M., Occhi G., Partesana N., Baldi N., Polimeni G., Furgi G., Nicolino A., Bevilacqua R., Ingignoli B., Massobrio N., Avogliero G., Pedretti R., Vaninetti R., Donnangelo L., Chiatto M., Gori P., Garbin R., RICCARDI, GABRIELE, VIGORITO, CARLO, Giannuzzi, P., Temporelli, P. L., Marchioli, R., Maggioni, A. P., Balestroni, G., Ceci, V., Chieffo, C., Gattone, M., Griffo, R., Schweiger, C., Tavazzi, L., Urbinati, S., Valagussa, F., Vanuzzo, D., Girardini, D., Francesconi, G., Vona, M., Santoni, R., Sarno, C., Calisi, P., Forzoni, M., Boncompagni, L., Tabouret, G., Canci, U., Rosato, G., Stanco, G., Gullace, G., Carbone, C., Gavazzi, A., Mazzoleni, D., Pinelli, G., Frizzelli, R., Tortelli, O., Pantaleoni, A., Mantovani, E., Pettinati, G., Storti, G., Riccio, C., Scrutinio, D., Passantino, A., Guiducci, D., Zobbi, G., Vanaria, D., Barbanti, P., Carini, V., Coco, R., Borrello, G., Mazza, M. L., Chiesa, F., Sansoni, C., Morbelli, E., Rossi, L., Ciglia, C., Di Giovanni, P., Cocchieri, M., Dò, V., Trudu, A., Albonic, D., Bendinelli, S., Iori, E., Balestra, G., Giacometti, N., Coppetti, S., Priori, S., Masotti, G., Fattirolli, F., Meniconi, L., Paolucci, P., Malinverni, C., Quarenghi, F., Fontanelli, A., Marini, R., Mandorla, S., Provvidenza, M., Giordano, A., De Giuli, F., Odoguardi, L., Barsotti, S., Moccetti, T., Molteni, A., Mauri, F., Lecchi, G., Bettini, R., Bertoldi, A., Zanettini, R., Centeleghe, P., Corallo, S., Rainoldi, M. L., Ferratini, M., Tavanelli, M., Leonetti, G., Malfatto, G., Pascotto, P., Zanocco, A., Buchberger, R., Masaro, G., Cobelli, F., Riccardi, Gabriele, Sala, L., Musca, G., Cauteruccio, M. A., Vigorito, Carlo, Giallauria, F., Mininni, N., Morra, P., Castello, A., Sarullo, F. M., Castelli, D., Tramarin, R., De Salvo, M., Porcellati, C., Giovagnoni, F., Anniboletti, P. F., Calisti, M. G., Vergoni, W., Iacopetti, L., Zelaschi, F., D'Cruz, S., Lopizzo, A., Caiazza, M., Gigli, G., Pastine, J., Pulitanò, G., Ruggeri, A., Piovaccari, G., Semprini, P., Zavatteri, G., Diaco, T., Lumia, F., Tamiz, A. M., Oliva, G., Galati, A., Picelli, A., Picelli, F., Bosco, R., Marcellini, G., Zanchè, E., Martin, G., Masutti, S., Milani, L., Pizzolato, G. M., Occhi, G., Partesana, N., Baldi, N., Polimeni, G., Furgi, G., Nicolino, A., Bevilacqua, R., Ingignoli, B., Massobrio, N., Avogliero, G., Pedretti, R., Vaninetti, R., Donnangelo, L., Chiatto, M., Gori, P., and Garbin, R.

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, GOSPEL, Angina Pectoris, law.invention, Angina, Randomized controlled trial, law, Internal medicine, Myocardial Revascularization, Secondary Prevention, Internal Medicine, medicine, Clinical endpoint, Humans, Myocardial infarction, Life Style, Stroke, Heart Failure, Cardiac Rehabilitation, business.industry, Surrogate endpoint, Hazard ratio, Middle Aged, medicine.disease, Heart failure, Physical therapy, Female, business, Stress, Psychological
Abstract

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

Published
2008
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2. MEDICAL SCIENCE. GISSI-2: A factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12 490 patients with acute myocardial infarction

Author

Feruglio, G. A., Lotto, A., Rovelli, F., Solinas, P., Tavazzi, L., Tognoni, G., De Vita, C., Franzosi, M. G., Maggiom, A. P., Mauri, F., Volpi, A., Selvini, A., Donato, L., Garattmi, S., Loi, U., Sirchia, G., Ambrosioni, E., Camerini, F., Campolo, L., Donati, M. B., Ferrari, M., Farchi, G., Geraci, E., Mannucci, P. M., Marubini, E., Neri Semeri, G. G., Peto, R., Prati, P. L., Specchia, G., Vecchio, C., Visani, L., Yusuf, S., Mezzanotte, G., Santoro, E., Bruno, M., Cappello, T., Coppini, A., Fincati, F., Mantovani, G., Pangrazzi, J., Pogna, M., Turazza, F. M., Ansehni, M., Barbonaglia, L., Bigi, R., Cavalli, A., Frigerio, M., Giordano, A., Gualtierotti, C., Torta, D., Vinci, P., Bossi, M., Furlanello, F., Braito, E., Giulia, V., Palmieri, M., Majoimo, P., Pinelli, G., Papi, L., Nardelli, A., Capestro, F., Rossi, A., Ricci, D., Mininni, N., Bianco, G., Barbuzzi, S., Plastina, F., Di Giovanna, F., Mereu, D., Giordano, F., Barlotti, R., Loparco, G., Boscarino, S., Ruggeri, G., Anastasi, R., Paciaroni, E., Tomassini, P. F., Purcaro, A., Francesconi, M., Figliolia, S., Tesse, S., Devoti, G., Giometti, R., Teoni, P., Burali, A., Zucconelli, V., Iervoglini, A., Amabili, S., Caratti, C. A., Zola, G., Ferraguto, P., Sagci, G., Rotiroti, D., Genovese, M., Da€™amato, N., Taurino, L., Colonna, L., Bovenzi, F., Messina, D., Sarcina, G., Compostella, L., Cucchini, F., Malacrida, R., Gradel, C., Bridda, A., Pellegrini, P., Acone, L., Bruno, A., Tespili, M., Guaghurrii, G., Casari, A., Bobba, F., Scaramuzzino, G., Berardi, C., De Castro, U., Fulvi, M., Lintner, W., Erlicher, A., Pitscheider, W., Scola Gagliardi, R., Bonizzato, G., Roggero, C., Perrini, A., Tsialtas, D., Straneo, U., Storelli, A., Verrienti, A., Albonico, B., Corradi, L., De Petra, V., Villani, C., Maxia, P., Bianco, A., Crabu, E., Centamore, G., Di Stefano, G., Vancheri, F., Amico, C., Baldini, F., Santopuoli, G., Pantaleoni, A., Contessotto, F., Terlizzi, R., Turchi, E., Teglio, V., Pignatti, F., Aletto, C., Gozzelino, G., Pettinati, G., De Santis, F., Correale, E., Romano, S., Perrotta, R., Tritto, C., May, L., Achilli, G., Suzzi, G., Cemetti, C., Longobardi, R., Somma, G., Palumbo, C., Gallone, P., Sorrentino, F., Dato, A., Della Monica, R., Pagano, L., Alberti, A., Orselli, L., Negrini, M., De Ponti, C., Acito, P., Capelletti, D., Bortolini, F., Coppola, V., Ciglia, C., De Cesare, M., De Lio, U., Maiolino, P., Giannini, R., Niccolini, A., Marinoni, C., Guasconi, C., Sonnino, S., Pagliei, M., Ferrari, G., Politi, A., Galli, M., De Rinaldis, G., Calcagnile, A., Bendinelli, S., Lusetti, L., Mollaioli, M., Cosmi, F., Venneri, N., Feraco, E., Lauro, A., Catelli, P., Poluzzi, C., Distante, S., Pedroni, P., Zampaglione, G., Lumare, R., Bruna, C., De Benedictis, N., Ziacchi, V., Lomanto, B., Riva, D., Bertocchi, P., Tirella, G., Tessitori, M., Bini, A., Peruzzi, F., Maresta, A., Pirazzini, L., Gaggi, S., Frausini, G., Malacame, C., Codeca, L., Cappato, R., Andreoli, L., Bastoni, L. A., Pucci, P., Sarro, F., Vergassola, R., Barchielli, M., De Matteis, D., Carrone, M., Liberati, R., Meniconi, L., Radogna, M., Tallone, M., Ieri, A., Ferreri, A., Guidali, P., Canziani, R., Mariello, F., Minelli, C., Muzio, L., Rota Baldini, M., Lupi, G., Cecchi, A., Giuliano, G., Bellotti, S., Livi, S., Corti, E., Rossi, P., Delfino, R., Iannetti, M., Pastorini, C., Pennesi, A., Di Giacinto, N., Bertolo, L., Slomp, L., Cresti, A., Svetoni, N., Distefano, S., Veneri, L., Moretti, S., Palermo, R., Giovanelli, N., Parchi, C., Dethomads, M., Paparella, N., Carrino, C., Aquaro, G., Idone, P., Marsili, P., Sideri, F., Valerio, A., Tullio, D., Ragazzini, G., Gramenzi, S., De Pasquale, B., Gelfo, P. G., Rosselli, P., De Marchi, E., Greco, M. R., Fazio, A. M., Savoia, M. T., Gerosa, C., Barbiero, M., Barbaresi, F., Volta, G., Da€™urbano, M., Passoni, F., Parola, G., Lanzini, A., Baldini, U., Del Bene, P., Orlandi, M., Oddone, A., Lazzari, M., Ballerini, B., Bozzi, L., Moccetti, T., Bemasconi, E., Sanguinetti, M., Tognoli, T., Bardelli, G., Maggi, A., Turato, R., Piva, M., Izzo, A., Tantalo, L., Rizzi, A., Scilabra, G., Varvaro, F., Colombo, G., Grieco, A., Dovico, E., Belluzzi, F., Casellato, F., Lecchi, G., Maugeri Sacci, C., Consolo, A., Piccolo, E., Zuin, G., Zappa, C., Sanna, G. P., Dossena, M. G., Corsini, C., Lettino, M., Marconi, M., Mafrici, A., Leonardi, G., Moreo, A., Seregni, R., Pastine, I., Casazza, F., Regalia, F., Maggiolini, S., Benenati, P. M., Rigo, R., Pascotto, P., Zanocco, A., Artusi, L., Cappelli, C., Bernardi, C., Pahnieri, M., Zilio, G., Sandri, R., Neri, G., Valagussa, F., Osculati, G., Cira, A., Da€™aniello, L., Piantadosi, F. R., Improta, M., Severino, S., Bisconti, C., Mostacci, M., Randon, L., Boschello, M., Allegri, M., Freggiaro, V., Mureddu, V., Soro, F., Marras, E., Marchi, S. M., De Luca, C., Manetta, M., Dalla Volta, S., Maddalena, F., Donzelli, M., Vitrano, M. G., Canonico, A., Ledda, A., Bellomare, D., Carrubba, A., Da€™antonio, E., Scardulla, C., Raineri, A., Traina, M., La Calce, C., Cirincione, V., Montanar, F., Strizzolo, L., Di Gregorio, D., Mantini, L., Chiriatti, G., Gazzola, U., Rosi, A., Mellini, M., Piazza, R., Micheli, G., Bechi, S., Martines, C., Marchese, D., Bigalli, A., Davini, P., Boem, A., Del Citerna, F., Giomi, A., Codeluppi, P., Negrelli, M., Brieda, M., Charmet, P. A., Petrella, A., Bardazzi, L., Bianco, G. A., Marco, A., Licitra, R., Lettica, G. V., Tumiotto, G., Bosi, S., Spitali, G., Casali, G., Bottoni, N., Parenti, G. F., Triulzi, E., Brighi, F., Benati, A., De Sanctis, A., Mene, A., Pesaresi, A., Bologna, F., Lumia, F., Barbato, G., Milazzotto, F., Proietti, F., Angrisani, G., Azzolini, P., Coppola, E., Trani, Carlo, Masini, V., Rocchi, M., Borgia, M. C., Luciani, C., Vitucci, N. C., Giuliani, P., Tugnoli, F., Vetta, C., Altieri, T., Gimigliano, F., Striano, U., Salituri, S., Zanazzi, G., Zonzin, P., Bugatti, U., Ravera, B., Allemano, P., Reynaud, S., Sanson, A., Milani, L., De Simone, M. V., Villella, A., Grazzini, M., Amidei, S., Ansehni, L., Benza, G., Tagliamonte, A., Messina, V., Etro, M. D., Vivaldi, F., Cortese, R., Ibba, G. V., Sannia, L., Pedrazzini, F., Gazzotti, G. L., Pizzuti, A., Antonielli, E., Becchi, G., Filice, A., Salmoiraghi, A., Caramanno, G., Caporicci, D., Brun, M., Ferrario, G., Giani, P., Ronconi, G., Douglas, S., Bianchi, C., Cucchi, G., Marieni, M., Marcellini, G., Speca, G., Beato, E., Serabni, N., Bazzucchi, M., Coronelli, R., Rossi, L., Basso, G., Presbitero, P., Bevilacqua, R., Pallisco, O., Di Leo, M., Golzio, P. G., Parigi, A., Belli, R., Trinchero, R., Gaschino, G., Barenghi, M., Poggio, G. L., Braschi, G. B., Sciacca, R., Sammartano, A., Braito, G., Cuzzato, V., Frigo, G., Perissinono, F., Galati, A., Accogli, M., Morgera, T., Barbieri, L., Slavich, G. A., Fresco, C., Cuda, A., Liguori, A., Cozzi, A., Caico, S., Alberio, M., Di Marco, G., De Vito, G., Valente, S., Zagatti, G., Zardini, P., Nidasio, G. P., Girardi, P., Mazzini, C., Nava, S., Achilli, A., Bisogno, A., Pasotti, C., Ballestra, A. M., and Giustarini, C.

Subjects
Aspirin, medicine.medical_specialty, business.industry, Streptokinase, acute myocardial infarction, General Medicine, Heparin, medicine.disease, Atenolol, Surgery, Anistreplase, Anesthesia, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, medicine, Myocardial infarction, business, Stroke, medicine.drug, Killip class
Abstract

A multicentre, randomised, open trial with a 2 x 2 factorial design was conducted to compare the benefits and risks of two thrombolytic agents, streptokinase (SK, 1·5 MU infused intravenously over 30-60 min) and alteplase (tPA, 100 mg infused intravenously over 3 h) in patients with acute myocardial infarction admitted to coronary care units within 6 h from onset of symptoms. The patients were also randomised to receive heparin (12 500 U subcutaneously twice daily until discharge from hospital, starting 12 h after beginning the tPA or SK infusion) or usual therapy. All patients without specific contraindications were given atenolol (5-10 mg iv) and aspirin (300-325 mg a day). The end-point of the study was the combined estimate of death plus severe left ventricular damage. 12 490 patients were randomised to four treatment groups (SK alone, SK plus heparin, tPA alone, tPA plus heparin). No specific differences between the two thrombolytic agents were detected as regards the combined end-point (tPA 23·1%; SK 22·5%; relative risk 1·04, 95% Cl 0·95-1·13), nor after the addition of heparin to the aspirin treatment (hep 22·7%, no hep 22·9%; RR 0·99, 95% Cl 0·91-1·08). The outcome of patients allocated to the four treatment groups was similar with respect to baseline risk factors such as age, Killip class, hours from onset of symptoms, and site and type of infarct. The rates of major in-hospital cardiac complications (reinfarction, post-infarction angina) were also similar. The incidence of major bleeds was significantly higher in SK and heparin treated patients (respectively, tPA 0·5%, SK 1·0%, RR 0·57, 95% Cl 0·38-0·85; hep 1·0%, no hep 0·6%, RR 1·64, 95% Cl 1·09-2·45), whereas the overall incidence of stroke was similar in all groups. SK and tPA appear equally effective and safe for use in routine conditions of care, in all infarct patients who have no contraindications, with or without post-thrombolytic heparin treatment. The 8·8% hospital mortality of the study population (compared with approximately 13% in the control cohort of the GISSI-1 trial) indicates the beneficial impact of the proven acute treatments for AMI.

Published
1990

3. Malignant germ cell tumors in childhood: results of the first Italian cooperative study 'TCG 91'

Author

Paolo Tamaro, Rita Alaggio, Margherita Lo Curto, Piero Luigi Almasio, Giovanni Cecchetto, Tina De Laurentis, Fortunato Siracusa, Andrea Di Cataldo, Francesca Lumia, Bruno De Bernardi, Paolo Indolfi, S. Bagnulo, LO CURTO, M, Lumia, F, Alaggio, R, Cecchetto, G, Almasio, P, Indolfi, P, Siracusa, F, Bagnulo, S, DE BERNARDI, B, DE LAURENTIS, T, DI CATALDO, A, and Tamaro, Paolo

Subjects
Male, Cancer Research, medicine.medical_treatment, Gastroenterology, Cohort Studies, chemistry.chemical_compound, Child, malignant germ cell tumors, Etoposide, Ovarian Neoplasms, Ifosfamide, Incidence, seminoma, Prognosis, Combined Modality Therapy, Primary tumor, Chemotherapy regimen, Treatment Outcome, Italy, Oncology, Child, Preschool, carboplatin, Female, Germinoma, medicine.drug, medicine.medical_specialty, Adolescent, Risk Assessment, risk factors in malignant germ cell, Age Distribution, Testicular Neoplasms, Internal medicine, Confidence Intervals, medicine, Humans, Sex Distribution, Survival analysis, Neoplasm Staging, Probability, Retrospective Studies, Chemotherapy, business.industry, Seminoma, medicine.disease, Survival Analysis, Carboplatin, Surgery, chemistry, Multivariate Analysis, Pediatrics, Perinatology and Child Health, business
Abstract

Background and Aims About 20% of patients with germ cell tumor (GCT) are still resistant to therapy. To investigate which features are present in resistant patients, a multicenter study on GCT in children was undertaken to correlate clinical and laboratory parameters with the outcome. Methods Patients aged less than 16 years, with histologically proven extracranial GCT were included. Results Ninety-five patients (median age 33 months, 45 males) were eligible. The site of the primary tumor was gonadal in 59, extragonadal in 36. The stage was I in 39; II in 5; IIIa (microscopic residue) in 7; IIIb (macroscopic residue) in 16; IIIc (unresectable) in 13; IV in 15. The treatment was surgery alone in 31; surgery plus radiotherapy in 1; chemotherapy ± surgery in 63. Post-chemotherapy resection in 19 (10 complete, 9 partial). The chemotherapy regimen was carboplatin 400 mg/m2/day on days 1, 2; etoposide 150 mg/m2/day on days 1, 2; ifosfamide 1,500 mg/m2/day on days 21, 22; dactinomycin 1.5 mg/m2/day on day 21; vincristine 1.5 mg/m2/day on day 21. Three patients died because of toxicity and two non-responders (to primary chemotherapy), died of progression; among the remaining 90 patients 20 relapsed, 9 are in second remission, 2 are alive with disease, and 9 died of disease progression (one from progression and intracranial hemorrhage). Overall survival was 82.7% and event-free survival: 71.5%. Survival according to: (a) site: testis: 100%; ovary: 88%; sacrococcyx: 69.6%; other sites: 33.3% (P

Published
2003

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