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1. A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial

Author

Ribichini F., Ansalone G., Bartorelli A., Beqaraj F., Berni A., Colangelo S., D'Amico M., Rovere F. D., Fiscella A., Gabrielli G., Indolfi C., La Vecchia L., Loschiavo P., Marinoni G., Marzocchi A., Milazzo D., Romano M., Sangiorgio P., Sheiban I., Tamburino C., Tuccillo B., Villani R., Cappi B., Quijada M. J. L., Vassanelli C., investigators group, C. Spaccarotella, Ribichini, F., Ansalone, G., Bartorelli, A., Beqaraj, F., Berni, A., Colangelo, S., D'Amico, M., Rovere, F. D., Fiscella, A., Gabrielli, G., Indolfi, C., La Vecchia, L., Loschiavo, P., Marinoni, G., Marzocchi, A., Milazzo, D., Romano, M., Sangiorgio, P., Sheiban, I., Tamburino, C., Tuccillo, B., Villani, R., Cappi, B., Quijada, M. J. L., Vassanelli, C., Investigators, Group, and Spaccarotella, C.

Subjects
medicine.medical_specialty, medicine.medical_treatment, Cost-Benefit Analysis, Coronary Artery Disease, Revascularization, Coronary artery disease, Coronary artery bypass surgery, Immunosuppressive Agent, Blood Vessel Prosthesis Implantation, Clinical Protocols, Internal medicine, Coronary stent, medicine, Drug-Eluting Stent, Myocardial Revascularization, Humans, Sirolimu, cardiovascular diseases, Everolimus, Prospective Studies, Cost-Benefit Analysi, Clinical Protocol, Sirolimus, Multivessel disease, medicine.diagnostic_test, business.industry, Angiography, Drug-Eluting Stents, General Medicine, medicine.disease, Immunosuppressive Agents, Research Design, Everolimu, Prospective Studie, Drug-eluting stent, Cardiology, Radiology, Randomized clinical trial, Cardiology and Cardiovascular Medicine, business, medicine.drug, Human
Abstract

Background: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 ± 0.41 mm in the XIENCE V EECSS arm and 0.30 ± 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. Conclusion: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD. © 2010 Italian Federation of Cardiology.

Published
2010

5. [Hemodynamic benefits of sequential atrioventricular pacing]

Author

Stefano Ghio, Marinoni G, Broglia P, Eleuteri E, Barba F, Bargiggia G, Bosatra C, Pantusa V, Perotti R, and Montemartini C

Subjects
Male, Pacemaker, Artificial, Echocardiography, Hemodynamics, Humans, Female, Stroke Volume, Middle Aged, Echocardiography, Doppler, Aged
Abstract

The purpose of this study was to evaluate the hemodynamic benefits of atrioventricular (A-V) sequential pacing. 30 pts implanted with DDD pacemakers underwent M-mode, B-mode and Doppler echocardiography. In each patient, left ventricular (LV) stroke volume was assessed by measuring the time-velocity integral of mitral inflow in the following modes and rates: VOO at 70 ppm or at the minimum stimulation rate and at 120 ppm; DOO at the same rates with different A-V delay (100, 150, 200, 250 and, whenever possible, 300 msec). The increase in stroke volume obtained with dual chamber pacing at the optimal A-V delay was 45 +/- 25% at 75 ppm and 29 +/- 14% at 120 ppm (p less than 0.05 75 vs 120 ppm). This increase was significantly higher in pts with than in pts without LV hypertrophy (respectively: 51.9 +/- 20.4 vs 36.9 +/- 20.8% at 75 ppm, p less than 0.05 and 33 +/- 13.4 vs 25.4 +/- 14.5% at 120 ppm, p = 0.08). Concerning the A-V delay, we noted that at 75 ppm stroke volume was significantly higher in DOO than in VOO with any A-V delay ranging +/- 100 msec from the optimal one; at 120 ppm the hemodynamic benefit of DOO pacing was observed only when the programmed A-V delay was the optimal one or very near to it. In conclusion, atrio-ventricular sequential pacing allows a significant increase in LV stroke volume over single chamber ventricular pacing both at 75 and 120 ppm. Programming the optimal A-V delay is absolutely necessary to obtain this hemodynamic benefit at the higher stimulation rate.

6. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study)

Author

Fox, K. M., Bertrand, M., Ferrari, Roberto, Remme, W. J., Simoons, M. L., Simoons, M., Bassand, J. P., Aldershvile, J., Hildebrandt, P., Cokkinos, D., Toutouzas, P., Eha, J., Erhardt, L., Erikssen, J., Grybauskas, P., Kalnins, U., Karsch, K., Sechtem, U., Keltai, M., Klein, W., Luscher, T., Mulcahy, D., Nieminen, M., Oto, A., Ozsaruhan, O., Paulus, W., Providencia, L., Riecansky, I., Ruzyllo, W., Ferrari, R., Santini, U., Tavazzi, L., Soler Soler, J., Widimsky, P., Julian, D., Dargie, H., Murray, G., Kubler, W., Thygesen, K., Duprez, D., Steg, G., Drexel, H., Gombotz, G., Heyndrickx, G. H., Legrand, V., Materne, P., Van Mieghem, W., Bocek, P., Branny, M., Cech, M., Charouzek, J., Drazka, J., Fabik, L., Florian, J., Francek, L., Groch, L., Havranek, P., Hradec, J., Jansky, P., Jirmar, R., Jokl, I., Krejcova, H., Kvasnak, M., Maratka, T., Marcinek, G., Moravcova, J., Nedbal, P., Peterka, K., Povolny, J., Rosolova, H., Semrad, B., Sochor, K., Spacek, R., Spinar, J., Stipal, R., Stuchlik, K., Sulda, M., Ulman, J., Vaclavicek, A., Vojtisek, P., Bjerregaard Andersen, H., Kristensen, K., Madsen, J. K., Markenvard, J., Meibom, J., Norgaard, A., Scheibel, M., Leht, A., Teesalu, R., Vahula, V., Itkonen, A., Juvonen, J., Karmakoski, J., Kilkki, E., Koskela, E., Melin, J., Nieminen, M. S., Savola, R., Terho, T., Voipio Pulkki, L. M., Apffel, F., Attali, P., Barjhoux, C., Baron, B., Berthier, Y., Dambrine, P., Decoulx, E., Deshayes, P., Fouche, R., Genest, M., Godard, S., Guillot, J. P., Hanania, G., Khattar, P., Leroy, F., Mansourati, J., Piquemal, R., Quiret, J. C., Raynaud, P., Rondepierre, D., Roynard, J. L., Sudhibhasilp, S., Van Belle, E., Bilbal, A., Lauer, B., Rettig Sturmer, G., Riessen, R., Rutsch, W., Sigel, H. A., Simon, R., Von Schacky, C., Winkelmann, B. R., Avgeropoulou, C., Christakos, S., Feggos, S., Floros, S., Fotiadis, I., Goudevenos, I., Kardara, D., Karidis, C., Koliopoulos, N., Kremastinos, D., Lekakis, I., Manolis, A., Pyrgakis, V., Papanikolaou, C., Papasteriadis, E., Skoufas, P., Stravrati, A., Stavridis, A., Syribeis, S., Vardas, P., Vassiliadis, I., Voudris, V., Zobolos, S., Berenyi, I., Edes, I., Janosi, A., Kalo, E., Karpati, P., Kornel, S., Pap, I., Polak, G., Reiber, I., Rusznak, M., Tarjan, J., Timar, S., Toth, K., Barton, J., Crean, P., Daly, K., Kearney, P., Meany, T. B., Quigley, P., Antolini, R., Azzolini, P., Bellone, E., Branzi, A., Brunelli, C., Capponi, E., Capucci, A., Casaccia, M., Cecchetti, E., Ceci, V., Celegon, L., Colombo, A., Corsini, G., Cucchini, F., Dalla Volta, S., De Caterina, R., De Luca, I., De Servi, S., Di Donato, M., Di Giacomo, U., Di Pasquale, G., Fiorentini, C., Gaddi, O., Giannetto, M., Giannuzzi, P., Giordano, A., Giovannini, E., Guarnierio, M., Iacono, A., Inama, G., Leghissa, R., Lorusso, R., Marinoni, G., Marzilli, M., Mauri, F., Mosele, G. M., Papi, S., Pela, G., Pettinati, G., Polimeni, M. R., Portaluppi, Francesco, Proto, C., Renaldini, E., Riva, S., Sanguinetti, M., Santini, M., Severi, S., Sinagra, G., Tantalo, L., Vajola, S. F., Volterrani, M., Ansmite, B., Gailiss, E., Gersamija, A., Ozolina, M. A., Baubiniene, A., Berukstis, E., Grigoniene, L., Kibarskis, A., Kirkutis, A., Marcinkus, R., Milvidaite, I., Vasiliauskas, D., Aalders, J. C. A., Bruggeling, W. A. J., De Feyter, P. J., De Leeuw, M. J., De Waard, D. E. P., De Weerd, G. J., De Zwaan, C., Dijkgraaf, R., Droste, H. T., Freericks, M. P., Hagoort Kok, A. W., Hillebrand, F., Jap, W. T. J., Jochemsen, G. M., Kiemeney, F., Kuijer, P. J. P., Mannaerts, H. F. J., Piek, J. J., Saelman, J. P. M., Slob, F. D., Smits, W. C. G., Suttorp, M. J., Tan, T. B., Van Beek, G. J., Van den Merkhof, L. F. M., Van der Heyden, R., Van Hessen, M. W. J., Van Langeveld, R. A. M., Van Nierop, P. R., Van Rey, F. J. W., Van Straalen, M. J., Vos, J., Werner, H. A., Westendorp, J. J. C., Achremczyk, P., Adamus, J., Baska, J., Bolinska Soltysiak, H., Bubinski, R., Ceremuzynski, L., Cieslinski, A., Dariusz, D., Drozdowski, P., Dubiel, J. S., Galewicz, M., Halawa, B., Janion, M., Jaworska, K., Kaszewska, I., Kleinrok, A., Kornacewicz Jach, Z., Krawczyk, W., Krynicki, R., Krzciuk, M., Krzeminska Pakula, M., Kuch, J., Kuzniar, J., Liszewska Pfejfer, D., Loboz Grudzien, K., Musial, W., Opolski, G., Pasyk, S., Piwowarska, W., Pulkowski, G., Rynkiewicz, A., Sinkiewicz, W., Skura, M., Slowinski, S., Smielak Korombel, W., Targonski, R., Templin, W., Tendera, M., Tracz, W., Trusz Gluza, M., Wodniecki, J., Zalewski, M., Zinka, E., Carrageta, M., Gil, J. C., Ferreira, R., Marques, A. L., Andrade, C. M. S., Seabra Gomes, R., Bada, V., Belicova, M., Dukat, A., Kaliska, G., Kamensky, G., Micko, K., Mikes, Z., Palinsky, M., Pella, D., Renker, B., Sefara, P., Sojka, G., Sulej, P., Szakacs, M., Salcedo, J. M. A., Orcajo, N. A., Garcia, P. A., Sanpera, J. M. A., Azcarate, J. A., Mayor, J. L. B., Martinez, V. B., Coronado, J. L. B., Ojeda, F. B., Caimari, R. B., Cortada, J. B., Valderrama, J. C., Ligorit, A. D., Caliani, J. S. E., Aviles, F. F., Guerrero, J. J. G., Lopez, D. G., Cocina, E. G., Urena, C. G., Lorente, L. J., Garcia Aranda, V. L., De Miguel, C. M., Montero, J. M., Romero, P. M., Benito, I. M., Lopez, F. N., Peiro, F. N., De Ros, J. O., Mas, J. O., Bermejo, M. A. P., Peralta, L. J. P., Padial, L. R., Sanz, A. S., Bonnin, J. S., Martin, E. S., Belsue, F. V., Ekdahl, S., Forslund, L., Ohlin, H., Pieper, M., Moccetti, T., Acarturk, E., Guzelsoy, D., Turkoglu, C., Adgey, A. A. J., Ahsan, A., Al Khafaji, M., Ball, S. G., Birkhead, J., Boon, N., Brack, M., Bridges, A., Buchalter, M., Calder, B., Cooke, R. A., Corr, L., Cowell, R., Curzen, N. P., Davidson, C., Davies, J., De Belder, M. A., Dhiya, L., Doig, J. C., Findlay, I. N., Francis, C. M., Glancy, J. M., Greenwood, T. W., Groves, P., Hall, A. S., Hamilton, G., Haq, I., Hillman, R., Hubbard, W., Hudson, I., Hutton, I., Ilsley, C., Innes, M., James, M., Jennings, K., Johnston, G., Jones, C. J. H., Joy, M., Keeling, P., Kooner, J., Lawson, C., Levy, R. D., Lip, G., Mclachlan, B., Montgomery, H. E., Morley, C. A., Murdoch, D. L., Muthusamy, R., Oakley, G. D. G., Penny, W., Percival, R., Purvis, J., Pye, M. P., Ramsdale, D., Roberts, D. H., Rozkovec, A., Salmassi, A. M., Saltissi, S., Sardar, S., Shapiro, L. M., Schofield, P. M., Stephens, J., Shakespeare, C., Srivastava, S., Swan, J. W., Tildesley, G., Travill, C., Wilkinson, P. R., Fratacci, M. D., Lerebours, G., and Deckers, J.

Subjects
Relative risk reduction, Male, medicine.medical_specialty, Myocardial Infarction, Angiotensin-Converting Enzyme Inhibitors, Coronary Disease, Coronary artery disease, Double-Blind Method, Internal medicine, Cause of Death, Clinical endpoint, Perindopril, Medicine, Humans, Myocardial infarction, Heart Failure, Ejection fraction, business.industry, General Medicine, Middle Aged, medicine.disease, Heart Arrest, Treatment Outcome, Cardiovascular Diseases, Heart failure, ACE inhibitor, Cardiology, Female, business, circulatory and respiratory physiology, medicine.drug, Follow-Up Studies
Abstract

Background Treatment with angiotensin-converting-enzyme (ACE) inhibitors reduces the rate of cardiovascular events among patients with left-ventricular dysfunction and those at high risk of such events. We assessed whether the ACE inhibitor perindopril reduced cardiovascular risk in a low-risk population with stable coronary heart disease and no apparent heart failure. Methods We recruited patients from October, 1997, to June, 2000. 13655 patients were registered with previous myocardial infarction (64%), angiographic evidence of coronary artery disease (61%), coronary revascularisation (55%), or a positive stress test only (5%). After a run-in period of 4 weeks, in which all patients received perindopril, 12218 patients were randomly assigned perindopril 8 mg once daily (n=6110), or matching placebo (n=6108). The mean follow-up was 4.2 years, and the primary endpoint was cardiovascular death, myocardial infarction, or cardiac arrest. Analysis was by intention to treat. Findings Mean age of patients was 60 years (SD 9), 85% were male, 92% were taking platelet inhibitors, 62% beta blockers, and 58% lipid-lowering therapy. 603 (10%) placebo and 488 (8%) perindopril patients experienced the primary endpoint, which yields a 20% relative risk reduction (95% CI 9-29, p=0.0003) with perindopril. These benefits were consistent in all predefined subgroups and secondary endpoints. Perindopril was well tolerated. Interpretation Among patients with stable coronary heart disease without apparent heart failure, perindopril can significantly improve outcome. About 50 patients need to be treated for a period of 4 years to prevent one major cardiovascular event. Treatment with perindopril, on top of other preventive medications, should be considered in all patients with coronary heart disease.

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