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Dall'abstract di ECTRIMS 2012
Introduzione:
L' Insufficienza venosa cronica cerebrospinale (CCSVI) è stata recentemente descritta come una condizione, caratterizzata da un drenaggio venoso cerebrale cronicamente compromesso, associata alla Sclerosi Multipla (SM).
Studi successivi non hanno confermato l'associazione tra CCSVI e SM e persino messo in dubbio che la CCSVI esista affatto.
Lo studio Cosmo è un grande, multicentrico studio case-control promosso dalla Fondazione Italiana Sclerosi Multipla (FISM) per indagare il rapporto tra CCSVI e SM.
Materiali e metodi:
Lo studio è stato condotto in 35 centri clinici italiani.
Sono stati arruolati 1.871 soggetti di età 18-55 anni (55 sono stati esclusi per violazioni maggiori del protocollo), in modo che l'analisi finale è stata basata su 1816 soggetti con SM
1202 (recidivante-remittente=72,6%, progressiva secondaria=13,5%, progressiva primaria=5,2% e Sindromi Clinicamente Isolata=8,7%)
382 controlli sani (HC) e 232 soggetti con altre patologie neurologiche (OND).
Un consenso informato è stato sottoscritto da tutti i soggetti iscritti.
L' Eco Color Doppler (ECD) è stato effettuato secondo un protocollo predefinito e tutti i sonologi sono stati appositamente addestrati ai criteri standardizzati dell' ECD per la CCSVI.
L'esame è stato registrato e inviato per una valutazione centrale in cieco, eseguita da uno dei 3 sonologi esperti centrali, che hanno avuto un accesso cieco ai dati ECD.
La diagnosi è stata confrontata tra il sonologo locale e quello centrale. In caso di accordo, è stata rilasciata una relazione finale. In caso di disaccordo, l'esame ECD è stato inviato in modo indipendente ad altri due sonologi centrali, e la diagnosi è stata fatta a maggioranza.
La raccolta centralizzata dei dati e il monitoraggio è stato gestito da un CRO indipendente.
I risultati qui presentati includono 1.678 esami con completata la valutazione locale e centrale.Risultati:
La prevalenza di CCSVI è stata :
3,24% (intervallo di confidenza 95% (CI) = [2.35%, 4.45%]) nei pazienti con sclerosi multipla
1,98% (95% IC = [0,96%, 4,03%]) e 2,80% (95 % CI = [1,29%; 5,98%]) rispettivamente in HC e nei pazienti con OND.
La differenza tra pazienti con SM e HC non era statisticamente significativa (OR = 1.66, 95% IC = [0,73; 3,77], p = 0,28), così come la differenza tra i pazienti affetti da SM e pazienti OND (OR = 1,16 [0.48,2.78 ], p = 0,99).
Non c'era alcuna associazione tra CCSVI e SM qualsiasi sottotipo.
Conclusioni:
La prevalenza di CCSVI rilevata in un contesto multicentrico da una valutazione condivisa locale e centrale era molto bassa e non significativamente associata con la SM.
Questi risultati non supportano il ruolo della CCSVI come un potenziale fattore causale nello sviluppo della sclerosi multipla.
Introduction: Chronic cerebrospinal venous insufficiency (CCSVI) has been recently described as a condition characterized by chronically impaired cerebral venous drainage associated to multiple sclerosis (MS). Subsequent studies failed to confirm the association between CCSVI and MS and even questioned whether CCSVI exist at all. The CoSMo study is a large, multicenter case-control study promoted by the Italian MS Foundation to investigate the relationship between CCSVI and MS.
Materials and method: This study was conducted in 35 Italian clinical centers. 1871 subjects aged 18-55 years were enrolled (55 were excluded for major protocol violations) so that the final analysis was based on 1816 subjects: 1202 with MS (72.6% Relapsing Remitting, 13.5% Secondary Progressive, 5.2% Primary Progressive and 8.7% Clinically Isolated Syndromes), 382 healthy controls (HC) and 232 subjects with other neurological diseases (OND). An informed consent was obtained for all the enrolled subjects. Eco Color Doppler (ECD) was performed according to a pre-defined protocol and all sonologist were specifically trained to standardized ECD criteria for CCSVI. The exam was recorded and sent for a central blind evaluation performed by one of 3 expert central sonologists. These had blind access to the ECD imaging. The diagnosis was compared between the local and one central sonologist. In case of agreement, a final report was issued. In case of disagreement, the ECD examination was sent independently to the other two central sonologists and the diagnosis made by a majority. Centralized data collection and monitoring was managed by an independent CRO. The results presented here include 1678 examinations with completed local and central assessment.
Results: The prevalence of CCSVI was 3.24% (95% Confidence Interval (CI)= [2.35%; 4.45%]) in MS patients, 1.98% (95%CI= [0.96%; 4.03%]) and 2.80% (95%CI=[1.29%; 5.98%]) respectively in HC and in patients with OND. The difference between MS patients and HC was not statistically significant (OR=1.66, 95%CI= [0.73;3.77], p=0.28), as well as the difference between MS patients and OND patients (OR=1.16 [0.48,2.78], p=0.99). There was no association between CCSVI and any MS subtype.
Conclusion: The prevalence of CCSVI detected in a multicenter setting by a shared local and central assessment was very low and not significantly associated with MS. These results do not support the role of CCSVI as a potential causal factor in the development of MS.
Dr. Battaglia has no conflicts of interest to declare. Dr A. Bertolotto has been on steering committees in clinical trials sponsored by Biogen Idec, Roche, and has received speaker honoraria from Biogen Idec, Merck Serono, TEVA, Bayer Schering, Sanofi-aventis, and Novartis; and has received research support from Biogen Idec, Bayer Schering, Merck Serono, Sanofi-Aventis, from the Italian Multiple Sclerosis Society, and the European Union Sixth Framework Programme. Dr. Comi has received consulting fees for participating on advisory boards from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, and Bayer Schering; lecture fees from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, Biogen Dompè, Bayer Schering and Serono Symposia International Foundation. He is member of the Board of the Italian MS Foundation. Dr. M. Del Sette has no conflicts of interest to declare. Dr A. Ghezzi received honoraria for speaking from Bayer-Schering, Biogen-Dompè, Merck-Serono, Novartis, Sanofi-Aventis and Allergan, for consultancy from Actelion, Merck-Serono, Teva and Novartis, received support for participation to National and International Congresses from Bayer-Schering, Biogen-Dompè, Merck- Serono, Novartis and Sanofi-Aventis. Dr G. Malferrari has no conflicts of interest to declare. Dr. GL Mancardi received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Schering, Biogen Idec, Sanofi-Aventis, Novartis and Merck Serono Pharmaceuticals. He is member of the Board of the Italian MS Foundation. Dr. M Salvetti declares grant support from Bayer-Schering, Merck-Serono, Sanofi-Aventis and Biogen Idec. Dr. MP Sormani has received consulting fee or honoraria from Biogen Idec, Merck Serono, Actelion, Synthon and TEVA. Dr. E. Stolz has received lecture fees from Boehringer Ingelheim, Bracco and Sanofi-Aventis and support from Schering. Dr. L. Tesio is member of the Board of the Italian MS Foundation.
Dall'abstract di ECTRIMS 2012
Introduzione:
L' Insufficienza venosa cronica cerebrospinale (CCSVI) è stata recentemente descritta come una condizione, caratterizzata da un drenaggio venoso cerebrale cronicamente compromesso, associata alla Sclerosi Multipla (SM).
Studi successivi non hanno confermato l'associazione tra CCSVI e SM e persino messo in dubbio che la CCSVI esista affatto.
Lo studio Cosmo è un grande, multicentrico studio case-control promosso dalla Fondazione Italiana Sclerosi Multipla (FISM) per indagare il rapporto tra CCSVI e SM.
Materiali e metodi:
Lo studio è stato condotto in 35 centri clinici italiani.
Sono stati arruolati 1.871 soggetti di età 18-55 anni (55 sono stati esclusi per violazioni maggiori del protocollo), in modo che l'analisi finale è stata basata su 1816 soggetti con SM
1202 (recidivante-remittente=72,6%, progressiva secondaria=13,5%, progressiva primaria=5,2% e Sindromi Clinicamente Isolata=8,7%)
382 controlli sani (HC) e 232 soggetti con altre patologie neurologiche (OND).
Un consenso informato è stato sottoscritto da tutti i soggetti iscritti.
L' Eco Color Doppler (ECD) è stato effettuato secondo un protocollo predefinito e tutti i sonologi sono stati appositamente addestrati ai criteri standardizzati dell' ECD per la CCSVI.
L'esame è stato registrato e inviato per una valutazione centrale in cieco, eseguita da uno dei 3 sonologi esperti centrali, che hanno avuto un accesso cieco ai dati ECD.
La diagnosi è stata confrontata tra il sonologo locale e quello centrale. In caso di accordo, è stata rilasciata una relazione finale. In caso di disaccordo, l'esame ECD è stato inviato in modo indipendente ad altri due sonologi centrali, e la diagnosi è stata fatta a maggioranza.
La raccolta centralizzata dei dati e il monitoraggio è stato gestito da un CRO indipendente.
I risultati qui presentati includono 1.678 esami con completata la valutazione locale e centrale.Risultati:
La prevalenza di CCSVI è stata :
3,24% (intervallo di confidenza 95% (CI) = [2.35%, 4.45%]) nei pazienti con sclerosi multipla
1,98% (95% IC = [0,96%, 4,03%]) e 2,80% (95 % CI = [1,29%; 5,98%]) rispettivamente in HC e nei pazienti con OND.
La differenza tra pazienti con SM e HC non era statisticamente significativa (OR = 1.66, 95% IC = [0,73; 3,77], p = 0,28), così come la differenza tra i pazienti affetti da SM e pazienti OND (OR = 1,16 [0.48,2.78 ], p = 0,99).
Non c'era alcuna associazione tra CCSVI e SM qualsiasi sottotipo.
Conclusioni:
La prevalenza di CCSVI rilevata in un contesto multicentrico da una valutazione condivisa locale e centrale era molto bassa e non significativamente associata con la SM.
Questi risultati non supportano il ruolo della CCSVI come un potenziale fattore causale nello sviluppo della sclerosi multipla.
Materials and method: This study was conducted in 35 Italian clinical centers. 1871 subjects aged 18-55 years were enrolled (55 were excluded for major protocol violations) so that the final analysis was based on 1816 subjects: 1202 with MS (72.6% Relapsing Remitting, 13.5% Secondary Progressive, 5.2% Primary Progressive and 8.7% Clinically Isolated Syndromes), 382 healthy controls (HC) and 232 subjects with other neurological diseases (OND). An informed consent was obtained for all the enrolled subjects. Eco Color Doppler (ECD) was performed according to a pre-defined protocol and all sonologist were specifically trained to standardized ECD criteria for CCSVI. The exam was recorded and sent for a central blind evaluation performed by one of 3 expert central sonologists. These had blind access to the ECD imaging. The diagnosis was compared between the local and one central sonologist. In case of agreement, a final report was issued. In case of disagreement, the ECD examination was sent independently to the other two central sonologists and the diagnosis made by a majority. Centralized data collection and monitoring was managed by an independent CRO. The results presented here include 1678 examinations with completed local and central assessment.
Results: The prevalence of CCSVI was 3.24% (95% Confidence Interval (CI)= [2.35%; 4.45%]) in MS patients, 1.98% (95%CI= [0.96%; 4.03%]) and 2.80% (95%CI=[1.29%; 5.98%]) respectively in HC and in patients with OND. The difference between MS patients and HC was not statistically significant (OR=1.66, 95%CI= [0.73;3.77], p=0.28), as well as the difference between MS patients and OND patients (OR=1.16 [0.48,2.78], p=0.99). There was no association between CCSVI and any MS subtype.
Conclusion: The prevalence of CCSVI detected in a multicenter setting by a shared local and central assessment was very low and not significantly associated with MS. These results do not support the role of CCSVI as a potential causal factor in the development of MS.
Dr. Battaglia has no conflicts of interest to declare. Dr A. Bertolotto has been on steering committees in clinical trials sponsored by Biogen Idec, Roche, and has received speaker honoraria from Biogen Idec, Merck Serono, TEVA, Bayer Schering, Sanofi-aventis, and Novartis; and has received research support from Biogen Idec, Bayer Schering, Merck Serono, Sanofi-Aventis, from the Italian Multiple Sclerosis Society, and the European Union Sixth Framework Programme. Dr. Comi has received consulting fees for participating on advisory boards from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, and Bayer Schering; lecture fees from Novartis, Teva Pharmaceutical Ind. Ltd., Sanofi-Aventis, Merck Serono, Biogen Dompè, Bayer Schering and Serono Symposia International Foundation. He is member of the Board of the Italian MS Foundation. Dr. M. Del Sette has no conflicts of interest to declare. Dr A. Ghezzi received honoraria for speaking from Bayer-Schering, Biogen-Dompè, Merck-Serono, Novartis, Sanofi-Aventis and Allergan, for consultancy from Actelion, Merck-Serono, Teva and Novartis, received support for participation to National and International Congresses from Bayer-Schering, Biogen-Dompè, Merck- Serono, Novartis and Sanofi-Aventis. Dr G. Malferrari has no conflicts of interest to declare. Dr. GL Mancardi received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Schering, Biogen Idec, Sanofi-Aventis, Novartis and Merck Serono Pharmaceuticals. He is member of the Board of the Italian MS Foundation. Dr. M Salvetti declares grant support from Bayer-Schering, Merck-Serono, Sanofi-Aventis and Biogen Idec. Dr. MP Sormani has received consulting fee or honoraria from Biogen Idec, Merck Serono, Actelion, Synthon and TEVA. Dr. E. Stolz has received lecture fees from Boehringer Ingelheim, Bracco and Sanofi-Aventis and support from Schering. Dr. L. Tesio is member of the Board of the Italian MS Foundation.
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