Efficacy and safety of extracranial vein angioplasty in multiple sclerosis

Paolo Zamboni, Luigi Tesio, Stefania Galimberti, Luca Massacesi, Fabrizio Salvi, Roberto D'Alessandro, Patrizia Cenni, Roberto Galeotti, Roberto D'Amico, Donato Papini, Silvana Simi, Maria Grazia Valsecchi, Graziella Filippini, Brave Dreams Research Group, Stefano Ceruti, Paolo Conforti, Anna Maria Malagoni, Erica Menegatti, Mirko Tessari, Francesca PancaldiMaria Elena Vanini, Elena Barbarossa, Ilaria Bartolomei, Lisa Pellegrino, Maria Grazia Piscaglia, Fabrizio Rasi, Maria Babini, Antonella Drea, Eugenia Guerrini, Enrico Maria Lotti, Agnese Morelli, Milena Peroni, Valentina Zalambani, Sauro Zecchini, Francesco Patti, Clara Chisari, Ignazio Chiaramonte, Vincenzo Cimino, Alessia Giaquinta, Luigi Di Pino, Gianni Failla, Pierfrancesco Veroux, Roberto Cantello, Maurizio Leone, Paolo Agostino Confalonieri, Angela Campanella, Valentina Caldiera, Elisa Ciceri, Alessandra Erbetta, Giuseppe Faragò, Valentina Torri Clerici

Research output: Contribution to journalArticle

Abstract

Importance: Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by restricted venous outflow from the brain and spinal cord. Whether this condition is associated with multiple sclerosis (MS) and whether venous percutaneous transluminal angioplasty (PTA) is beneficial in persons with MS and CCSVI is controversial. Objective: To determine the efficacy and safety of venous PTA in patients with MS and CCSVI. Design, Setting, and Participants: We analyzed 177 patients with relapsing-remitting MS; 62 were ineligible, including 47 (26.6%) who did not have CCSVI on color Doppler ultrasonography screening. A total of 115 patients were recruited in the study timeframe. All patients underwent a randomized, double-blind, sham-controlled, parallel-group trial in 6MS centers in Italy. The trial began in August 2012 and concluded in March 2016; data were analyzed from April 2016 to September 2016. The analysis was intention to treat. Interventions: Patients were randomly allocated (2:1) to either venous PTA or catheter venography without venous angioplasty (sham). Main Outcomes and Measures: Two primary end pointswere assessed at 12 months: (1) a composite functional measure (ie, walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity) and (2) a measure of new combined brain lesions on magnetic resonance imaging, including the proportion of lesion-free patients. Combined lesions included T1 gadolinium-enhancing lesions plus new or enlarged T2 lesions. Results: Of the included 115 patients with relapsing-remitting MS, 76 were allocated to the PTA group (45 female [59%]; mean [SD] age, 40.0 [10.3] years) and 39 to the sham group (29 female [74%]; mean [SD] age, 37.5 [10.6] years); 112 (97.4%) completed follow-up. No serious adverse events occurred. Flow restoration was achieved in 38 of 71 patients (54%) in the PTA group. The functional composite measure did not differ between the PTA and sham groups (41.7%vs 48.7%; odds ratio, 0.75; 95%CI, 0.34-1.68; P = .49). The mean (SD) number of combined lesions on magnetic resonance imaging at 6 to 12 months were 0.47 (1.19) in the PTA group vs 1.27 (2.65) in the sham group (mean ratio, 0.37; 95%CI, 0.15-0.91; P = .03: adjusted P = .09) and were 1.40 (4.21) in the PTA group vs 1.95 (3.73) in the sham group at 0 to 12 months (mean ratio, 0.72; 95%CI, 0.32-1.63; P = .45; adjusted P = .45). At follow-up after 6 to 12 months, 58 of 70 patients (83%) in the PTA group and 22 of 33 (67%) in the sham group were free of new lesions on magnetic resonance imaging (odds ratio, 2.64; 95%CI, 1.11-6.28; P = .03; adjusted P = .09). At 0 to 12 months, 46 of 73 patients (63.0%) in the PTA group and 18 of 37 (49%) in the sham group were free of new lesions on magnetic resonance imaging (odds ratio, 1.80; 95%CI, 0.81-4.01; P = .15; adjusted P = .30). Conclusion and Relevance: Venous PTA has proven to be a safe but largely ineffective technique; the treatment cannot be recommended in patients with MS.
Original languageItalian
Pages (from-to)35-43
Number of pages9
JournalJAMA Neurology
Volume75
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

Cite this

Zamboni, P., Tesio, L., Galimberti, S., Massacesi, L., Salvi, F., D'Alessandro, R., Cenni, P., Galeotti, R., D'Amico, R., Papini, D., Simi, S., Valsecchi, M. G., Filippini, G., Group, B. D. R., Ceruti, S., Conforti, P., Malagoni, A. M., Menegatti, E., Tessari, M., ... Clerici, V. T. (2018). Efficacy and safety of extracranial vein angioplasty in multiple sclerosis. JAMA Neurology, 75(1), 35-43. https://doi.org/10.1001/jamaneurol.2017.3825