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Prospective randomized trial of venous angioplasty in MS (PREMiSe) (CROSBI ID 212354)

Prilog u časopisu | ostalo

Siddiqui AH1, Zivadinov R1, Benedict RH2, Karmon Y2, Yu J2, Hartney ML2, Marr KL2, Valnarov V2, Kennedy CL2, Ramanathan M2, Ramasamy DP2, Dolic K2, Hojnacki DW2, Carl E2, Levy EI2, Hopkins LN2, Weinstock-Guttman B2 Prospective randomized trial of venous angioplasty in MS (PREMiSe) // Neurology, 83(5) (2014), 441-449

Podaci o odgovornosti

Siddiqui AH1, Zivadinov R1, Benedict RH2, Karmon Y2, Yu J2, Hartney ML2, Marr KL2, Valnarov V2, Kennedy CL2, Ramanathan M2, Ramasamy DP2, Dolic K2, Hojnacki DW2, Carl E2, Levy EI2, Hopkins LN2, Weinstock-Guttman B2

engleski

Prospective randomized trial of venous angioplasty in MS (PREMiSe)

OBJECTIVE: We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) with findings of extracranial venous anomalies, considered hallmarks of chronic cerebrospinal venous insufficiency (CCSVI), in a 2-phase study (ClinicalTrials.gov NCT01450072). METHODS: Phase 1 was an open-label safety study (10 patients) ; phase 2 was sham-controlled, randomized, and double-blind (10 sham procedure, 9 treated). All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI. Assessment was at 1, 3, and 6 months postprocedure with MRI, clinical, and hemodynamic outcomes. Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life. RESULTS: No perioperative complications were noted ; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as nonsignificant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow- up. No differences in other endpoints were detected. CONCLUSION: Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity. CLASSIFICATION OF EVIDENCE: This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure.

multiple sclerosis; endovascular treatment; chronic cerebrospinal venous insufficiency; safety; sham-controlled; double-blind; randomized; efficacy; relapses; lesion activity

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nije evidentirano

nije evidentirano

nije evidentirano

nije evidentirano

nije evidentirano

Podaci o izdanju

83(5)

2014.

441-449

objavljeno

0028-3878

Povezanost rada

Kliničke medicinske znanosti

Indeksiranost