UBC CCSVI clinical trial results to be presented Wednesday, March 8, 2017 at SIR meeting in Washington DC:
A Multicenter Prospective Randomized Blinded Sham Controlled Trial Of Jugular Venoplasty In Multiple Sclerosis: Week 48 Result
Wed, 3/8/2017: 10:35 - 10:43 AM
Marriott Marquis Washington DC
L Machan1, A Traboulsee2, D Klass2, B Hardy3
1University of British Columbia Hospital, 2University of British Columbia
3University of Manitoba,
To compare the clinical efficacy of balloon versus sham venoplasty of jugular and azygos vein stenoses in patients with multiple sclerosis 48 weeks post procedure.
MS patients, including relapsing and progressive, from 4 academic MS clinics, recruited after clinical and ultrasound screening were blinded by deep conscious sedation. If catheter venography confirmed jugular or azygos vein stenosis they were prospectively randomized 1:1 intra-procedure by sealed envelope to receive balloon or sham venoplasty of all stenoses. Patient questionnaires were given at baseline, 24 hours and 12 weeks, physical exam at the baseline and at weeks 12, 24, 36, and 48, and MR at baseline and weeks 24 and 48. Patients, clinical neurologists, research staff and radiologists reporting MRIs were all blinded. Safety outcomes including serious adverse events, venous thrombosis, and restenosis were monitored by an independent data safety monitoring board, and clinical trial monitors provided trial oversight. Patients initially randomized to venoplasty received a sham procedure 1 year later, and vice versa. Extensive efforts were made so the patient experience was the same for both procedures.
274 patients were screened and 104 randomized. All patients were followed up to 48 weeks. Outcomes included patient reported quality of life, fatigue scales, EDSS, protocol defined relapses, and new MRI disease activity (gadolinium enhancing T1 and/or new T2 lesions). Database lock to week 48 was completed December 23rd, 2016. Statistical analysis is underway.
This will be the first presentation of a randomized, double blind clinical trial of jugular and azygos venoplasty in MS, including patient reported, clinical, and MRI outcomes. The presentation will include all data from the first 48 weeks in all patients after their first procedure only, comparing sham to venoplasty.
Frankly this is terrifying. My fears are greater than my hopes. I want them to have done the procedure expertly and captured accurate data and the data to be supportive.