BRAVE-DREAMS Trial Confirms Venous PTA Ineffective Treatment for MS
November 21, 2017—Data from the BRAVE-DREAMS trial published online in JAMA Neurology by Paolo Zamboni, MD, et al found that venous percutaneous transluminal angioplasty (PTA), while considered safe, is largely ineffective and cannot be recommended for patients with relapsing-remitting multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency.
According to researchers, venous PTA did not increase the proportion of MS patients who improved functionally nor did it reduce the mean number of new combined brain lesions on MRI at 12 months.
As summarized in JAMA Neurology, the BRAVE-DREAMS trial is a randomized, double-blind, sham-controlled, parallel-group study that evaluated 115 patients with relapse-remitting MS in six MS centers in Italy. Patients were randomly allocated (2:1) to either venous PTA or catheter venography without venous angioplasty (sham). Among all patients analyzed, 76 were allocated to the PTA group (45 [59%] women; mean age, 40.0 ± 10.3 years) and 39 to the sham group (29 [74%] women; mean age, 37.5 ± 10.6 years), and 112 (97.4%) patients completed follow-up.
Investigators assessed two primary endpoints at 12 months. The first was a composite of functional measure (ie, walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity), and the second was a measure of new combined brain lesions on MRI, including the proportion of lesion-free patients. Combined lesions included T1 gadolinium-enhancing lesions plus new or enlarged T2 lesions.
Overall, no serious adverse events occurred. Flow restoration was achieved in 38 of 71 (54%) patients in the PTA group. The functional composite measure did not differ between the PTA and sham groups (41.7% vs 48.7%; odds ratio [OR], 0.75; 95% confidence interval [CI], 0.34–1.68; P = .49).
At 0 to 12 months, mean number of combined lesions on MRI was 1.40 ± 4.21 in the PTA group versus 1.95 ± 3.73 in the sham group (mean ratio, 0.72; 95% CI, 0.32–1.63; P = .45; adjusted P = .45). Over the same period, 46 of 73 (63%) patients in the PTA group and 18 of 37 (49%) patients in the sham group were free of new lesions on MRI (OR, 1.80; 95% CI, 0.81–4.01; P = .15; adjusted P = .30).
At 6- to 12-month follow-up, the mean number of combined lesions on MRI was 0.47 ± 1.19 in the PTA group versus 1.27 ± 2.65 in the sham group (mean ratio, 0.37; 95% CI, 0.15–0.91; P = .03; adjusted P = .09). During the same follow-up period, 58 of 70 (83%) patients in the PTA group and 22 of 33 (67%) patients in the sham group were free of new lesions on MRI (OR, 2.64; 95% CI, 1.1–16.28; P = .03, adjusted P = .09).
There was a tendency for more patients to become free of new lesions after venous PTA, mainly due to a reduction in new lesions appearing 6 to 12 months after randomization, advised investigators in JAMA Neurology.