Table 3. Outcome measures of the two groups.
Variables | Stenting (n=64) | Balloon (n=58) | P value |
---|---|---|---|
Primary outcome | |||
Asymptomatic at discharge | |||
Headache | 11/45 (24.4) | 4/44 (9.1) | 0.087 |
Papilledema | 22/54 (40.7) | 2/48 (4.2) | <0.001 |
Visual disturbances | 22/52 (42.3) | 4/43 (9.3) | <0.001 |
Sixth nerve palsy | 5/11 (45.5) | 1/10 (10.0) | 0.149 |
Tinnitus | 6/13 (46.2) | 1/9 (11.1) | 0.165 |
Asymptomatic at 3 months | |||
Headache | 23/45 (51.1) | 5/44 (11.4) | <0.001 |
Papilledema | 28/54 (51.9) | 3/48 (6.3) | <0.001 |
Visual disturbances | 25/52 (48.1) | 4/43 (9.3) | <0.001 |
Sixth nerve palsy | 7/11 (63.6) | 1/10 (10) | 0.024 |
Tinnitus | 8/13 (61.5) | 1/9 (11.1) | 0.031 |
Asymptomatic at 6 months | |||
Headache | 34/45 (75.6) | 6/44 (13.6) | <0.001 |
Papilledema | 42/54 (77.8) | 3/48 (6.3) | <0.001 |
Visual disturbances | 42/52 (80.8) | 6/43 (14.0) | <0.001 |
Sixth nerve palsy | 8/11 (72.7) | 2/10 (20.0) | 0.030 |
Tinnitus | 10/13 (76.9) | 2/9 (22.2) | 0.027 |
Asymptomatic at 12 months | |||
Headache | 36/45 (80.0) | 5/44 (11.4) | <0.001 |
Papilledema | 46/54 (85.2) | 6/48 (12.5) | <0.001 |
Visual disturbances | 48/52 (92.3) | 5/43 (11.6) | <0.001 |
Sixth nerve palsy | 9/11 (81.8) | 2/10 (20.0) | 0.009 |
Tinnitus | 12/13 (92.3) | 2/9 (22.2) | 0.001 |
Secondary outcomes | |||
Papilledema Frisén grade | |||
Pre-op | 3 [3, 3] | 3 [2, 3] | 0.482 |
Post-op | 1 [0, 1] | 2 [1, 2] | <0.001 |
LP opening pressure | |||
Pre-op (mmH2O) | 392.27±87.88 | 377.33±69.73 | 0.304 |
Post-op (mmH2O) | 210.86±60.24 | 241.12±58.34 | 0.006 |
Stenosis pressure gradient | |||
Pre-op (mmHg) | 20.23±7.65 | 19.84±7.81 | 0.781 |
Post-op (mmHg) | 1.98±2.51 | 3.72±3.79 | 0.004 |
Safety outcomes/complications | 0.755 | ||
Puncture site hematoma | 0 | 1/58 (1.7) | |
Recurrent in situ stenosis | 2/64 (3.1) | 5/58 (8.6) | |
Distal stent thrombosis | 1/64 (1.6) | N/A | |
Distal stent stenosis | 2/64 (3.1) | N/A |
Data are presented as mean ± SD, n/N (%) or median [IQR]. IQR, interquartile range; LP, lumbar puncture; SD, standard deviation; N/A, not applicable.