Objective
To compare patient characteristics, procedure, perioperative and mid-term results of the carotid artery stenting (CAS) with the dual-layer micromesh RoadsaverTM stent vs single-layer stents.
Study Group
| Roadsaver N = 100
| Single layer stents N = 90
|
Symptomatic stenosis
| 35%
| 18%
|
Asymptomatic stenosis | 65%
| 82%
|
Procedure
| Roadsaver N = 100
| Single layer stents N = 90
| P
|
ICA stenosis grade (%)
| 75.6±8.0
| 75.7±8.1
| 0.931
|
Peak systolic velocity (cm/s)
| 312±119
| 327±107
| 0.364
|
Contralateral ICA stenosis (%)
| 40.6±25.5
| 42.9±27.7
| 0.552
|
"High-risk" plaque type
| 63 (63%)
| 40 (44%)
| 0.013
|
Symptomatic stenosis
| 35 (35%)
| 16 (18%)
| 0.008
|
Reintervention
| 41 (41%)
| 49 (54%)
| 0.080
|
Neck irradiation
| 19 (19%)
| 9 (10%)
| 0.101
|
Carotid severe tortuosity
| 10 (10%)
| 4 (4%)
| 0.171
|
Aortic arch type 2 or 3
| 3 (3%)
| 2 (2%)
| 1.0 |
Bovine trunk
| 5 (5%)
| 2 (2%)
| 0.449
|
Ipsilaterally positive brain CT-scan
| 28 (28%)
| 10 (11%)
| 0.003
|
| Roadsaver N = 100 | Single layer stents N = 90 | P |
Radial access | 23 (23%) | 4 (5%) | < 0.001 |
Cervical surgical access | 1 (1%) | 14 (16%) | < 0.001 |
Use of embolic protection devices | 98 (98%) | 84 (93%) | 0.152 |
Need of predilatation | 2 (2%) | 3 (3%) | 0.669 |
Number of implanted stents | 1.1±0.3 | 1.1±0.3 | 1.0 |
Stent length (mm) | 31.0±5.5 | 36.8±5.5 | < 0.01 |
Stent post-dilatation | 92 (92%) | 70 (78%) | 0.007 |
Atropine administration | 16 (16%) | 12 (13%) | 0.684 |
Duration of procedure (min) | 40.7±16.9 | 49.4±27.3 | 0.008v |
Results
30-day Outcomes
| Roadsaver N = 100 | Single layer stents N = 90 | P |
Length of stay (mean ± SD) | 2.25± .22 | 2.27±1.03 | 0.903 |
Access complications | 0 (0%) | 2 (2%) | 0.223 |
Cerebral hemorrhage | 0 (0%) | 0 (0%) | 1.0 |
Inotropic support | 3 (3%) | 3 (3%) | 1.0 |
Arrhythmias | 1 (1%) | 1 (1%) | 1.0 |
TIA | 3 (3%) | 1 (1%) | 0.623 |
Stroke | 0 (0%) | 0 (0%) | 1.0 |
MI | 0 (0%) | 0 (0%) | 1.0 |
Death | 0 (0%) | 0 (0%) | 1.0 |
Any complications | 6 (6%) | 6 (7%) | 1.0 |
Stroke/TIA/Death | 3 (3%) | 1 (1%) | 0.623 |
Follow-up
(22.3 + 13.9 months)
Conclusion
- Due to its technical features, operators tend to select Roadsaver for use in high-risk cases (in symptomatic pts, with vulnerable plaques & difficult access)
- Despite expected higher rate of complications in these patients, CAS with RoadsaverTM resulted in very good clinical outcomes (early and late)
- Roadsaver low-profile and high deliverability allow more frequent use of radial access, avoid cervical surgical cut-down, reduce arch manipulation, and decrease procedural time
Link to the full publication: https://doi.org/10.1177/15266028211025046