| carotid stenosis | All results are NS for efficacy inferior to surgery in terms of Death or any stroke within 30 days in WALLSTENT (Alberts), 2001 inferior to surgery in terms of Death or any stroke (during follow up) in WALLSTENT (Alberts), 2001 inferior to surgery in terms of long term restenosis in CAVATAS-CEA, 2001 inferior to surgery in terms of Death or any stroke within 30 days in EVA-3S (Mas), 2000 inferior to surgery in terms of Death or any stroke (during follow up) in EVA-3S (Mas), 2000 inferior to surgery in terms of Death or stroke or myocardial infarction in EVA-3S (Mas), 2000 inferior to surgery in terms of Stroke within 30 days in EVA-3S (Mas), 2000 inferior to surgery in terms of Stroke within 30 days in CREST, 2010 inferior to surgery in terms of Death during follow up in ICSS, 2010 inferior to surgery in terms of Death or stroke or myocardial infarction in ICSS, 2010 inferior to surgery in terms of Stroke within 30 days in ICSS, 2010 inferior to surgery in terms of Stroke during follow up in ICSS, 2010 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Leicester (Naylor), 1998 | vs surgery | | | Death or any stroke within 30 days ∞ [NaN; ∞] Death or disabling stroke within 30 days ∞ [NaN; ∞] | | WALLSTENT (Alberts), 2001 | vs surgery | | Death or any stroke within 30 days 2.72 [1.00; 7.37] Death or any stroke (during follow up) 3.40 [1.15; 10.11] | | | CAVATAS-CEA, 2001 | vs surgery | Death or neurological complication within 30 days 0.51 [0.33; 0.80] | long term restenosis 2.82 [1.75; 4.55] | long term disabling stroke or death 1.67 [0.54; 5.16] Death or any stroke within 30 days 1.00 [0.59; 1.70] Death or any stroke (during follow up) 0.60 [0.22; 1.63] Death or stroke or myocardial infarction 0.90 [0.54; 1.49] Stroke within 30 days 0.86 [0.47; 1.58] Death within 30 days 1.76 [0.52; 5.93] Death or disabling stroke within 30 days 1.07 [0.54; 2.12] long term fatal stroke 2.52 [0.99; 6.39] non-perioperative ipsilateral stroke 1.24 [0.61; 2.53] long term stroke 1.23 [0.76; 1.99] Cranial neuropathy within 30 days 0.00 [0.00; NaN] | | Kentucky A (Brooks), 2001 | vs surgery | | | Death or any stroke within 30 days 0.00 [0.00; NaN] Death within 30 days 0.00 [0.00; NaN] Death or disabling stroke within 30 days 0.00 [0.00; NaN] | | SPACE, 2000 | vs surgery | | | Death or any stroke within 30 days 1.18 [0.78; 1.79] Stroke within 30 days 1.22 [0.80; 1.86] Death within 30 days 0.78 [0.21; 2.89] Death or disabling stroke within 30 days 1.24 [0.72; 2.14] non-perioperative ipsilateral stroke 1.16 [0.50; 2.66] | | EVA-3S (Mas), 2000 | vs surgery | Cranial neuropathy within 30 days 0.15 [0.04; 0.49] | Death or any stroke within 30 days 2.47 [1.21; 5.04] Death or any stroke (during follow up) 1.92 [1.07; 3.42] Death or stroke or myocardial infarction 2.14 [1.10; 4.15] Stroke within 30 days 3.25 [1.42; 7.44] | Death during follow up 0.49 [0.09; 2.68] Death within 30 days 0.66 [0.11; 3.91] Death or disabling stroke within 30 days 2.23 [0.70; 7.16] Stroke during follow up 1.98 [0.37; 10.70] Death or neurological complication within 30 days 0.92 [0.57; 1.50] non-perioperative ipsilateral stroke 0.99 [0.25; 3.91] | | BACASS (Hoffman), 2006 | vs surgery | | | Death or any stroke within 30 days 0.00 [0.00; NaN] Death during follow up ∞ [NaN; ∞] Death or any stroke (during follow up) ∞ [NaN; ∞] Death or stroke or myocardial infarction 0.00 [0.00; NaN] Stroke within 30 days 0.00 [0.00; NaN] Death within 30 days NaN [NaN; NaN] Death or disabling stroke within 30 days NaN [NaN; NaN] Stroke during follow up NaN [NaN; NaN] Death or neurological complication within 30 days 0.00 [0.00; NaN] Cranial neuropathy within 30 days NaN [NaN; NaN] | | Kentucky B (Brooks), 2004 | vs surgery | | | Death or any stroke within 30 days 1.05 [0.19; 5.75] Death or disabling stroke within 30 days 0.00 [0.00; NaN] | | SAPPHIRE (yadav), 2004 | vs surgery | | | Death or any stroke within 30 days 0.89 [0.35; 2.25] Death during follow up 0.57 [0.29; 1.12] Death or any stroke (during follow up) 0.67 [0.41; 1.09] Death or stroke or myocardial infarction 0.50 [0.22; 1.14] Stroke within 30 days 1.20 [0.37; 3.86] Death within 30 days 0.50 [0.09; 2.69] Death or disabling stroke within 30 days 0.57 [0.17; 1.92] Stroke during follow up 0.83 [0.37; 1.88] Death or neurological complication within 30 days 0.47 [0.21; 1.06] Cranial neuropathy within 30 days 0.00 [0.00; NaN] | | TESCAS-C (Ling), 2006 | vs surgery | | | Death or any stroke within 30 days 0.68 [0.12; 3.98] Death or any stroke (during follow up) 0.82 [0.34; 1.97] Death within 30 days 0.51 [0.05; 5.54] | | CREST, 2010 | vs surgery | Cranial neuropathy within 30 days 0.07 [0.02; 0.23] | Stroke within 30 days 1.79 [1.14; 2.82] | non-perioperative ipsilateral stroke 0.94 [0.50; 1.76] | | ICSS, 2010 | vs surgery | | Death during follow up 2.72 [1.15; 6.45] Death or stroke or myocardial infarction 1.73 [1.18; 2.53] Stroke within 30 days 1.92 [1.28; 2.87] Stroke during follow up 1.86 [1.25; 2.78] | Death or any stroke (during follow up) 1.26 [0.77; 2.08] |
| Trial | Treatments | Patients | Method |
|---|
| Leicester (Naylor), 1998 | Self-expanding Wallstent (n=11) vs. surgery (n=12) | patients with focal carotid territory symptoms and severe ICA stenosis (> 70%) | open Parallel groups Sample size: 11/12 Primary endpoint: death or stroke FU duration: 1 month | | WALLSTENT (Alberts), 2001 | Wallstent (n=107) vs. (n=112) | | open Parallel groups Sample size: 107/112 Primary endpoint: FU duration: 12 months | | CAVATAS-CEA, 2001 | Pre-1994: PTA only after 1994: Wallstent, Streker, Palmaz (n=251) vs. carotid endarterectomy (n=253) | patients of any age with symptomatic or asymptomatic carotid artery stenosis suitable for surgery | open Parallel groups Sample size: 251/253 Primary endpoint: disabling stroke or death FU duration: 36 months (4y) | | Kentucky A (Brooks), 2001 | Wallstent (n=53) vs. surgery (n=51) | patients presenting with cerebrovascular ischemia ipsilateral to carotid stenosis | open Parallel groups Sample size: 53/51 Primary endpoint: FU duration: 48 months | | SPACE, 2000 | carotid-artery stenting (Carotid Wallstent; Precise; Acculink) (n=607) vs. Carotid endarterectomy (n=589) | patients with symptomatic carotid-artery stenosis within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) | open Parallel groups Sample size: 607/589 Primary endpoint: ipsilateral ischaemic stroke or death FU duration: 1 month | | EVA-3S (Mas), 2000 | various stent (n=261) vs. endarterectomy (n=259) | patients with a symptomatic carotid stenosis of at least 60% | open Parallel groups Sample size: 261/259 Primary endpoint: any stroke or death within 30 days FU duration: 6 months | | BACASS (Hoffman), 2006 | stent (n=-9) vs. CEA (n=-9) | patients with symptomatic carotid stenosis > 70% | open Parallel groups Sample size: -9/-9 Primary endpoint: periprocedural stroke, death or MI FU duration: 45 months | | Kentucky B (Brooks), 2004 | Wallstent, Dynalink (n=43) vs. carotid endarterectomy (n=42) | patients with asymptomatic carotid stenosis of more than 80% were selected | open Parallel groups Sample size: 43/42 Primary endpoint: FU duration: 48 months | | SAPPHIRE (yadav), 2004 | Smart or Precise (self-expanding nitinol stent)age/pj (n=167) vs. surgery (n=167) | patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent | open Parallel groups Sample size: 167/167 Primary endpoint: major cardiovascular event FU duration: 36 months | | TESCAS-C (Ling), 2006 | (n=-9) vs. (n=-9) | | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 6 months | | CREST, 2010 | carotid artery stenting (with distal-protection) (n=2502) vs. carotid endarterectomy (n=0) | patients with both asymptomatic and symptomatic extracranial carotid stenosis | open Parallel groups Sample size: 2502/0 Primary endpoint: periprocedural stroke,MI, death, ipsi stroke FU duration: 2.5y | | ICSS, 2010 | carotid artery stenting (n=855) vs. endarterectomy (n=858) | patients with symptomatic carotid stenosis of greater than 50% within last six months | open Parallel groups Sample size: 855/858 Primary endpoint: fatal or disabling stroke in any territory FU duration: 120 days The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction |
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