| endarterectomy | carotid endarterectomy | versus placebo or control No demonstrated result for efficacy carotid endarterectomy inferior to control in terms of Perioperative stroke or death in ACAS, 1995 carotid endarterectomy inferior to control in terms of Perioperative stroke or death in VA, 1993 | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ACAS, 1995 | carotid endarterectomy vs control | Perioperative stroke or death or any subsequent stroke 0.71 [0.51; 0.97] Perioperative stroke or death or subsequent ipsilateral stroke 0.64 [0.42; 0.98] | Perioperative stroke or death 6.40 [1.90; 21.55] | Any stroke or death 0.83 [0.67; 1.03] | | ACST, 1994 | carotid endarterectomy vs control | Perioperative stroke or death or any subsequent stroke 0.63 [0.48; 0.82] | | Any stroke or death 0.90 [0.79; 1.03] Perioperative stroke or death or subsequent ipsilateral stroke 0.73 [0.51; 1.03] | | VA, 1993 | carotid endarterectomy vs control | | Perioperative stroke or death 6.63 [1.50; 29.26] | Any stroke or death 0.93 [0.75; 1.16] Perioperative stroke or death or any subsequent stroke 0.92 [0.56; 1.51] Perioperative stroke or death or subsequent ipsilateral stroke 0.78 [0.43; 1.41] | | ECST, 1998 | carotid endarterectomy vs control | | | | | NASCET, 1998 | carotid endarterectomy vs control | | | | | VA309, 1991 | carotid endarterectomy vs control | | | |
| Trial | Treatments | Patients | Method |
|---|
| ACAS, 1995 | carotid endarterectomy, aspirin 325 mg daily (n=825) vs. aspirin 325 mg daily (n=834) | Asymptomatic carotid artery stenosis of 60% or greater | open Parallel groups Sample size: 825/834 Primary endpoint: ipsilateral stroke or any perioperative stroke or death FU duration: 2.7 y mean | | ACST, 1994 | CEA as soon as possible, standard medical treatment including antiplatelet drugs (n=1560) vs. no CEA unless symptoms occurred, standard medical treatment including antiplatelet
drugs (n=1560) | Asymptomatic carotid artery stenosis of 60% or greater | open Parallel groups Sample size: 1560/1560 Primary endpoint: perioperative stroke or death, non-perioperative stroke FU duration: 3.4y mean | | VA, 1993 | carotid endarterectomy aspirin 650 mg bd (n=211) vs. aspirin 650 mg bd (n=233) | Asymptomatic carotid artery stenosis of 50-99% | open Parallel groups Sample size: 211/233 Primary endpoint: ipsilateral neurological eventsm FU duration: 4 y (mean) | | ECST, 1998 | surgery (n=1811) vs. control (n=1213) | men and women of any age, with some degree of carotid stenosis, who within the previous 6 months had had at least one transient or mild symptomatic ischaemic vascular event in the distribution of one or both carotid arteries | open Sample size: 1811/1213 Primary endpoint: FU duration: 6.1 years | | NASCET, 1998 | carotid endarterectomy (n=1108) vs. medical care alone (n=1118) | Patients with moderate (<70%) carotid stenosis and transient ischemic attacks or nondisabling strokes on the same side as the stenosis (ipsilateral) within 180 days | open Sample size: 1108/1118 Primary endpoint: FU duration: 5 years | | VA309, 1991 | Carotid endarterectomy plus the best medical care (n=91) vs. best medical care alone (n=98) | Men who presented within 120 days of onset of symptoms that were consistent with transient ischemic attacks, transient monocular blindness, or recent small completed strokes and with with angiographic internal carotid artery stenosis greater than 50% ipsilateral to the presenting symptoms | open Sample size: 91/98 Primary endpoint: FU duration: 11.9 months |
|
| endovascular treatment | carotid artery stenting | versus surgery No demonstrated result for efficacy carotid artery stenting inferior to surgery in terms of Death or any stroke within 30 days in WALLSTENT (Alberts), 2001 carotid artery stenting inferior to surgery in terms of Death or any stroke (during follow up) in WALLSTENT (Alberts), 2001 carotid artery stenting inferior to surgery in terms of long term restenosis in CAVATAS-CEA, 2001 carotid artery stenting inferior to surgery in terms of Death or any stroke within 30 days in EVA-3S (Mas), 2000 carotid artery stenting inferior to surgery in terms of Death or any stroke (during follow up) in EVA-3S (Mas), 2000 carotid artery stenting inferior to surgery in terms of Death or stroke or myocardial infarction in EVA-3S (Mas), 2000 carotid artery stenting inferior to surgery in terms of Stroke within 30 days in EVA-3S (Mas), 2000 carotid artery stenting inferior to surgery in terms of Stroke within 30 days in CREST, 2010 carotid artery stenting inferior to surgery in terms of Death during follow up in ICSS, 2010 carotid artery stenting inferior to surgery in terms of Death or stroke or myocardial infarction in ICSS, 2010 carotid artery stenting inferior to surgery in terms of Stroke within 30 days in ICSS, 2010 carotid artery stenting inferior to surgery in terms of Stroke during follow up in ICSS, 2010 | 12 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Leicester (Naylor), 1998 | carotid artery stenting vs surgery | | | Death or any stroke within 30 days ∞ [NaN; ∞] Death or disabling stroke within 30 days ∞ [NaN; ∞] | | WALLSTENT (Alberts), 2001 | carotid artery stenting 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 | carotid artery stenting vs surgery | Death or neurological complication within 30 days 0.51 [0.33; 0.80] | long term restenosis 2.82 [1.75; 4.55] | 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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 | carotid artery stenting 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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