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Tratamiento inmediato versus tardío para la estenosis de la arteria carótida con síntomas recientes

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Referencias

References to studies included in this review

McCollum 2004 {published data only}

Mead GE, Murray H, Farrell A, O'Neill PA, McCollum CN. Pilot study of carotid surgery for acute stroke. British Journal of Surgery 1997;84:990‐2. CENTRAL
Welsh S, Mead G, Chant H, Picton A, O'Neill PAA, McCollum CN. Early carotid surgery in acute stroke: a multicentre randomised pilot study. Cerebrovascular Diseases 2004;18:200‐5. [DOI: 10.1159/000079942]CENTRAL

References to studies excluded from this review

Ballota 2002 {published data only}

Ballota E, Giau G, Baracchini C, Abbruzzese E, Saladini M, Meneghetti G. Early versus delayed endarterectomy after a nondisabling ischemic stroke: a prospective randomized study. Surgery 2002;131:287‐92. [DOI: 10.1067/msy.2002.119987]CENTRAL

Keunen 2012 {published data only}

Keunen RWM, van Sonderen A, Hunfeld M, Remmers M, Tavy DL, de Bruijn, et al. Exploration of a zero‐tolerance regime on cerebral embolism in symptomatic carotid artery disease. Prospectives In Medicine 2012;1:218‐23. [DOI: 10.1016/j.permed.2012.02.064]CENTRAL

Sbatigia 2003 {published data only}

Sbatigia E, Toni D, Speziale F, Falcou A, Sachetti ML, Panico MA, et al. Emergency and early carotid endarterectomy in patients with acute ischemic stroke selected with a predefined protocol: a prospective pilot study. International Angiology 2003;22:426‐30. CENTRAL

References to ongoing studies

SPREAD‐STACI {unpublished data only}

Lanza G, Ricci S, Speziale F, Toni D, Sbarigia E, Setacci C, et al. SPREAD‐STACI study: a protocol for a randomized multicenter clinical trial comparing urgent with delayed endarterectomy in symptomatic carotid artery stenosis. International Journal of Stroke 2012;7(1):81‐5. CENTRAL

Antonopoulos 2011

Antonopoulos CN, Kakisis JD, Sergentanis TN, Liapis CD. Eversion versus conventional carotid endarterectomy: a meta‐analysis of randomised and non‐randomised studies. European Journal of Vascular and Endovascular Surgery 2011;42(6):751‐65. [DOI: 10.1016/j.ejvs.2011.08.012]

Battocchio 2012

Battocchio C, Fantozzi C, Rizzo L, Persiani F, Raffa S, Taurino M. Urgent carotid surgery: is it still out of debate?. International Journal of Vascular Medicine 2012;2012:536392. [DOI: 10.1155/2012/536392]

Bonati 2012

Bonati LH, Lyrer P, Ederle J, Featherstone R, Brown MM. Percutaneous transluminal balloon angioplasty and stenting for carotid artery stenosis. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD000515.pub3]

Brott 2011

Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Developed in collaboration with the American Academy of Neurology and Society of Cardiovascular Computed Tomography. Catheterization and Cardiovascular Interventions 2013;81(1):E76‐123. [DOI: 10.1002/ccd.22983]

Capoccia 2011

Capoccia L, Sbarigia E, Speziale F, Toni D, Fiorani P. Urgent carotid endarterectomy to prevent recurrence and improve neurologic outcome in mild‐to‐moderate acute neurologic events. Journal of Vascular Surgery 2011;53(3):622‐8. [DOI: 10.1016/j.jvs.2010.09.016]

Capoccia 2012

Capoccia L, Sbarigia E, Speziale F, Toni D, Biello A, Montelione N, et al. The need for emergency surgical treatment in carotid‐related stroke in evolution and crescendo transient ischemic attack. Journal of Vascular Surgery 2012;55(6):1611‐7. [DOI: 10.1016/j.jvs.2011.11.144]

Dechartres 2013

Dechartres A, Trinquart L, Boutron I, Ravaud P. Influence of trial sample size on treatment effect estimates: meta‐epidemiological study. BMJ 2013;346:f2304.

Deeks 2011

Deeks JJ, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta‐analyses. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from handbook.cochrane.org/.

EMPIRE 2011

Clair DG, Hopkins LN, Mehta M, Kasirajan K, Schermerhorn M, Schönholz C, et al. Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study. Catheterization and Cardiovascular Interventions 2011;77(3):420‐9. [DOI: 10.1002/ccd.22789]

Ferrero 2014

Ferrero E, Ferri M, Viazzo A, Labate C, Berardi G, Pecchio A, et al. A retrospective study on early carotid endarterectomy within 48 hours after transient ischemic attack and stroke in evolution. Annals of Vascular Surgery 2014;28:227‐38. [DOI: 10.1016/j.avsg.2013.02.015]

Flaherty 2013

Flaherty ML, Kissela B, Khoury JC, Alwell K, Moomaw CJ, Woo D, et al. Carotid artery stenosis as a cause of stroke. Neuroepidemiology 2013;40(1):36‐41.

Giles 2007

Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta‐analysis. Lancet Neurology 2007;6(12):1063‐72.

GRADE 2015 [Computer program]

GRADE Working Group, McMaster University (developed by Evidence Prime, Inc.). Available from gradepro.org. GRADEpro GDT 2015: GRADEpro Guideline Development Tool [Software]. Hamilton (ON): GRADE Working Group, McMaster University (developed by Evidence Prime, Inc.). Available from gradepro.org, 2015.

Halm 2009

Halm EA, Tuhrim S, Wang JJ, Rockman C, Riles TS, Chassin MR. Risk factors for perioperative death and stroke after carotid endarterectomy: results of the New York carotid artery surgery study. Stroke 2009;40(1):221‐9. [DOI: 10.1161/STROKEAHA]

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analysis. BMJ 2003;327(7414):557‐60. [PUBMED: 12958120]

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from handbook.cochrane.org/.

Imai 2005

Imai K, Mori T, Izumoto H, Watanabe M, Majima K. Emergency carotid artery stent placement in patients with acute ischemic stroke. American Journal of Neuroradiology 2005;26:1249‐58.

Johansson 2013

Johansson EP, Arnerlöv C, Wester P. Risk of recurrent stroke before carotid endarterectomy: the ANSYSCAP study. International Journal of Stroke 2013;8(4):220‐7. [DOI: 10.1111/j.1747‐4949.2012.00790.x]

Kakisis 2012

Kakisis JD, Avgerinos ED, Antonopoulos CN, Giannakopoulos TG, Moulakakis K, Liapis CD. The European Society for Vascular Surgery guidelines for carotid intervention: an updated independent assessment and literature review. European Journal of Vascular and Endovascular Surgery 2012;44(3):238‐43. [DOI: 10.1016/j.ejvs.2012.04.015]

Lovett 2003

Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke 2003;34(8):138‐40.

Mackay 2004

Mackay J, Mensah G. The Atlas of Heart Disease and Stroke. Geneva: World Health Organization (WHO), 2004.

Marnane 2011

Marnane M, Ni Chroinin D, Callaly E, Sheehan OC, Merwick A, Hannon N, et al. Stroke recurrence within the time window recommended for carotid endarterectomy. Neurology 2011;77(8):738‐43. [DOI: 10.1212/WNL.0b013e31822b00cf]

Mokin 2013

Mokin M, Dumont TM, Kass‐Hout T, Levy EI. Carotid and vertebral artery disease. Primary Care 2013;40(1):135‐51.

Naylor 2009

Karkos CD, Hernandez‐Lahoz I, Naylor AR. Urgent carotid surgery in patients with crescendo transient ischaemic attacks and stroke‐in‐evolution: a systematic review. European Journal of Vascular and Endovascular Surgery 2009;37(3):279‐88.

Paraskevas 2016

Paraskevas KI, Veith FJ, Parodi JC. Commentary: Transcervical carotid artery stenting (CAS) with flow reversal: a promising technique for the reduction of strokes associated With CAS. Journal of Endovascular Therapy 2016;23(2):255‐7. [DOI: 10.1177/1526602816633830]

Park 2012

Park JH, Razuk A, Saad PF, Telles GJ, Karakhanian WK, Fioranelli A, et al. Carotid stenosis: what is the high‐risk population?. Clinics (São Paulo) 2012;67(10):1233.

Rantner 2011

Rantner B, Kollerits B, Schmidauer C, Willeit J, Thauerer M, Rieger M, et al. Carotid endarterectomy within seven days after the neurological index event is safe and effective in stroke prevention. European Journal of Vascular and Endovascular Surgery 2011;42(6):732‐9. [DOI: 10.1016/j.ejvs.2011.08.004]

Rantner 2013

Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G, Carotid Stenting Trialists' Collaboration. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. Journal of Vascular Surgery 2013;57(3):619‐26.

Rerkasem 2009

Rerkasem K, Rothwell PM. Systematic review of the operative risks of carotid endarterectomy for recently symptomatic stenosis in relation to the timing of surgery. Stroke 2009;40(10):e564‐72.

Rerkasem 2011

Rerkasem K, Rothwell PM. Carotid endarterectomy for symptomatic carotid stenosis. Cochrane Database of Systematic Reviews 2011, Issue 4. [DOI: 10.1002/14651858.CD001081.pub2]

RevMan 2014 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Ricotta 2011

Ricotta JJ, Aburahma A, Ascher E, Eskandari M, Faries P, Lal BK, Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease: executive summary. Journal of Vascular Surgery 2011;54:832‐6. [DOI: 10.1016/j.jvs.2011.07.004]

Rothwell 2003

Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, Carotid Endarterectomy Trialists' Collaboration. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet 2003;361(9352):107‐16. [12531577]

Sharpe 2013

Sharpe R, Sayers RD, London NJ, Bown MJ, McCarthy MJ, Nasim A, et al. Procedural risk following carotid endarterectomy in the hyperacute period after onset of symptoms. European Journal of Vascular and Endovascular Surgery 2013;46(5):519‐24.

Strömberg 2012

Strömberg S, Gelin J, Osterberg T, Bergström GML, Karlström L, Osterberg K, Swedish Vascular Registry (Swedvasc) Steering Committee. Very urgent carotid endarterectomy confers increased procedural risk. Stroke 2012;43(5):1331‐5. [DOI: 10.1161/STROKEAHA.111.639344]

Tsivgoulis 2014

Tsivgoulis G, Krogias C, Georgiadis GS, Mikulik R, Safouris A, Meves SH, et al. Safety of early endarterectomy in patients with symptomatic carotid artery stenosis: an international multicenter study. European Journal of Neurology 2014;21(10):1251–e76. [DOI: 10.1111/ene.12461]

Wach 2014

Wach MM, Dumont TM, Mokin M, Kass‐Hout T, Snyder KV, Hopkins LN, et al. Early carotid angioplasty and stenting may offer non‐inferior treatment for symptomatic cases of carotid artery stenosis. Journal of Neurointerventional Surgery 2014;6(4):276‐80. [DOI: 10.1136/neurintsurg‐2013‐010744]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

McCollum 2004

Methods

Randomized

Multicenter
12 months follow‐up
Intention‐to‐treat analysis

Participants

40 participants within 7 days of the onset of symptoms

Partial anterior circulation infarction

More than 70% ipsilateral carotid stenosis

Barthel score > 18

Interventions

Early surgery (usually within 2 to 6 hours)

Late surgery (6 to 8 weeks)

Outcomes

Outcome measures were recorded using Barthel Activities of Daily Living score for disability and Modified Rankin scale for independence

Notes

Study dates not reported

Nine of the 21 participants randomized to the late surgery group did not undergo surgery

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were randomized by computer

Allocation concealment (selection bias)

Unclear risk

Method not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Blinding of study participants and personnel could not be done as 1 treatment group had surgery arranged as soon as possible while the other group did not

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

High risk

Allocation to the delayed surgical group was retained in accordance with the 'intention‐to‐treat' principle

Selective reporting (reporting bias)

Low risk

Data on pre‐specified primary and secondary outcomes were presented

Other bias

High risk

Size: sample size less than 50 per treatment arm

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Ballota 2002

Non‐acute study (participants in the early group received carotid endarterectomy between 15 and 30 days)

Keunen 2012

Confounded with no control group; not randomized

Sbatigia 2003

Not randomized

Characteristics of ongoing studies [ordered by study ID]

SPREAD‐STACI

Trial name or title

SPREAD‐STACI study

Methods

Randomized

Multicenter

Blind follow‐up at 90 days

Participants

People presenting with TIA, amaurosis fugax or minor stroke within only a few hours of their first symptom

Stenosis ranging between 51% and 99% of the carotid artery

Interventions

CEA within 48 hours or between 48 hours and 15 days from their initial ischemic symptom

Outcomes

Primary outcome: any type of stroke, myocardial infarction, and death due to the procedures

Secondary outcome: ipsilateral stroke, identification of predictive risk factors, confirmation of the safety of urgent CEA

Starting date

2010

Contact information

Dr Gaetano Lanza – U.O. Chirurgia Vascolare, Ospedale MultiMedica, V.le Piemonte, 70, 21053 Castellanza (Va)

Notes

Size: 456 participants

CEA: carotid endarterectomy
TIA: transient ischemic attack

Data and analyses

Open in table viewer
Comparison 1. Stroke

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Stroke and death < 30days Show forest plot

1

40

Risk Ratio (M‐H, Random, 95% CI)

3.32 [0.38, 29.23]

Analysis 1.1

Comparison 1 Stroke, Outcome 1 Stroke and death < 30days.

Comparison 1 Stroke, Outcome 1 Stroke and death < 30days.

2 Perioperative death and all strokes Show forest plot

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.14, 1.58]

Analysis 1.2

Comparison 1 Stroke, Outcome 2 Perioperative death and all strokes.

Comparison 1 Stroke, Outcome 2 Perioperative death and all strokes.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Stroke, Outcome 1 Stroke and death < 30days.
Figuras y tablas -
Analysis 1.1

Comparison 1 Stroke, Outcome 1 Stroke and death < 30days.

Comparison 1 Stroke, Outcome 2 Perioperative death and all strokes.
Figuras y tablas -
Analysis 1.2

Comparison 1 Stroke, Outcome 2 Perioperative death and all strokes.

Summary of findings for the main comparison. Very early cerebral revascularization compared with delayed treatment for recently symptomatic carotid artery stenosis

Very early cerebral revascularization compared with delayed treatment for recently symptomatic carotid artery stenosis

Patient or population: people with recently symptomatic carotid artery stenosis

Settings: hospital

Intervention: very early cerebral revascularization (within two days)

Comparison: delayed treatment (after two days)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Very early cerebral revascularization

Delayed Treatment

Stroke and Death < 30 days

This outcome was poorly reported

RR 3.3 (0.4 to 29.2)

40 (1 study)

⊝⊝⊝
very low1,2,3

Perioperative death and strokes

This outcome was poorly reported

RR 0.5 (0.1 to 1.6)

40 (1 study)

⊝⊝⊝
very low1,2,3

Lenght of hospital stay

This outcome was poorly reported: One study reported no difference between groups. No standard deviation was reported.

Myocardial infarction < 30 days

This outcome was not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded one level: one study with small sample size

2Downgraded one level due to risk of bias: incomplete outcome data

3Downgraded one level due to uncertainty in outcome measurement

Figuras y tablas -
Summary of findings for the main comparison. Very early cerebral revascularization compared with delayed treatment for recently symptomatic carotid artery stenosis
Comparison 1. Stroke

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Stroke and death < 30days Show forest plot

1

40

Risk Ratio (M‐H, Random, 95% CI)

3.32 [0.38, 29.23]

2 Perioperative death and all strokes Show forest plot

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.14, 1.58]

Figuras y tablas -
Comparison 1. Stroke