Carotid Artery Stenting - Association For Medical Ethics

Predictive Value
for Success

EXCELLENT
> 25% of all studies are Level I

GOOD
> 25% of all studies are Level II or better

FAIR
> 25% of all studies are Level III or better

POOR
> 25% of all studies are Level IV or better

VERY POOR
< 25% of all studies are Level IV or better

Evidence Based
Medicine
Level Rating System

LEVEL I
Randomized, controlled clinical trials - This is the most objective and valid study results. This study has posted the highest level of quality for evidence based medicine.

LEVEL II
Prospective non-randomized, comparative studies - This is the second most objective and valid study results.

LEVEL III
Retrospective comparative or case controlled studies - These studies look back historically and compare them with other cases in the past. The problem with this system is that these past patients may not have been chosen or treated - or not treated at all - on equal standings.

LEVEL IV
Case Series - This where a group of patients have a particular treatment, and then observations are made about them. This does not differentiate between the success or failure of the treatment compared to other treatments or no treatment at all. For example treating back pain for 10 days by drinking pomegranate juice may show all patients got better and conclude this should be the treatment for back pain. However, usually all back pain gets better in 10 days no matter what one does.

LEVEL V
Expert opinion. This is a person's opinion only. It's an editorial, and is considered the lowest level of evidence to support a position. AME considers this to be Comparable to hearsay.

For More Information
On Evidence Based Medicine
Rating System Click Here

AME Star Rating System

ARTERY STENTING

CAROTID ARTERY STENTING

AME STAR RATING:
POOR Predictive Value for success of procedure

METHOD: Pubmed was searched for carotid artery stenting compared to carotid enderterectomy and limited to therepeutic analyses only comparing the two in English language publications resulting in 26 articles included. Repetitive evaluation and similar results of same date sets were not included.

TOTAL: 26 CAROTID ARTERY STENTING STUDIES
Studies FAVORABLE Click Here to see studies	12 Studies	1 Level III 4 Level IV 7 Level V
Studies UNFAVORABLE Click Here to see study	4 Studies	1 Level IV 3 Level V
Studies NEUTRAL Click Here to see studies	10 Studies:	5 Level I 1 Level II 2 Level III 2 Level V
Preponderance of studies are favorable or neutral with favorable studies being >25% being Level IV. Neutral studies with highest Evidence Based Medicine rating with studies being >25% being Level II

Click Here for description of Evidence Based Medicine Click Here for description of AME Rating System

REFERENCES

CAROTID ARTERY STENTING
Studies Favorable: Total 12

Level III: 1 Study

1. Carotid Artery Stenosis: An Endovascular Specialist's Perspective
Tex Heart Inst J. 2005; 32(3): 318–322.
Copyright © 2005 by the Texas Heart® Institute, Houston
Neil E. Strickman, MD and Pranav Loyalka, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1336701
Level III - Favorable Systematic review of Level 3 studies Supports

Level IV: 4 Studies

1. Carotid Stenting Done Exclusively by Vascular Surgeons
First 175 Cases
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1357751
Retrospective review of 175 cases Supports CAS
Level IV - Favorable

2. Carotid artery stenting in the first 100 consecutive patients: results and follow up
Heart. 2002 October; 88(4): 381–386.
Copyright © Copyright 2002 by Heart
G Stankovic,1 F Liistro,2 S Moshiri,2 C Briguori,2 N Corvaja,1 G Gimelli,2 A Chieffo,2 M Montorfano,2 L Finci,1 V Spanos,2 C Di Mario,1 and A Colombo1
1Columbus Hospital, Milan, Italy
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1767376
Level IV - Favorable Case series Supports

3. Carotid Stenting for Post-Endarterectomy Restenosis and Radiation-Induced Occlusive Disease
Tex Heart Inst J. 2000; 27(2): 159–165.
Copyright 2000 by the Texas Heart® Institute, Houston
Eduardo Hernandez-Vila, MD, Neil E. Strickman, MD, Mark Skolkin, MD, Barry D. Toombs, MD, and Zvonimir Krajcer, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=101051
Level IV - Favorable Case series Supports

4. Angioplasty and Stenting of the Extracranial Carotid Arteries
Tex Heart Inst J. 2000; 27(2): 150–158.
Copyright 2000 by the Texas Heart® Institute, Houston
Michel Henry, MD, Max Amor, MD, Christos Klonaris, MD, Isabelle Henry, MD, Isabelle Masson, MD, Zukai Chati, MD, Edmond Leborgne, MD, and Michèle Hugel, RN
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=101050
Level IV - Favorable Case series – Supports

Level V: 7 Studies

1. Carotid artery stenting
Francesco Liistro and Carlo Di Mario
Heart. 2003 August; 89(8): 944–948
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1767778
Opinion
Level V - Favorable Supports

2. 2004 That Was the Year That Was
Tex Heart Inst J. 2005; 32(1): 2–6.
Copyright © 2005 by the Texas Heart® Institute, Houston
James J. Ferguson, III, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=555812
Expert opinion
Level V - Favorable Supports

3. Carotid Endarterectomy is Better than Carotid Artery Stenting for Asymptomatic Patients
PRO Position
Tex Heart Inst J. 2006; 33(2): 209–210.
Copyright © 2006 by the Texas Heart® Institute, Houston
Edward B. Diethrich, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1524721
Level V - Favorable Expert opinion Supports

4. Carotid angioplasty and stenting. Will they match the gold standard?
Tex Heart Inst J. 1998; 25(1): 1–9.
Copyright notice
E B Diethrich
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=325494
Level V - Favorable Expert opinion Supports

5. Distal protection devices during percutaneous coronary and carotid interventions
Curr Control Trials Cardiovasc Med. 2001; 2(6): 286–291.
Published online 2001 November 23. doi: 10.1186/cvm-2-6-286.
Copyright © 2001 BioMed Central Ltd
Panayotis Fasseas,1 James L Orford,1 Ali E Denktas,1 and Peter B Berger
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=64830
Level V - Favorable Expert opinion – product review Supports

6. Bilateral stenting of symptomatic and asymptomatic internal carotid artery stenosis due to
fibromuscular dysplasia
J Neurol Neurosurg Psychiatry. 2000 November; 69(5): 683–686.
doi: 10.1136/jnnp.69.5.683.
Copyright notice
J Finsterer, J Strassegger, A Haymerle, and G Hagmuller
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1763440
Level V - Favorable Expert opinion – case report Supports

7. Carotid Artery Stenting
Tex Heart Inst J. 2005; 32(4): 620.
Copyright © 2005 by the Texas Heart® Institute, Houston
C. Steven Powell, MD, FACS
Professor of Surgery, Department of Surgery, Brody School of Medicine, Greenville, North
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1351853
Level V - Favorable Expert opinion Supports limited use

CAROTID ARTERY STENTING
Studies Unfavorable: Total 4

Level IV: 1 Study

1. Carotid endarterectomy in SAPPHIRE-eligible high-risk patients: implications for selecting patients for carotid angioplasty and stenting.
Mozes G, Sullivan TM, Torres-Russotto DR, Bower TC, Hoskin TL, Sampaio SM, Gloviczki P, Panneton JM, Noel AA, Cherry KJ Jr.
http://www.ncbi.nlm.nih.gov/pubmed/15111844?ordinalpos=12&itool=EntrezSystem2.
PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_
RVDocSum
Level IV - Unfavorable Case series Against

3 Level V

1. Angioplasty and stenting in the carotid and vertebral arteries.
Postgrad Med J. 1998 January; 74(867): 7–10.
Copyright notice
F. Crawley, M. M. Brown, and A. G. Clifton
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2360800
Level V - Unfavorable Expert opinion Against – experimental

2. Carotid Endarterectomy is Better than Carotid Artery Stenting for Asymptomatic Patients
CON Position
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1524684
Opinion
Level V - Unfavorable Against CAS

3. Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial.
Naylor AR, Bolia A, Abbott RJ, Pye IF, Smith J, Lennard N, Lloyd AJ, London NJ, Bell PR.http://www.ncbi.nlm.nih.gov/pubmed/9719328
Level V - Unfavorable RCT – prospective – trial stopped due to CAS complications - Against

CAROTID ARTERY STENTING
Studies Neutral: Total 10

Level I: 5 Studies
1. Carotid artery stenting versus carotid endarterectomy: current status
Neurosurg Clin N Am. 2008 Jul;19(3):447-58, vi. Links
Barrett KM, Brott TG.
Level I – Neutral systematic review of 5 star studies and below - neutral systematic review of 5 star

2. The Evidence for Vascular or Endovascular Reconstruction
Ann Surg. 2003 August; 238(2): 304.
doi: 10.1097/01.SLA.0000081090.78661.ca
Copyright © 2003 Lippincott Williams & Wilkins, Inc.
Reviewed by Lucy S. Brevetti, MD
New Brunswick, New Jersey
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1422680
Level I – Neutral Systematic review of 5 star and below studies - Recommends further studies to compare

3. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial.
Lancet. 2001 Jun 2;357(9270):1729-37
http://www.ncbi.nlm.nih.gov/pubmed/11403808
Level I - Neutral RCT – prospective. Comparable alternative to CEA.

4. New Developments in Endovascular Interventions for Extracranial Carotid Stenosis
Tex Heart Inst J. 2000; 27(3): 273–280.
Copyright 2000 by the Texas Heart® Institute, Houston
Walter A. Tan, MS, MD, Chester R. Jarmolowski, MD, Lawrence R. Wechsler, MD, and Mark H. Wholey, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=101079
Level I - Neutral

5. SAPPHIRE study Yadav JS, Wholey MH,Kuntz RE, et al: Protected carotid-ar-tery stenting versus endarterectomy inhigh-risk patients. N Engl J Med 351: 1493–1501, 2004
Level I - Neutral
RCT of CAS and CEA – neutral – non-inferiority study

Level II: 1 Study

1. Update on Endovascular Treatment of Peripheral Vascular Disease: New Tools, Techniques,
and Indications
Tex Heart Inst J. 2000; 27(4): 369–385.
Copyright 2000 by the Texas Heart® Institute, Houston
Zvonimir Krajcer, MD and Marcus H. Howell, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=101107
Level II - Neutral Systematic review of 4 star studies and below – Recommends further studies to compare

Level III: 2 Studies

1. Current role of medical treatment and invasive management in carotid atherosclerotic disease
Poorya Fazel, MD and Kenneth Johnson, MD
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2277346
Systematic review of Level 3 studies
Level III - Neutral

2. Critical appraisal of medical devices in the management of cerebrovascular disease
Michael J Schneck
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2503654#b72
Systematic review of Level 3 studies
Level III - Neutral

Level V: 2 Studies

1. Recent developments in vascular surgery
BMJ. 2003 October 18; 327(7420): 911–915.
doi: 10.1136/bmj.327.7420.911.
Copyright © 2003, BMJ Publishing Group Ltd.
Jeremy Crane, clinical research fellow1 and Nick Cheshire, consultant vascular surgeon
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=218817
Level V - Neutral Expert opinion – neutral

2. Carotid Screening Guidelines – Overvalued
MedGenMed. 2007; 9(1): 54.
Published online 2007 March 16.
Copyright ©2007 Medscape
Frank J. Veith, MD, Professor of Surgery; Professor of Surgery; Chairman
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1924991
Level V - Neutral Expert opinion – neutral