CAROTID ARTERY STENTING -
METHOD: Pubmed was searched for carotid artery stenting compared to carotid enderterectomy and limited to Therapeutic 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
1 Level II
12 Studies 4 Level IV
7 Level V
4 Studies 1 Level IV
3 Level V
5 Level I
10 Studies 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
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CAROTID ARTERY STENTING
Studies Favorable: Total 12
Level III: 1 Study
1. Carotid Artery Stenosis: An Endovascular Specialist’s Perspective
Neil E. Strickman, MD and Pranav Loyalka, MD
Tex Heart Inst J. 2005; 32(3): 318–322.
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
Mark K. Eskandari, MD, G Matthew Longo, MD, Jon S. Matsumura, MD, Melina R. Kibbe, MD, Mark D. Morasch, MD, Kelley R. Cardeira, BA, and William H. Pearce, MD
Retrospective review of 175 cases Supports CAS
Level IV – Favorable
2. Carotid artery stenting in the first 100 consecutive patients: results and follow up
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 Colombo 1
1 Columbus Hospital, Milan, Italy
Heart. 2002 October; 88(4): 381–386.
Level IV – Favorable Case series Supports
3. Carotid Stenting for Post-Endarterectomy Restenosis and Radiation-Induced Occlusive Disease
Eduardo Hernandez-Vila, MD, Neil E. Strickman, MD, Mark Skolkin, MD, Barry D. Toombs, MD, and Zvonimir Krajcer, MD
Tex Heart Inst J. 2000; 27(2): 159–165.
Level IV – Favorable Case series Supports
4. Angioplasty and Stenting of the Extracranial Carotid Arteries
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
Tex Heart Inst J. 2000; 27(2): 150–158.
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
Opinion
Level V – Favorable Supports
2. 2004 That Was the Year That Was
James J. Ferguson, III, MD
Tex Heart Inst J. 2005; 32(1): 2–6.
Expert opinion
Level V – Favorable Supports
3. Carotid Endarterectomy is Better than Carotid Artery Stenting for Asymptomatic Patients
PRO Position
Edward B. Diethrich, MD
Tex Heart Inst J. 2006; 33(2): 209–210.
Level V – Favorable Expert opinion Supports
4. Carotid angioplasty and stenting. Will they match the gold standard?
E B Diethrich
Tex Heart Inst J. 1998; 25(1): 1–9.
Level V – Favorable Expert opinion Supports
5. Distal protection devices during percutaneous coronary and carotid interventions
Panayotis Fasseas,1 James L Orford,1 Ali E Denktas,1 and Peter B Berger
Curr Control Trials Cardiovasc Med. 2001; 2(6): 286–291.
Published online 2001 November 23. doi: 10.1186/cvm-2-6-286.
Level V – Favorable Expert opinion – product review Supports
6. Bilateral stenting of symptomatic and asymptomatic internal carotid artery stenosis due to fibromuscular dysplasia
J Finsterer, J Strassegger, A Haymerle, and G Hagmuller
J Neurol Neurosurg Psychiatry. 2000 November; 69(5): 683–686.
Level V – Favorable Expert opinion – case report Supports
7. Carotid Artery Stenting
C. Steven Powell, MD, FACS
Professor of Surgery, Department of Surgery, Brody School of Medicine, Greenville, North
Tex Heart Inst J. 2005; 32(4): 620.
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.
Level IV – Unfavorable Case series Against
Level V: 3 Studies
1. Angioplasty and stenting in the carotid and vertebral arteries.
F. Crawley, M. M. Brown, and A. G. Clifton
Postgrad Med J. 1998 January; 74(867): 7–10.
Level V – Unfavorable Expert opinion Against – experimental
2. Carotid Endarterectomy is Better than Carotid Artery Stenting for Asymptomatic Patients
CON Position
Subbarao V. Myla, MD
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.
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
Barrett KM, Brott TG.
Neurosurg Clin N Am. 2008 Jul;19(3):447-58, vi.
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
Reviewed by Lucy S. Brevetti, MD
Ann Surg. 2003 August; 238(2): 304.
New Brunswick, New Jersey
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.
Level I – Neutral RCT – prospective. Comparable alternative to CEA.
4. New Developments in Endovascular Interventions for Extracranial Carotid Stenosis
Walter A. Tan, MS, MD, Chester R. Jarmolowski, MD, Lawrence R. Wechsler, MD, and Mark H. Wholey, MD
Tex Heart Inst J. 2000; 27(3): 273–280.
Level I – Neutral
5. Protected carotid-ar-tery stenting versus endarterectomy in high-risk patients.
Jay S. Yadav, M.D., Mark H. Wholey, M.D., Richard E. Kuntz, M.D., M.Sc., Pierre Fayad, M.D., Barry T. Katzen, M.D., Gregory J. Mishkel, M.D., Tanvir K. Bajwa, M.D., Patrick Whitlow, M.D., Neil E. Strickman, M.D., Michael R. Jaff, D.O., Jeffrey J. Popma, M.D., David B. Snead, Ph.D., Donald E. Cutlip, M.D., Brian G. Firth, M.D., Ph.D., and Kenneth Ouriel, M.D.
N Engl J Med 351: 1493–1501, 2004
Level I – Neutral RCT of CAS and CEA – neutral – non-inferiority
Level II: 1 Study
1. Update on Endovascular Treatment of Peripheral Vascular Disease: New Tools, Techniques, and Indications
Zvonimir Krajcer, MD and Marcus H. Howell, MD
Tex Heart Inst J. 2000; 27(4): 369–385.
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
Systematic review of Level 3 studies
Level III – Neutral
2. Critical appraisal of medical devices in the management of cerebrovascular disease
Michael J Schneck
Systematic review of Level 3 studies
Level III – Neutral
Level V: 2 Studies
1. Recent developments in vascular surgery
Jeremy Crane, clinical research fellow and Nick Cheshire, consultant vascular surgeon
BMJ. 2003 October 18; 327(7420): 911–915.
Level V – Neutral Expert opinion – neutral
2. Carotid Screening Guidelines – Overvalued
Frank J. Veith, MD, Professor of Surgery; Professor of Surgery; Chairman
MedGenMed. 2007; 9(1): 54.
Published online 2007 March 16.
Level V – Neutral Expert opinion – neutral
LEVEL I
Randomized, controlled clinical trials. Researchers would use a computer program to randomly assign patients with back pain into two groups of 20. The first group (placebo group known as the control) would drink water (that only tasted like pomegranate juice but was not) for 10 days. The second group would drink real pomegranate juice for 10 days. None of the patients would know if they were drinking the real pomegranate juice or not. (This is called a blinded study). Then a researcher who does not know which person drank what (which now makes this a what’s called a “double blinded” study) would interview the patients to determine if their back pain was reduced, worsened or stayed the same. After this was all done, the information about which patients drank what would then be revealed. One could then see if those who drank the real pomegranate juice were better or not than the water drinking group.
LEVEL II
Non-randomized, prospective comparative study. A researcher looks at 40 patients medical records to select 20 patients for the pomegranate drinking group and 20 patients for the control group who will drink water. This is called a “cohort,” namely a control and experimental patient make a cohort. Here the researcher may introduce his own bias whether he intends to or not. If he believes pomegranate is a safe, effective treatment for back pain then whether he means to or not he may put the healthier patients with less back pain in the pomegranate group and patients complaining of more back pain in the water-drinking group. (This particular bias is called “selection bias.” See section on types of research bias.)
LEVEL III
Retrospective (already occurred) comparative study or case controlled study (each “experimental“ patient is matched to a patient that never had the experimental). This is not a reliable standard for determining one treatment over another, though it can be helpful to, say, see how many complications a certain treatment has. Researchers do a retrospective study for example reviewing 20 patient records of patients who reported they have been drinking pomegranate juice in the past and then 20 patients who have not reported drinking pomegranate juice. Then the researchers review the patients’ medical records determine if the back pain was reported better, worse or stayed the same. Here again, the selection process may introduce bias intentionally or not. In this case it may not only be selection bias, but could involve “recall” bias, or “expectation bias” or “attention bias.” (See Bias in Research section).
LEVEL IV
Case series do not determine success or failure of a treatment compared to other treatments or no treatment at all. Researchers or a physician does a case study on 20 patients who drink pomegranate juice for 10 days and then report the results. In this case there is no control group or comparison to patients who are not drinking pomegranate juice. It does not take into consideration that back pain could get better in 10 days if the patient takes nothing at all for the pain. These studies are easier and cheaper. They can be of value to determine better methods of doing a particular treatment, or what the complications of a certain treatment are, but NOT for determining if one treatment is better than another.
LEVEL V
Expert opinion. One physician expert’s opinion on if pomegranate juice helps reduce back pain. No original research is conducted. Instead, just a written opinion or editorial that may talk about other research and give opinions, but no clinical study is conducted. AME considers this to be one step above hearsay for determining one treatment over another, though it may be valuable for stimulating discussion and ideas on a particular topic.
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