This Article Full Text (PDF) All Versions of this Article: 34/8/1941    most recent 01.STR.0000080938.80364.75v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Eckert, B. Articles by Zeumer, H. Search for Related Content PubMed PubMed Citation Articles by Eckert, B. Articles by Zeumer, H. Pubmed/NCBI databases Medline Plus Health Information Carotid Artery Disease

(Stroke. 2003;34:1941.)
© 2003 American Heart Association, Inc.

Original Contributions

Editorial Comment—Carotid Artery Stenting With or Without Protection Devices? Strong Opinions, Poor Evidence!

Bernd Eckert, MD, Guest Editor Hermann Zeumer, MD, Guest Editor

Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany

In recent years, endovascular treatment of carotid artery stenosis has profited from substantial technical improvements, but the dominant point of discussion circles around the so-called cerebral protection devices. In this issue of Stroke, Cremonesi et al¹ report their impressive single-center experience with protected carotid artery stenting (CAS) in 442 patients. The overall complication rate was 3.4%, and the 30-day ipsilateral stroke/death rate was 1.1%. The authors conclude that protection devices are feasible and effective in preventing distal embolization. In a recent Stroke issue, Kastrup et al,² who systematically reviewed single-center CAS studies, concluded that protection devices appear to reduce thromboembolic complications during CAS.

The appearance of debris during CAS and carotid endarterectomy (CEA) is a common event.^3,4 At first glance, it seems reasonable to apply protection systems to catch particles by means of occlusive balloon systems or filtration baskets in the internal carotid artery. The beneficial use of such devices seems to be supported by a growing number of publications, mostly from the field of cardiology, reporting declining neurological complication rates. Despite the lack of further controlled studies, the use of protection devices has even become obligatory in the CREST (United States)⁵ and EVA3S (France) trials testing for equivalence of CAS and CEA.

Paradoxically, some neuroradiologists continue to successfully perform CAS without protection devices and hesitate to apply protection devices that demand an increase in both catheter time and technical complexity. In centers in which experience with unprotected CAS has been gathered, skepticism about the assumed self-evident improvement on implementation of protection devices is based not only on the low neurological complication rate without them but also on the technical complications related to their use.⁶ Such experiences have apparently been poorly reported until now.

In unprotected CAS, procedural steps include guide wire passage (0.36 mm), stent placement (1.67 mm), and postdilatation. Predilatation of the stenosis has been deemed necessary in only 2% of the cases.⁷ In transcranial Doppler (TCD) monitoring, our own experience (unpublished data) and data from the literature⁸ indicate that 60% of microembolic signals appear during the procedural steps before postdilatation. In another TCD study during unprotected CAS,⁹ only the detection of embolic signals in the step of primary guide wire passage was related to neurological symptoms. A primary passage must always be an unprotected maneuver.

In protected CAS, predilatation is often necessary (37% of patients in the present study) before the protection device (0.9 to 1.67 mm) is placed. After stent placement and postdilatation, removal of protection devices causes additional microembolization.⁸ From a procedural point of view, protection devices may reduce but certainly do not eliminate plaque embolization, as demonstrated by TCD⁸ and MRI studies.¹⁰

Supplementing the recent dramatic technical progress (eg, less traumatic, self-expandable stent devices, more friction-resistant introducer catheters, and better guide wire systems leading to marked improvement of CAS), 2 other factors quietly evolved: the associated learning curve of active interventionalists¹¹ and the improved periprocedural anticoagulation regimens using combined platelet inhibitors (acetylsalicylic acid, clopidogrel), low-molecular-heparin at least 3 days before the procedure, and full heparinization (activated clotting time >250 seconds) during CAS. These improvements may have been important cofactors in preventing cerebral embolism during the recent era of protected CAS studies.

The work of Cremonesi et al¹ specifically addresses the risk of protection devices. A remarkably low number of technical complications such as dissection of the internal carotid artery (0.7%) or trapped guide wire needing surgical approach (0.2%) were observed, and all these events were clinically well tolerated. Even the authors probably would not expect such a favorable outcome in these events. Hemodynamic intolerance in occlusive balloon systems (5% to 15% of patients^4,10) and congested nets are other typical problems. Neither Cremonesi et al¹ nor Kastrup et al² reported on the failure rate on application of protection systems, alluding that the success rate was 100%. This uncommonly high success rate, together with the small number of observed technical complications, indicates extraordinary skill in this group, which is especially spectacular compared with study groups reputed for their skills and long experience, in which a failure rate of up to 20% was reported.¹⁰

In a former publication by Cremonesi et al¹² on a CAS cohort of 119 patients treated without protection devices, the ischemic neurological event rate was 2.5% (2 minor strokes, 1 transient ischemic attack). In the present study, 6 patients suffered transient neurological symptoms resulting from intolerance of occlusive protection devices. Adding these events (n=6), transient ischemic attacks (n=4), minor strokes (n=4), and the 1 major stroke, the ischemic neurological event rate in the present report would also come to 2.5%. The 0.9% asymptomatic technical complication rate should simply be kept in mind.

The review by Kastrup et al² from the neurological perspective included a variety of single-center studies from 1996 to 2003, with patients being treated under very heterogeneous conditions. The combined stroke and death rate within 30 days was 1.8% in CAS with protection and 5.5% in CAS without protection. From a neuroradiological perspective, concentrating our attention on the 10 studies appearing since 2002,^4,13–21 when most of 966 treated vessels in 923 patients were probably treated under more comparable conditions, including technical and anticoagulation progress, the combined stroke and death rate within 30 days in protected CAS^4,19–21 was 2.0% and in unprotected CAS was 3.2%.^13–18 In our view, this does not justify the strong recommendation of the use of protection devices.

The NASCET trial²² eliminated the prejudice that the complication rate in CEA was only 1% as reported in the vast majority of uncontrolled single-center studies. Apparently, the scientific debate on CAS in general and protection devices in particular is still in a "pre- NASCET stage." Future attempts should concentrate all efforts on finishing the pending trials comparing CEA and CAS (CREST in the United States, EVA3S in France, ICSS or CAVATAS2 in the United Kingdom, and SPACE in Germany). All European studies have the same primary end point and are designed to promote secondary analysis. A later subgroup analysis of protection device use could be carried out because in SPACE and CAVATAS2 the use of protection devices is only optional.

We must all confess that our decisions to date are simply not evidence based. It is too early to draw binding conclusions with all clinical and economic consequences. We feel that the ongoing trials with a NASCET analog design should be supported, the results awaited, and then the conclusions implemented.

	Acknowledgment

 
We thank Dr Jarold Knispel, Hamburg, for his language advice.

	References

Top References

 

1. Cremonesi A, Manetti R, Castriota F, Setacci F, Setacci C. Protected carotid stenting: clinical advantages and complications of embolic protection devices in 442 consecutive patients. Stroke. 2003; 34: 1936–1943.[Abstract/Free Full Text]
2. Kastrup A, Groschel K, Krapf H, Brehm BR, Dichgans J, Schulz JB. Early outcome of carotid angioplasty and stenting with and without cerebral protection devices: a systematic review of the literature. Stroke. 2003; 34: 813–819.[Abstract/Free Full Text]
3. Crawley F, Clifton A, Buckenham T, Loosemore T, Taylor RS, Brown MM. Comparison of hemodynamic cerebral ischemia and microembolic signals detected during carotid endarterectomy and carotid angioplasty. Stroke. 1997; 28: 2460–2464.[Abstract/Free Full Text]
4. Whitlow PL, Lylyk P, Londero H, Mendiz OA, Mathias K, Jaeger H, Parodi J, Schonholz C, Milei J. Carotid artery stenting protected with an emboli containment system. Stroke. 2002; 33: 1308–1314.[Abstract/Free Full Text]
5. Hobson RW 2nd, Brott T, Ferguson R, Roubin G, Moore W, Kuntz R, Howard G, Ferguson J. CREST: Carotid Revascularization Endarterectomy Versus Stent Trial. Cardiovasc Surg. 1997; 5: 457–458.[CrossRef][Medline] [Order article via Infotrieve]
6. Tan WA, Bates MC, Wholey MH. Cerebral protection systems for distal emboli during carotid artery interventions. J Interv Cardiol. 2001; 14: 465–474.[Medline] [Order article via Infotrieve]
7. Koch C, Kucinski T, Eckert B, Wittkugel O, Röther J, Zeumer H. Endovaskuläre Behandlung hochgradiger Halsgefäßstenosen: Stentgeschützte Perkutane Angioplastie der Carotis ohne Protektion. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr. 2002; 147: 1506–1510.[CrossRef]
8. Al-Mubarak N, Roubin GS, Vitek JJ, Iyer SS, New G, Leon MB. Effect of the distal-balloon protection system on microembolization during carotid stenting. Circulation. 2001; 104: 1999–2002.[Abstract/Free Full Text]
9. Orlandi G, Fanucchi S, Fioretti C, Acerbi G, Puglioli M, Padolecchia R, Sartucci F, Murri L. Characteristics of cerebral microembolism during carotid stenting and angioplasty alone. Arch Neurol. 2001; 58: 1410–1413.[Abstract/Free Full Text]
10. Jaeger H, Mathias K, Drescher R, Hauth E, Bockisch G, Demirel E, Gissler HM. Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. Cardiovasc Intervent Radiol. 2001; 24: 249–256.[CrossRef][Medline] [Order article via Infotrieve]
11. Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001; 103: 532–537.[Abstract/Free Full Text]
12. Cremonesi A, Castriota F, Manetti R, Balestra R, Liso A. Endovascular treatment of carotid atherosclerotic disease: early and late outcome in a non-selected population. Ital Heart J. 2000; 1: 801–809.[Medline] [Order article via Infotrieve]
13. Bonaldi G. Angioplasty and stenting of the cervical carotid bifurcation: report of a 4-year series. Neuroradiology. 2002; 44: 164–174.[CrossRef][Medline] [Order article via Infotrieve]
14. Criado FJ, Lingelbach JM, Ledesma DF, Lucas PR. Carotid artery stenting in a vascular surgery practice. J Vasc Surg. 2002; 35: 430–434.[CrossRef][Medline] [Order article via Infotrieve]
15. Hobson RW 2nd, Lal BK, Chakhtoura EY, Goldstein J, Kubicka R, Haser PB, Padberg FT Jr, Pappas PJ, Jamil Z. Carotid artery closure for endarterectomy does not influence results of angioplasty-stenting for restenosis. J Vasc Surg. 2002; 35: 435–438.[CrossRef][Medline] [Order article via Infotrieve]
16. Jaeger HJ, Mathias KD, Hauth E, Drescher R, Gissler HM, Hennigs S, Christmann A. Cerebral ischemia detected with diffusion-weighted MR imaging after stent implantation in the carotid artery. AJNR Am J Neuroradiol. 2002; 23: 200–207.[Abstract/Free Full Text]
17. Kastrup A, Skalej M, Krapf H, Nagele T, Dichgans J, Schulz JB. Early outcome of carotid angioplasty and stenting versus carotid endarterectomy in a single academic center. Cerebrovasc Dis. 2003; 15: 84–89.[CrossRef][Medline] [Order article via Infotrieve]
18. Qureshi AI, Suri MF, New G, Wadsworth DC Jr, Dulin J, Hopkins LN. Multicenter study of the feasibility and safety of using the Memotherm carotid arterial stent for extracranial carotid artery stenosis. J Neurosurg. 2002; 96: 830–836.[CrossRef][Medline] [Order article via Infotrieve]
19. Adami CA, Scuro A, Spinamano L, Galvagni E, Antoniucci D, Farello GA, Maglione F, Manfrini S, Mangialardi N, Mansueto GC, et al. Use of the Parodi anti-embolism system in carotid stenting: Italian trial results. J Endovasc Ther. 2002; 9: 147–154.[CrossRef][Medline] [Order article via Infotrieve]
20. Al-Mubarak N, Colombo A, Gaines PA, Iyer SS, Corvaja N, Cleveland TJ, Macdonald S, Brennan C, Vitek JJ. Multicenter evaluation of carotid artery stenting with a filter protection system. J Am Coll Cardiol. 2002; 39: 841–846.[Abstract/Free Full Text]
21. Guimaraens L, Sola MT, Matali A, Arbelaez A, Delgado M, Soler L, Balaguer E, Castellanos C, Ibanez J, Miquel L, Theron J. Carotid angioplasty with cerebral protection and stenting: report of 164 patients (194 carotid percutaneous transluminal angioplasties). Cerebrovasc Dis. 2002; 13: 114–119.[CrossRef][Medline] [Order article via Infotrieve]
22. North American Symptomatic Carotid Endarterectomy TC. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991; 325: 445–453.[Abstract]

This article has been cited by other articles:

				W. Theiss, P. Hermanek, K. Mathias, H. Bruckmann, J. Dembski, F.-J. Hoffmann, R. Kerner, F. Leisch, H. Mudra, K.-L. Schulte, et al. Predictors of Death and Stroke After Carotid Angioplasty and Stenting: A Subgroup Analysis of the Pro-CAS Data Stroke, August 1, 2008; 39(8): 2325 - 2330. [Abstract] [Full Text] [PDF]

				M. Maynar, S. Baldi, R. Rostagno, T. Zander, M. Rabellino, R. Llorens, J. Alvarez, and F. Barajas Carotid Stenting without Use of Balloon Angioplasty and Distal Protection Devices: Preliminary Experience in 100 Cases AJNR Am. J. Neuroradiol., August 1, 2007; 28(7): 1378 - 1383. [Abstract] [Full Text] [PDF]

				A. Cremonesi, C. Setacci, A. Bignamini, L. Bolognese, F. Briganti, G. Di Sciascio, D. Inzitari, G. Lanza, L. Lupattelli, S. Mangiafico, et al. Carotid Artery Stenting: First Consensus Document of the ICCS-SPREAD Joint Committee Stroke, September 1, 2006; 37(9): 2400 - 2409. [Abstract] [Full Text] [PDF]

				K. Shilling, B. F. Uretsky, and G. C. Hunter Entrapment of a Cerebral Embolic Protection Device: A Case Report Vascular and Endovascular Surgery, May 1, 2006; 40(3): 229 - 233. [Abstract] [PDF]

				S. P. Lownie, D. M. Pelz, D. H. Lee, S. Men, I. Gulka, and P. Kalapos Efficacy of Treatment of Severe Carotid Bifurcation Stenosis By Using Self-Expanding Stents without Deliberate Use of Angioplasty Balloons AJNR Am. J. Neuroradiol., May 1, 2005; 26(5): 1241 - 1248. [Abstract] [Full Text] [PDF]

				B. S. Geisler, J. Rother, T. Kucinski, H. Zeumer, and B. Eckert Emergency Carotid Artery Stenting in Persistent Hemodynamic Deficit Associated with Severe Carotid Stenosis AJNR Am. J. Neuroradiol., March 1, 2005; 26(3): 549 - 552. [Abstract] [Full Text] [PDF]

				J. A. Vos, J. C. van den Berg, S. M. P. G. Ernst, M. J. Suttorp, T. T. C. Overtoom, H. W. Mauser, O. J. M. Vogels, H. P. M. van Heesewijk, F. L. Moll, Y. van der Graaf, et al. Carotid Angioplasty and Stent Placement: Comparison of Transcranial Doppler US Data and Clinical Outcome with and without Filtering Cerebral Protection Devices in 509 Patients Radiology, February 1, 2005; 234(2): 493 - 499. [Abstract] [Full Text] [PDF]

				L. K. Sztriha, E. Voros, K. Sas, R. Szentgyorgyi, A. Pocsik, P. Barzo, P. Szikra, A. Makai, A. Szolics, P. Elek, et al. Favorable Early Outcome of Carotid Artery Stenting Without Protection Devices Stroke, December 1, 2004; 35(12): 2862 - 2866. [Abstract] [Full Text] [PDF]

				W. Theiss, P. Hermanek, K. Mathias, R. Ahmadi, L. Heuser, F.-J. Hoffmann, R. Kerner, F. Leisch, H. Sievert, S. von Sommoggy, et al. Pro-CAS: A Prospective Registry of Carotid Angioplasty and Stenting Stroke, September 1, 2004; 35(9): 2134 - 2139. [Abstract] [Full Text] [PDF]

				D. Pelz, P. Lylyk, and M. Negoro Interventional Neuroradiology Stroke, February 1, 2004; 35(2): 381 - 382. [Full Text] [PDF]

				M. Forsting Editorial Comment--With or Without Protection? The Second Important Question in Carotid Artery Stenting Stroke, January 1, 2004; 35 (1): e20 - e21. [Full Text] [PDF]

				J. D. Barr, J. J. Connors III, D. Sacks, J. C. Wojak, G. J. Becker, J. F. Cardella, B. Chopko, J. E. Dion, A. J. Fox, R. T. Higashida, et al. Quality Improvement Guidelines for the Performance of Cervical Carotid Angioplasty and Stent Placement: Developed by a Collaborative Panel of the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, and the Society of Interventional Radiology AJNR Am. J. Neuroradiol., November 1, 2003; 24(10): 2020 - 2034. [Full Text] [PDF]

This Article Full Text (PDF) All Versions of this Article: 34/8/1941    most recent 01.STR.0000080938.80364.75v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Eckert, B. Articles by Zeumer, H. Search for Related Content PubMed PubMed Citation Articles by Eckert, B. Articles by Zeumer, H. Pubmed/NCBI databases Medline Plus Health Information Carotid Artery Disease