(Circulation. 2001;104:e121.)
© 2001 American Heart Association, Inc.
Correspondence |
Immediate and Late Clinical Outcomes of Carotid Artery Stenting in Patients With Symptomatic and Asymptomatic Carotid Artery Stenosis: A 5-Year Prospective Analysis
Chief, Section of Vascular Surgery, Department of Medical & Surgical Sciences, University of Padua, School of Medicine, Padova, Italy
To the Editor:
In a recent article, Roubin et al 1 performed a prospective analysis of the experience of a single group of operators to establish the immediate and late stroke rates in a series of symptomatic and asymptomatic patients undergoing carotid stenting (CS). In our opinion, the authors’ conclusions that CS carries an acceptable 30-day complication rate and that it is comparable with carotid endarterectomy (CEA) may be misleading.
If we analyze the results with respect to the indications for CS, although symptomatic and asymptomatic patients had similar periprocedural complication rates after CS, the incidence of perioperative events was 8.2% (26/317) in symptomatic patients and 6.5% (19/287) in asymptomatic patients: both values exceed the recommended upper limits for perioperative risk and mortality rates supporting the beneficial effects of CEA in symptomatic and asymptomatic patients.2 Moreover, the periprocedural complication rate among symptomatic patients (8.2%) was more than twice as high as with surgery according to 20 recent studies on CEA for symptomatic patients.3 An alternative conclusion might therefore be that the risks outweighed the benefits in this series of symptomatic and asymptomatic patients undergoing CS.
For the subgroup of patients aged 80 years or older, the periprocedural complication rate was 16%, which is unacceptable. This is more than 4 times higher than 3.6% combined perioperative stroke risk and death rate recently reported in a series of 1036 over-80-year-olds undergoing CEA, 4 which suggests that CEA is likely to benefit elderly patients with acceptable perioperative risks, so age over 80 is not a predictor of perioperative events. Thus, a further alternative conclusion might be that CS is dangerous and contraindicated in the very elderly.
The findings of Roubin et al 1 would suggest that CS is currently not a safe option for most patients presenting with symptomatic and asymptomatic carotid lesions, even in experienced hands. A number of carefully-controlled randomized studies have attempted to compare the outcome of CS and CEA. Most of them were suspended before the planned number of patients was enrolled because of the evident superiority of CEA over CS. 5 Scientific evidence demonstrating the safety of CS is not available. The promotion of CS, however, at many ongoing-education programs and the expanding experience of institutions participating in industry-sponsored trials may generate such enthusiasm for CS that the procedure may become accepted practice without the best level of evidence available.
References
1.
Roubin GS, New G, Iyer SS, et al. 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.
2.
Biller J, Feinberg WM, Castaldo JE, et al. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke.. 1998; 29: 554–562.
3.
Golledge J, Mitchell A, Greenhalgh RM, et al. Systematic comparison of the early outcome of angioplasty and endarterectomy for symptomatic carotid artery disease. Stroke.. 2000; 31: 1439–1443.
4. Perler BA, Dardik A, Burleyson GP, et al. Influence of age and hospital volume on the results of carotid endarterectomy: a statewide analysis on 9918 cases. J Vasc Surg.. 1998; 27: 25–33.[Medline] [Order article via Infotrieve]
5. Alberts MJ. Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy. Stroke.. 2001; 32: 325d.Abstract.
Response
Lenox Hill Heart & Vascular Institute, Lenox Hill Hospital, 130 E 77th Street, New York, NY 10021
We would like to thank Dr Ballotta for his comments. Unfortunately, none of the references cited by Dr Ballotta support his arguments. We acknowledge that our overall periprocedural complication rates for carotid stenting (CS), including our early experience, are higher than that reported in the NASCET1 and ACAS 2 studies. However, in the last 2 years of the study, our outcomes have fallen within the recommended guidelines.3 Dr Ballotta compares our work to the report by Golledge et al, 4 which is a highly biased selection of carotid endarterectomy (CEA) and carotid stenting (CS) case series results. In this article, there are no definitions or methods of assessing neurological complications. Without evidence of objective neurological assessment of all patients post endarterectomy, no comparison and no "alternative" conclusions can be "scientifically" made.
We acknowledge that periprocedural stroke rates in patients over 80 years of age were apparently higher in our series. Consequently, we now perform carotid stenting in the elderly only when we use embolic protection devices. A recent series of patients reported in Circulation 5 by a leading center in Italy showed that outcomes of stenting with neuroprotection demonstrated a 1.2% neurological complication rate. Dr Ballotta quotes Perler et al 6 as evidence that complication rates following endarterectomy have declined in patients over 80 years of age. This study of complication rates after CEA was based on DRG coding (Diagnosis Related Grouping). Simply stated, to compare this level of audit to prospective independent neurological assessment defies logic.
Finally, Ballotta argues that a number of careful randomized studies have compared carotid stenting with endarterectomy. To support this, he references only one study, unpublished, that was terminated prematurely for commercial reasons. Alternatively, no mention is made of the recent seminal publication of the CAVATAS study in The Lancet. 7 This study is the first completed and published comparison of angioplasty versus endarterectomy the results of which demonstrated equivalent early and long-term neurological complication rates. This class I level of evidence also suggests that Dr Ballotta’s statement that "Scientific evidence demonstrating the safety of carotid stenting is not available" is also incorrect. The purpose of our study was to notify the medical community of the apparently excellent late outcomes after CS and to engender community support for the pivotal NIH sponsored CREST study8 that will hopefully address the doubts of our surgical colleagues.
References
1. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med.. 1991; 325: 445–453.[Abstract]
2.
Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA.. 1995; 273: 1421–1428.
3. Roubin GS, New G, Iyer SS, et al. 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.
4. Golledge J, Mitchell A, Greenhalgh RM, et al. Systematic comparison of the early outcome of angioplasty and endarterectomy for symptomatic carotid artery disease. Stroke.. 2000; 31: 1439–1443.
5.
Reimers B, Corvaja N, Moshiri S, et al. Cerebral protection with filter devices during carotid artery stenting. Circulation.. 2001; 104: 12–15.
6. Perler BA, Dardik A, Burleyson GP, et al. Influence of age and hospital volume on the results of carotid endarterectomy: a statewide analysis of 9918 cases. J Vasc Surg.. 1998; 27: 25–31;discussion 31–33.
7. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet.. 2001; 357: 1729–1737.[Medline] [Order article via Infotrieve]
8. Hobson RW2nd, Brott T, Ferguson R, et al. CREST: carotid revascularization endarterectomy versus stent trial. Cardiovasc Surg.. 1997; 5: 457–458.[Medline] [Order article via Infotrieve]
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