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Carotid artery stenting versus endarterectomy for carotid stenosis
Carotid artery stenting versus endarterectomy for carotid stenosis
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The International Carotid Stenting Study (ICSS; March 20, p 985),1 which compared carotid artery stenting with carotid endarterectomy in patients with symptomatic carotid artery stenosis, showed a higher incidence of stroke and death with stenting than with endarterectomy. As the ICSS investigators mention, these results are consistent with those seen in previous randomised trials comparing stenting with endarterectomy in symptomatic patients (Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis [EVA-3S]2 and Stent-Protected Angioplasty versus Carotid Endarterectomy [SPACE]).3 As well as being associated with higher rates of stroke1,2 and recurrent carotid stenosis,3 carotid stenting is also substantially more costly than carotid endarterectomy.4 Thus, a reasonable question is: why should anyone attempt to establish carotid stenting as an alternative to carotid endarterectomy? Current data1–3 indicate that, with some exceptions (eg, distal lesions not accessible with carotid endarterectomy, previous irradiation therapy of the neck, and recurrent stenosis after previous endarterectomy), carotid endarterectomy should remain the gold standard for the treatment of carotid stenosis in symptomatic patients. Carotid stenting should be reserved for a minority of symptomatic patients for whom endarterectomy cannot be offered.5 I declare that I have no conflicts of interest.
Kosmas I Paraskevas [email protected] Department of Vascular Surgery, Red Cross Hospital, Iraklio 14122, Athens, Greece 1
International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010; 375: 985–97.
www.thelancet.com Vol 376 July 31, 2010
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Mas JL, Trinquart L, Leys D, et al; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol 2008; 7: 885–92. Eckstein HH, Ringleb P, Allenberg JR, et al. Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol 2008; 7: 893–902. McPhee JT, Schanzer A, Messina LM, Eslami MH. Carotid artery stenting has increased rates of postprocedure stroke, death, and resource utilization than does carotid endarterectomy in the United States, 2005. J Vasc Surg 2008; 48: 1442–50. Paraskevas KI, Mikhailidis DP, Veith FJ. Are symptomatic patients appropriate candidates for carotid artery stenting? No (at least not at present). Vascular (in press).
We would like to congratulate the International Carotid Stenting Study (ICSS) investigators1 for including myocardial infarction in the main outcome measure for the interim safety analysis at 120 days. Indeed, although the prevalence of coronary artery disease is known to be high in patients with carotid stenosis, cardiac complications have been frequently neglected in carotid revascularisation trials. However, neither in the current publication nor in the paper describing the trial protocol2 do the authors mention whether cardiac enzymes were obtained routinely after the procedure or only in the presence of clinical suspicion of myocardial ischaemia. On the basis of the exceedingly low incidence of myocardial infarction reported in the trial (<0·5% in both groups), we assume that the second scenario was applied. The SAPPHIRE trial,3 the only other randomised carotid stenting versus endarterectomy study that included myocardial infarction as an endpoint, detected far higher event rates and a broader gap between the two revascularisation strategies, with a 30-day myocardial infarction rate in the stenting group of 2·4% and in the endarterectomy group of 6·1%. Although we acknowledge that the population enrolled in the two trials might have differed, we believe
that the lack of systematic tracking of cardiac enzymes in ICSS could have artificially lowered the event rates, especially in the carotid endarterectomy group, to the detriment of the endovascular group. Systematic tracking of cardiac enzymes in patients undergoing vascular surgery is crucial since even asymptomatic troponin elevation in this setting has been associated with late mortality.4,5
Science Photo Library
Correspondence
See Editorial page 304
MR declares no conflicts of interest. AC has received consultancy fees and travel expenses from Boston Scientific, Abbott Vascular, Medtronic, and Invatec.
*Marco Roffi, Alberto Cremonesi marco.roffi@hcuge.ch Interventional Cardiology Unit, Division of Cardiology, University Hospital, 1211 Geneva 14, Switzerland (MR); and Interventional Cardio-Angiology Unit, Villa Maria Hospital, Cotignola, Italy (AC) 1
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International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010; 375: 985–97. Featherstone RL, Brown MM, Coward LJ. International Carotid Stenting Study: protocol for a randomised clinical trial comparing carotid stenting with endarterectomy in symptomatic carotid artery stenosis. Cerebrovasc Dis 2004; 18: 69–74. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004; 351: 1493–501. Landesberg G, Shatz V, Akopnik I, et al. Association of cardiac troponin, CK-MB, and postoperative myocardial ischemia with longterm survival after major vascular surgery. J Am Coll Cardiol 2003; 42: 1547–54. Kertai MD, Boersma E, Klein J, et al. Long-term prognostic value of asymptomatic cardiac troponin T elevations in patients after major vascular surgery. Eur J Vasc Endovasc Surg 2004; 28: 59–66.
Authors’ reply We agree with Kosmas Paraskevas that costs associated with carotid artery stenting are higher than with carotid endarterectomy, in Europe1 as well as the USA. This is partly explained by higher risks with stenting, but also reflects higher procedural costs related to device use. Thus, even if the clinical outcomes of carotid stenting and endarterectomy were equivalent, health-care providers might still favour endarterectomy because of
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
327
2
3
The International Carotid Stenting Study (ICSS; March 20, p 985),1 which compared carotid artery stenting with carotid endarterectomy in patients with symptomatic carotid artery stenosis, showed a higher incidence of stroke and death with stenting than with endarterectomy. As the ICSS investigators mention, these results are consistent with those seen in previous randomised trials comparing stenting with endarterectomy in symptomatic patients (Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis [EVA-3S]2 and Stent-Protected Angioplasty versus Carotid Endarterectomy [SPACE]).3 As well as being associated with higher rates of stroke1,2 and recurrent carotid stenosis,3 carotid stenting is also substantially more costly than carotid endarterectomy.4 Thus, a reasonable question is: why should anyone attempt to establish carotid stenting as an alternative to carotid endarterectomy? Current data1–3 indicate that, with some exceptions (eg, distal lesions not accessible with carotid endarterectomy, previous irradiation therapy of the neck, and recurrent stenosis after previous endarterectomy), carotid endarterectomy should remain the gold standard for the treatment of carotid stenosis in symptomatic patients. Carotid stenting should be reserved for a minority of symptomatic patients for whom endarterectomy cannot be offered.5 I declare that I have no conflicts of interest.
Kosmas I Paraskevas [email protected] Department of Vascular Surgery, Red Cross Hospital, Iraklio 14122, Athens, Greece 1
International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010; 375: 985–97.
www.thelancet.com Vol 376 July 31, 2010
4
5
Mas JL, Trinquart L, Leys D, et al; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol 2008; 7: 885–92. Eckstein HH, Ringleb P, Allenberg JR, et al. Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol 2008; 7: 893–902. McPhee JT, Schanzer A, Messina LM, Eslami MH. Carotid artery stenting has increased rates of postprocedure stroke, death, and resource utilization than does carotid endarterectomy in the United States, 2005. J Vasc Surg 2008; 48: 1442–50. Paraskevas KI, Mikhailidis DP, Veith FJ. Are symptomatic patients appropriate candidates for carotid artery stenting? No (at least not at present). Vascular (in press).
We would like to congratulate the International Carotid Stenting Study (ICSS) investigators1 for including myocardial infarction in the main outcome measure for the interim safety analysis at 120 days. Indeed, although the prevalence of coronary artery disease is known to be high in patients with carotid stenosis, cardiac complications have been frequently neglected in carotid revascularisation trials. However, neither in the current publication nor in the paper describing the trial protocol2 do the authors mention whether cardiac enzymes were obtained routinely after the procedure or only in the presence of clinical suspicion of myocardial ischaemia. On the basis of the exceedingly low incidence of myocardial infarction reported in the trial (<0·5% in both groups), we assume that the second scenario was applied. The SAPPHIRE trial,3 the only other randomised carotid stenting versus endarterectomy study that included myocardial infarction as an endpoint, detected far higher event rates and a broader gap between the two revascularisation strategies, with a 30-day myocardial infarction rate in the stenting group of 2·4% and in the endarterectomy group of 6·1%. Although we acknowledge that the population enrolled in the two trials might have differed, we believe
that the lack of systematic tracking of cardiac enzymes in ICSS could have artificially lowered the event rates, especially in the carotid endarterectomy group, to the detriment of the endovascular group. Systematic tracking of cardiac enzymes in patients undergoing vascular surgery is crucial since even asymptomatic troponin elevation in this setting has been associated with late mortality.4,5
Science Photo Library
Correspondence
See Editorial page 304
MR declares no conflicts of interest. AC has received consultancy fees and travel expenses from Boston Scientific, Abbott Vascular, Medtronic, and Invatec.
*Marco Roffi, Alberto Cremonesi marco.roffi@hcuge.ch Interventional Cardiology Unit, Division of Cardiology, University Hospital, 1211 Geneva 14, Switzerland (MR); and Interventional Cardio-Angiology Unit, Villa Maria Hospital, Cotignola, Italy (AC) 1
2
3
4
5
International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 2010; 375: 985–97. Featherstone RL, Brown MM, Coward LJ. International Carotid Stenting Study: protocol for a randomised clinical trial comparing carotid stenting with endarterectomy in symptomatic carotid artery stenosis. Cerebrovasc Dis 2004; 18: 69–74. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004; 351: 1493–501. Landesberg G, Shatz V, Akopnik I, et al. Association of cardiac troponin, CK-MB, and postoperative myocardial ischemia with longterm survival after major vascular surgery. J Am Coll Cardiol 2003; 42: 1547–54. Kertai MD, Boersma E, Klein J, et al. Long-term prognostic value of asymptomatic cardiac troponin T elevations in patients after major vascular surgery. Eur J Vasc Endovasc Surg 2004; 28: 59–66.
Authors’ reply We agree with Kosmas Paraskevas that costs associated with carotid artery stenting are higher than with carotid endarterectomy, in Europe1 as well as the USA. This is partly explained by higher risks with stenting, but also reflects higher procedural costs related to device use. Thus, even if the clinical outcomes of carotid stenting and endarterectomy were equivalent, health-care providers might still favour endarterectomy because of
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
327