Fire in the Hole
2011; Lippincott Williams & Wilkins; Volume: 123; Issue: 22 Linguagem: Inglês
10.1161/circulationaha.111.034314
ISSN1524-4539
Autores Tópico(s)Intracranial Aneurysms: Treatment and Complications
ResumoHomeCirculationVol. 123, No. 22Fire in the Hole Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBFire in the HoleCarotid Stenting Versus Endarterectomy Scott Kinlay, MBBS, PhD Scott KinlayScott Kinlay From the VA Boston Healthcare System, Brigham and Women's Hospital, Harvard Medical School, Boston MA. Originally published23 May 2011https://doi.org/10.1161/CIRCULATIONAHA.111.034314Circulation. 2011;123:2522–2525Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2011: Previous Version 1 Carotid artery stenting has weathered a withering attack during the past year.1–3 Comparisons of the 3 recent randomized trials from Europe comparing carotid stenting with endarterectomy in symptomatic patients4,5 lead many to favor endarterectomy.1–3 The other 2 trials from North America included a mix of symptomatic and asymptomatic patients with carotid stenosis,6,7 and suggest more muted differences, pointing to equivalence or at least equipoise between the 2 modes of revascularization (Figure). This transatlantic tug-of-war is particularly focused on the importance of adequate training and experience in stenting among operators, the different end points between these trials, and patient selection.Download figureDownload PowerPointFigure. Individual and pooled absolute risk reduction (carotid artery stenting – endarterectomy) for any stroke or death. Intention-to-treat analysis of events from randomization to 30 days postprocedure, stratified by symptoms and operator credentialing (from review of 20 or more carotid procedures) in the recent randomized trials.4–7,14–17 Analysis was performed using the STATA statistical package with random-effects model and heterogeneity assessed by the I-squared statistic. CAS indicates carotid artery stenting; CEA, carotid endarterectomy; ARR, absolute risk reduction; EVA-3S, Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; SPACE, Stent-Protected Angioplasty versus Carotid Endarterectomy; SAPPHIRE, Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy; CREST, Carotid Revascularization Endarterectomy Versus Stenting Trial; and ICSS, International Carotid Stenting Study.Operator Experience and SkillAs with carotid endarterectomy, adequate operator training, credentialing, and auditing are important aspects of carotid stenting.2 Credentialing to select surgeons with low complication rates was a major feature of the randomized trials of endarterectomy in comparison with medical therapy 2 decades ago.8–13 The minimization of periprocedural stroke and death permitted an assessment of the maximum efficacy of endarterectomy in symptomatic and asymptomatic patients. However, this principle was applied selectively in the recent major trials of carotid stenting compared with carotid endarterectomy.4–6,14,15 Whereas carotid endarterectomy required specific criteria for demonstrating volume and low procedural complications in all trials, relatively inexperienced operators could do carotid stenting in some European studies.4,5 Embolic protection devices, often considered an essential tool to prevent periprocedural stroke, were used variably in the European studies,4,5,14 and could be a marker of operator experience or carotid plaque with a perceived higher risk of embolization in these trials. Notably, the absolute difference in periprocedural stroke between endarterectomy and stenting was lower in the North American trials, where credentialing for stenting by case review of 20 or more carotid stent cases was a prerequisite for operators (Figure).6,7,15–17 Because the differences in outcomes are much less after the periprocedural period,6,7,18,19 operator skill and other factors related to low periprocedural adverse events will determine the long-term value and widespread applicability of either mode of revascularization.Periprocedural End PointsRecent reviews criticize the inclusion of periprocedural myocardial infarction as an end point in Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) and Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).1,2 They claim that this loads the dice in favor of stenting, in particular, when general anesthesia and vascular surgery have higher risks of periprocedural myocardial infarction. This argument is supported by the analysis of quality of life at 1 year in CREST.6 In these post hoc analyses, periprocedural major and minor stroke, but not myocardial infarction, significantly lowered physical and mental component scales.6 Although the declines with major stroke were consistent across scales, the declines with minor stroke were smaller, and similar in magnitude to, patients experiencing periprocedural myocardial infarction. The CREST trial did not report the quality-of-life differences between endarterectomy and stenting, in contrast to the SAPPHIRE trial, where there were no differences in quality of life between the 2 modes of intervention at 1 year.20 Nevertheless, the CREST results propagated a view by prominent neurologists that stroke was a more important periprocedural adverse event than myocardial infarction.1,2Article see p 2571The debate is tackled head on by the CREST investigators in the current issue of Circulation.21 Rebutting this opinion, Blackshear et al show that both conventionally defined myocardial infarction and silent myocardial infarction (cardiac enzyme elevation alone) in the first 30 days after carotid revascularization were associated with a higher risk of death over the subsequent 4 years of the study. Although they demonstrate the importance of periprocedural myocardial infarction from the patient's perspective, the low incidence limited its impact on all deaths over the subsequent 4 years (a low population-attributable risk for death). Perhaps this is why the higher rate of periprocedural myocardial infarction in the endarterectomy group did not pan out to greater deaths in comparison with stenting over the 4 years of the study.Mechanistic versus Patient-Orientated End PointsThe end points of clinical trials in the treatment of carotid disease to prevent stroke also require more thought. Arguably, there are 2 important perspectives to consider (Table). These include a more mechanistic question of whether endarterectomy, stenting, or medical therapy alone can reduce stroke caused by a significant carotid stenosis. The efficacy end points most suitable for this question are the long-term risk of ipsilateral stroke and cerebrovascular death (including periprocedural events). Because asymptomatic disease generally requires >3 years for benefit over medical therapy, a 4- to 5-year time frame for this end point is appropriate; whereas, in symptomatic patients, a shorter time frame of 1 to 2 years may be adequate.Table. Potential End Points for Future Trials of Managing Severe Carotid StenosisEnd PointsTime FrameAsymptomatic Carotid StenosisSymptomatic Carotid StenosisEfficacy Primary mechanistic end point Ipsilateral stroke4–5 y1–2 y CV death Primary patient-orientated end point Any stroke4–5 y1–2 y All-cause death Myocardial infarction Secondary patient-orientated end point Cognitive function4–5 y1–2 y Independence of daily living Quality of lifeProcedural safety Primary Any stroke<30 d<30 d Any death Periprocedural MI Secondary Silent MI<30 d 75 years, operator/surgical experience and skill, mild cognitive defects or dementia, recent acute coronary syndromes, and prior cardiovascular disease).6,21,24–28 Other risk factors are more relevant for increasing the risk with stenting (heavily calcified lesions and excessive tortuosity of the internal carotid),27 and some risk factors are specific to endarterectomy (congestive heart failure, very high or very low lesions, prior radiotherapy, prior ipsilateral carotid endarterectomy, and contralateral occlusion).11,24,26,28 However, contemporary studies of carotid revascularization make assumptions of benefit based on antique medical therapy.Optimal Medical Therapy: An Untested TreatmentThis highlights the major deficiency in our knowledge on the management of carotid disease for stroke prevention. Contemporary optimal medical therapy directed against atherosclerosis and platelet activity potently prevents stroke in populations at high cardiovascular risk. For example, in the randomized trials of coronary disease prevention, statins lowered the risk of ischemic stroke by 20% to 50%.29 In the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, which enrolled patients with transient ischemic attack or minor stroke, intensive statin therapy lowered the 5-year rate of fatal or nonfatal stroke risk by an absolute difference of 1.9% (relative reduction of 16%).30 Although these studies did not specifically enroll patients with significant carotid stenoses, similar magnitudes of effect were observed in the ACST study among patients receiving lipid lowering of varying intensity.12 Optimal medical therapy attacks the biological processes of plaque instability and inflammation (fire in the hole) responsible for ischemic stroke in patients with carotid disease.31 Thus, contemporary optimal medical therapy is likely to erode the potential incremental benefit from carotid revascularization.3Current PracticeThe wide variation in periprocedural adverse events between the stent versus endarterectomy trials points to a measured approach when deciding on any carotid revascularization or the mode of revascularization. When the risk of stroke without revascularization is high, carotid stenting will be favored in patients with higher periprocedural surgical risk and endarterectomy will be favored in patients at high periprocedural risk from stenting. Both modes of revascularization require operators who are adequately trained, credentialed, and audited for low periprocedural adverse events. The relative merits of stent versus surgery for patients at average periprocedural risk are less concerning with good operator experience than the more pressing issue of improving our ability to define patients who really obtain benefit from revascularization beyond optimal medical therapy.Importantly, antiatherosclerotic (statins, antihypertensives, nonsmoking, and weight reduction) and antiplatelet (aspirin and thienopyridines) therapy are not placebo treatment, and may be the preferred alternative in patients with characteristics that portend high periprocedural risk from either stenting or surgery (inexperienced operator/surgeon, patients with extreme age, cognitive deficits or dementia, or recent acute coronary syndromes).6,24–28In clinical practice, the balance of risks may require true grit on the part of operators and surgeons to refer to other specialties or decline revascularization in favor of optimal medical therapy alone. As a profession, the future of carotid revascularization depends on our courage to test optimal medical therapy with and without revascularization in randomized trials against mechanistic and patient-orientated outcomes.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Scott Kinlay, MBBS, PhD, Director, Cardiac Catheterization Laboratory and Vascular Medicine, Cardiovascular Division, VA Boston Healthcare System, 1400 VFW Parkway, West Roxbury, MA 02132. E-mail scott.[email protected]govReferences1. Amarenco P, Labreuche J, Mazighi M. Lessons from carotid endarterectomy and stenting trials. Lancet. 2010; 376:1028–1031.CrossrefMedlineGoogle Scholar2. Davis SM, Donnan GA. Carotid-artery stenting in stroke prevention. N Engl J Med. 2010; 363:80–82.CrossrefMedlineGoogle Scholar3. Rothwell PM. 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Weinberg I, Beckman J, Matsumura J, Rosenfield K, Ansel G, Chaturvedi S, Gray W, Metzger D, Riles T, Shu Y, Wechsler L and Jaff M (2018) Carotid Stent Fractures Are Not Associated With Adverse Events, Circulation, 10.1161/CIRCULATIONAHA.117.030030, 137:1, (49-56), Online publication date: 2-Jan-2018. Rosenfield K, Matsumura J, Chaturvedi S, Riles T, Ansel G, Metzger D, Wechsler L, Jaff M and Gray W (2016) Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis, New England Journal of Medicine, 10.1056/NEJMoa1515706, 374:11, (1011-1020), Online publication date: 17-Mar-2016. Bonaca M and Beckman J (2014) Primary Stroke Prevention, Interventional Cardiology Clinics, 10.1016/j.iccl.2013.08.003, 3:1, (1-11), Online publication date: 1-Jan-2014. Bonaca M and Beckman J (2013) Management of Asymptomatic Carotid Artery Stenosis, Current Treatment Options in Cardiovascular Medicine, 10.1007/s11936-013-0237-6, 15:2, (252-263), Online publication date: 1-Apr-2013. Tadros R, Vouyouka A, Chung C, Malik R, Krishnan P, Ellozy S, Marin M and Faries P (2013) The Effect of Statin Use on Embolic Potential During Carotid Angioplasty and Stenting, Annals of Vascular Surgery, 10.1016/j.avsg.2012.06.007, 27:1, (96-103), Online publication date: 1-Jan-2013. Tadros R, Malik R, Vouyouka A, Ellozy S, Marin M and Faries P (2013) A systematic review of carotid stent design and selection: strategies to optimize procedural outcomes, Interventional Cardiology, 10.2217/ica.13.8, 5:2, (203-211), Online publication date: 1-Apr-2013. Wimmer N, Yeh R, Cutlip D and Mauri L (2012) Risk Prediction for Adverse Events After Carotid Artery Stenting in Higher Surgical Risk Patients, Stroke, 43:12, (3218-3224), Online publication date: 1-Dec-2012. Tadros R, Spyris C, Vouyouka A, Chung C, Krishnan P, Arnold M, Marin M and Faries P (2012) Comparing the embolic potential of open and closed cell stents during carotid angioplasty and stenting, Journal of Vascular Surgery, 10.1016/j.jvs.2011.12.077, 56:1, (89-95), Online publication date: 1-Jul-2012. Frey P and Kinlay S (2012) The Management of Carotid Stenoses in the Elderly, Current Cardiovascular Risk Reports, 10.1007/s12170-012-0258-9, 6:5, (425-430), Online publication date: 1-Oct-2012. June 7, 2011Vol 123, Issue 22 Advertisement Article InformationMetrics © 2011 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.111.034314 Originally publishedMay 23, 2011 Keywordscarotid endarterectomycarotid artery stentingcarotid arteriescarotid stentingPDF download Advertisement SubjectsCerebrovascular ProceduresPercutaneous Coronary InterventionStenosisTreatment
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