Current status of carotid artery stenting
2006; Elsevier BV; Volume: 43; Issue: 2 Linguagem: Inglês
10.1016/j.jvs.2005.11.012
ISSN1097-6809
AutoresPhilip P. Goodney, Marc L. Schermerhorn, Richard J. Powell,
Tópico(s)Acute Ischemic Stroke Management
ResumoThis Clinical Update summarizes the results of larger case series, industry-sponsored registries, and randomized trials of carotid artery stenting (CAS). In >20 case series that studied >24,000 patients undergoing CAS, 51% of patients were symptomatic, most procedures (97%) resulted in successful stent deployment, and 30-day stroke rates varied from 1% to 8%, with a trend toward lower rates as experience and embolic protection device (EPD) use increased. In 12 industry-sponsored registries (none were published in peer-reviewed journals), 30-day stroke rates varied from 2% to 7%, and 30-day combined adverse events, including stroke, death, and myocardial infarction, were 3% to 9%. More than 12 randomized trials comparing CAS and carotid endarterectomy (CEA) have been initiated since 1998. Results have varied over time, depending on the population studied and the technology used. However, the largest and most recent results of the completed SAPPHIRE trial in high-risk patients undergoing CAS with the use of EPDs demonstrated that CAS is at least not inferior to CEA, with a 1-year combined adverse event rate of 12% for CAS and 20% for CEA (P = .05). Other ongoing trials will address not only whether CAS could be superior to CEA in high-risk patients but also, more importantly, whether CAS is beneficial in other subgroups, such as low-risk and asymptomatic patients. This Clinical Update summarizes the results of larger case series, industry-sponsored registries, and randomized trials of carotid artery stenting (CAS). In >20 case series that studied >24,000 patients undergoing CAS, 51% of patients were symptomatic, most procedures (97%) resulted in successful stent deployment, and 30-day stroke rates varied from 1% to 8%, with a trend toward lower rates as experience and embolic protection device (EPD) use increased. In 12 industry-sponsored registries (none were published in peer-reviewed journals), 30-day stroke rates varied from 2% to 7%, and 30-day combined adverse events, including stroke, death, and myocardial infarction, were 3% to 9%. More than 12 randomized trials comparing CAS and carotid endarterectomy (CEA) have been initiated since 1998. Results have varied over time, depending on the population studied and the technology used. However, the largest and most recent results of the completed SAPPHIRE trial in high-risk patients undergoing CAS with the use of EPDs demonstrated that CAS is at least not inferior to CEA, with a 1-year combined adverse event rate of 12% for CAS and 20% for CEA (P = .05). Other ongoing trials will address not only whether CAS could be superior to CEA in high-risk patients but also, more importantly, whether CAS is beneficial in other subgroups, such as low-risk and asymptomatic patients. Carotid artery stenting (CAS) is increasingly used in place of carotid endarterectomy (CEA) even though few randomized trials have directly compared these alternatives. This is based in part on case series and industry-sponsored registries, many of which have not yet been published in peer-reviewed journals. This Clinical Update reviews the status of CAS based on currently available data. Since the advent of CAS in the mid 1990s, >20 case series of at least 99 patients have been published, reporting >24,000 patients (Table I). A weighted average of these studies indicates that 51% of patients treated were symptomatic and >97% received the planned stent. Independent outcome evaluation by a neurologist was performed in 64% of series.Table ICase series of carotid artery stentingStudy authorYearPatients/arteries (N)% symptomatic% with stentDominant stent% with EPDDominant EPDNeuro MD30-day stroke %30-day death %30-day MI %30-day combined %Restenosis %Follow-up (months)Dietrich22Diethrich E.B. Ndiaye M. Reid D.B. Stenting in the carotid artery initial experience in 110 patients.J Endovasc Surg. 1996; 3: 42-62Crossref PubMed Scopus (558) Google Scholar1996110/1172899Palmaz0NoneNo6.40.9—10.93.43Yadav23Yadav J.S. Roubin G.S. Iyer S. Vitek J. King P. Jordan W.D. et al.Elective stenting of the extracranial carotid arteries.Circulation. 1997; 95: 376-381Crossref PubMed Scopus (638) Google Scholar1997107/12659100Variable0NoneYes7.00.9—7.94.96Bergeron24Bergeron P. Becquemin J.P. Jausseran J.M. Biasi G. Cardon J.M. Castellani L. et al.Percutaneous stenting of the internal carotid artery: the European CAST I Study. Carotid Artery Stent Trial.J Endovasc Surg. 1999; 6: 155-159Crossref PubMed Scopus (97) Google Scholar199997/994497Palmaz0NoneYes5.00.00.05.03.013Henry25Henry M. Amor M. Masson I. Henry I. Tzvetanov K. Chati Z. et al.Angioplasty and stenting of the extracranial carotid arteries.J Endovasc Surg. 1998; 5: 293-304Crossref PubMed Scopus (151) Google Scholar2000290/3154299Palmaz52PercusurgeYes4.20.3——4.713Shawl26Shawl F. Kadro W. Domanski M.J. Lapetina F.L. Iqbal A.A. Dougherty K.G. et al.Safety and efficacy of elective carotid artery stenting in high-risk patients.J Am Coll Cardiol. 1721; 35: 1721-1728Abstract Full Text Full Text PDF Scopus (174) Google Scholar2000170/1926199Palmaz0NoneYes2.90.00.00.02.019Roubin27Roubin G.S. New G. Iyer S.S. 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: 532-537Crossref PubMed Scopus (709) Google Scholar2001528/6044898Variable0NoneNo5.80.00.07.43.136Ahmadi28Ahmadi R. Willfort A. Lang W. Schillinger M. Alt E. Gschwandtner M.E. et al.Carotid artery stenting effect of learning curve and intermediate-term morphological outcome.J Endovasc Ther. 2001; 8: 539-546Crossref PubMed Scopus (150) Google Scholar2001303/3203893Wallstent0NoneYes7.80.60.08.48.012Criado29Criado F.J. Lingelbach J.M. Ledesma D.F. Lucas P.R. Carotid artery stenting in a vascular surgery practice.J Vasc Surg. 2002; 35: 430-434Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar2002132/1354098SMART0NoneNo3.000.03.03.016Guimaraens30Guimaraens L. Sola M.T. Matali A. Arbelaez A. Delgado M. 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Gimelli G. et al.Carotid artery stenting in the first 100 consecutive patients results and follow up.Heart. 2002; 88: 381-386Crossref PubMed Scopus (36) Google Scholar2002100/1023797Variable67NeuroshieldYes7.00.00.07.03.412Kastrup34Kastrup A. Skalej M. Krapf H. Nagele T. Dichgans J. Schulz J.B. Early outcome of carotid angioplasty and stenting versus carotid endarterectomy in a single academic center.Cerebrovasc Dis. 2003; 15: 84-89Crossref PubMed Scopus (39) Google Scholar2003100/10063100SMART0NoneNo7.01.00.08.0——Cremonesi35Cremonesi A. Manetti R. Setacci F. Setacci C. Castriota F. Protected carotid stenting clinical advantages and complications of embolic protection devices in 442 consecutive patients.Stroke. 2003; 34: 1936-1941Crossref PubMed Scopus (330) Google Scholar2003442/4425799Wallstent100AngioguardYes1.10.00.03.4⁎Combined complications included carotid dissection and intracranial hemorrhage30 daysWholey36Wholey M.H. Al-Mubarek N. Wholey M.H. Updated review of the global carotid artery stent registry.Catheter Cardiovasc Interv. 2003; 60: 259-266Crossref PubMed Scopus (463) Google Scholar†Self reported multi-practitioner registry, not a case series200311234/123925398Variable38VariableNo4.00.8—4.82.436Cernetti37Cernetti C. Reimers B. Picciolo A. Sacca S. Pasquetto G. Piccolo P. et al.Carotid artery stenting with cerebral protection in 100 consecutive patients immediate and two-year follow-up results.Ital Heart J. 2003; 4: 695-700PubMed Google Scholar2003100/1042399Variable98PercusurgeYes3.01.01.05%1.824Hobson38Hobson R.W.2nd Lal B.K. Chakhtoura E. Goldstein J. Haser P.B. Kubicka R. et al.Carotid artery stenting analysis of data for 105 patients at high risk.J Vasc Surg. 2003; 37 ([see comment][erratum appears in J Vasc Surg. 2003 Sep;38(3):497 Note: Chaktoura Ellie Y [corrected to Chakhtoura Elie Y]]) (1234): 1234-1239Abstract Full Text Full Text PDF PubMed Scopus (84) Google Scholar2003105/11439100Wallstent25AccunetYes1.02.01.03.03.826Hobson5Hobson R.W. Howard V.J. Roubin G.S. Brott T.G. Ferguson R.D. Popma J.J. et al.Carotid artery stenting is associated with increased complications in octogenarians 30-day stroke and death rates in the CREST lead-in phase.J Vasc Surg. 2004; 40: 1106-1111Abstract Full Text Full Text PDF PubMed Scopus (517) Google Scholar2004749/7493199Acculink88AccunetYes4.00.8—4.4.——Sztriha39Sztriha L.K. Voros E. Sas K. Szentgyorgyi R. Pocsik A. Barzo P. et al.Favorable early outcome of carotid artery stenting without protection devices.Stroke. 2004; 35: 2862-2866Crossref PubMed Scopus (37) Google Scholar2004245/2605399Wallstent0NoneYes3.10.40.03.5——Henry40Henry M. Polydorou A. Henry I. Hugel M. Carotid angioplasty under cerebral protection with the PercuSurge GuardWire System.Catheter Cardiovasc Interv. 2004; 61: 293-305Crossref PubMed Scopus (46) Google Scholar2004246/27264100Palmaz99PercusurgeNo1.90.40.02.30.523Riemers41Reimers B. Schluter M. Castriota F. Tubler T. Corvaja N. Cernetti C. et al.Routine use of cerebral protection during carotid artery stenting results of a multicenter registry of 753 patients.Am J Med. 2004; 116 ([see comment]): 217-222Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar2004753/80826100Multiple100MultipleYes5.60.10.05.7——Theiss21Theiss W. Hermanek P. Mathias K. Ahmadi R. Heuser L. Hoffmann F.J. et al.Pro-CAS a prospective registry of carotid angioplasty and stenting.Stroke. 2004; 35: 2134-2139Crossref PubMed Scopus (145) Google Scholar20043270/38535693Multiple64MultipleYes2.5‡Some results in this series represent 69 day results, not 30-day results0.6‡Some results in this series represent 69 day results, not 30-day results—2.8^Sganzerla42Sganzerla P. Bocciarelli M. Savasta C. Bonin M. Tavasci E. Fini M. et al.The treatment of carotid artery bifurcation stenoses with systematic stenting experience of first 100 consecutive cardiological procedures.J Invasive Cardiol. 2004; 16: 592-595PubMed Google Scholar200494/10034100Variable100VariableYes5.00.00.05.0——Vos43Vos J.A. van den Berg J.C. Ernst S.M. Suttorp M.J. Overtoom T.T. Mauser H.W. 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. 2005; 234: 493-499Crossref PubMed Scopus (144) Google Scholar2005509/5093398Wallstent30FilterwireYes3.71.004.7——Yen44Yen M.H. Lee D.S. Kapadia S. Sachar R. Bhatt D.L. Bajzer C.T. et al.Symptomatic patients have similar outcomes compared with asymptomatic patients after carotid artery stenting with emboli protection.Am J Cardiol. 2005; 95: 297-300Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar2005174/17436100Acculink100AngioguardYes1.71.7—3.4——Boseirs45Bosiers M. Peeters P. Deloose K. Verbist J. Sievert H. Sugita J. et al.Does carotid artery stenting work on the long run 5-year results in high-volume centers.J Cardiovasc Surg. 2005; 46: 241-247PubMed Google Scholar†Self reported multi-practitioner registry, not a case series20052712/21724199Multiple85MultipleNo1.23.472Zahn46Zahn R. Ischinger T. Mark B. Gass S. Zeymer U. Schmalz W. et al.Embolic protection devices for carotid artery stenting is there a difference between filter and distal occlusive devices?.J Am Coll Cardiol. 2005; 45: 1769-1774Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar20051734/184155100Multiple42EmboshieldNo3.00.8—3.8——Neuro MD, Independent neurologic evaluation by a neurologist; MI, myocardial infarction; EPD, embolic protection device.This list represents all case series reported in peer-reviewed journals with greater than or equal to 99 patients or arteries.Stent type or EPD type reported as "multiple" if there was not a dominant type used.Stent type or EPD type reported as "variable" if stents or EPDs were not used on each patient in the series.In some registries, individual patients experienced multiple adverse events. Therefore combined rate is not always additive Combined complications included carotid dissection and intracranial hemorrhage† Self reported multi-practitioner registry, not a case series‡ Some results in this series represent 69 day results, not 30-day results Open table in a new tab Neuro MD, Independent neurologic evaluation by a neurologist; MI, myocardial infarction; EPD, embolic protection device. This list represents all case series reported in peer-reviewed journals with greater than or equal to 99 patients or arteries. Stent type or EPD type reported as "multiple" if there was not a dominant type used. Stent type or EPD type reported as "variable" if stents or EPDs were not used on each patient in the series. In some registries, individual patients experienced multiple adverse events. Therefore combined rate is not always additive After 2002, embolic protection devices (EPDs) were widely used. In terms of outcomes, 30-day stroke rates varied from 1% to 8%, but there was a trend toward lower rates as experience increased with time and EPD use became more widespread. Overall, the average 30-day stroke rate was 3% across all studies, and the average combined 30-day rate of stroke, myocardial infarction, or death was 4%. These outcomes should be interpreted with caution, however, because rates varied with year of procedure, EPD use, neurologist examination, and patient characteristics. Lastly, early restenosis rates appeared low (1% to 8%), albeit only reported in half the studies. Results from >10 industry-sponsored trials of specific CAS systems have been presented at national meetings, but none have yet been published in a peer-reviewed journal. All of these registries, except for the Acculink for Revascularization of Carotids in High Risk Patients 1 (ARCHeR 1), routinely used EPDs. (Table II). Stroke rates varied from 2% to 7% at 30 days, and combined adverse outcome measures (stroke, death or myocardial infarction) varied from 3% to 8% at 30 days. A weighted average across these registries showed that 27% of patients were symptomatic, 4% of patients experienced periprocedural strokes, and combined adverse outcome measures were 6% at 30 days.Table IITrials of carotid artery stentingNamePatients (N)Year results presentedPublished in peer-reviewed journal% symptomaticStentEmbolic protection device30-day stroke %30-day death %30-day MI %30-day combined %SECuRITY47http://www.clevelandclinic.org/heartcenter/pub/news/archive/2003/security9_17.asp. Accessed Oct 15, 2005Google Scholar3052003NoNot reportedXactEmboshield6.90.307.2ARCHER148Gray WH. The ARCHeR Trials: one year results. AHA Scientific Sessions 2004. Accessed Oct 15, 2005.Google Scholar1582004No25AcculinkNone4.42.52.57.6ARCHeR248Gray WH. The ARCHeR Trials: one year results. AHA Scientific Sessions 2004. Accessed Oct 15, 2005.Google Scholar2782004No24AcculinkAccunet2.25.82.98.6ARCHeR348Gray WH. The ARCHeR Trials: one year results. AHA Scientific Sessions 2004. Accessed Oct 15, 2005.Google Scholar1452004No21AcculinkAccunet1.46.20.78.3MOMA49Clinical Trial Update. Endovasc Today p. 60-1. Accessed Oct 15, 2005.Google Scholar1572005NoNot reportedVariableMOMA5.7—05.7PRIAMUS49Clinical Trial Update. Endovasc Today p. 60-1. Accessed Oct 15, 2005.Google Scholar4162005No63VariableMOMA4.20.4—4.6PASCAL49Clinical Trial Update. Endovasc Today p. 60-1. Accessed Oct 15, 2005.Google Scholar1132005NoNot reportedExponentVariable———8.0MAVERiC50http://www.strokecenter.org/trials/TrialDetail.asp?ref=283&browse=M. Accessed Oct 15, 2005Google Scholar4982004No24ExponentGuardwire2.02.01.25.1CREATE51http://www.medpagetoday.com/tbindex.cfm?tbid=825&topicid=8. 2004. Accessed Oct 15, 2005Google Scholar4192004No17ProtégéSpider3.31.00.54.8BEACH52http://www.ptca.org/press_rel/20050427pr_boston.html. Accessed Oct 15, 2005Google Scholar4802005No25WallstentFilterwire4.21.50.85.8CABERNET53http://salesandmarketingnetwork.com/news_release.php?ID=2000813&key=TCT. Accessed Oct 15, 2005Google Scholar4332005No24NexStentFilterwire3.40.50.23.8SHELTER54http://www.strokecenter.org/trials/TrialDetail.asp?ref=192&browse=S. Accessed Oct 15, 2005Google Scholar——No—WallstentGuardwire Plus————Neuro MD, Independent neurologic evaluation by a neurologist; MI, myocardial infarction.Trials reported in chronological order of when results were presented. In some registries, individual patients experienced multiple adverse events; therefore combined rate is not always additive. Open table in a new tab Neuro MD, Independent neurologic evaluation by a neurologist; MI, myocardial infarction. Trials reported in chronological order of when results were presented. In some registries, individual patients experienced multiple adverse events; therefore combined rate is not always additive. Two registries have led to device approval by the US Food and Drug Administration (FDA). The ARCHeR registry was utilized by Guidant (Indianapolis, Ind) to obtain United States Food and Drug Administration (FDA) approval for the Accunet/Acculink system, and the SECuRITY registry allowed Abbott (Abbott Park, Ill) to obtain FDA approval for the Xact/Emboshield system. These registries achieved low stroke rates for CAS. It is important to note, however, that in the process of achieving FDA approval, these results were compared with historical controls of CEA in high-risk patients. For example, in ARCHeR, the estimated stroke rate for high-risk patients undergoing CEA was 14.5%. In many centers of excellence, combined adverse event rates after CEA in high-risk patients were much lower than that assumed by these registries, between 5% and 7%1Ouriel K. Hertzer N.R. Beven E.G. O'hara P.J. Krajewski L.P. Clair D.G. et al.Preprocedural risk stratification identifying an appropriate population for carotid stenting.J Vasc Surg. 2001; 33: 728-732Abstract Full Text Full Text PDF PubMed Scopus (167) Google Scholar, 2Mozes G. Sullivan T.M. Torres-Russotto D.R. Bower T.C. Hoskin T.L. Sampaio S.M. et al.Carotid endarterectomy in SAPPHIRE-eligible high-risk patients implications for selecting patients for carotid angioplasty and stenting.J Vasc Surg. 2004; 39: 958-965Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar at 1 year. At least 12 trials directly comparing CAS and CEA have been initiated (Table III). All except Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS)3CARESS Steering CommitteeCarotid revascularization using endarterectomy or stenting systems (CARESS) phase I clinical trial.J Endovasc Ther. 2003; 10: 1021-1030Crossref PubMed Scopus (174) Google Scholar were randomized controlled trials. All used independent neurologist examinations to determine outcomes. Nearly all trials initiated after 2001 utilized EPDs. Unlike the other trials, CARESS assigned patients to CAS or CEA via "selection criteria reflective of broad clinical practice."3CARESS Steering CommitteeCarotid revascularization using endarterectomy or stenting systems (CARESS) phase I clinical trial.J Endovasc Ther. 2003; 10: 1021-1030Crossref PubMed Scopus (174) Google Scholar CARESS achieved some of the lowest stroke and overall complication rates reported across all trials for both CAS and CEA, indicating the possibility that careful patient selection may be one of the most important determinants of outcome for both CAS and CEA.Table IIIRandomized trials of carotid artery stentingNameCAS patientsCEA PatientsYear results presentedPublished in a peer-reviewed journal?DominantstentDominant EPDNeuro MDFollow-up30-day stroke%30-day death %30 day MI %30-day combined outcomeCASCEACASCEACASCEACASCEANaylor et al 55Naylor A. Bolia A. Abbott R. Pye I.F. Smith J. Lennard N. et al.Randomized study of carotid angioplasty and stenting versus carotid endarterectomy a stopped trial.J Vasc Surg. 1998; 31: 622-624Google Scholar7101998YesNoneNoneYes30 days710Alberts .et al56Alberts M.J. Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.Stroke. 2001; 32 (abstract): 325Crossref Scopus (7) Google Scholar1071122001YesWallstentNoneYes1 year12.13.6Brooks et al57Brooks W.H. McClure R.R. Jones M.R. Coleman T.C. Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy randomized trial in a community hospital.J Am Coll Cardiol. 2001; 38 ([see comment]): 1589-1595Abstract Full Text Full Text PDF PubMed Scopus (361) Google Scholar52522001YesVariableVariableYes30 days00.003.0Brooks et al58Brooks W.H. McClure R.R. Jones M.R. Coleman T.L. Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis a randomized trial in a community hospital.Neurosurgery. 2004; 54: 318-324Crossref PubMed Scopus (217) Google Scholar43422004YesWallstent/DynalinkNoneYes2 years0000CAVATAS:20Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) a randomised trial.Lancet. 2001; 357: 1729-1737Abstract Full Text Full Text PDF PubMed Scopus (1364) Google Scholar2512532001YesVariableNoneYes30 days8.08.03.02.0——10.09.9CARESS3CARESS Steering CommitteeCarotid revascularization using endarterectomy or stenting systems (CARESS) phase I clinical trial.J Endovasc Ther. 2003; 10: 1021-1030Crossref PubMed Scopus (174) Google Scholar†Number of patients listed represents the number planned for enrollment.‡Not randomized. Patients assigned via "selection criteria reflective of broad clinical practice."2541432003YesWallstentGuardwire PlusYes30 days2.13.60.00.40.00.82.14.4SAPPHIRE4Yadav J.S. Wholey M.H. Kuntz R.E. Fayad P. Katzen B.T. Mishkel G.J. et al.Protected carotid-artery stenting versus endarterectomy in high-risk patients.N Engl J Med. 2004; 351: 1493-1501Crossref PubMed Scopus (2549) Google Scholar1671672004YesSmart/PreciseAngioguardYes2 years3.63.11.22.52.46.14.89.8EVAS-3S8http://eva3s.hegp.bhdc.jussieu.fr/. Accessed Oct 15, 2005Google Scholar, 59Mas J.L. Chatellier G. Beyssen B. Investigators E.-S. Carotid angioplasty and stenting with and without cerebral protection clinical alert from the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial.Stroke. 2004; 35: e18-e20PubMed Google Scholar⁎Trial currently ongoing.†Number of patients listed represents the number planned for enrollment.1501502004YesMultipleMultipleYes4 years8.6§CAS stroke rate based on first 80 patients in CAS arm. Stent type or EPD type reported as "multiple" if there was not a dominant type used.CREST5Hobson R.W. Howard V.J. Roubin G.S. Brott T.G. Ferguson R.D. Popma J.J. et al.Carotid artery stenting is associated with increased complications in octogenarians 30-day stroke and death rates in the CREST lead-in phase.J Vasc Surg. 2004; 40: 1106-1111Abstract Full Text Full Text PDF PubMed Scopus (517) Google Scholar⁎Trial currently ongoing.†Number of patients listed represents the number planned for enrollment.12501250——AcculinkAccunetYes4 years————————ICSS6http://www.ion.ucl.ac.uk/cavatas_icss/summary.htm. Accessed Oct 15, 2005.Google Scholar⁎Trial currently ongoing.†Number of patients listed represents the number planned for enrollment.750750——MultipleMultipleYes30 days————————CAVATAS II60http://www.ion.ucl.ac.uk/cavatas_icss/cavatas.htm. Accessed Oct 15, 2005Google Scholar⁎Trial currently ongoing.†Number of patients listed represents the number planned for enrollment.233233——MultipleMultipleYes5 years————————ACT I9http://www.ptca.org/pr_abbott/20050118.html. Accessed Oct 15, 2005Google Scholar⁎Trial currently ongoing.†Number of patients listed represents the number planned for enrollment.750750——XactEmboshieldYes1 year————————SPACE7http://www.space.stroke-trial.com/. Accessed Oct 15, 2005Google Scholar†Number of patients listed represents the number planned for enrollment.⁎Trial currently ongoing.430430——AcculinkAccunetYes30 days————————CAS, Carotid artery stenting, CEA, carotid endarterectomy; Neuro MD, independent neurologic evaluation by neurologist; MI, myocardial infarction; EPD, embolic protection device. Trial currently ongoing.† Number of patients listed represents the number planned for enrollment.‡ Not randomized. Patients assigned via "selection criteria reflective of broad clinical practice."§ CAS stroke rate based on first 80 patients in CAS arm. Stent type or EPD type reported as "multiple" if there was not a dominant type used. Open table in a new tab CAS, Carotid artery stenting, CEA, carotid endarterectomy; Neuro MD, independent neurologic evaluation by neurologist; MI, myocardial infarction; EPD, embolic protection device. Although 7 of the 12 trials have publicly reported outcomes, the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial is most widely cited because it reported 2-year results with uniform usage of EPDs. In this trial, 334 patients who were considered high risk for CEA were randomized to CEA or CAS.4Yadav J.S. Wholey M.H. Kuntz R.E. Fayad P. Katzen B.T. Mishkel G.J. et al.Protected carotid-artery stenting versus endarterectomy in high-risk patients.N Engl J Med. 2004; 351: 1493-1501Crossref PubMed Scopus (2549) Google Scholar High-risk was defined as having at least one of the following risk factors: clinically significant heart disease, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal nerve palsy, previous radical neck surgery or radiation therapy to the neck, recurrent stenosis after endarterectomy, or age >80 years. The combined 30-day end point of stroke, death, or myocardial infarction was 4.4% for CAS vs 9.8% for CEA (P = .06). At 1 year, this combined end point was 12% for CAS vs 20% for CEA (P = .05). The authors concluded that carotid stenting with embolic protection is not inferior to CEA in high-risk patients. This trial was terminated early when recruitment slowed; it is likely that a larger trial would have shown CAS to be superior to CEA in high-risk patients as defined in this study. Multiple ongoing randomized controlled trials are focused on both high- and lower-risk patients, including Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST),5Hobson R.W. Howard V.J. Roubin G.S. Brott T.G. Ferguson R.D. Popma J.J. et al.Carotid artery stenting is associated with increased complications in octogenarians 30-day stroke and death rates in the CREST lead-in phase.J Vasc Surg. 2004; 40: 1106-1111Abstract Full Text Full Text PDF PubMed Scopus (517) Google Scholar International Carotid Stenting Study (ICSS),6http://www.ion.ucl.ac.uk/cavatas_icss/summary.htm. Accessed Oct 15, 2005.Google Scholar Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE)7http://www.space.stroke-trial.com/. Accessed Oct 15, 2005Google Scholar, Endarterectomy Versus Angioplasty in Patients with Severe Symptomatic Carotid Stenosis (EVA-3S),8http://eva3s.hegp.bhdc.jussieu.fr/. Accessed Oct 15, 2005Google Scholar and Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease Trial" (ACT I).9http://www.ptca.org/pr_abbott/20050118.html. Accessed Oct 15, 2005Google Scholar CREST is a randomized trial comparing CEA and CAS in low-risk patients with both symptomatic stenoses ≥50% and asymptomatic stenoses ≥80%. As part of the lead-in phase to this study, 749 patients (31% symptomatic) underwent CAS. Thirty-day stroke-death rates increased with age such that there was a 12.1% 30-day stroke-death rate for patients ≥80 years old compared with 3.2% for patients 70% stenosis in CMS-approved centers. Additionally, in approved clinical trials, CMS will reimburse for symptomatic, high-risk patients with 50% to 69% stenosis and asymptomatic patients with >80% stenosis. Furthermore, all such cases must be entered into a registry to track outcome for potential CMS review. In this regard, the Society for Vascular Surgery has established a registry that meets these requirements and which should provide useful future data.19http://svs.vascularweb.org/. Accessed Oct 15, 2005Google Scholar Evaluation of current case series, industry-sponsored registries, and randomized trials reveals variation in study design and outcome measurement: First, duration of follow-up varies from 30 days in the Carotid and Vertebral Artery Transluminal Angioplasty Study-I (CAVATAS-I),20Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) a randomised trial.Lancet. 2001; 357: 1729-1737Abstract Full Text Full Text PDF PubMed Scopus (1364) Google Scholar 1 year in SAPPHIRE,4Yadav J.S. Wholey M.H. Kuntz R.E. Fayad P. Katzen B.T. Mishkel G.J. et al.Protected carotid-artery stenting versus endarterectomy in high-risk patients.N Engl J Med. 2004; 351: 1493-1501Crossref PubMed Scopus (2549) Google Scholar and up to 2 years in Prospective Registry of Carotid Angioplasty and Stenting (Pro-CAS),21Theiss W. Hermanek P. Mathias K. Ahmadi R. Heuser L. Hoffmann F.J. et al.Pro-CAS a prospective registry of carotid angioplasty and stenting.Stroke. 2004; 35: 2134-2139Crossref PubMed Scopus (145) Google Scholar albeit some of this variation simply represents differences in the current stage of result reporting. Although inherent differences in follow-up duration are likely, it becomes difficult to compare outcomes across trials with such distinct differences. Second, outcome event measurement has not been standardized. For example, SAPPHIRE classified strokes as minor and major, according to the National Institutes of Health Stroke Scale. CAVATAS, meanwhile, divided major adverse outcomes into "disabling stroke or death" or "stroke lasting more than 7 days." Third, primary endpoints have also varied. ARCHeR 1 and 2 considered all deaths, strokes, and myocardial infarctions at 30 days and ipsilateral strokes until 1 year as primary end points, but ARCHeR 3 reported only all deaths, strokes, and myocardial infarctions at 30 days. Reporting standards need to be established to allow comparison and interpretation across studies. As with other minimally invasive surgical procedures, CAS has developed rapidly over the last decade. Although equivalency with CEA has been established in high-risk patients, the effectiveness of CAS in lower-risk patients is not yet established. However, the choice of CEA vs CAS in individual patients is currently based more on individual practitioner experience than on clear evidence-derived guidelines. Nonetheless, the popularity of less invasive therapy combined with marketing of new CAS systems has increased the utilization of CAS. Ongoing randomized trials will help determine optimal carotid revascularization strategies in the future.
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