Intracranial Stenting
2013; Lippincott Williams & Wilkins; Volume: 44; Issue: 6_suppl_1 Linguagem: Italiano
10.1161/strokeaha.111.000370
ISSN1524-4628
AutoresColin P. Derdeyn, David Fiorella, Michael Lynn, Tanya N. Turan, Bethany F Lane, L. Scott Janis, Marc I. Chimowitz,
Tópico(s)Moyamoya disease diagnosis and treatment
ResumoHomeStrokeVol. 44, No. 6_suppl_1Intracranial Stenting Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBIntracranial StentingSAMMPRIS Colin P. Derdeyn, MD, David Fiorella, MD, PhD, Michael J. Lynn, MS, Tanya N. Turan, MD, Bethany F. Lane, RN, L. Scott Janis, PhD and Marc I. Chimowitz, MB, ChB Colin P. DerdeynColin P. Derdeyn From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). , David FiorellaDavid Fiorella From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). , Michael J. LynnMichael J. Lynn From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). , Tanya N. TuranTanya N. Turan From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). , Bethany F. LaneBethany F. Lane From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). , L. Scott JanisL. Scott Janis From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). and Marc I. ChimowitzMarc I. Chimowitz From the Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., B.F.L.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). Originally published1 Jun 2013https://doi.org/10.1161/STROKEAHA.111.000370Stroke. 2013;44:S41–S44Current StatusThe Stenting and Aggressive Medical management for the Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial established aggressive medical management as superior to angioplasty and stenting for symptomatic intracranial atherosclerotic disease. This presentation addresses some criticisms of the trial, emphasizes key knowledge gained from the study and proposes potential new directions for research in this area. At present, the data from the trial are limited to complete 30-day outcomes for all enrolled patients and follow-up to 1 year in approximately half of the cohort.1 Enrollment was stopped early at the recommendation of the Data and Safety Monitoring Board because of higher than expected 30-day complication rates in the stenting arm and a futility analysis indicating essentially no chance that stenting would be proven superior. A total of 451 patients (59% of the target) had been enrolled, with 227 randomized to aggressive medical management alone and 224 to aggressive medical management plus stenting. Follow-up was completed in March 2013 and study close-out is underway. Presentation of the final primary results is planned for the Fall of 2013.Primary OutcomeThe 30-day rate of stroke and death was 14.7% in the percutaneous transluminal angioplasty and stenting group (12.5% nonfatal stroke, 2.2% fatal stroke) and 5.8% in the medical group (5.3% nonfatal stroke, 0.4% nonstroke death; P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. These events were predefined primary end points and were blindly adjudicated. Mean duration of follow-up at the time of this analysis was 11.9 months. The Kaplan–Meier curves were significantly different (P=0.009) and yield 1-year rates of the primary end point of 20.0% in the percutaneous transluminal angioplasty and stenting group and 12.2% in the medical group. We concluded that aggressive medical management was superior to angioplasty and stenting for patients with symptomatic intracranial atherosclerotic disease. Because of the clinical importance and conclusive nature of the early data, these results were published in 2011. As noted above, follow-up of enrolled patients continues, and some changes in the long-term rates of stroke in both groups are possible.Common QuestionsThree issues have been raised at meetings or published critiques: the patient population chosen for the trial, the medical regimen, and the impact of operator experience on the 30-day outcomes in the trial.2,3 Some of these published critiques have had responses from the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) investigators.4,5Was This the Right Patient Population?Yes. The best (prospective, longitudinal, and adjudicated outcomes) definition of a high-risk group was provided by the Warfarin versus Aspirin for Symptomatic Intracranial Disease (WASID) trial.6 This was a randomized trial of warfarin versus aspirin for patients with 50% to 99% atherosclerotic stenosis of a major (ie, amenable to angioplasty and stenting) intracranial artery: the internal carotid, M1 segment of middle cerebral artery, vertebral and basilar arteries. Patients were required to have had recent (within 90 days) ischemic symptoms to qualify for enrollment. Kasner et al7,8 performed a prespecified analysis to identify high-risk subgroups. Patients with 70% to 99% stenosis and transient ischemic attack or stroke within 30 days before enrollment had the highest rate of ischemic stroke in the territory of the symptomatic artery: 22.9% at 1 year (95% confidence interval, 15.4%–30.4%), 25.0% at 2 years (95% confidence interval, 17.2%–32.9%). SAMMPRIS was designed using risk estimates from this latter group. The likelihood that angioplasty and stenting would be beneficial in patients without these high-risk features was considered low.These prospective data from WASID laid to rest a number of hypotheses generated from previous retrospective studies: posterior circulation stenosis was not a higher risk disease than anterior circulation,9 posterior circulation stenosis did not respond better to warfarin than aspirin,9 and patients already on antithrombotic medication were not at higher risk for stroke.10 Patients in WASID who had their qualifying event on an antithrombotic agent were at no higher risk for a recurrent event than those on no treatment at the time of their qualifying event.11 SAMMPRIS results to date have also not found any relationship between failure of antithrombotic therapy and higher risk of recurrent stroke either (Lutsep et al 2012 International Stroke Conference oral abstract).Was the SAMMPRIS Medical Regimen Real World?The medical regimen in SAMMPRIS was carefully developed on the basis of the data from WASID, national guideline recommendations for risk factor control, results from recent stroke prevention trials, and the need to balance antiplatelet medication between the stenting and the medical groups. In WASID, patients with poorly controlled blood pressure or elevated low-density lipoprotein during follow-up had a significantly higher rate of stroke, vascular death, or myocardial infarction compared with patients with good control of these risk factors.12 Blood pressure (systolic <140 in patients with non–diabetes mellitus and <130 in patients with diabetes mellitus) and low-density lipoprotein ( 10) of Wingspan cases submitted for credentialing tended to have higher rates of 30-day events (19.0% versus 9.9%) than those with <10 cases. High enrolling sites in the trial tended to have lower rates of hemorrhagic stroke (9.8% at sites enrolling 300 seconds) with parenchymal hemorrhage.23The majority of the 19 periprocedural ischemic strokes in stented patients were local perforator occlusions, and most of these were in the basilar artery Multivariate analysis found an association of nonsmoking, basilar location, older age, and diabetes mellitus with a higher risk of perioperative ischemic stroke. The smokers paradox has also been observed in studies of coronary intervention and may relate to confounding risk factor variables and the possible interaction between smoking and clopidogrel responsiveness.24Future DirectionsGiven these results, future areas for research in this population include the identification of subgroups at a high risk of stroke despite aggressive medical therapy. If safer and more effective endovascular procedures can be developed, further trials will be needed to determine if these procedures lower the risk of stroke compared with aggressive medical therapy in these high-risk subgroups. In addition, the identification of clinical, imaging, or technical factors predisposing to parenchymal hemorrhage or perforator infarction after angioplasty and stenting will be important.Sources of FundingThe Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial was funded by a research grant (U01 NS058728) from the US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS). In addition, the following Clinical and Translational Science Awards, funded by the National Institutes of Health, provided local support for the evaluation of patients in the trial: Medical University of South Carolina (UL1RR029882), University of Florida (UL1RR029889), University of Cincinnati (UL1RR029890), and University of California, San Francisco (UL1RR024131). Corporate support was from Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided study devices and supplemental funding for third-party device distribution, site monitoring, and study auditing. This research was also supported by the Investigator-Sponsored Study Program of AstraZeneca that donates rosuvastatin (Crestor) to study patients. None of the Executive Committee, charged with design and execution of the trial, had any relationships with these industry sponsors.DisclosuresDrs Fiorella, Derdeyn, Turan, Janis, and Chimowitz, Michael Lynn, and B Lane serve on the Executive Committee of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. All receive salary support from the SAMMPRIS grant. All other authors were investigators in SAMMPRIS and were reimbursed from the SAMMPRIS grant for their effort. Additional support is listed below. Dr Derdeyn has received research grant support from the National Institute of Neurological Disorders and Stroke (NINDS; P50 55977; R01 NS051631). He is also on the Scientific Advisory Board for W.L Gore and Associates and is the Chair of the Scientific Advisory Board for Pulse Therapeutics. Dr Fiorella has received institutional research support from Seimens Medical Imaging and Microvention, consulting fees from Codman/Johnson and Johnson, NFocus, W.L. Gore and Associates, and EV3/Covidien, and royalties from Codman/Johnson and Johnson. He has received honoraria from Scientia and has ownership interest in CVSL and Vascular Simulations. M.J. Lynn has received grant support from the National Eye Institute. He is the principal investigator of the Coordinating Center for Infant Aphakia Treatment Study (EY013287) and a coinvestigator on the Core Grant for Vision Research (EY006360). B.F. Lane has received consulting fees from Microvention Terumo. Dr Turan is a past recipient of funding from the American Academy of Neurology (AAN) Foundation Clinical Research Training Fellowship and is the current recipient of a K23 grant from NIH/NINDS (1 K23 NS069668-01A1). She has also served as an expert witness in medical legal cases. Dr Janis is a program director at NINDS. He has no relevant relationships. M. Chimowitz has received research grants from NINDS to fund the WASID trial (1 R01 NS36643) and to fund other research on intracranial stenosis (1 K24 NS050307 and 1 R01 NS051688). He currently serves on the stroke adjudication committee of an industry funded osteoporosis drug trial (Merck and Co., Inc.) and on the DSMB of another industry funded patent foramen ovale closure trial (W.L Gore and Associates) and is compensated for those activities. He has also served as an expert witness in medical legal cases.FootnotesCorrespondence to Colin P. Derdeyn, MD, Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, Campus Box 8131, 510 S Kingshighway Blvd, St Louis, MO. E-mail [email protected]References1. Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, et alSAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis.N Engl J Med. 2011; 365:993–1003.CrossrefMedlineGoogle Scholar2. Alexander MJ. Intracranial stenting for intracranial atherosclerotic disease: still much to learn.J Neurointerv Surg. 2012; 4:85–86.CrossrefMedlineGoogle Scholar3. Abou-Chebl A, Steinmetz H. Critique of "Stenting versus aggressive medical therapy for intracranial arterial stenosis" by Chimowitz et al in the New England Journal of Medicine.Stroke. 2012; 43:616–620.LinkGoogle Scholar4. Derdeyn CP, Fiorella D, Chimowitz M. Response from the SAMMPRIS trial principal investigators regarding inaccuracies in this editorial.J NeuroIntervent Surg. Published online September 5, 2012. doi:10.1136/neurintsurg-2012-010496. Available at: http://jnis.bmj.com/content/early/2012/09/04/neurintsurg-2012-010496.full?sid=e797d31b-bc32-43c6-84c0-fca6de53e389.Google Scholar5. Chimowitz MI, Fiorella D, Derdeyn CP, Turan TN, Lane BF, Janis S, et al. 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Moore B, Taylor R, Nguyen C and Smith M (2018) Carotid and Intracranial Stent Placement Neurocritical Care Management of the Neurosurgical Patient, 10.1016/B978-0-323-32106-8.00034-0, (345-355), . Al Kasab S, Derdeyn C, Guerrero W, Limaye K, Shaban A and Adams H (2018) Intracranial Large and Medium Artery Atherosclerotic Disease and Stroke, Journal of Stroke and Cerebrovascular Diseases, 10.1016/j.jstrokecerebrovasdis.2018.02.050, 27:7, (1723-1732), Online publication date: 1-Jul-2018. Leung T, Wang L, Soo Y, Ip V, Chan A, Au L, Fan F, Lau A, Leung H, Abrigo J, Wong A, Mok V, Ng P, Tsoi T, Li S, Man C, Fong W, Wong K and Yu S (2015) Evolution of intracranial atherosclerotic disease under modern medical therapy, Annals of Neurology, 10.1002/ana.24340, 77:3, (478-486), Online publication date: 1-Mar-2015. Gao P, Zhao Z, Wang D, Wu J, Cai Y, Li T, Wu W, Shi H, He W, Zhu F, Jiao L and Ling F (2015) China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China, Interventional Neuroradiology, 10.1177/1591019915581778, 21:2, (196-204), Online publication date: 1-Apr-2015. Yang F, Su Y and Lin S (2015) Discrepancy Between Duplex Sonography and Digital Subtraction Angiography When Investigating Extra- and Intracranial Ulcerated Plaque, Journal of Medical Ultrasound, 10.1016/j.jmu.2015.01.002, 23:2, (98-103), Online publication date: 1-Jun-2015. Zhang F, Ran Y, Zhu M, Lei X, Niu J, Wang X, Zhang Y, Li S, Zhu J, Gao X, Mossa-Basha M, Cheng J and Zhu C (2021) The Use of Pointwise Encoding Time Reduction With Radial Acquisition MRA to Assess Middle Cerebral Artery Stenosis Pre- and Post-stent Angioplasty: Comparison With 3D Time-of-Flight MRA and DSA, Frontiers in Cardiovascular Medicine, 10.3389/fcvm.2021.739332, 8 June 2013Vol 44, Issue 6_suppl_1 Advertisement Article InformationMetrics © 2013 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.111.000370PMID: 23709726 Manuscript receivedDecember 3, 2012Manuscript acceptedFebruary 26, 2013Originally publishedJune 1, 2013 Keywordsrisk factor managementstrokeangioplastystentingclinical trialPDF download Advertisement SubjectsTreatment
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