Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial
Brajesh K Lal, Kirk W Beach, Gary S Roubin, Helmi L Lutsep, Wesley S Moore, Mahmoud B Malas, David Chiu, Nicole R Gonzales, J Lee Burke, Michael Rinaldi, James R Elmore, Fred A Weaver, Craig R Narins, Malcolm Foster, Kim J Hodgson, Alexander D Shepard, James F Meschia, Robert O Bergelin, Jenifer H Voeks, George Howard, Thomas G Brott, CREST Investigators, Wayne Clark, William Brooks, Ariane Mackey, Michael Hill, Pierre Leimgruber, Vito Mantese, Carlos Timaran, Nelson Hopkins, David Chiu, Richard Begg, Zafar Jamil, Robert Hye, Bart Demaerschalk, O W Brown, Royal Oak, Gary Roubin, Donald Heck, Richard Farb, Irfan Altafullah, Gary Ansel, Albert Sam 2nd, Nicole Gonzales, Peter Soukas, Lawrence Wechsler, Daniel Clair, Mark Reisman, John Eidt, Steven Orlow, James Burke, Mahmoud Malas, Michael Rinaldi, Sanger Heart, Kenneth Rosenfield, Charles Sternbergh 3rd, Richard McCann, Charles O'Mara, Albert Hakaim, Barry Katzen, Robert Spetzler, Anthony Pucillo, James Elmore, William Jordan, David Lew, Richard Powell, Robert Bulas, Bryan Kluck, Joseph Rapp, Gregory Mishkel, Fred Weaver, Munier Nazzal, Craig Narins, Robert Molnar, Mark Eskandari, Herbert Aronow, Fayaz Shawl, Robert Rosenwasser, Hollace Chastain, Malcolm Foster, Rodney Raabe, David Pelz, Grant Stotts, Harry Cloft, Louis Heller, Bhagat Reddy, Kim Hodgson, Ken Fraser, William Gray, Alexander Shepard, Walter Montanera, Wes Moore, Elliot Chaikof, Sarah Johnson, Richard Zelman, Avery Evans, David Burkart, Dennis Bandyk, Percy Karanjia, Jamal Zarghami, Adam Arthur, Manish Mehta, Anthony Comerota, Kannan Natarajan, Jay Howington, Daniel Selchen, Marc Schermerhorn, Steven Laster, Mark Sanz, Eric Lopez, Joseph Andriole, Andrew Ringer, John Martin, Randy Guzman, Philip Teal, Frank Hellinger, George Petrossian, Mark Bates, Joseph Mills, Michael Golden, Ashraf Mansour, Andrew MacBeth, L A Iannone, Kimberly Hansen, Winston Salem, Jose Biller, John Shuck, Pierre Gobin, Kent Dauterman, Jim Melton, Daniel Benckart, Walter Lesley, Michael Belkin, Tanvir Bajwa, Subbarao Myla, Jeffrey Snell, Harish Shownkeen, Alex Abou-Chebl, Brajesh K Lal, Kirk W Beach, Gary S Roubin, Helmi L Lutsep, Wesley S Moore, Mahmoud B Malas, David Chiu, Nicole R Gonzales, J Lee Burke, Michael Rinaldi, James R Elmore, Fred A Weaver, Craig R Narins, Malcolm Foster, Kim J Hodgson, Alexander D Shepard, James F Meschia, Robert O Bergelin, Jenifer H Voeks, George Howard, Thomas G Brott, CREST Investigators, Wayne Clark, William Brooks, Ariane Mackey, Michael Hill, Pierre Leimgruber, Vito Mantese, Carlos Timaran, Nelson Hopkins, David Chiu, Richard Begg, Zafar Jamil, Robert Hye, Bart Demaerschalk, O W Brown, Royal Oak, Gary Roubin, Donald Heck, Richard Farb, Irfan Altafullah, Gary Ansel, Albert Sam 2nd, Nicole Gonzales, Peter Soukas, Lawrence Wechsler, Daniel Clair, Mark Reisman, John Eidt, Steven Orlow, James Burke, Mahmoud Malas, Michael Rinaldi, Sanger Heart, Kenneth Rosenfield, Charles Sternbergh 3rd, Richard McCann, Charles O'Mara, Albert Hakaim, Barry Katzen, Robert Spetzler, Anthony Pucillo, James Elmore, William Jordan, David Lew, Richard Powell, Robert Bulas, Bryan Kluck, Joseph Rapp, Gregory Mishkel, Fred Weaver, Munier Nazzal, Craig Narins, Robert Molnar, Mark Eskandari, Herbert Aronow, Fayaz Shawl, Robert Rosenwasser, Hollace Chastain, Malcolm Foster, Rodney Raabe, David Pelz, Grant Stotts, Harry Cloft, Louis Heller, Bhagat Reddy, Kim Hodgson, Ken Fraser, William Gray, Alexander Shepard, Walter Montanera, Wes Moore, Elliot Chaikof, Sarah Johnson, Richard Zelman, Avery Evans, David Burkart, Dennis Bandyk, Percy Karanjia, Jamal Zarghami, Adam Arthur, Manish Mehta, Anthony Comerota, Kannan Natarajan, Jay Howington, Daniel Selchen, Marc Schermerhorn, Steven Laster, Mark Sanz, Eric Lopez, Joseph Andriole, Andrew Ringer, John Martin, Randy Guzman, Philip Teal, Frank Hellinger, George Petrossian, Mark Bates, Joseph Mills, Michael Golden, Ashraf Mansour, Andrew MacBeth, L A Iannone, Kimberly Hansen, Winston Salem, Jose Biller, John Shuck, Pierre Gobin, Kent Dauterman, Jim Melton, Daniel Benckart, Walter Lesley, Michael Belkin, Tanvir Bajwa, Subbarao Myla, Jeffrey Snell, Harish Shownkeen, Alex Abou-Chebl
Abstract
Background: In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion.
Methods: Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732.
Findings: 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63-1·29; p=0·58). Female sex (1·79, 1·25-2·56), diabetes (2·31, 1·61-3·31), and dyslipidaemia (2·07, 1·01-4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34-3·77) but not after carotid artery stenting (0·77, 0·41-1·42).
Interpretation: Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation.
Funding: National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.
Conflict of interest statement
Author conflicts of interest information: B.K. Lal: None. K.W. Beach: None. G.S. Roubin: Royalties, Abbott Vascular and Cook, Inc. H.L. Lutsep: Consultant/Advisory Board, Gore. W.S. Moore: Consultant/Advisory Board, WL Gore. M.B. Malas: None. D. Chiu: None. N.R. Gonzales: None. J.L. Burke: None. M. Rinaldi: Consultant/Advisory Board, Abbott, Cordis, and Boston Scientific. J.R. Elmore: None. F.A. Weaver: None. C.R. Narins: None. M. Foster: Honoraria, Abbott Vascular. K. Hodgson: None. A.D. Shepard: None. J.F. Meschia: None. R.O. Bergelin: None. J.H. Voeks: None. G. Howard: Support from Abbott Vascular for preparation of FDA materials. T.G. Brott: None.
Copyright © 2012 Elsevier Ltd. All rights reserved.
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Source: PubMed