@article{23e07a70fa8d426fbe4651b1967bf3a4,
title = "Carotid stent fractures are not associated with adverse events results from the ACT-1 multicenter randomized trial (carotid angioplasty and stenting versus endarterectomy in asymptomatic subjects who are at standard risk for carotid endarterectomy with signifcant extracranial carotid stenotic disease)",
abstract = "Background: The impact of carotid artery stent fractures on the incidence of adverse clinical events remains unclear. The objective of this study is to report the stent fracture rate and its association with in-stent restenosis and adverse outcomes in the ACT-1 trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Signifcant Extracranial Carotid Stenotic Disease). METHODS: ACT-1 is a prospective multicenter trial of patients who have standard surgical risk with severe asymptomatic carotid artery stenosis randomly assigned to carotid artery stenting or carotid endarterectomy (Abbott Vascular). The primary end point was a composite of death, stroke, or myocardial infarction during the 30 days after the procedure or ipsilateral stroke during the 365 days after the procedure. After 771 patients were enrolled, successively randomly assigned patients were required to undergo annual radiographic (X-ray) analysis for stent fracture. Images were independently adjudicated by a core laboratory. RESULTS: Of 1021 patients treated with carotid artery stenting during a mean follow-up of 3.1±1.6 years, 939 had at least 1 X-ray during the follow-up period. Stent fracture was reported in 51 (5.4%) patients. With a maximum follow-up period of 5 years, adverse clinical outcomes occurred in 39 patients with at least 1 X-ray during the follow-up. Of 826 (80.9%) subjects who underwent both duplex ultrasound and X-ray, 822 (99.5%) were interpretable. There was no association between stent fracture and the primary end point (P=0.86) or with restenosis (P=0.53). CONCLUSIONS: In this large, independently adjudicated, multicenter study, the stent fracture rate was low and not associated with major adverse clinical events or in-stent restenosis.",
keywords = "Carotid arteries, Carotid stenosis, Carotid stent fracture, Endarterectomy, carotid, Myocardial infarction, Stents, Stroke",
author = "Ido Weinberg and Beckman, {Joshua A.} and Matsumura, {Jon S.} and Kenneth Rosenfeld and Ansel, {Gary M.} and Seemant Chaturvedi and William Gray and {Chris Metzger}, D. and Tom Riles and Yu Shu and Lawrence Wechsler and Jaff, {Michael R.}",
note = "Funding Information: Dr Beckman has consulted for Astra Zeneca, Sanofi, Aralez, and Abbott. Dr Beckman serves on the data safety and monitoring board for Bayer; received a research grant from Merck; has ownership in EMX and Janacare; and serves on a nonprofit board for VIVA. Dr Matsumura has received research grants from Abbott, Gore, Cook, Endologix, and Medtronic. Dr Rosenfield serves on advisory boards for Abbott Vascular, Cardinal Health, Surmodics, Inari Medical, Volcano/Philips, and Proteon; receives fees and stock options for serving on advisory boards for Cruzar Systems, Valcare, and Eximo; receives stock options for serving on advisory boards for Capture Vascular, Shockwave, Micell, Endospan, and Silk Road Vascular; receives stock options for serving on the advisory boards of and holding equity positions in Contego, Access Vascular, and MD Insider; holds stock/stock options in Emboli-tech, Janacare, Primacea, and PQ Bypass; will receive a future payout from a previous equity position in Vortex; and receives grant support paid to his institution from Abbott Vascular, Atrium/Maquet, and Lutonix/Bard. Dr Ansel consults for Abbott Vascular, Medtronic, and Boston Scientific. Dr Chaturvedi is an executive committee member of ACT-1 and CREST-2. Dr Metzger receives proctor fees and symposia honoraria from Abbott. Dr Shu is an employee of Abbott Vascular. Dr Wechsler is on the steering committee of ACT I; holds stock in Silk Road Medical; and is an investigator for CREST-2. Dr Jaff is a noncompensated advisor for Abbott Vascular, Boston Scientific, Cordis, and Medtronic; is a consultant for Philips/Volcano; has equity investment in PQ Bypass, Primacea, Vascular Therapies, and Venarum; and is a board member for VIVA Physicians, a 501(c)(3) not-for-profit education and research organization. The other authors report no conflicts. Funding Information: This study was funded by Abbott Vascular. Publisher Copyright: {\textcopyright} 2017 American Heart Association, Inc.",
year = "2018",
month = jan,
doi = "10.1161/CIRCULATIONAHA.117.030030",
language = "English (US)",
volume = "137",
pages = "49--56",
journal = "Circulation",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins",
number = "1",
}