The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial

Yan Ma, Yuxiang Gu, Xiaoguang Tong, Jiyue Wang, Dong Kuai, Donghai Wang, Jun Ren, Lian Duan, Aili Maimaiti, Yiling Cai, Yujie Huang, Xiaojian Wang, Yi Cao, Chao You, Jiasheng Yu, Liqun Jiao, Feng Ling, Yan Ma, Yuxiang Gu, Xiaoguang Tong, Jiyue Wang, Dong Kuai, Donghai Wang, Jun Ren, Lian Duan, Aili Maimaiti, Yiling Cai, Yujie Huang, Xiaojian Wang, Yi Cao, Chao You, Jiasheng Yu, Liqun Jiao, Feng Ling

Abstract

Background: Patients with symptomatic internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion with haemodynamic insufficiency are at high risk for recurrent stroke when treated medically.

Methods: The Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) trial is an ongoing, government-funded, prospective, multicentre, randomised controlled trial. The CMOSS will recruit 330 patients with symptomatic ICA or MCA occlusion (parallel design, 1:1 allocation ratio) and haemodynamic insufficiency. Participants will be allocated to best medical treatment alone or best medicine plus extracranial-intracranial (EC-IC) bypass surgery. The primary outcome events are all strokes or deaths occurring between randomisation and 30 days post operation or post randomisation and ipsilateral ischaemic stroke within 2 years. Recruitment will be finished by December 2016. All the patients will be followed for at least 2 years. The trial is scheduled to complete in 2019.

Discussion: The CMOSS will test the hypothesis that EC-IC bypass surgery plus best medical therapy reduces subsequent ipsilateral ischaemic stroke in patients with symptomatic ICA or MCA occlusion and haemodynamic cerebral ischaemia. This manuscript outlines the rationale and the design of the study. CMOSS will allow for more critical reappraisal of the EC-IC bypass for selected patients in China.

Trial registration: NCT01758614 with ClinicalTrials.gov. Registered on 24 December 2012.

Keywords: Bypass surgery; Carotid artery; China; Haemodynamic; Ischaemic stroke; Middle cerebral artery; Occlusion.

References

    1. Paciaroni M, Caso V, Venti M, Milia P, Kappelle LJ, Silvestrelli G, Palmerini F, Acciarresi M, Sebastianelli M, Agnelli G. Outcome in patients with stroke associated with internal carotid artery occlusion. Cerebrovasc Dis. 2005;20(2):108–13. doi: 10.1159/000086800.
    1. Rutgers DR, Klijn CJ, Kappelle LJ, van der Grond J. Recurrent stroke in patients with symptomatic carotid artery occlusion is associated with high-volume flow to the brain and increased collateral circulation. Stroke. 2004;35(6):1345–9. doi: 10.1161/01.STR.0000128697.52150.75.
    1. Kern R, Steinke W, Daffertshofer M, Prager R, Hennerici M. Stroke recurrences in patients with symptomatic vs asymptomatic middle cerebral artery disease. Neurology. 2005;65(6):859–64. doi: 10.1212/01.wnl.0000175983.76110.59.
    1. Flaherty ML, Flemming KD, McClelland R, Jorgensen NW, Brown RD., Jr Population-based study of symptomatic internal carotid artery occlusion: incidence and long-term follow-up. Stroke. 2004;35(8):e349–52. doi: 10.1161/01.STR.0000135024.54608.3f.
    1. Brozici M, van der Zwan A, Hillen B. Anatomy and functionality of leptomeningeal anastomoses: a review. Stroke. 2003;34:2750–62. doi: 10.1161/01.STR.0000095791.85737.65.
    1. Liebeskind DS. Collateral circulation. Stroke. 2003;34:2279–84. doi: 10.1161/01.STR.0000086465.41263.06.
    1. Liebeskind DS, Cotsonis GA, Saver JL, Lynn MJ, Cloft HJ, Chimowitz MI. Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Investigators. Collateral circulation in symptomatic intracranial atherosclerosis. J Cereb Blood Flow Metab. 2011;31(5):1293–301. doi: 10.1038/jcbfm.2010.224.
    1. Krabbe-Hartkamp MJ, van der Grond J, de Leeuw FE. Circle of Willis: morphologic variation on three-dimensional time-of-flight MR-angiograms. Radiology. 1998;207:103–11. doi: 10.1148/radiology.207.1.9530305.
    1. Hoksbergen AW, Majoie CB, Hulsmans FJ, Legemate DA. Assessment of the collateral function of the circle of Willis: three-dimensional time-of-flight MR angiography compared with transcranial color-coded duplex sonography. AJNR Am J Neuroradiol. 2003;24(3):456–62.
    1. Powers WJ. Atherosclerotic carotid artery occlusion. Curr Treat Options Cardiovasc Med. 2003;5(6):501–9. doi: 10.1007/s11936-003-0039-3.
    1. Grubb RL, Jr, Derdeyn CP, Fritsch SM, et al. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998;280(12):1055–60. doi: 10.1001/jama.280.12.1055.
    1. Derdeyn CP, Powers WJ, Grubb RL., Jr Hemodynamic effects of middle cerebral artery stenosis and occlusion. AJNR Am J Neuroradiol. 1998;19(8):1463–9.
    1. Yonas H, Pindzola RR. Effect of acetazolamide reactivity and long-term outcome in patients with major cerebral artery occlusive diseases. Stroke. 1998;29(8):1742–4. doi: 10.1161/01.STR.29.8.1742.
    1. Fiorella D, Heiserman J, Prenger E, Partovi S. Assessment of the reproducibility of postprocessing dynamic CT perfusion data. AJNR. 2004;25(1):97–107.
    1. Waaijer A, van der Schaaf IC, Velthuis BK, Quist M, van Osch MJ, Vonken EP, van Leeuwen MS, Prokop M. Reproducibility of quantitative CT brain perfusion measurements in patients with symptomatic unilateral carotid artery stenosis. AJNR. 2007;28(5):927–32.
    1. Kamath A, Smith WS, Powers WJ, Cianfoni A, Chien JD, Videen T, Lawton MT, Finley B, Dillon WP, Wintermark M. Perfusion CT compared to H(2) (15)O/O (15)O PET in patients with chronic cervical carotid artery occlusion. Neuroradiology. 2008;50(9):745–51. doi: 10.1007/s00234-008-0403-9.
    1. Yamauchi H, Fukuyama H, Nagahama Y, Nabatame H, Nakamura K, Yamamoto Y, Yonekura Y, Konishi J, Kimura J. Evidence of misery perfusion and risk for recurrent stroke in major cerebral arterial occlusive diseases from PET. J Neurol Neurosurg Psychiatry. 1996;61(1):18–25. doi: 10.1136/jnnp.61.1.18.
    1. Ogasawara K, Ogawa A, Yoshimoto T. Cerebrovascular reactivity to acetazolamide and outcome in patients with symptomatic internal carotid or middle cerebral artery occlusion: a xenon-133 single-photon emission computed tomography study. Stroke. 2002;33(7):1857–62. doi: 10.1161/01.STR.0000019511.81583.A8.
    1. Kuroda S, Houkin K, Kamiyama H, Mitsumori K, Iwasaki Y, Abe H. Long-term prognosis of medically treated patients with internal carotid or middle cerebral artery occlusion: can acetazolamide test predict it? Stroke. 2001;32(9):2110–6. doi: 10.1161/hs0901.095692.
    1. Powers WJ, Clarke WR, Grubb RL, Jr, Videen TO, Adams HP, Jr, Derdeyn CP. COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011;306(18):1983–92. doi: 10.1001/jama.2011.1610.
    1. Reynolds MR, Derdeyn CP, Grubb RL, Jr, Powers WJ, Zipfel GJ. Extracranial-intracranial bypass for ischemic cerebrovascular disease: what have we learned from the Carotid Occlusion Surgery Study? Neurosurg Focus. 2014;36(1):E9. doi: 10.3171/2013.10.FOCUS13427.
    1. Carlson AP, Yonas H, Chang YF, Nemoto EM. Failure of cerebral hemodynamic selection in general or of specific positron emission tomography methodology?: Carotid Occlusion Surgery Study (COSS) Stroke. 2011;42(12):3637–9. doi: 10.1161/STROKEAHA.111.627745.
    1. Grubb RL, Jr, Powers WJ, Derdeyn CP, Adams HP, Jr, Clarke WR. The Carotid Occlusion Surgery Study. Neurosurg Focus. 2003;14(3):e9. doi: 10.3171/foc.2003.14.3.10.
    1. Grubb RL, Jr, Powers WJ, Clarke WR, Videen TO, Adams HP, Jr, Derdeyn CP. Carotid Occlusion Surgery Study Investigators. Surgical results of the Carotid Occlusion Surgery Study. J Neurosurg. 2013;118(1):25–33. doi: 10.3171/2012.9.JNS12551.
    1. Horn P, Scharf J, Peña-Tapia P, Vajkoczy P. Risk of intraoperative ischemia due to temporary vessel occlusion during standard extracranial-intracranial arterial bypass surgery. J Neurosurg. 2008;108(3):464–9. doi: 10.3171/JNS/2008/108/3/0464.
    1. Amin-Hanjani S, Barker FG, 2nd, Charbel FT, Connolly ES, Jr, Morcos JJ, Thompson BG. Cerebrovascular Section of the American Association of Neurological Surgeons; Congress of Neurological Surgeons. Extracranial-intracranial bypass for stroke—is this the end of the line or a bump in the road? Neurosurgery. 2012;71(3):557–61. doi: 10.1227/NEU.0b013e3182621488.

Source: PubMed

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