Journal of Korean Neurosurgical Society

  • 제65권6호
  • /
  • Pages.765-771
  • /
  • 2022
  • /
  • 2005-3711(pISSN)
  • /
  • 1598-7876(eISSN)
대한신경외과학회 (The Korean Neurosurgical Society)
권호 표지
DOI QR코드

DOI QR Code

Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Kwon, O-Ki (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Kim, Young Deok (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Kim, Bum-Tae (Department of Neurosurgery, Soonchunhyang University Bucheon Hospital) ;
  • Oh, Jae Sang (Department of Neurosurgery, Soonchunhyang University Cheonan Hospital) ;
  • Kim, Kang Min (Department of Neurosurgery, Seoul National University College of Medicine) ;
  • Kim, Chang Hyeun (Department of Neurosurgery, Pusan National University Yangsan Hospital) ;
  • Kim, Chang-Hyun (Department of Neurosurgery, Keimyung University Dongsan Medical Center) ;
  • Choi, Jai Ho (Department of Neurosurgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Kim, Young Woo (Department of Neurosurgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Lim, Yong Cheol (Department of Neurosurgery, Ajou University Medical Center, Ajou University School of Medicine) ;
  • Byoun, Hyoung Soo (Department of Neurosurgery, Chungnam National University Sejong Hospital) ;
  • Park, Sukh Que (Department of Neurosurgery, Soonchunhyang University Seoul Hospital) ;
  • Chung, Joonho (Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine) ;
  • Park, Keun Young (Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine) ;
  • Park, Jung Cheol (Department of Neurosurgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Kwon, Hyon-Jo (Department of Neurosurgery, Chungnam National University Hospital) ;
  • Korean NeuroEndovascular Society, (Korean NeuroEndovascular Society)
  • 투고 : 2022.04.17
  • 심사 : 2022.06.14
  • 발행 : 2022.11.01
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

키워드

과제정보

Trial Registration : Clinical Research Information Service Identifier (KCT0006651)/ClinicalTrials.Gov Identifier (NCT05257824). This research is supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry & Welfare, Republic of Korea (grant number : HC20C0057).

참고문헌

  1. Cho WS, Hong HS, Kang HS, Kim JE, Cho YD, Kwon OK, et al. : Stability of cerebral aneurysms after stent-assisted coil embolization: a propensity score-matched analysis. Neurosurgery 77 : 208-216, 2015 https://doi.org/10.1227/NEU.0000000000000759
  2. Hwang G, Huh W, Lee JS, Villavicencio JB, Villamor RB Jr, Ahn SY, et al. : Standard vs modified antiplatelet preparation for preventing thromboembolic events in patients with high on-treatment platelet reactivity undergoing coil embolization for an unruptured intracranial aneurysm: a randomized clinical trial. JAMA Neurol 72 : 764-772, 2015 https://doi.org/10.1001/jamaneurol.2015.0654
  3. Hwang G, Kim JG, Song KS, Lee YJ, Villavicencio JB, Suroto NS, et al. : Delayed ischemic stroke after stent-assisted coil placement in cerebral aneurysm: characteristics and optimal duration of preventative dual antiplatelet therapy. Radiology 273 : 194-201, 2014 https://doi.org/10.1148/radiol.14140070
  4. Kim CH, Hwang G, Kwon OK, Ban SP, Chinh ND, Tjahjadi M, et al. : P2Y12 reaction units threshold for implementing modified antiplatelet preparation in coil embolization of unruptured aneurysms: a prospective validation study. Radiology 282 : 542-551, 2017 https://doi.org/10.1148/radiol.2016160542
  5. Kim KS, Fraser JF, Grupke S, Cook AM : Management of antiplatelet therapy in patients undergoing neuroendovascular procedures. J Neurosurg 129 : 890-905, 2018 https://doi.org/10.3171/2017.5.JNS162307
  6. Kim MS, Jo KI, Yeon JY, Kim JS, Kim KH, Jeon P, et al. : Safety and efficacy of antiplatelet response assay and drug adjustment in coil embolization: a propensity score analysis. Neuroradiology 58 : 1125-1134, 2016 https://doi.org/10.1007/s00234-016-1742-6
  7. Kim T, Kim CH, Kang SH, Ban SP, Kwon OK : Relevance of antiplatelet therapy duration after stent-assisted coil embolization for unruptured intracranial aneurysms. World Neurosurg 116 : e699-e708, 2018 https://doi.org/10.1016/j.wneu.2018.05.071
  8. Lijnen HR, Collen D : Endothelium in hemostasis and thrombosis. Prog Cardiovasc Dis 39 : 343-350, 1997 https://doi.org/10.1016/S0033-0620(97)80032-1
  9. Matsumoto Y, Nakai K, Tsutsumi M, Iko M, Nii K, Narita S, et al. : Onset time of ischemic events and antiplatelet therapy after intracranial stentassisted coil embolization. J Stroke Cerebrovasc Dis 23 : 771-777, 2014 https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.07.008
  10. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. : Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 123 : 2736-2747, 2011 https://doi.org/10.1161/CIRCULATIONAHA.110.009449
  11. Mocco J, Fargen KM, Albuquerque FC, Bendok BR, Boulos AS, Carpenter JS, et al. : Delayed thrombosis or stenosis following enterprise-assisted stent-coiling: is it safe? Midterm results of the interstate collaboration of enterprise stent coiling. Neurosurgery 69 : 908-913; discussion 913-914, 2014
  12. Rossen JD, Chalouhi N, Wassef SN, Thomas J, Abel TJ, Jabbour PM, et al. : Incidence of cerebral ischemic events after discontinuation of clopidogrel in patients with intracranial aneurysms treated with stentassisted techniques. J Neurosurg 117 : 929-933, 2012 https://doi.org/10.3171/2012.8.JNS12185
  13. Roy D, Milot G, Raymond J : Endovascular treatment of unruptured aneurysms. Stroke 32 : 1998-2004, 2001 https://doi.org/10.1161/hs0901.095600
  14. Shoda K, Enomoto Y, Egashira Y, Kinoshita T, Mizutani D, Iwama T : Long-term complications after stent assist coiling dependent on clopidogrel response. BMC Neurol 21 : 247, 2021 https://doi.org/10.1186/s12883-021-02270-0
  15. Song J, Yeon JY, Kim JS, Hong SC, Kim KH, Jeon P : Delayed thromboembolic events more than 30 days after self expandable intracranial stent-assisted embolization of unruptured intracranial aneurysms. Clin Neurol Neurosurg 135 : 73-78, 2015 https://doi.org/10.1016/j.clineuro.2015.05.013
  16. Tantry US, Bonello L, Aradi D, Price MJ, Jeong YH, Angiolillo DJ, et al. : Consensus and update on the definition of on-treatment platelet reactivity to adenosine diphosphate associated with ischemia and bleeding. J Am Coll Cardiol 62 : 2261-2273, 2013 https://doi.org/10.1016/j.jacc.2013.07.101
  17. Tateshima S, Tanishita K, Hakata Y, Tanoue SY, Vinuela F : Alteration of intraaneurysmal hemodynamics by placement of a self-expandable stent. Laboratory investigation. J Neurosurg 111 : 22-27, 2009 https://doi.org/10.3171/2009.2.JNS081324
  18. Yang H, Li Y, Jiang Y : Insufficient platelet inhibition and thromboembolic complications in patients with intracranial aneurysms after stent placement. J Neurosurg 125 : 247-253, 2016 https://doi.org/10.3171/2015.6.JNS1511