kpcczКомплексные проблемы сердечно-сосудистых заболеванийComplex Issues of Cardiovascular Diseases2306-12782587-9537Federal State Budgetary Institution “Research Institute for Complex Issues of Cardiovascular Diseases”10.17802/2306-1278-2018-7-3-83-93kpccz-455Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESТРАНСРАДИАЛЬНЫЙ И ТРАНСФЕМОРАЛЬНЫЙ ДОСТУП ПРИ КАРОТИДНОМ СТЕНТИРОВАНИИ С АКЦЕНТОМ НА ДИАГНОСТИКУ МИКРОЭМБОЛИЧЕСКИХ ОЧАГОВ НА ДВ МРТ (TACTILE TRIAL)TRANSRADIAL AND TRANSFEMORAL ACCESS FOR CAROTID ARTERY STENTING WITH AN EMPHASIS ON THE DETECTION OF MICROEMBOLIZATION WITH DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING (TACTILE TRIAL).МалаевД. У.MalaevD. U.

Малаев Дастан Урматович, врач по рентгенэндоваскулярным диагностике и лечению, аспирант. 

ул. Речкуновская, 15, Новосибирск, 630055.

Malaev Dastan U., interventional cardiologist, PhD student.

 

КретовЕ. И.KretovE. I.

Кретов Евгений Иванович, кандидат медицинских наук, ведущий научный сотрудник центра интервенционной кардиологии, врач по рентгенэндоваскулярным диагностике и лечению. 

ул. Речкуновская, 15, Новосибирск, 630055.

Kretov Evgeniy I., MD, PhD, leading researcher at the Center for Interventional Cardiology, interventional cardiologist.

15, Rechkunovskaya Street, Novosibirsk, 630055.

БайструковВ. И.BaystrukovV. I.

Байструков Виталий Игоревич, кандидат медицинских наук, врач по рентгенэндоваскулярным диагностике и лечению.

ул. Речкуновская, 15, Новосибирск, 630055.

Baystrukov Vitaliy I., PhD, interventional cardiologist.

15, Rechkunovskaya Street, Novosibirsk, 630055.

НайденовР. А.NaidenovR. A.

Найденов Роман Александрович, кандидат медицинских наук, врач по рентгенэндоваскулярным диагностике и лечению. 

ул. Речкуновская, 15, Новосибирск, 630055.

Naidenov Roman A., PhD, interventional cardiologist.

15, Rechkunovskaya Street, Novosibirsk, 630055.

ПрохорихинА. А.ProkhorikhinA. A.

Прохорихин Алексей Андреевич, врач по рентгенэндоваскулярным диагностике и лечению, аспирант.

ул. Речкуновская, 15, Новосибирск, 630055.

Prokhorikhin Alexey A., interventional cardiologist, PhD student. 

15, Rechkunovskaya Street, Novosibirsk, 630055.

БойковА. А.BoykovA. A.

Бойков Андрей Александрович, врач по рентгенэндоваскулярным диагностике и лечению, аспирант.

ул. Речкуновская, 15, Новосибирск, 630055.

Boykov Andrey A., interventional cardiologist, PhD student .

15, Rechkunovskaya Street, Novosibirsk, 630055.

Федеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр имени акад. Е.Н. Мешалкина» Министерства здравоохранения Российской Федерации, Центр новых хирургических технологий.РоссияE. Meshalkin National Medical Research Centre.Russian Federation201821092018738393Copyright © Малаев Д.У., Кретов Е.И., Байструков В.И., Найденов Р.А., Прохорихин А.А., Бойков А.А., 20182018Малаев Д.У., Кретов Е.И., Байструков В.И., Найденов Р.А., Прохорихин А.А., Бойков А.А.Malaev D.U., Kretov E.I., Baystrukov V.I., Naidenov R.A., Prokhorikhin A.A., Boykov A.A.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.nii-kpssz.com/jour/article/view/455Цель

Цель. Оценить эффективность и безопасность трансрадиального (ТР) и трансфеморального (ТФ) доступов при каротидном стентировании (КС) с акцентом на диагностику микроэмболических очагов на диффузионно-взвешенной магнитно-резонансной томографии (ДВ МРТ).

Материалы и методы

Материалы и методы. С января 2015 г. по октябрь 2017 г. 96 пациентов были включены в исследование и рандомизированы 1:1 в группы КС ТР-доступом и КС ТФдоступом. Критериями включения в исследование были: симптомный стеноз внутренней сонной артерии (ВСА) >70% или асимптомный стеноз ВСА >80%. Наличие в анамнезе инсульта, инфаркта миокарда или открытой операции <1 месяца явились критерием исключения из исследования. Первичной конечной точкой была частота микроэмболических очагов, полученных на ДВ МРТ. Все процедуры КС были выполнены двумя опытными операторами.

Результаты

Результаты. В данном исследовании успех процедуры при ТР-доступе составил 46 (96%) против 48 (100%) при ТФ-доступе (p = 0,495). Частота перехода в другую группу (кроссовер) составила 4% в группе ТР. Частота достижения первичной конечной точки в группах ТР и ТФ составила 50 и 52% соответственно, разница абсолютных рисков составила -2% (доверительный интервал (ДИ) 95% [-0,21; 0,17]; p (non-inferiority) = 0,03). При «on-treatment» анализе наблюдалась тенденция к снижению микроэмболичских очагов при вмешательстве на правой ВСА через ТР-доступ, чем при ТФ (44% против 68%; p = 0,478), и обратная тенденция при вмешательстве на левой ВСА через ТР- и ТФ-доступами (57% против 36% соответственно; p = 0,437).

Заключение

Заключение. Трансрадиальный доступ при каротидном стентировании имеет не бо́льшую частоту возникновения микроэмболических поражений головного мозга, чем трансфеморальный. Не было получено достоверной разницы по частоте МАССЕ и сосудистых осложнений при каротидном стентировании трансрадиальным доступом по сравнению с трансфеморальным доступом. Частота успеха процедуры при трансрадиальном доступе по сравнению с трансфеморальным доступом достоверно не отличалась. Время флюроскопии при КС ТР-доступом выше, чем при ТФ-доступе, однако продолжительность процедуры в группах не отличалась.

Aim

Aim. To compare transradial (TR) and transfemoral (TF) approach for carotid artery stenting (CAS) with an emphasis on the detection of micro-embolization with diffusion-weighted magnetic resonance imaging (DW-MRI).

Methods

Methods. 96 patients were included in the study in the period from January 2015 to October 2017 with further randomized 1 : 1 to the TR and TF groups. The inclusion criteria were the following: symptomatic stenosis ICA >70%; or asymptomatic stenosis ICA >80%. The positive history of stroke, myocardial infarction or open heart surgery <1 month were the exclusion criteria for the study. The primary endpoint was the incidence of new cerebral ischemic lesions as assessed by DW-MRI. All CAS procedures were performed by two experienced operators according to the approved protocol.

Results

Results. Procedural success with TR approach was 46 (96%) versus 48 (100%) with TF approach (p = 0.495). Crossover rate was 4% in the TR group. The rate of primary endpoint in the TR and TF groups was 50 and 52%, respectively. The absolute risk difference was -2% (95% CI [-0.21, 0.17], p (non-inferiority) = 0.03). An «on-treatment» analysis revealed a tendency towards a reduced microembolic foci when intervening on the right ICA via TR approach compared to TF (44% vs. 68%, p = 0.478), and a reverse trend when intervening on the left ICA via TR compared to TF approach (57% versus 36%, respectively, p = 0.437).

Conclusion

Conclusion. Carotid stenting via transradial approach is noninferior for cerebral embolism to transfemoral approach. The rates of MACCE and vascular complications were similar in both groups. There was no significant difference in the procedural success rate in the transfemoral and transradial groups. The fluoroscopy time during transradial carotid stenting was higher in comparison with transfemoral carotid stenting, though the procedure duration was similar in both groups.

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The authors declare that there are no conflicts of interest present.