kpcczКомплексные проблемы сердечно-сосудистых заболеванийComplex Issues of Cardiovascular Diseases2306-12782587-9537Federal State Budgetary Institution “Research Institute for Complex Issues of Cardiovascular Diseases”10.17802/2306-1278-2015-1-25-31kpccz-112Research ArticleКЛИНИЧЕСКИЕ АСПЕКТЫСLINICAL ASPECTSАНТИКОАГУЛЯНТНОЕ СОПРОВОЖДЕНИЕ ЧРЕСКОЖНЫХ КОРОНАРНЫХ ВМЕШАТЕЛЬСТВ С ИСПОЛЬЗОВАНИЕМ БИВАЛИРУДИНА ИЛИ НЕФРАКЦИОНИРОВАННОГО ГЕПАРИНА ПРИ РАЗЛИЧНЫХ СОСУДИСТЫХ ДОСТУПАХANTICOAGULANT SUPPORT OF PERCUTANEOUS CORONARY INTERVENTIONS WITH BIVALIRUDIN OR UNFRACTIONATED HEPARIN AT VARIOUS VASCULAR ACCESSESСиньковМ. А.SinkovM. A.

Лаборатория интервенционных методов диагностики и лечения атеросклероза

tarars@kemcardio.ruШиловА. А.ShilovA. A.

Лаборатория интервенционных методов диагностики и лечения атеросклероза

 

Laboratory of Interventional Cardiology

tarars@kemcardio.ruТарасовР. С.TarasovR. S.

Для корреспонденции: Тарасов Роман Сергеевич Адрес: 650002, г. Кемерово, Сосновый бульвар, д. 6 Тел. 8 (3842) 64-18-06 E-mail: tarars@kemcardio.ru

Лаборатория интервенционных методов диагностики и лечения атеросклероза

Laboratory of Interventional Cardiology/

For correspondence:Tarasov Roman Address: 6, Sosnoviy blvd., Kemerovo, 650002, Russian Federation Tel. 8 (3842) 64-18-06 E-mail: tarars@kemcardio.ru

tarars@kemcardio.ruГанюковВ. И.GanyukovV. I.

Лаборатория интервенционных методов диагностики и лечения атеросклероза

Laboratory of Interventional Cardiology

tarars@kemcardio.ruНаучно-исследовательский институт комплексных проблем сердечно-сосудистых заболеваний, КемеровоРоссияResearch Institute for Complex Issues of Cardiovascular Diseases, KemerovoRussian Federation201503072015012531Copyright © Синьков М.А., Шилов А.А., Тарасов Р.С., Ганюков В.И., 20152015Синьков М.А., Шилов А.А., Тарасов Р.С., Ганюков В.И.Sinkov M.A., Shilov A.A., Tarasov R.S., Ganyukov V.I.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.nii-kpssz.com/jour/article/view/112Цель

Цель. В настоящее время доказано, что использование бивалирудина вместо нефракционированного гепарина (НФГ) во время первичного чрескожного коронарного вмешательства (ЧКВ) позволяет уменьшить количество геморрагических осложнений. Но в то же время нет убедительных данных о клиническом преимуществе использования бивалирудина над НФГ во время планового ЧКВ. Целью работы являлось сопоставление ближайших и отдаленных результатов ЧКВ у больных со стабильным течением ишемической болезни сердца (ИБС) на фоне инфузии бивалирудина и гепарина в зависимости от вида сосудистого доступа (трансрадиальный и трансфеморальный).

Материалы и методы

Материалы и методы . В исследование включено 127 больных со стабильной ИБС, которым было проведено плановое ЧКВ. Методом простой рандомизации пациенты были разделены на две группы: «Бивалирудин + трансфеморальный доступ» (n=65) – в качестве антикоагулянта во время проведения вмешательства трансфеморальным доступом использовался бивалирудин, и «Гепарин + трансрадиальный доступ» (n=62). Группы были сопоставимы по основным клинико-демографическим показателям и факторам риска геморрагических осложнений (14±7 против 13±6 баллов по «Mehran Score», р=0,451). Конечными точками являлись смерть, инфаркт миокарда (ИМ), повторная реваскуляризации миокарда (ПРМ), эпизоды кровотечений во время госпитализации и общее количество неблагоприятных сердечно-сосудистых событий в течение госпитализации и через год после рандомизации. Результаты. Через 30 дней наблюдения группа бивалирудина (трансфеморальный доступ, n=65) и группа НФГ (трансрадиальный доступ, n=62) не различались по количеству летальных исходов (ни одного случая в обеих группах), частоте ПРМ (1,5 % против 1,6 % соответственно, р=0,998), ИМ (3,1 % против 1,6 %, соответственно р=0,899), эпизодов кровотечений за время пребывания в стационаре (4,6 % против 3,2 % соответственно, р=0,899). Общее количество сердечно-сосудистых осложнений составило 4,6 и 3,2 % соответственно, р=0,675.

 Результаты одного года наблюдения в обеих группах также не различались по количеству летальных исходов (0 % против 1,6 % соответственно, р=0,946), ИМ (7,7 % против 6,5 % соответственно, р=0,656), ПРМ (7,7 % против 4,8 % соответственно, р=0,785), МАСЕ (15,3 % против 11,3 % соответственно, р=0,677).

Выводы

Выводы. Ближайшие и отдаленные результаты планового ЧКВ, выполненного трансрадиальным доступом на фоне антикоагулянтного сопровождения НФГ и ЧКВ, выполненного трансфеморальным доступом на фоне введения бивалирудина, сопоставимы как по количеству послеоперационных геморрагических осложнений, так и по числу неблагоприятных сердечно-сосудистых событий.

Purpose

Purpose. Nowadays it is proved that the use of bivalirudin instead of unfractionated heparin (UFH) during primary percutaneous coronary intervention (PCI) allows to reduce the number of bleeding complications. But at the same time there is no conclusive data on the clinical advantage of the use of bivalirudin over UFH during planned PCI. The purpose of the work was a comparison of shortterm and longterm results of PCI in subjects with stable coronary artery disease (CAD) associated with the infusion of bivalirudin and heparin, depending on the type of vascular access (transradial and transfemoral).

Materials and methods

Materials and methods. The study included 127 stable CAD subjects who underwent a planned PCI. By the method of simple randomization the subjects were divided into two groups: «Bivalirudin + transfemoral access» group (n=65) – bivalirudin was used as an anticoagulant during the intervention by femoral access and «Heparin + transradial access» group (n=62). The groups were comparable on major clinical and demographic indicators and risk factors for bleeding complications (14±7 vs. 13±6 scores on «Mehran Score», p=0,451). Endpoints were death, myocardial infarction (MI), repeated myocardial revascularization (RMR), episodes of bleeding during hospitalization and the total number of adverse cardiovascular events during hospitalization and in 1 year after randomization.

Results

Results. After 30 days of observation, the group «bivalirudin» (transfemoral access, n=65) and the group «UFH» (transradial access, n=62) did not differ in the number of fatal outcomes (no cases in both groups), the frequency of RMR (1,5% vs 1,6%, correspondingly, p=0,998), MI (3,1% vs. 1,6%, correspondingly, p=0,899), bleeding episodes during the hospital stay (4,6%, vs. 3,2%, correspondingly, p=0,899). The total number of cardiovascular complications was 4,6% and 3,2%, correspondingly, p=0,675. The results of one year follow-up in both groups also did not differ in the number of fatal outcomes (0% vs. 1,6%, correspondingly, p=0,946), MI (7,7% vs. 6,5%, correspondingly, p=0,656), RMR (7,7% vs. 4,8%, correspondingly, p=0,785), MACE (15,3% vs. 11,3%, correspondingly, p=0,677).

Conclusion

Conclusion. Short-term and long-term results of planned PCI performed by transradial access with UFH anticoagulant support and PCI performed by transfemoral access ) associated with administration of bivalirudin are comparable both in the number of postoperative bleeding complications and in the number of adverse cardiovascular events.

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