Бивалирудин - это интересно ;)

[mizin1]

Уважаемые модераторы, предлагаю устроить опрос: "Нужно ли использовать при коронарных ангиопластиках бивалирудин, если вы работаете через лучевой доступ с гепарином в дозе 70 ед/кг без ИГПР?"

[Dr.Vad]

Должна же быть какая-то альтернатива гепарину для пациентов с гепарин-индуцированной тромбоцитопенией или для тех, у кого большой риск ее развития.

[Yariko]

Сообщение от Bluesbart

Насколько мне известно, в спонсорах значилась астра зенека (брилинта). Могло ли это повлиять на результаты? Не имею доступа к полному тексту статьи. Много вопросов...

и что, его и the Medicines Company спонсировалась


The study was supported by unrestricted grants from the Medicines Company and AstraZeneca.

[mizin1]

Сообщение от Dr.Vad

Должна же быть какая-то альтернатива гепарину для пациентов с гепарин-индуцированной тромбоцитопенией или для тех, у кого большой риск ее развития.

Хорошо. Давайте так: "Нужно ли использовать при коронарных ангиопластиках бивалирудин, если вы работаете через лучевой доступ с гепарином в дозе 70 ед/кг с селективным использованием ИГПР у пациентов без риска ГИТ?"

[oldangio]

Сообщение от Abugov

Мой конфликт интересов можно уместить только в Гранд Каньоне. Кстати, пафосным лектором из Москвы, который не понравился Лёше, вполне мог бы быть я.

Господа, а разве на просторах нашей необъятной родины и в ее окрестностях кто-то не знает проф. Абугова, требую провести голосование.

[WYRN]

FYI

Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction

doi: 10.1093/eurheartj/ehu182 First published online: May 9, 2014

Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has never been assessed in specifically designed randomized trials.

Methods and results The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study is an investigator-initiated, randomized, open-label, multicentre trial, designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome. Owing to slow recruitment, the trial was stopped prematurely after enrolment of 548 of 1240 planned patients. At 30 days, the primary composite endpoint of death, myocardial infarction, unplanned revascularization of the infarct related artery, stent thrombosis, stroke, or bleeding was observed in 42 patients (15.6%) randomized to prasugrel plus bivalirudin and 40 patients (14.5%) randomized to clopidogrel plus heparin [relative risk, 1.09; one-sided 97.5% confidence interval (CI) 0–1.79, P = 0.680]. The composite ischaemic endpoint of death, myocardial infarction, unplanned revascularization of the infarct-related artery, stent thrombosis, or stroke occurred in 13 patients (4.8%) in the prasugrel plus bivalirudin group and 15 patients (5.5%) in the clopidogrel plus heparin group (relative risk, 0.89; 95% CI 0.40–1.96, P = 0.894). Bleeding according to the HORIZONS-AMI definition was observed in 38 patients (14.1%) in the prasugrel plus bivalirudin group and 33 patients (12.0%) in the clopidogrel plus heparin group (relative risk, 1.18; 95% CI 0.74–1.88, P = 0.543). Results were consistent across various subgroups of patients.

Conclusion In this randomized trial of STEMI patients, we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin. Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin. However, the results must be interpreted in view of the premature termination of the trial.

[Ссылки доступны только зарегистрированным пользователям ]

[mizin1]

Наверное, уже все читали про MATRIX Antithrombin? [Ссылки доступны только зарегистрированным пользователям ]

- randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion.

- The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P = 0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P = 0.34).

- the sponsor and funders had no role in the design of the study, the collection, monitoring, analysis, and interpretation of the data, or the writing of the report.

[ZhaStas]

В предыдущих публикациях указание на непричастность спонсоров отсутствовало!

Сообщение от mizin1

- the sponsor and funders had no role in the design of the study, the collection, monitoring, analysis, and interpretation of the data, or the writing of the report.

Алексей Геннадьевич, крепко Вас зацепил гастролер из столичной известной клиники!)

[Dr.Vad]

на мой взгляд, все тонкости/промахи обсуждаются в ред. комментарии

[mizin1]

На недавнем ТСТ в Вашингтоне обсуждали бивалирудин и гепарин при ОКС.
Опрос участников - см. картинку.

И еще готовится к выходу в Am J Cardiol большой метаанализ "Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention".

Выводы:
Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p [ 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p [ 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p [ 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.


Цена ангиокса 250мг №10 для нашей больницы 326 750 руб
Цена гепарина BBRAUN 25000 №10 1190 руб.