ROCKET AF: Эра Варфарина заканчивается?

Обсуждение медицинских новостей

Модератор: Pyankov Vasily

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Pyankov Vasily
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ROCKET AF: Эра Варфарина заканчивается?

Сообщение Pyankov Vasily »

Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Hypothesis:
Rivaroxaban will be noninferior to warfarin in preventing stroke and embolism.

Drugs/Procedures Used:
Patients with AF at increased risk for stroke were randomized to rivaroxaban 20 mg oral daily (n = 7,131) versus warfarin with target international normalized ratio (INR) 2-3 (n = 7,133).

Principal Findings:
Overall, 14,171 patients were randomized. In the rivaroxaban group, the mean age was 73 years, 40% were women, mean CHADS2 score was 3.5, 40% had diabetes, and 55% had prior stroke, transient ischemic attack (TIA), or systemic embolism.

The primary outcome per 100 patient-years, stroke, or non&#8210;central nervous system systemic embolism occurred in 1.7 of the rivaroxaban group versus 2.2 of the warfarin group (p for noninferiority < 0.001, p for superiority by intention to treat 0.12). By on-treatment analysis, rivaroxaban was superior to warfarin (p = 0.015).

By on-treatment analysis, vascular death, stroke, or embolism per 100 patient-years occurred in 3.1 versus 3.6 (p = 0.034), non&#8210;central nervous system embolism occurred in 0.04 versus 0.2 (p = 0.003), myocardial infarction occurred in 0.9 versus 1.1 (p = 0.12), and all-cause mortality occurred in 1.9 versus 2.2 (p = 0.07), respectively, for rivaroxaban versus warfarin.

Major and nonmajor clinically relevant bleeding per 100 patient-years occurred in 14.9 versus 14.5 (p = 0.44), intracranial hemorrhage occurred in 0.5 versus 0.7 (p = 0.019), study drug discontinuation occurred in 16% versus 15%, and any serious adverse event occurred in 37% versus 38%, respectively.

Interpretation:
Among patients with AF and increased risk for stroke, the use of the direct Xa inhibitor rivaroxaban was noninferior to warfarin. Rivaroxaban (on-treatment analysis) was associated with reduced incidence of the primary outcome without an excess of major bleeding or serious adverse events. In addition to rivaroxaban, an alternative to warfarin for AF patients includes the direct thrombin inhibitor dabigatran studied in the RE-LY trial. The signal for increased myocardial infarction observed with dabigatran was not seen with rivaroxaban.

Study Design:
Blinded. Parallel. Randomized.
Primary Endpoints:
Stroke or non&#8210;central nervous system systemic embolism
Secondary Endpoints:
Major or nonmajor clinically relevant bleeding
Patient Population:
Patients with AF and history of stroke, TIA, or systemic embolism
Patients without stroke, TIA, or systemic embolism were eligible if they had at least two additional risk factors for stroke, defined as congestive heart failure, hypertension, age &#8805;75 years, or diabetes

Number of enrollees: 14,171
Duration of follow-up: 2.6 years
Mean patient age: 73 years
Percentage female: 40%

References:
Presented by Dr. Kenneth Mahaffey at the American Heart Association Scientific Sessions, Chicago, IL, November 15, 2010.
MGilarov
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Откуда: Москва, ММА им. И.М. Сеченова

Сообщение MGilarov »

Небезынтересно мнение уважаемой E. Hylek:
However, discussant Elaine Hylek (Boston University, MA, USA) pointed out that there were more bleeds requiring transfusions and drops in hematocrit in the rivaroxaban group, “making the overall safety profile less clear”.

Hylek also cautioned that the time in therapeutic range among patients on warfarin was only 57.8%, “raising questions about the performance of the active control treatment”, and that the difference between the per-protocol and ITT findings could be down to poor adherence to rivaroxaban. The latter observation raises concerns about the relevance of the per-protocol analysis to real-world practice, she said, “particularly for a drug taken once a day with a half-life of 5–13 hours”.

Nevertheless, Hylek concluded that, “based on both the ITT and per-protocol analysis, rivaroxaban is non-inferior to warfarin…for the prevention of stroke in AF,” which she said in itself is “an exciting finding”.
С уважением,
Гиляров Михаил Юрьевич
MGilarov
Сообщения: 441
Зарегистрирован: Вс апр 01, 2007 8:10 pm
Откуда: Москва, ММА им. И.М. Сеченова

Сообщение MGilarov »

Подробнее про ROCKET AF
http://www.medscape.com/viewarticle/732 ... ac=21672DR
С уважением,
Гиляров Михаил Юрьевич
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