WATCHMAN в ушко и никакого варфарина

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AOkhotin
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WATCHMAN в ушко и никакого варфарина

Сообщение AOkhotin »

Наверное, самый неприятный кардиологический препарат -- это варфарин. Есть надежда, что у больных с мерцательной аритмией можно будет от него избавиться. Специальное устройство из саморасправляющейся нитиноловой сеточки, покрытой тканью, засовывается в ушко левого предсердия и препятствует образованию тромбов в нем. Первые результаты впечатляют: риск инсульта и смерти был даже ниже, чем при использовании варфарина.
PROTECT AF: WATCHMAN device might be effective alternative to warfarin for stroke prevention in atrial fibrillation

28 March 2009

MedWire News: A novel implantable device might be a worthy alternative to blood thinners in patients with nonvalvular atrial fibrillation (AF), according to the results of the prospective, randomized PROTECT AF (WATCHMAN left atrial appendage system forembolic PROTECTion in patients with Atrial Fibrillation) trial.

The study found that the WATCHMAN device was superior to warfarin at preventing hemorrhagic stroke and was as good as warfarin at protecting against other types of stroke and cardiovascular events. Early safety concerns about the device and the risk of pericardial effusion were ameliorated by technical adjustments and enhanced training.

Patients with AF have a five-fold increased risk of stroke, and more than 87% of these strokes are thromboembolic. AF patients require long-term anticoagulation, typically with warfarin. Warfarin is effective but has major disadvantages. Those receiving warfarin are subject to dietary restrictions, and frequent monitoring and dose adjustments are required. Only about 60% of patients who receive warfarin achieve a therapeutic range.

WATCHMAN is a fabric-covered expandable nitinol cage that, when implanted, blocks the formation of clots in the left atrial appendage, a common site of clot formation.

“The placement of the WATCHMAN device achieves excellent outcomes, eliminating hemorrhagic strokes and major bleeding often associated with the use of warfarin,” said David R. Holmes, Jr. (Mayo Graduate School of Medicine, Rochester, MN, USA). Dr. Holmes reported the PROTECT AF results at a late-breaking clinical trials session on the first day of the 58th Annual Scientific Session of the American College of Cardiology, in Orlando, Florida.

The PROTECT AF trial assigned 707 patients with nonvalvular AF to receive WATCHMAN (n=463 patients) or long-term warfarin treatment. Patients in the device arm were slated to receive warfarin for 45 days. Enrollment for the trial is ongoing in a Continuous Access Registry.

At 45 days, 87% of patients in the device arm were able to stop warfarin. By 6 months, 92.5% of device patients were off warfarin, and the rate continued to increase over time.

The device was successfully implanted in 90.9% (408/449) of attempts. Results were presented as an intent-to-treat analysis after accrual of 900 patient years of follow-up. The combined rate of stroke (ischemic and hemorrhagic) and cardiovascular death was 3.4% in the device group versus 5.0% in the warfarin group - a 32% reduction in event rate overall with the device - showing that that the device was non-inferior to warfarin.

More procedural-related complications were observed in the device arm: 8.7 per 100 patient years versus 4.2; pericardial effusion occurred in 6.5% of patients early in the trial, but the rate was reduced to 4.4% after the implementation of device modifications and training enhancement. Dr. Holmes noted that the rate of pericardial effusion is now down to 1.1% in the Continued Access Registry.

Five ischemic stroke events occurred in the device group, all of them periprocedural. One hemorrhagic stroke occurred in the device group versus six in the control group (0.2% versus 1.9%, respectively). The hemorrhagic stroke in the device group occurred 15 days post implant. This happened while the patient was still on warfarin, which Dr. Holmes called “double jeopardy.” Death occurred in one patient with hemorrhagic stroke in the device group and in four of the six hemorrhagic stroke patients in the warfarin group.

The number of deaths was 17 in the device group (two from stroke, three from unknown/other cardiovascular causes and 12 from non-cardiovascular causes) and 15 in the warfarin group (four from stroke, six from unknown/other cardiovascular causes, and five from non-cardiovascular). No deaths in the device group were procedure- or device-related, Dr. Holmes said.

“Results of this study suggest that the WATCHMAN device is an alternative to warfarin,” Dr. Holmes stated.

The study was supported by a grant from Atritech (Plymouth, MN, USA).
Картинки из J Am Coll Cardiol, 2007; 49:1490-1495
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Сообщение OlegZinovyev »

А как их разделили?
Получается смертность была на 11,7% выше в группе девайса...?
Зиновьев О.В.
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