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PROTECT AF: Difference between revisions
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It is estimated that only 50% of patients with non-valvular atrial fibrillation who qualify for warfarin are actually treated.<ref> | It is estimated that only 50% of patients with non-valvular atrial fibrillation who qualify for warfarin are actually treated.<ref>{{#pmid:10610643}}</ref> This is a concern as the annual risk of stroke among those who are not anticoagulated range from 1.5% in individuals aged 50–59 years to 23.5% for those aged 80–89 years.<ref>{{#pmid:1866765}}</ref> Alternatives to anticoagulation have thus been pursued. One strategy involves obliteration of the left atrial appendage (LAA) since this site is a common location of clot formation in non-valvular AF. | ||
PROTECT AF was a randomized controlled trial conducted in the US and Europe which randomized 707 patients with non-valvular AF and CHADS2 score of ≥1 to either LAA closure with the WATCHMAN device or to warfarin control in a 2:1 fashion. Those randomized to LAA closure discontinued their warfarin therapy 6 weeks after device placement. The study's objective was to determine noninferiority of LAA closure compared to warfarin. Patients were followed for the primary composite outcome of stroke, cardiovascular or unexplained death, or systemic embolism. With a median follow-up of 18 months, the primary outcome rate was 3.0 per 100 person-years in the LAA closure group compared to 4.9 per 100 person-years in the warfarin control (RR 0.62) and non-inferiority criteria were met. Adverse events were more common in the device group compared to warfarin controls (RR 1.69); in the device group these occurred early, whereas in the warfarin group these occurred late. Notably ischemic strokes were more common in the device group than in the warfarin controls, and most of the events in the device group were attributed to periprocedural air embolism. The authors conclude that LAA closure may be a reasonable option for patients in whom long-term anticoagulation is not desirable. The 2014 AHA/ASA guidelines contend that LAA closure with the WATCHMAN device may be most appropriate for patients with AF at high risk of stroke who are poor candidates for anticoagulation. | PROTECT AF was a randomized controlled trial conducted in the US and Europe which randomized 707 patients with non-valvular AF and CHADS2 score of ≥1 to either LAA closure with the WATCHMAN device or to warfarin control in a 2:1 fashion. Those randomized to LAA closure discontinued their warfarin therapy 6 weeks after device placement. The study's objective was to determine noninferiority of LAA closure compared to warfarin. Patients were followed for the primary composite outcome of stroke, cardiovascular or unexplained death, or systemic embolism. With a median follow-up of 18 months, the primary outcome rate was 3.0 per 100 person-years in the LAA closure group compared to 4.9 per 100 person-years in the warfarin control (RR 0.62) and non-inferiority criteria were met. Adverse events were more common in the device group compared to warfarin controls (RR 1.69); in the device group these occurred early, whereas in the warfarin group these occurred late. Notably ischemic strokes were more common in the device group than in the warfarin controls, and most of the events in the device group were attributed to periprocedural air embolism. The authors conclude that LAA closure may be a reasonable option for patients in whom long-term anticoagulation is not desirable. The 2014 AHA/ASA guidelines contend that LAA closure with the WATCHMAN device may be most appropriate for patients with AF at high risk of stroke who are poor candidates for anticoagulation. | ||