PREVAIL

Efficacy and safety of left atrial appendage closure compared with oral anticoagulation in atrial fibrillation: a meta-analysis of randomized controlledtrials and propensity-matched studies.

Backgrounds: Two recent randomized controlled trials (RCTs), the PROTECT-AF and the PREVAIL, showed that in atrial fibrillation (AF) patients, left atrial appendage closure (LAAC) is comparable to oral anticoagulants (OAC) in the prevention of stroke and could also possibly reduce mortality. Nevertheless, this net clinical benefit was not confirmed in the most recent RCT comparing LAAC vs. OAC, the PRAGUE-17 trial.

Aim: Aim of the present study was to evaluate the efficacy and safety of LAAC compared with OAC among available high-quality studies.

Methods: A systematic search of electronic databases (Medline, Scopus, Embase and the Cochrane Library) was performed to identify eligible RCTs and observational studies with propensity score matching (PSM) analysis. PRISMA guidelines were used for abstracting data and assessing data quality and validity. Outcomes of interest were the occurrence of cardiovascular death (CVD), all-cause death, all-type stroke, and major bleedings.

Results: A total of 3 RCTs and 7 PMS studies involving 25,700 patients were identified. 12,961 patients received LAAC while 12,739 received OAC therapy. After a median follow-up of 2.6 years (IQR 2–4.4), patients who received LAAC had lower risk of CVD (RR = 0.62; 95% CI, 0.51–0.74, I2 = 0%), all-cause death (RR = 0.67; 95% CI, 0.57–0.78, I2 68%) and major bleedings (RR = 0.68; 95% CI, 0.48–0.95 I2 = 87%) compared with patients on OAC. No difference was found between the two groups regarding strokes incidence (RR = 0.94; 95% CI, 0.77–1.15, I2 = 0%).

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Dispositivi per la chiusura dell’auricola: Watchman contro Amulet.

Il dispositivo Watchman per la chiusura dell’auricola si è dimostrato superiore al warfarin a 5 anni di follow-up nella prevenzione della mortalità, dell’ictus emorragico e dell’ictus fatale o inabilitante negli studi PROTECTAF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) e PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy). Il meccanismo di chiusura di Watchman è basato su un singolo disco che occlude l’ostio dell’auricola; dispositivi, come Amulet, che si avvalgono di un doppio meccanismo di “sealing” (un lobo che viene posizionato all’interno dell’auricola e un disco a esso connesso a chiudere l’ostio) potrebbero garantire una chiusura più efficace e un minore rischio di leaks. Non ci sono tuttavia in letteratura studi randomizzati di confronto tra i due dispositivi.

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