Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p = .17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p = .81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p = .77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p = .96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p = .08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p = .02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p < .0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group.
Background Several clinical studies have produced diverse results regarding the efficacy and safety of early intravenous beta-blockers in patients with acute ST-segment elevation myocardial infarction (STEMI). A study-level meta-analysis of randomized clinical trials (RCTs) comparing early intravenous beta-blockers versus placebo or routine care in STEMI patients undergoing primary percutaneous coronary intervention (PCI) was performed. Methods A database search was conducted using PubMed, EMBASE, the Cochrane Library, and Clinicaltrials.gov for randomized clinical trials (RCTs) that compared intravenous beta-blockers versus placebo or routine care in STEMI patients who underwent primary PCI. The efficacy outcomes were infarct size (IS, % of LV) and the myocardial salvage index (MSI) based on magnetic resonance imaging, electrocardiographic findings, heart rate, ST-segment reduction percent (STR%), and complete STR. Safety outcomes included arrhythmias in the first 24 h (ventricular tachycardia and fibrillation [VT/VF], atrial fibrillation [AF], bradycardia, and advanced atrioventricular [AV] block), cardiogenic shock and hypotension during hospitalization, left ventricular ejection fraction (LVEF), and major adverse cardiovascular events (cardiac death, stroke, reinfarction, and heart failure readmission) at follow-up. Results Seven RCTs with 1428 patients were included in this study, with 709 patients in the intravenous beta-blockers and 719 in the control group. Intravenous beta-blockers improved MSI compared to the control group (weighted mean difference [WMD] 8.46, 95% confidence interval [CI] 3.12–13.80, P = 0.002, I2 = 0%), but no differences were observed in IS (% of LV) between groups. Compared to the control group, the intravenous beta-blockers group had a lower risk of VT/VF (relative risk [RR] 0.65, 95% CI 0.45–0.94, P = 0.02, I2 = 35%) without an increase of AF, bradycardia, and AV-block and significantly decreased HR, hypotension. LVEF at 1 week ± 7 days (WMD 2.06, 95% CI 0.25–3.88, P = 0.03, I2 = 12%) and 6 months ± 7 days (WMD 3.24, 95% CI 1.54–4.95, P = 0.0002, I2 = 0%) was improved in the intravenous beta-blockers group compared to the control group. Subgroup analysis showed that intravenous beta-blockers before PCI decreased the risk of VT/VF and improved LVEF compared to the control group. Furthermore, sensitivity analysis showed that patients with a left anterior descending (LAD) artery lesion had a smaller IS (% of LV) in the intravenous beta-blockers group compared to the control group. Conclusion Intravenous beta-blockers improved the MSI, decreased the risk of VT/VF in the first 24 h, and were associated with increased LVEF at 1 week and 6 months following PCI. In particular, intravenous beta-blockers started before PCI is beneficial for patients with LAD lesions.
BackgroundPivotal trials of percutaneous left atrial appendage closure (LAAC) used dedicated post-procedure antithrombotic protocols. However, there is no consensus on the selection of new oral anticoagulants (NOAC) and warfarin monotherapy after LAAC. This study aims to compare NOAC with warfarin monotherapy for efficacy and safety in patients undergoing LAAC.MethodsA database search was conducted using PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov for trials that compared NOAC with warfarin monotherapy after LAAC. The effective outcomes included any major adverse events (all-cause death, stroke, major bleeding) and their individual components. Safety outcomes included all-cause death, major bleeding, total bleeding, DRT, and PDL >5 mm.ResultsWe included 10 non-randomized clinical trials with 10,337 patients, of whom 4,960 patients received NOAC, while 5,377 patients received warfarin. There were no statistically significant differences in any major adverse events (LogOR: −0.11, 95% CI: −0.27, 0.04, P = 0.16), stroke (LogOR: 0.00, 95% CI: −0.42, 0.42, P = 1.00), all-cause death (LogOR: −0.23, 95% CI: −0.48, 0.02, P = 0.07), major bleeding (LogOR: −0.22, 95% CI: −0.45, 0.01, P = 0.06). NOAC was associated with a significant reduction in total bleeding (LogOR: −1.01, 95% CI: −1.47, −0.55, P < 0.0001) compared to warfarin. No statistically significant differences were found in DRT (LogOR: −0.19, 95% CI: −0.15, 0.52, P = 0.27) and PDL >5 mm (LogOR: 0.19, 95% CI: −0.33, 0.72, P = 0.47). Meta-regression and subgroup analysis showed that total bleeding (LogOR: −1.56, 95% CI: −2.15, −0.97, P < 0.001) was significantly lower in the NOAC group in the subgroup of <75 y.ConclusionAfter LAAC, NOAC monotherapy was associated with a lower risk of bleeding compared to warfarin monotherapy for 45 days. There was no significant difference between NOAC and warfarin in terms of other results.Systematic review registrationwww.york.ac.uk/inst/crd, identifier: CRD42022361244.
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