Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation

Aims The aim of this study was to analyse randomized controlled study and real-world outcomes of patients with non-valvular atrial fibrillation (NVAF) undergoing left atrial appendage closure (LAAC) with the Watchman device and to compare costs with available antithrombotic therapies. Methods and results Registry data of LAAC from two centres were prospectively collected from 110 patients with NVAF at risk of stroke, suitable and unsuitable for long-term anticoagulation (age 71.3 ± 9.2 years, CHADS2 2.8 ± 1.2, CHA2DS2-VASc 4.5 ± 1.6, and HAS-BLED 3.8 ± 1.1). Outcomes from PROTECT AF and registry study LAAC were compared with warfarin, dabigatran, rivaroxaban, apixaban, aspirin, and no treatment using a network meta-analysis. Costs were estimated over a 10-year horizon. Uncertainty was assessed using sensitivity analyses. The procedural success rate was 92% (103/112). Follow-up was 24.1 ± 4.6 months, during which annual rates of stroke, major bleeding, and all-cause mortality were 0.9% (2/223 patient-years), 0.9% (2/223 patient-years), and 1.8% (4/223 patient-years), respectively. Anticoagulant therapy was successfully stopped in 91.2% (93/102) of implanted patients by 12 months. Registry study LAAC stroke and major bleeding rates were significantly lower than PROTECT AF results: mean absolute difference of stroke, 0.89% (P = 0.02) and major bleeding, 5.48% (P
Source: European Heart Journal - Category: Cardiology Authors: Tags: Thrombosis and antithrombotic therapy Source Type: research

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Conclusion: DOAC discontinuation rates varied significantly and appeared related to drug-specific side effects, patient-initiated discontinuation, and bleeding. We observed longer-term administration of apixaban, suggesting that this drug is better tolerated than dabigatran or rivaroxaban. PMID: 32011180 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Conclusion and Relevance: Female patients with a high stroke risk were less likely to receive guideline-recommended treatment. This study provides new information on prescribing trends within the Australian setting and highlights the opportunity to improve the management of female patients with AF and 1 or more additional stroke risk factors. PMID: 32019321 [PubMed - as supplied by publisher]
Source: The Annals of Pharmacotherapy - Category: Drugs & Pharmacology Authors: Tags: Ann Pharmacother Source Type: research
In conclusion, elderly and frail patients requiring anticoagulation for AF or VTE are at higher risk of adverse outcomes, but also have a higher absolute benefit from OAC. Important practical aspects to improve efficacy and safety in this challenging population are summarized in this overview. PMID: 32000266 [PubMed - as supplied by publisher]
Source: Hamostaseologie - Category: Hematology Authors: Tags: Hamostaseologie Source Type: research
Background: It is important to understand the risk of thromboembolism and bleeding in patients with nonvalvular atrial fibrillation (NVAF) receiving direct oral anticoagulants; however, data on risk factors in Japanese patients are limited. Methods: XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation) is a prospective observational study examining the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. We investigated risk factors for stroke/noncentral nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI) and major ...
Source: Journal of Stroke and Cerebrovascular Diseases - Category: Neurology Authors: Source Type: research
CONCLUSION:  Moderate quality evidence suggests lower INR targets reduce bleeding but increase thromboembolism in AF. The data are dominated by East-Asian studies, limiting generalizability to Western populations. Until higher quality data demonstrate otherwise, an INR range of 2 to 3 should remain standard for thromboembolic prophylaxis in AF. PMID: 31940677 [PubMed - as supplied by publisher]
Source: Thrombosis and Haemostasis - Category: Hematology Authors: Tags: Thromb Haemost Source Type: research
The introduction of the direct oral anticoagulants for stroke prevention in atrial fibrillation and the management of thromboembolism has transformed the care of patients with these disorders. These drugs, which selectively and reversibly inhibit factor Xa or thrombin in the common pathway of the coagulation cascade, have a wide therapeutic window; this allows for simplified dosing regimens without laboratory monitoring of most adult patients as contrasted to vitamin K antagonists. This class of drug is also associated with a lower bleeding risk than vitamin K antagonists, which has been most clearly demonstrated by a 50% ...
Source: JAMA - Category: General Medicine Source Type: research
AbstractThe use of direct oral anticoagulants for stroke prevention in atrial fibrillation continues to rise. Certain populations may be at higher risk for increased drug exposure and adverse events. Pharmacokinetic studies suggest increased exposure of rivaroxaban and apixaban with combined P-gp and moderate CYP3A4 inhibitors but the clinical relevance of this is unknown. This retrospective cohort study included patients receiving rivaroxaban or apixaban from January 1, 2012 to December 31, 2016 with a moderate inhibitor (amiodarone, dronedarone, diltiazem, verapamil) for at least 3 months in the drug –drug interact...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
Bleeding is the most serious undesirable event of antithrombotic therapy, though this treatment has shown benefits in terms of venous or arterial thrombosis prevention, particularly in case of atrial fibrillation, stroke, venous thromboembolism, and coronary disease.
Source: Thrombosis Research - Category: Hematology Authors: Tags: Letter to the Editors-in-Chief Source Type: research
AbstractApixaban is prescribed for stroke prevention in nonvalvular atrial fibrillation (NVAF) in patients with varying degrees of renal dysfunction. While pharmacokinetic data support apixaban in severe renal impairment, clinical safety outcomes data are limited. This retrospective cohort analysis was conducted to evaluate the safety of apixaban in patients with NVAF and renal impairment. A total of 340 patients with NVAF receiving apixaban 5  mg or 2.5 mg twice daily were included for analysis; 287 preserved renal function (pRF: CrCl ≥ 25 ml/min and SCr ≤ 2.5 mg/dl) and 53 impaired renal functio...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
CONCLUSIONS: Very low- to moderate-certainty evidence suggests no meaningful difference in efficacy outcomes between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists following percutaneous coronary interventions (PCI) in people with non-valvular atrial fibrillation. NOACs probably reduce the risk of recurrent hospitalisation for adverse events compared with vitamin K antagonists. Low- to moderate-certainty evidence suggests that dabigatran may reduce the rates of major and non-major bleeding, and apixaban and rivaroxaban probably reduce the rates of non-major bleeding compared with vitamin K an...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
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