Boston Sci Initiates New Watchman FLX Study

Boston Scientific has initiated a study that will compare the Watchman FLX left atrial appendage (LAA) closure device’s safety and effectiveness to that of anticoagulants for reducing stroke risk in atrial fibrillation patients in a new trial. The randomized, controlled OPTION trial will enroll 1,600 patients with non-valvular AFib who are suitable for oral anticoagulants (OAC) therapy and have recently had or will have an ablation. Patients at as many as 130 global sites will be randomized to receive the newest-generation Watchman FLX device or an OAC, inclusive of commonly prescribed direct oral anticoagulants or warfarin. The primary effectiveness endpoint is all cause death, stroke and systemic embolism through 36 months, and the primary safety endpoint is non-procedural bleeding through 36 months. "Beyond advancing the robust clinical literature supporting the Watchman therapy, findings from the OPTION trial have the potential to expand the number of patients with atrial fibrillation who can receive an alternative to life-long anticoagulants and thus avoid their potential side effects," Dr. Ian Meredith, AM, executive vice president and global CMO, Boston Scientific, said in a release. "The unique study design encompasses patients who will receive a Watchman FLX device either after or concurrent to an ablation procedure." Watchman was a game-changer for the Marlborough, MA-based company. The firm’s acquisition of th...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news

Related Links:

AbstractThe optimal management of oral anticoagulation (OAC) in the acute phase of non valvular atrial fibrillation (NVAF)-related acute ischemic stroke (AIS) remains controversial, especially in very old patients. Therefore, the aim of our study was to evaluate the practical management of OAC in this context. We conducted an observational retrospective study on patients 85-years old and older admitted to two Italian hospitals for NVAF-related AIS. For each patient, clinical and brain computed tomography data were recorded. Type of OAC (vitamin K antagonists, VKAs or Direct Oral Anticoagulants, DOACs), dosage and starting ...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
CONCLUSIONS: The risks of ischemic stroke/SE and major bleeding were significantly higher in HIV-infected patients compared with non-HIV-infected patients with AF. Despite this, the actual use of OACs among AF patients with HIV was suboptimal. PMID: 31619594 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
CONCLUSIONS: Although the incidences of stroke/TIA, major bleeding, and death were relatively low among patients for whom OAC therapy was discontinued, stroke/TIA occurrence was strongly associated with a high baseline stroke risk rather than with OAC status. Thus, discontinuation of OAC therapy requires careful consideration, especially in patients with a high baseline stroke risk. PMID: 31619591 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
AbstractPercutaneous left atrial appendage closure (LAAC) may decrease risks of stroke and bleeding in elderly patients with non-valvular atrial fibrillation (NVAF), but it is still lacking of evidence. The present study aimed at evaluating the efficacy and safety of LAAC in patients with NVAF over 75  years. 351 patients with NVAF who underwent LAAC were retrospectively analyzed on the LAAC procedure characteristics and the clinical follow-up according to age (age ≥ 75 years or 
Source: Heart and Vessels - Category: Cardiology Source Type: research
AbstractFor Japanese patients with non-valvular atrial fibrillation (NVAF), the risk of stroke and major bleeding events was assessed by using the CHADS2, CHA2DS2-VASc, and HAS-BLED scores. The risk factors for embolism and major bleeding under DOAC may be different from current reports. We analyzed the data set of the EXPAND Study to determine the risk factors for events among Japanese NVAF patients in the era of direct oral anticoagulant. Using the data of EXPAND Study, the validity for predictability of the CHADS2, CHA2DS2-VASc, and HAS-BLED scores was identified using the receiver operating characteristic curve analysi...
Source: Heart and Vessels - Category: Cardiology Source Type: research
Conclusions: The rhythm control strategy demonstrated a beneficial effect to lower the risk of ischemic stroke during a 1-year follow-up compared to the rate control strategy. PMID: 31597907 [PubMed - as supplied by publisher]
Source: The Korean Journal of Internal Medicine - Category: Internal Medicine Authors: Tags: Korean J Intern Med Source Type: research
ConclusionsIn our study, DOACs appeared to be as efficacious and safe in CKD IV and V as in CKD III. In addition, DOACs appeared to be more effective than, and as safe as warfarin when compared with reference studies of patients with advanced CKD. Our findings support the use of DOACs for thromboembolism prevention in patients with advanced CKD and AF.This article is protected by copyright. All rights reserved
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: ELECTROPHYSIOLOGY Source Type: research
Conclusions: Among patients with AF at risk for stroke, there was an approximately four-fold difference in the frequency of the most severe bleeding events across commonly used bleeding scales. Further, the relative safety of edoxaban as compared with warfarin tended to increase with greater severity of bleeding. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT00781391. PMID: 31597460 [PubMed - as supplied by publisher]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
AbstractBackgroundLeft atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with non ‐valvular atrial fibrillation (AF). Our aim was to study long‐term outcomes in patients undergoing LARIAT procedure.MethodsWe analyzed patients screened for LARIAT device in 4 centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other pre ‐procedural contraindications were included in control group. We analyzed thromboembolism, bleeding events and mortality between...
Source: Journal of Cardiovascular Electrophysiology - Category: Cardiology Authors: Tags: ORIGINAL ‐ CLINICAL Source Type: research
Authors: Gumprecht J, Domek M, Lip GY Abstract Introduction: The non-vitamin K antagonist oral anticoagulants (NOACs) are changing the landscape for stroke prevention in atrial fibrillation (AF) and prevention or treatment of venous thromboembolism (VTE). In patients with AF and concomitant acute coronary syndrome (ACS), the treatment regimen of combined NOACs and P2Y12 inhibitors is gaining popularity. Areas covered: The authors conducted a review of studies published in the last 10 years regarding safety evaluation and effectiveness of apixaban for the treatment of AF and ACS, both alone and in combination with d...
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
More News: Atrial Fibrillation | Bleeding | Cardiology | Cardiovascular | Coumadin | Heart | Medical Devices | Stroke | Study | Warfarin