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

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Authors: Ho CY, Nunn C, White J, Kerr A, Lee M Abstract BACKGROUND: Concomitant atrial fibrillation (AF) and acute coronary syndrome (ACS) present the difficult therapeutic dilemma of balancing bleeding, cardio-embolic and coronary thrombotic risks with appropriate combinations of antithrombotic medications. We aim to evaluate current New Zealand practice by identifying the incidence of AF in ACS; describe the population characteristics; and assess our antithrombotic management. METHODS: Consecutive patients ≥18y presenting with ACS who had coronary angiography (2017-2018) were identified from the All New Ze...
Source: New Zealand Medical Journal - Category: General Medicine Tags: N Z Med J Source Type: research
Authors: Maruhashi T, Higashi Y Abstract INTRODUCTION: Stroke remains one of the major public health problems in Japan. The number of patients with atrial fibrillation (AF) has been steadily increasing with the aging of the Japanese population. Appropriate oral antithrombotic therapy is necessary to prevent AF-related stroke and bleeding complications. AREAS COVERED: The authors summarize the Japanese guidelines for antithrombotic therapy, as well as the current status of antithrombotic therapy, and future perspectives for antithrombotic therapy for patients with AF in Japan. EXPERT OPINION: Further improve...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
AbstractEarly administration of direct oral anticoagulants in patients with acute large vessel occlusion (LVO) and nonvalvular atrial fibrillation (NVAF) is a concern, as endovascular therapy (EVT) became highly utilized. We conducted a historical and prospective multicenter registry at 38 centers in Japan from July 2016 to February 2018. Patients aged ≥ 20 years with NVAF and acute LVO or stenosis who received apixaban within 14 days from onset were included. We compared patients who received apixaban
Source: Translational Stroke Research - Category: Neurology Source Type: research
Conclusions: Changing national guidelines with discard of contraindications for anticoagulation and the introduction of DOACs led to a broader recommendation of oral anticoagulation. However, both, new guidelines and DOACs, were not found to be associated with an increasing percentage of patients discharged from our hospital already on recommended anticoagulant prevention. This might be explained by the decreasing length of hospital stay during the study period and a missing evidence of early bleeding risk of DOACs in patients with acute brain infarction. Evidence-based data to close this therapeutic gap are needed.Cerebrovasc Dis
Source: Cerebrovascular Diseases - Category: Neurology Source Type: research
There were 33,269 apixaban-warfarin, 9,345 dabigatran-warfarin, and 42,156 rivaroxaban-warfarin matched pairs, with a median follow-up of 4-5 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.52; 95% confidence interval [95% CI], 0.43-0.62), major bleeding (HR 0.60; 95% CI, 0.55-0.66) and stroke/myocardial infarction/all-cause mortality (HR 0.70; 95%CI, 0.66-0.74); dabigatran was associated with lower rates of major bleeding (HR: 0.73; 95% CI, 0.62-0.85); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-ca...
Source: The American Journal of Medicine - Category: General Medicine Authors: Tags: Corrigendum Source Type: research
This study evaluated the association between postoperative warfarin use and complications after mitral valve repair, including bleeding and thromboembolic incidents, readmission, and mortality.MethodsThis retrospective study investigated 1097 patients who underwent elective mitral valve repair between April 2003 and March 2017, and was na ïve to atrial fibrillation or prior cardiac surgery. This cohort had no other indication for or against anticoagulation. About 775 patients were placed on warfarin with international normalized ratio goal 2.5 and 322 patients were not anticoagulated. The association between anticoagu...
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
Purpose of review Direct oral anticoagulants (DOACs) are variably eliminated by the kidneys rendering their use potentially problematic in patients with chronic kidney disease (CKD) or necessitating appropriate dose adjustment. Recent findings Both observational and limited randomized trial data for DOACs compared with no treatment or with warfarin for patients with atrial fibrillation on maintenance dialysis were recently published. In a randomized trial in patients on hemodialysis, there was no significant difference in vascular calcification between patients who received rivaroxaban with or without vitamin K2 or vi...
Source: Current Opinion in Nephrology and Hypertension - Category: Urology & Nephrology Tags: PHARMACOLOGY AND THERAPEUTICS: Edited by Sankar D. Navaneethan Source Type: research
CONCLUSION: The findings show that NOACs are effective and safe for preventing stroke/SE in patients with both NVAF and PAD. PMID: 32728781 [PubMed - as supplied by publisher]
Source: Herz - Category: Cardiology Tags: Herz Source Type: research
Conclusions: Differences in study populations can and should be considered quantitatively to ensure results are relevant to populations of interest, particularly when comparing trial with nonexperimental findings. See video abstract: http://links.lww.com/EDE/B703.
Source: Epidemiology - Category: Epidemiology Tags: Cardiovascular Disease Source Type: research
Conclusion Our study highlights how DOACs are a safe and effective option for anticoagulation, even in frail elderly people; the introduction of these drugs is leading to an increased use of anticoagulation therapy in this population. Prospective trials will be needed to reinforce these results and to consider new variables in the thrombotic and hemorrhagic risk scores underlying the prescription of DOACs.
Source: Journal of Cardiovascular Medicine - Category: Cardiology Tags: Research articles: Arrhythmias Source Type: research
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