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Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to Tweet: Jan...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Oral Anticoagulation.
CONCLUSION: The evidence base for anticoagulation over a time frame of several years is inadequate at present, and direct comparative data for the different types of NOAC are not yet available. PMID: 30602410 [PubMed - in process]
Source: Deutsches Arzteblatt International - January 5, 2019 Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research

EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial
Publication date: November 2018Source: American Heart Journal, Volume 205Author(s): Nicolas M. Van Mieghem, Martin Unverdorben, Marco Valgimigli, Roxana Mehran, Eric Boersma, Usman Baber, Christian Hengstenberg, Minggao Shi, Cathy Chen, Shigeru Saito, Roland Veltkamp, Pascal Vranckx, George D. DangasTranscatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate...
Source: American Heart Journal - August 30, 2018 Category: Cardiology Source Type: research

‘Ten Commandments’ of the EHRA Guide for the Use of NOACs in AF
Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF), and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. In 2013, the first “EHRA Practical Guide” was published to provide practical guidance for situations; an update was published in 2015. Below ...
Source: European Heart Journal - April 21, 2018 Category: Cardiology Source Type: research

Beyond Stroke Prevention in Atrial Fibrillation: Exploring Further Unmet Needs with Rivaroxaban.
This article provides an update on three randomized controlled trials of rivaroxaban, a direct, oral factor Xa inhibitor, that are complete or are ongoing, in these unmet areas of stroke prevention: oPen-label, randomized, controlled, multicentre study explorIng twO treatmeNt stratEgiEs of Rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in patients with Atrial Fibrillation who undergo Percutaneous Coronary Intervention (PIONEER AF-PCI) trial; the New Approach riVaroxaban Inhibition of factor Xa in a Global trial vs Aspirin to prevenT Embolism in Embolic Stroke of Undetermined Source (NAVIGATE E...
Source: Thrombosis and Haemostasis - March 22, 2018 Category: Hematology Authors: Gibson CM, Hankey GJ, Nafee T, Welsh RC Tags: Thromb Haemost Source Type: research

Oral anti-Xa anticoagulation after Trans-Aortic Valve Implantation for Aortic Stenosis: The randomized ATLANTIS trial
Conclusions ATLANTIS tests the superiority of an apixaban-based strategy versus the recommended standard of care strategy to reduce the risk of post-TAVR thromboembolic and bleeding complications in an all comer population.
Source: American Heart Journal - March 10, 2018 Category: Cardiology Source Type: research

Factors associated with non –vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
Conclusions In contemporary clinical practice, up to three-fourths of patients with new-onset AF are now initially treated with a NOAC for stroke prevention. Those selected for NOAC treatment had lower stroke and bleeding risk profiles, were more likely treated by cardiologists, and had higher socioeconomic status. Trial registration clinicaltrials.gov Identifier: NCT01701817
Source: American Heart Journal - April 25, 2017 Category: Cardiology Source Type: research

Pre-treatment clinical assessment in head and neck cancer: United Kingdom National Multidisciplinary Guidelines.
Authors: Robson A, Sturman J, Williamson P, Conboy P, Penney S, Wood H Abstract This is the official guideline endorsed by the specialty associations involved in the care of head and neck cancer patients in the UK. This paper provides recommendations on the pre-treatment clinical assessment of patients presenting with head and neck cancer. Recommendations • Comorbidity data should be collected as it is important in the analysis of survival, quality of life and functional outcomes after treatment as well as for comparing results of different treatment regimens and different centres. (R) • Patients with hypertens...
Source: Journal of Laryngology and Otology - November 15, 2016 Category: ENT & OMF Tags: J Laryngol Otol Source Type: research

Direct Oral Anticoagulants in Emergency Trauma Admissions.
CONCLUSION: DOACs in the setting of hemorrhage are a clinical challenge in the traumatological emergency room because of the inadequate validity of the relevant laboratory tests. An emergency antidote is now available only for dabigatran. PMID: 27658470 [PubMed - in process]
Source: Deutsches Arzteblatt International - September 24, 2016 Category: Journals (General) Tags: Dtsch Arztebl Int Source Type: research

Spotlight on unmet needs in stroke prevention: The PIONEER AF-PCI, NAVIGATE ESUS and GALILEO trials.
This article focuses on three randomised controlled trials (RCTs) that are investigating the utility of rivaroxaban, a direct, oral, factor Xa inhibitor, in additional areas of stroke prevention where data for anticoagulants are lacking: oPen-label, randomized, controlled, multicentre study explorIng twO treatmeNt stratEgiEs of Rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment (PIONEER AF-PCI); New Approach riVaroxoban Inhibition of factor Xa in a Global trial vs Aspirin to prevenT Embolism in Embolic Stroke of Undetermined Source (NAVIGATE ESUS); and Global study comparing a rivAroxaban-based antithrombo...
Source: Thrombosis and Haemostasis - September 13, 2016 Category: Hematology Authors: Hemmrich M, Peterson ED, Thomitzek K, Weitz JI Tags: Thromb Haemost Source Type: research

Cochrane corner: vitamin K for improved anticoagulation control in patients receiving warfarin
There has been a substantial increase in the use of oral anticoagulants, notably in the ageing population. This is primarily driven by the use of warfarin in people with atrial fibrillation (AF) in order to reduce the risks of thromboembolic events such as stroke.1 In elderly patients with AF, warfarin use has been shown to reduce the relative risk of stroke by >50% compared with aspirin alone.2 Warfarin is also used to treat patients with deep vein thrombosis, mechanical heart valve replacement, cardioversion, cardiomyopathy and antiphospholipid syndrome.1 The clinical benefits of warfarin must also be balanced with po...
Source: Heart - October 11, 2015 Category: Cardiology Authors: Mahtani, K. R., Nunan, D., Heneghan, C. Tags: Drugs: cardiovascular system, Cochrane Corner, Venous thromboembolism, Epidemiology Editorials Source Type: research

How to define valvular atrial fibrillation?
Abstract Atrial fibrillation (AF) confers a substantial risk of stroke. Recent trials comparing vitamin K antagonists (VKAs) with non-vitamin K antagonist oral anticoagulants (NOACs) in AF were performed among patients with so-called "non-valvular" AF. The distinction between "valvular" and "non-valvular" AF remains a matter of debate. Currently, "valvular AF" refers to patients with mitral stenosis or artificial heart valves (and valve repair in North American guidelines only), and should be treated with VKAs. Valvular heart diseases, such as mitral regurgitation, aortic stenosis (AS) and aortic insufficiency, do...
Source: Archives of Cardiovascular Diseases - July 13, 2015 Category: Cardiology Authors: Fauchier L, Philippart R, Clementy N, Bourguignon T, Angoulvant D, Ivanes F, Babuty D, Bernard A Tags: Arch Cardiovasc Dis Source Type: research

Changing practice of anticoagulation: will target-specific anticoagulants replace warfarin?
Abstract The target-specific oral anticoagulants are a class of agents that inhibit factor Xa or thrombin. They are effective and safe compared to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation and for the treatment of venous thromboembolism, and they are comparable to low-molecular-weight heparin for thromboprophylaxis after hip or knee arthroplasty. For other indications, however, such as the prevention of stroke in patients with mechanical heart valves, initial studies have been unfavorable for the newer agents, leaving warfarin the anticoagulant of choice. Furt...
Source: Annual Review of Medicine - January 14, 2015 Category: Journals (General) Authors: Arepally GM, Ortel TL Tags: Annu Rev Med Source Type: research

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