Which Is Better? Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke

MedicalResearch.com Interview with:

Prof. Jean-Louis MAS Université Paris Descartes INSERM UMR S 894 Service de Neurologie et Unité Neurovasculaire Hôpital Sainte-Anne Paris 

Prof. Jean Louis MAS

Prof. Jean-Louis MAS
Université Paris Descartes
INSERM UMR S 894
Service de Neurologie et Unité Neurovasculaire
Hôpital Sainte-Anne
Paris 

MedicalResearch.com: What is the background for this study?

Response: Stroke is a major cause of death, disability and dementia affecting 17 million people each year worldwide. About 80% of strokes are ischemic strokes due to occlusion of a cerebral artery by a thrombus, itself the consequence of various arterial or heart diseases. In 30 to 40% of cases, no definite cause of ischemic stroke can be identified. Cryptogenic stroke is the term used to refer to these strokes of unknown etiology.

The patent foramen ovale (PFO) is a defect between the upper two heart chambers (called atria) though which a thrombus of venous origin may reach the systemic circulation and cause a stroke. This mechanism is called paradoxical embolism. Several case-control studies have shown an association between PFO and cryptogenic ischemic stroke, particularly in patients less than 60 years old, in those who have an atrial septal aneurysm (defined as an abnormal protrusion of the interatrial septum in the right or the left atrium or both) in addition to a PFO, and in those who have a PFO with a large right-to-left shunt. These findings suggested that a PFO might be responsible for stroke and that PFO closure with a device may decrease the risk of stroke recurrence. However, the causative relationship between PFO and stroke and the best strategy to prevent stroke recurrence have long been a hot topic of debate. Three previous randomized clinical trials failed to demonstrate any superiority of PFO closure over antithrombotic therapy.

Continue reading

Contraindications Not The Reason Atrial Fibrillation Patients Not Prescribed Anticoagulants

MedicalResearch.com Interview with:

Tom Marshall, MSc, PhD, MRGP, FFPH Professor of public health and primary care Institute of Applied Health Research University of Birmingham Birmingham UK

Prof. Marshall

Tom Marshall, MSc, PhD, MRGP, FFPH
Professor of public health and primary care
Institute of Applied Health Research
University of Birmingham
Birmingham UK 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is widely recognised that anticoagulants are underused in patients with atrial fibrillation (AF) although they are effective in reducing risk of stroke. We investigated whether this could be explained by the fact that many AF patients have conditions which are considered relative contraindications to their use.

We analysed electronic medical records from 645 general practices from 2004 to 2015 and included over 1 million patients with AF. We found that about 6% of AF patients had are relative contraindications such as recent history of major bleeding. In each of the 12 years, similar numbers of patients with and without contraindications were prescribed anticoagulants.

Continue reading

Head-to-Head Study Compares All Costs Associated With New Anticoagulants in Non-Valvular AFib

MedicalResearch.com Interview with:

Sabine Luik, M.D.</strong> Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc.

Sabine Luik

Sabine Luik, M.D.
Senior vice president, Medicine & Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study is the first real-world, matched head-to-head study comparing all cause healthcare costs and healthcare resource utilization (HCRU) among novel oral anticoagulants (NOACs).

The study analyzed claims data from 70,898 newly-diagnosed NVAF patients who were newly treated with Pradaxa, rivaroxaban or apixaban.

The analysis found that Pradaxa was associated with lower all-cause costs and HCRU compared to rivaroxaban. Compared to apixaban, Pradaxa was associated with similar all-cause costs and hospitalizations, but higher all-cause outpatient and pharmacy HCRU.

Continue reading

After PCI, Two Anticoagulants May Be As Effective As Three

MedicalResearch.com Interview with:

Nayan Agarwal MD Intervention Cardiology Fellow, University of Florida, Gainesville, FL

Dr. Agarwal

Nayan Agarwal MD
Intervention Cardiology Fellow,
University of Florida,
Gainesville, FL

MedicalResearch.com: What is the background for this study?

Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI).

Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk.

Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC.

Continue reading

Pradaxa: Compared To Warfarin, Lower Risk of Stroke and Bleeding in Non-Valvular AFib

MedicalResearch.com Interview with:

Sabine Luik, M.D. Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Sabine Luik

Sabine Luik, M.D.
Senior vice president, Medicine & Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Data from more than 20,000 patients with non-valvular atrial fibrillation (NVAF) were included in this study and the results demonstrate that Pradaxa® (dabigatran etexilate mesylate) was associated with a lower risk of stroke and major bleeding compared to warfarin. The study analyzed 7,245 PRADAXA patients and 14,490 warfarin patients with NVAF who had no prior use of an oral anticoagulant (OAC), using data from an administrative claims database from October 1, 2010, to April 30, 2014.

Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). PRADAXA was associated with a lower risk for serious secondary outcomes, including a 68 percent reduced risk of hemorrhagic stroke (HR, 0.32; 95% Cl, 0.14-0.76), an 18 percent reduced risk of major extracranial bleeding (HR, 0.82; 95% Cl, 0.70-0.96), a 48 percent reduced risk of venous thromboembolism (HR, 0.52; 95% Cl, 0.38-0.70), and a 27 percent reduced risk of death (HR, 0.73; 95% Cl, 0.61-0.88).

MedicalResearch.com: What should readers take away from your report?
Response: These results support the benefits of PRADAXA therapy for patients with NVAF and are consistent with those of previous studies evaluating PRADAXA and warfarin. Through a robust clinical trial, Pradaxa was proven superior to warfarin in reducing the risk of stroke in patients with NVAF.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Real-world data are critical for improving our understanding of treatment for patients with chronic conditions such as NVAF. We believe by working with diverse stakeholders to continue to study PRADAXA in the real world, we can help the community better understand gaps in treatment, identify opportunities to improve care and increase patient and physician assurance in treatment decisions.

MedicalResearch.com: Is there anything else you would like to add?

Response: Pradaxa has the longest real-world experience of any available NOAC. This research includes seven clinical trials with more than 32,000 patients and real-world experience through 11 studies and assessments, including more than 120,000 PRADAXA patients with NVAF.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

INTERNATIONAL STROKE CONFERENCE ORAL ABSTRACTSSESSION TITLE: PREVENTIVE STRATEGIES ORAL ABSTRACTS
Abstract 75: Bleeding and Ischemic Stroke Risk in Patients with Atrial Fibrillation Standard or Low Dose Dabigatran and Concomitant P-gp Inhibitors
Mary Vaughan Sarrazin, Alexander Mazur, Michael P Jones, Elizabeth Chrischilles
Stroke. 2017;48:A75

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation

MedicalResearch.com Interview with:

Xiaoxi Yao, PhD, MPH, MS Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic Rochester, MN

Dr. Xiaoxi Yao

Xiaoxi Yao, PhD, MPH, MS
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery
Mayo Clinic
Rochester, MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Atrial fibrillation (AF) is the most common arrhythmia requiring treatment, affecting 3-6 million Americans. AF is associated with a 5 fold risk of stroke, which can be substantially reduced by oral anticoagulants. For over a half century, warfarin was the only option for long-term oral anticoagulation in the U.S., but the use of warfarin can be cumbersome. Warfarin has numerous interactions with food and other drugs, and requires regular lab testing and dose adjustment. Since 2010, four non–vitamin K antagonist oral anticoagulants (NOACs) have been approved by the FDA. In comparison to warfarin, the fixed-dosage NOACs provide more convenient therapeutic options and demonstrated at least equivalent efficacy and safety in large phase III clinical trials. However, the outcomes achieved in idealized clinical trial settings may not necessarily translate to routine clinical practice.

In this large cohort of patients with nonvalvular AF, we assessed the real-world effectiveness and safety of three NOACs (dabigatran, rivaroxaban, and apixaban), comparing each agent with warfarin. We found apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin.

Continue reading

Venous Thromboembolism: Review Compares Eight Treatment Options

Dr. Marc Carrier, MD MSc Scientist, Clinical Epidemiology, Ottawa Hospital Research Institute Physician, Hematology (Thrombosis), The Ottawa Hospital Associate Professor, Department of Medicine, Faculty of Medicine, and Research Chair in Venous Thromboembolism and Cancer (Tier 2) at the University of OttawaMedicalResearch.com Interview with:
Dr. Marc Carrier, MD MSc
Scientist, Clinical Epidemiology, Ottawa Hospital Research Institute
Physician, Hematology, The Ottawa Hospital
Associate Professor, Department of Medicine, Faculty of Medicine, and Research Chair in Venous Thromboembolism and Cancer (Tier 2) at the University of Ottawa

MedicalResearch.com: What are the main findings of this study?

Dr. Carrier: Venous thromboembolism (VTE), comprised of deep vein thrombosis and pulmonary embolism, is the third leading cause of cardiovascular death. There are many anticoagulant treatments available but there is little guidance about which treatment is most effective and safe. This systematic review and network meta-analysis evaluated eight different treatment options for acute Venous thromboembolism.  Forty-five trials were included in the analysis and there were no significant differences in clinical or safety outcomes associated with most treatment options when compared to the combination of LMWH-VKA..
Continue reading