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.

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Stroke Prevention: No Advantage To Taking Three Blood Thinners After First Stroke

MedicalResearch.com Interview with:

Professor Philip Bath Stroke Association Professor of Stroke Medicine/Head of Division of Clinical Neuroscience Faculty of Medicine & Health Sciences University of Nottingham

Prof. Philip Bath

Professor Philip Bath
Stroke Association Professor of Stroke Medicine/Head of Division of Clinical Neuroscience
Faculty of Medicine & Health Sciences
University of Nottingham 

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

Response: Blood thinning (antiplatelets) drugs reduce further strokes (recurrence) after stroke and mini-stroke (TIA). One antiplatelet, such as aspirin, is better than none, and two different drugs are better than one. The question then is whether three would be better still, providing excess bleeding is not problematic.

3096 patients with ischaemic stroke (stroke due to a blood clot) or mini-stroke were enrolled within 48 hours. They were randomised to take intensive separate antiplatelet therapy (three drugs comprising aspirin, clopidogrel and dipyridamole) or guideline therapy (either clopidogrel alone, or combined aspirin and dipyridamole) for 30 days (after which they took guideline treatment). At 90 days we assessed whether patients had had another stroke or mini-stroke, and how dependent or disabled this had left them.

There were slightly fewer recurrent strokes and mini-strokes between intensive and guideline treatment but the difference was not different statistically, so a neutral trial. In contrast, major bleeding was significantly increased in the intensive group as compared with guideline treatment. When looking at the net benefit/harm, there was no difference between the treatment groups.

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Rank, Not Race, Associated with Stroke Outcomes in Military

MedicalResearch.com Interview with:

Matthew D. Holtkamp, D.O. CPT, MC, USA Medical Director, Intrepid Spirit, Traumatic Brain Injury Clinic Staff Neurologist, Department of Medicine Teaching Fellow, Uniformed Services University Carl R. Darnall Army Medical Center Fort Hood, Texas 76544

Dr. Mathew Holtkamp,

Matthew D. Holtkamp, D.O. CPT, MC, USA
Medical Director, Intrepid Spirit, Traumatic Brain Injury Clinic
Staff Neurologist, Department of Medicine
Teaching Fellow, Uniformed Services University
Carl R. Darnall Army Medical Center
Fort Hood, Texas 76544

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

Response: Racial and Socioeconomic disparities in the outcomes of stroke patients is well documented in the US Civilian Healthcare system.

That Healthcare system has wide variations in access to care and in the levels of available care. In contrast, the Military Healthcare system is a single payer system meaning that every member has the same healthcare benefits.

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Food Insecurity Common Among Inner City Stroke Patients

MedicalResearch.com Interview with:

Dr. Lakshmi Warrior MD Assistance Professor, Neurology Cook County Health & Hospitals System Chicago

Dr. Lakshmi Warrior

Dr. Lakshmi Warrior MD
Assistance Professor, Neurology
Cook County Health & Hospitals System
Chicago

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

Response: In 2015, 42.2 million Americans lived in food insecure households. Food insecurity is defined as “limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire acceptable foods in socially acceptable ways”. Previous work has demonstrated associations between food insecurity and chronic diseases such as hypertension, diabetes, hyperlipidemia.

Cook County Health and Hospitals System serves a population of largely uninsured and underinsured patients. This pilot study sought determine the prevalence of food insecurity in our population of patients who were recently discharged home from the hospital with the diagnosis of stroke.

MedicalResearch.com: What are the main findings?

Response: We found that food insecurity is a prevalent problem in our patient population with more than 1 in 5 identifying as food insecure. It also appears that food insecure stroke patients had a higher prevalence of diabetes (54% vs 28%)and hypertension (86% vs. 67%) as compared to food secure patients.

MedicalResearch.com: What should readers take away from your report?

Response: Food insecurity is a prevalent issue in our patient population. There should be consideration for food insecurity screening in high-risk populations as food insecurity can complicate the management of diet-related diseases such as hypertension and diabetes. For patients with food insecurity, a multi-disciplinary approach using case and social workers in addition to medical management should be considered.

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

Response: Further study of this topic is needed. A larger, retrospective review of our stroke patients is currently underway. We are also planning for a prospective study of our inpatient stroke patients to evaluate if these patients are at higher risk for not only vascular risk factors but also re-hospitalization and poor outcomes.

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

Citation: Abstract presented at the  AHA/ASA International Stroke Conference February 2017

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

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Psychiatric Illness Linked To Increased Risk of Stroke

MedicalResearch.com Interview with:

Jonah P. Zuflacht M.D. Candidate | Class of 2017 Columbia University, College of Physicians & Surgeons

Jonah Zuflacht

Jonah P. Zuflacht
M.D. Candidate | Class of 2017
Columbia University, College of Physicians & Surgeons

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

Response: Recent evidence suggests that psychological distress, including the symptoms of psychiatric illness, may increase the risk of stroke. However, existing studies have been limited by small sample sizes, methodological bias, and poorly defined criteria for what constitutes psychological distress. We used a case-crossover design to assess the relationship between hospitalization or emergency department visit for a psychiatric condition and stroke in adults. We found that psychiatric hospitalization increases the short-term risk of stroke, particularly within the 15-day period following the diagnosis. This effect is particularly pronounced in younger patients.

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ASTER Trial Supports Aspiration Of Clots in Acute Ischemis Stroke

MedicalResearch.com Interview with:

Michel Piotin, MD PhD Principal investigator and interventional neuroradiologis Rothschild Fondation Hospital Paris

Dr. Michel Piotin

Michel Piotin, MD PhD
Principal investigator and Interventional Neuroradiologist
Rothschild Fondation Hospital, Paris 

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

Response: Mechanical thrombectomy (MT) with a stent retriever (SR), in association with intravenous rtPA, is now the standard of care in anterior circulation ischemic stroke caused by large vessel occlusion

Thrombectomy (MT) with a stent retriever (SR), in association with intravenous (IV) rtPA, is now the standard of care in anterior circulation ischemic stroke caused by large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New techniques for MT such as ADAPT (A Direct first pass Aspiration Technique) is promising to increase reperfusion status and clinical outcome in retrospective studies. Our study objective was to determine which technique should be used in frontline strategy (ADAPT or Stent Retriever) to achieve maximum reperfusion. The ASTER study is the first independent large randomized controlled trial focusing on ADAPT technique with blinded assessment data.

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Medtronic Pipeline Embolization Device Found Safe For Smaller Aneurysms

MedicalResearch.com Interview with:

Ricardo A Hanel, MD PhD Endovascular and Skull Base Neurosurgery Director, Baptist Neurological Institute Endowed Chair, Stroke and Cerebrovascular Surgery Jacksonville, FL

Dr. Hanel

Ricardo A Hanel, MD PhD
Endovascular and Skull Base Neurosurgery
Director, Baptist Neurological Institute
Endowed Chair, Stroke and Cerebrovascular Surgery
Jacksonville, FL

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

Response: Medtronic Pipeline Embolization Device has been approved for carotid artery aneurysms over 10mm in size, from the petrous to clinoid segment but given the efficacy of results on these larger lesions, it has been widely utilized for treatment of smaller lesions. PREMIER came from the need of assessing the results , safety and efficacy, of pipeline for use of aneurysms under 12mm, located on the carotid artery, all segments, and V3 segment of the vertebral artery.
PREMIER enrolled 141 patients treated at 22 centers (21 US, 1 Canada). Primary Safety effectiveness defined as total aneurysm occlusion, core lab adjudicated , at 1 year was 83.5%; with safety endpoint of major stroke/death at 30 days of 1.4% (2 patients), with 1-year major stroke and death rate of 2.1%.

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