Author Interviews, Clots - Coagulation, Heart Disease, Karolinski Institute, Kidney Disease / 06.10.2022

MedicalResearch.com Interview with: Juan Jesus Carrero Pharm PhD Professor of Epidemiology Cardio-renal Department of Medical Epidemiology and Biostatistics Karolinska Institutet, Stockholm MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Concerns on the possibility of (direct oral anticoagulants)  DOAC-related nephropathy may limit its use. In this cohort study of non-valvular AF patients from routine clinical practice, initiation of DOAC vs (vitamin K antagonists) VKA was associated with more favorable kidney outcomes, i.e., a lower risk of the composite of kidney failure and sustained 30% eGFR decline, as well as a lower risk of AKI occurrence. In agreement with trial evidence, we also showed that DOAC vs VKA treatment was associated with a lower risk of major bleeding, but a similar risk of the composite of stroke, systemic embolism or death. (more…)
Author Interviews, Cancer Research, Clots - Coagulation / 18.04.2022

MedicalResearch.com Interview with: Dr. med. univ. Cornelia Englisch Medical University of Vienna MedicalResearch.com:  What is the background for this study?  Response: Patients with cancer are at high risk for developing venous thromboembolism (VTE). Venous thromboembolism includes deep vein thrombosis (DVT), when blood clots form in the deep veins of the legs and pulmonary embolism (PE), a potential life-threatening condition when a clot breaks free and lodges in the arteries of the lung. Having a non-O blood type, meaning blood types A, AB or B, is a known risk factor for VTE in the general – non-cancer – population. Interestingly, it is the most common genetic risk factor for thrombosis. If this is also the case in patients with cancer has not been clarified yet. We therefore wanted to assess the role of ABO blood type in cancer-associated thrombosis. To achieve our goal, we utilized the dataset of the Vienna Cancer and Thrombosis Study (CATS); an observational cohort study including adult patients with active cancer. (more…)
Alzheimer's - Dementia, Author Interviews, Clots - Coagulation, Heart Disease / 23.11.2021

MedicalResearch.com Interview with: Bruno Caramelli MD PhD Associate Professor of Medicine University of Sao Paulo, Brasil Director, Interdisciplinary Medicine in Cardiology Unit Chairman of the PhD program in Medical Sciences at the University of Sao Paulo, Brazil. President of the Department of Clinical Cardiology at the Brazilian Society of Cardiology FESC: Fellow of the European Society of Cardiology MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is the most common cardiac arrhythmia in older adults, and it is associated with an increased risk of stroke, cognitive impairment, and dementia. Stroke can occur when a blood clot blocks blood flow to the brain, and oral anticoagulants, such as dabigatran and warfarin, are typically prescribed to prevent stroke. Dabigatran has been found to be comparable to warfarin for the prevention of stroke and also has a lower risk of major bleeding complications. Previous research has shown that people with atrial fibrillation taking oral anticoagulation therapy have a lower risk of dementia, however, the mechanism involved in this benefit is unknown, and previous clinical trials have not evaluated cognitive and functional impairment outcomes among patients. It’s possible that cognitive decline is related to the formation of small blood clots in the brain, which is treated by effective medications that prevent blood clots. Since dabigatran offers a more stable anticoagulation status, we investigated whether it would be more effective than warfarin for the prevention of cognitive decline in patients with atrial fibrillation. Previous studies were retrospective and observational studies and considered tests that evaluate global cognitive function in a generic, global, and non-specific way. In that way its not possible to exclude different causes of dementia as Alzheimer's disease and others making it difficult to establish an effect directly related to atrial fibrillation or the anticoagulation treatment. (more…)
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Hematology, Neurological Disorders, Pain Research / 22.05.2021

MedicalResearch.com Interview with: Daniel Chasman, PhD Pamela Rist, ScD, Yanjun Guo, MD, PhD Division of Preventative Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been speculation in the field about relationships between coagulation and migraine susceptibility for some time, but previous research has been largely inconclusive. In this study, we leveraged Mendelian randomization, a mode of genetic analysis that can support or refute potential causal effects on a health outcome, to examine whether hemostatic factors may contribute to risk of MA. (more…)
Author Interviews, CDC, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 05.05.2021

MedicalResearch.com Interview with: Isaac See, MD Centers for Disease Control and Prevention COVID-19 Response Team Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: On February 27, 2021 the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Janssen/Johnson & Johnson (J&J) COVID-19 Vaccine in people 18 years of age or older in the United States.  The Janssen/J&J COVID-19 Vaccine uses a replication-deficient (i.e., cannot cause infections) human adenovirus vector.  In mid-March, the European Medicines Agency announced that they had conducted a preliminary investigation of cases of blood clots and low counts of blood cells called platelets in patients who had recently received the Oxford/AstraZeneca COVID-19 Vaccine, which uses a replication-deficient chimpanzee adenovirus vector.  This syndrome of blood clots and low platelet counts has been called thrombosis with thrombocytopenia syndrome, or TTS.  The European investigation showed that over 70% of their cases specifically involved blood clots in particular veins inside the brain, a condition caused cerebral venous sinus thrombosis (CVST), in addition to low platelet counts (thrombocytopenia is the medical term for low platelet counts). CVST is already a rare condition, and CVST with thrombocytopenia is even rarer.  By April 12, 2021, approximately 7 million doses of the Janssen/J&J COVID-19 Vaccine had been given in the United States, and six cases of CVST and thrombocytopenia after receipt of the Janssen/J&J COVID-19 Vaccine had been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), which is the U.S. national vaccine safety monitoring system.  The next day (April 13, 2021) CDC and FDA recommended a pause in use of the vaccine recommended to allow for further investigation of these events.  On April 23, 2021 data about the first 12 cases reported after authorization of the Janssen/J&J COVID-19 Vaccine were presented at an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) to decide what to recommend regarding the Janssen COVID-19 vaccine.  The ACIP concluded that the benefits of resuming Janssen COVID-19 vaccination among persons aged 18 years or older outweighed the risks and reaffirmed its interim recommendation under the FDA’s Emergency Use Authorization.  The FDA’s Emergency Use Authorization includes a new warning for rare clotting events among women aged 18 to 49 years. Our report provides clinical details about these first reported 12 U.S. cases of CVST and thrombocytopenia following receipt of the Janssen COVID-19 Vaccine. (more…)
Author Interviews, Clots - Coagulation, COVID -19 Coronavirus, Heart Disease, JAMA / 30.12.2020

MedicalResearch.com Interview with: Ana Blasco, MD, PhD Cardiology Department, Hospital Universitario Puerta de Hierro–Majadahonda Madrid, Spain MedicalResearch.com: What is the background for this study? Response: Our group has been investigating issues related to coronary thrombosis in patients with acute myocardial infarction for years. Recently, we developed a standardized technique for the detection and quantification of extracellular neutrophil networks (NETs) in coronary thrombi. During the first wave of the COVID-19 pandemic in Madrid, Spain, we had some cases of myocardial infarctions with ST elevation and a large thrombotic component among patients with severe SARS-CoV-2 infection. Given the important participation of NETs in severe COVID-19 disease, causing occlusion of microvessels as shown in pulmonary samples, we decided to analyze their role in coronary thrombi. Thanks to similar previous analyzes in patients without COVID-19, we have been able to compare our results with a historical series. (more…)
Author Interviews, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 12.08.2020

MedicalResearch.com Interview with: Morayma Reyes Gil M.D., Ph.D. Director of hematology and Coagulation Labs Associate Professor, Pathology Montefiore Medical Center and Albert Einstein School of Medicine Bronx, NY 10467 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Antiphospholipid Syndrome is an entity caused by autoantibodies that cause arterial and venous thrombosis as well as miscarriages. During the COVID-19 pandemic, we tested 187 patients for Lupus anticoagulant (LA); 68 turned out to be COVID positive. 30 of the 68 COVID-positive patients were found to be positive for LA by the DRVVT test, and 17 of them were also determined to be positive by the hexagonal phospholipid neutralization STACLOT-LA test. Importantly, of the 30 patients who were LA positive, 19 had documented thrombosis (arterial and venous), an event rate of 63%, as compared with a rate of 34% (p = .03) for LA-negative patients. We also checked CRP, an inflammatory marker known to affect the hexagonal phospholipid neutralization STACLOT-LA test. Although the mean CRP level was higher in patients testing positive for LA by DRVVT (14.4 vs 7.5 mg/dL; P < .01), patients with thrombosis did not have significantly higher CRP levels than those with no thrombosis. Hence, we adjusted for CRP, and LA was found to be independently associated with thrombosis (odds ratio, 4.39; 95% CI, 1.45-14.57; p= .01). No statistically significant difference was found by anticoagulation at the time of thrombosis, gender, race, ethnicity, ventilation, and mortality between patients who tested LA positive vs. negative.  (more…)
Author Interviews, Clots - Coagulation, NEJM / 12.08.2020

MedicalResearch.com Interview with: Elizabeth Webb, M.P.H Physiotherapy Department Calvary Public Hospital Bruce Bruce, Australia MedicalResearch.com: What is the background for this study? Response: Our study showed that in patients with a history of leg swelling (chronic edema), compression therapy by a skilled lymphedema therapist reduced the risk of infection in the leg (cellulitis) by a huge 77%. With up to 47% of patients experiencing recurrence of cellulitis in their legs within 3 years, this result is a game-changer in terms of our approach to managing patients with leg swelling and recurrent cellulitis. Until now, the use of prophylactic antibiotics to prevent cellulitis has been the only evidence-based practice. We know however, there are many reasons why avoidance of antibiotics is important within our community. (more…)
Author Interviews, Clots - Coagulation, JAMA, Kidney Disease / 09.06.2020

MedicalResearch.com Interview with: Manish M Sood MD FRCPC MSc Jindal Research Chair for the Prevention of Kidney Disease Associate Professor of Medicine, Dept. of Medicine and the School of Epidemiology and Public Health University of Ottawa Scientist, Ottawa Hospital Research Institute Nephrologist, The Ottawa Hospital Ottawa, Ontario, Canada  MedicalResearch.com: What is the background for this study? Response: Early work has suggested a very commonly used antibiotic, clarithromycin, may interfere with the metabolism of the most widely used type of blood thinning medication (called direct oral anticoagulants or DOACs) such that the blood level of the DOAC increases and may place the patient at a higher risk for bleeding.  In our study we looked at patients of advanced age (>66 years old) who were given clarithromycin while on a DOAC in Ontario, Canada. We compared patients on clairthromycin-DOAC to patients given a very similar antibiotic, azithromycin, that does not interfere with the metabolism of DOAC. (more…)
Author Interviews, Blood Clots, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 29.05.2020

MedicalResearch.com Interview with: Dr Tristan Morichau-Beauchant, MD. Intensive Care Unit Centre Cardiologique du Nord Saint-Denis, France MedicalResearch.com: What is the background for this study? Response: During the spread of the COVID-19 epidemic in France, early reports on severe patients stated a highly increased inflammatory response associated with procoagulant changes in coagulation pathways and high D-Dimer levels. Preliminary reports from the intensive care community signaled frequent events of deep vein thrombosis (DVT) among this population. We decided to perform prospectively a venous ultrasonogram of the inferior limbs for all patients with severe COVID-19 pneumonia at admission in our ICU.  All patients had acute respiratory distress syndrome according to the Berlin definition an required mechanical ventilation. Considering the high prevalence of venous thrombosis at admission we repeated a venous ultrasonography after 48 hours if the first exam was normal. All patients received standard anticoagulant prophylaxis since hospital admission. (more…)
Alzheimer's - Dementia, Author Interviews, Clots - Coagulation / 09.10.2019

MedicalResearch.com Interview with: Marta Cortes Canteli, PhD Miguel Servet Research Fellow Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) Madrid, Spain MedicalResearch.com: What is the background for this study? Response: Alzheimer´s disease is the most common form of dementia affecting more than 30 million people worldwide. Research in recent years has linked the disease to a reduction in the cerebral circulation; this results in an insufficient supply of nutrients and oxygen to brain cells, leading to their death. Alzheimer disease is also known to be linked to an underlying chronic prothrombotic state. The present study combined physiological and molecular analyses to demonstrate that long-term anticoagulation effectively slows disease progression in a transgenic mouse model of Alzheimer disease. (more…)
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Diabetes, Heart Disease, Lancet / 08.09.2019

MedicalResearch.com Interview with: Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI). (more…)
Annals Internal Medicine, Author Interviews, Clots - Coagulation, Heart Disease, Kidney Stones / 16.07.2019

MedicalResearch.com Interview with: Sunil Badve MBBS, MD, DNB, FRACP, PhD, FASN Senior Research Fellow, Renal & Metabolic Division Staff specialist nephrologist | St George Hospital University of New South Wales The George Institute for Global Health Australia MedicalResearch.com: What is the background for this study? Response: Despite the high prevalence of cardiovascular thrombotic events and venous thromboembolism (VTE) in chronic kidney disease (CKD), oral anticoagulant therapy is often underutilized in patients with advanced CKD and dialysis-dependent end-stage kidney disease (ESKD) due to uncertainty of benefit and potential bleeding complications. This comprehensive systematic review was performed to study the benefits and harms of oral anticoagulant therapy in patients with CKD. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 11.06.2019

MedicalResearch.com Interview with: Prof. Dr. med. Dirk Sibbing, MHBA, FESC Oberarzt, Medizinische Klinik und Poliklinik I Ludwig-Maximilians-Universität (LMU) München Chairperson ESC Working Group on Thrombosis München, Germany  MedicalResearch.com: What is the background for this consensus statement? What are the main findings that led to these conclusions? Response: The availability of different P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment concepts. Such concepts may include escalation or de-escalation of P2Y12 inhibiting therapy. Alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early vs. chronic treatment) and patient risk for ischemic and bleeding complications. As always in clinical medicine, guidance by means of biomarkers or risk scores is always helpful and warranted. Here specifically, a tailored DAPT approach may be potentially guided by platelet function (PFT) or genetic testing. (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Author Interviews, Clots - Coagulation, NEJM, Neurology / 09.05.2019

MedicalResearch.com Interview with: Geoffrey A Donnan AO MBBS, MD, FRCP, FRACP, FAAHMS Professor of Neurology University of Melbourne, Melbourne Brain Centre Royal Melbourne and Austin Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Currently the thrombolysis time window for acute ischemic stroke is restricted to less than 4.5 hours from stroke onset and patients with wake-up stroke are not eligible. EXTEND is a multi-centre randomised placebo-controlled trial involving patient with acute ischemic stroke who presented between 4.5 to 9 hours of stroke onset or with wake-up-stroke and had penumbral tissue demonstrated on automated perfusion imaging. Patients were randomised to receive either alteplase or placebo. In total there were 225 patients recruited and the patients who received alteplase had higher rate of excellent functional outcome at 3 months (35.4% vs 29.5% adjusted odd ration 1.44 with 95% confidence interval 1.01 – 2.06 p=0.04). Patients who received alteplase achieved higher rate of early neurological improvement at day 3, reperfusion and recanalization at 24 hours. There was numerically more haemorrhage in the alteplase group but this not negate the functional benefit and there was no difference in the rate of mortality between the two groups.  (more…)
AHA Journals, Author Interviews, Clots - Coagulation, Heart Disease, Stroke / 19.04.2019

MedicalResearch.com Interview with: Martine Jandrot-Perrus MD, PhD. Emeritus Research Professor Inserm University Paris Diderot Acticor Biotech Hôpital Bichat France  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Blood platelets are key actors in thrombosis a leading cause of global mortality estimated to account for 1 in 4 death worldwide in 2010. Thrombosis is associated with cardiovascular diseases (myocardial infarction, stroke, lower limb ischemia, venous thromboembolism), and with numerous pathologies such as cancer, infections or inflammatory diseases. Currently available antiplatelet drugs are the cornerstone of therapy for patients with acute coronary syndromes. However, these drugs all carry an inherent risk of bleeding that restricts their use in sensitive populations and when arterial thrombosis occurs in the cerebral territory. At present the only acute treatment option available for ischemic stroke consists in revascularization by thrombolysis, and/or mechanical thrombectomy. But the number of patients eligible to these treatments is low (» 15% of all patients) and the success rate does not exceed 50%. The responsibility of platelets in the failure for thrombolysis / thrombectomy to restore vascular patency is strongly suspected. There is thus a clear medical need for new antiplatelet drugs with an improved safety profile. We set out to develop ACT017, a novel, first in class, therapeutic antibody to platelet glycoprotein VI with potent and selective antiplatelet effects. The interest of GPVI resides in the fact that it's a receptor involved in the development of occlusive thrombi but that it is not strictly required for physiological hemostasis. (more…)
Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019

MedicalResearch.com Interview with: Yaseen M. Arabi, M.D Intensive Care Department Ministry of National Guard Health Affairs Riyadh, Saudi Arabia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, is a complication of critical illness. Studies have demonstrated that despite pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular weight heparin, 5-20% of critically ill patients develop deep vein thrombosis (DVT). The PREVENT trial evaluated whether adjunctive intermittent pneumatic compression reduces incident proximal lower limb DVT as detected on twice-weekly lower limb ultrasonography in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin. The trial was conducted in 20 sites in Saudi Arabia, Canada, Australia and India and included 2003 patients. The trial found no difference in the primary end point of proximal leg DVT. The addition of intermittent pneumatic compression to pharmacologic thromboprophylaxis did not result in a lower incidence of pulmonary embolism or a composite outcome of venous thromboembolism or death from any cause at 28 days when compared to pharmacologic thromboprophylaxis alone. (more…)
Author Interviews, Clots - Coagulation, Duke, Heart Disease, NEJM / 21.03.2019

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question. Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%. Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome. Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo. (more…)
Author Interviews, Clots - Coagulation, Heart Disease / 18.03.2019

MedicalResearch.com Interview with: Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg) Professor, Clinical Trials, and Medical Director Center for Thrombosis and Hemostasis (CTH) Johannes Gutenberg University Mainz Mainz, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Acute pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. It encompasses a wide spectrum of clinical symptoms and severity, ranging from massive, immediately life-threatening PE with hemodynamic collapse to the low-risk, stable patient with very few symptoms. These latter patients with acute low-risk PE may qualify for early discharge from hospital (e.g., within 48 hours) and continuation of treatment at home. This is a very promising strategy, because it may not only increase patient satisfaction and quality of life, but also help to reduce hospital-related complications and costs. However, it needed to be clearly determined, and tested in a prospective management trial, who are the appropriate candidates for an effective and safe home treatment approach. To this date, trials suggesting favorable clinical outcomes with home treatment of PE are small and date back to the era of vitamin K antagonists. Direct oral anticoagulants permitting a single drug treatment of PE are more promising in this regard, as they may make an early transition from hospital to ambulatory care both safer and more convenient. The international Home Treatment of Pulmonary Embolism (HoT-PE) phase 4 management trial tested the efficacy and safety of early discharge and ambulatory anticoagulation treatment with the direct factor Xa inhibitor rivaroxaban in patients with acute low-risk PE. Patients were identified on the basis of
  • clinical criteria or PE severity, comorbidity, and contraindications; and
  • the absence of right heart failure or intracardiac thrombi on cardiac imaging. Early termination of the study was possible following the prespecified interim analysis, which was performed after recruitment and 3-month evaluation of 525 patients (50% of the planned trial population). At the interim analysis, the primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in only 3 (0.6%) patients (compared to an estimated 1.7% rate based on historical data). This rate was sufficiently low to reject the primary hypothesis as predefined in the statistical analysis plan. None of the recurrent events was nonfatal.Major bleeding occurred in 6 (1.2%) patients of the safety population. The study could therefore be terminated early for efficacy. 
(more…)
Author Interviews, Clots - Coagulation, Heart Disease, JAMA / 05.03.2019

MedicalResearch.com Interview with: Geoffrey Barnes, MD, MSc Assistant Professor Vascular and Cardiovascular Medicine University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Both aspirin and warfarin are commonly used medications meant to prevent thrombotic complications, but might increase rates of bleeding complications. We used a multi-center anticoagulation collaborative to explore how often patients being treated with warfarin were also taking aspirin but without a clear indication. We found that more than one-third (37.5%) of warfarin-treated patients without a clear reason for aspirin therapy were receiving aspirin. And these patients on both warfarin and aspirin experienced higher rates of bleeding and emergency department visits for bleeding than the patients taking warfarin alone. There were no differences in the rate of thrombotic events between the patients taking warfarin alone or those taking warfarin plus aspirin.  (more…)
Annals Internal Medicine, Author Interviews, Clots - Coagulation, Heart Disease / 27.02.2019

MedicalResearch.com Interview with: Dr Vanessa Selak, MBChB, MPH, PhD, FAFPHM, FNZCPHM Senior Lecturer, Section of Epidemiology & Biostatistics School of Population Health Faculty of Medical and Health Sciences University of Auckland MedicalResearch.com: What is the background for this study? Response: In order to determine the balance of benefits and harms of aspirin in primary prevention there’s a need to know an individual’s risk of CVD and their risk of a major bleed without aspirin. We have lots of equations that can be used to determine, among people considering aspirin for primary prevention, an individual’s risk of CVD, but few bleeding risk equations that can be used to determine their risk of a major bleed. We sought to develop a bleeding risk equation that can be used to determine the risk of a major bleed among people in whom aspirin is being considered for the primary prevention of CVD. (more…)
Author Interviews, BMJ, Endocrinology, Heart Disease, Hormone Therapy, Menopause, Thromboembolism / 11.01.2019

MedicalResearch.com Interview with: Yana Vinogradova, PhD Research Fellow Department of Primary Care School of Medicine University of Nottingham University Park, Nottingham MedicalResearch.com: What is the background for this study?   Response: The study targeted middle age women going through menopause.  This is the stage of life when women naturally reach the end of their reproductive life and their hormones gradually decrease.  Some women experience unpleasant effects such as hot flushes, night sweats, mood swings, memory and concentration loss, headaches.  Quality of life may be severely affected.  Hormone replacement therapy uses a class of drugs, which, like all drugs, have side effects.   VTE is a serious side effect which can have a lethal outcome. There are different preparations of hormones available for such women.  Some of them were extensively studied in a large American Trial Women’s Health Initiative and showed the risk of VTE to be twice as high for women who took them.  However, these well-studied drugs are mostly prescribed in America.  The more popular drugs in Europe and the UK have been much less studied, so it was unclear how they compared.  (more…)
Author Interviews, Clots - Coagulation, J&J-Janssen / 05.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 900,000 Americans experience a venous thromboembolism (VTE) each year, with about one-third of these occurrences being fatal. Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a Factor Xa inhibitor, like XARELTO® (rivaroxaban), for three months or longer. For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years. This study examined extended use of XARELTO® after the recommended three-month treatment period in patients who experienced an initial VTE, showing XARELTO® was associated with a decreased risk of recurrent VTE with no increase in major bleeding during this time period.  (more…)
Author Interviews, Cost of Health Care, Hematology, J&J-Janssen, Thromboembolism / 04.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite being largely preventable, venous thromboembolism (VTE) is the second leading cause of death in people with cancer. The risk of VTE is five times greater in people with cancer than those without cancer, and that risk is magnified in those receiving certain types of chemotherapy, in the newly diagnosed and in those with more advanced, metastatic disease. This 6,194-patient study examined economic burden associated with VTE, and found patients newly diagnosed with cancer who are at a higher risk of a VTE had significantly higher all-cause and VTE-related health care costs compared to patients with a lower risk of VTE. (more…)
Author Interviews, Clots - Coagulation, Hematology, J&J-Janssen / 04.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Treatment of venous thromboembolism (VTE) is complicated among morbidly obese patients. Current guidelines do not recommend use of Factor Xa inhibitors in these patients due to limited clinical data available. That's why Janssen undertook this study to examine XARELTO® (rivaroxaban) in these patients. In this 5,780-patient retrospective study, results found patients treated with XARELTO® had a similar risk of recurrent VTE and major bleeding compared to those taking warfarin. However, treatment with XARELTO® was associated with less all-cause health care resource utilization (HCRU) (e.g., inpatient hospitalizations and outpatient visits) and reduced total medical costs compared to warfarin. Of note, patients taking XARELTO® had an average $2,829 lower total medical costs per patient per year (PPPY) than those taking warfarin, which was mainly driven by lower hospitalization costs. (more…)
Annals Internal Medicine, Author Interviews, Blood Clots, Emergency Care, Kaiser Permanente, Pulmonary Disease, UC Davis / 13.11.2018

MedicalResearch.com Interview with: David R. Vinson, MD Department of Emergency Medicine Kaiser Permanente Sacramento Medical Center Sacramento, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: At least one-third of emergency department (ED) patients with acute blood clots in the lung, or pulmonary embolism (PE), are eligible for expedited discharged to home, either directly from the ED or after a short (<24 hour) period of observation. Yet in in most hospitals in the U.S. and around the world nearly all ED patients with acute PE are hospitalized. These unnecessary hospitalizations are a poor use of health care resources, tie up inpatient beds, and expose patients to the cost, inconvenience, and risk of inpatient care. The better-performing medical centers have two characteristics in common: they help their physicians identify which PE patients are candidates for outpatient care and they facilitate timely post-discharge follow-up. At Kaiser Permanente Northern California (KPNC), we have had the follow-up system in place for some time, but didn’t have a way to help our physicians sort out which patients with acute PE would benefit from home management. To correct this, we designed a secure, web-based clinical decision support system that was integrated with the electronic health record. When activated, it presented to the emergency physician the validated PE Severity Index, which uses patient demographics, vital signs, examination findings, and past medical history to classify patients into different risk strata, correlated with eligibility for home care. To make use of the PE Severity Index easier and more streamlined for the physician, the tool drew in information from the patient’s comprehensive medical records to accurately auto-populate the PE Severity Index. The tool then calculated for the physician the patient’s risk score and estimated 30-day mortality, and also offered a site-of-care recommendation, for example, “outpatient management is often possible.” The tool also reminded the physician of relative contraindications to outpatient management. At the time, only 10 EDs in KPNC had an on-site physician researcher, who for this study served as physician educator, study promotor, and enrollment auditor to provide physician-specific feedback. These 10 EDs functioned as the intervention sites, while the other 11 EDs within KPNC served as concurrent controls. Our primary outcome was the percentage of eligible ED patients with acute PE who had an expedited discharge to home, as defined above. During the 16-month study period (8-month pre-intervention and 8-months post-intervention), we cared for 1,703 eligible ED patients with acute PE. Adjusted home discharge increased at intervention sites from 17% to 28%, a greater than 60% relative increase. There were no changes in home discharge observed at the control sites (about 15% throughout the 16-month study). The increase in home discharge was not associated with an increase in short-term return visits or major complications.  (more…)
Author Interviews, Clots - Coagulation, Critical Care - Intensive Care - ICUs, NEJM / 04.10.2018

MedicalResearch.com Interview with: Alex C Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - The Center for Health Innovations and Outcomes Research - The Feinstein Institute for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital New York, NY 10075 MedicalResearch.com: What is the background for this study? Response: Hospitalised medically ill patients have a significant risk of developing venous thromboembolism (VTE) within 6 weeks after discharge. The role of extended thromboprophylaxis in this population with either low molecular weight heparin or the direct oral anticoagulants remains uncertain, as it has shown either excess bleeding or beneficial effects mainly from reducing asymptomatic deep vein thrombosis (DVT). The MARINER trial was designed to compare rivaroxaban with placebo for the prevention of the composite outcome of symptomatic VTE and VTE-related death in medically ill patients at increased risk of VTE post-hospital discharge. The principal safety objective was major bleeding. The trial was a randomized, double-blind, placebo-controlled, event-driven study that included a total of 12,024 patients aged ≥40 years who had been hospitalised with an acute medical illness for 3-10 consecutive days and had additional VTE risk factors as defined by the modified IMPROVE VTE risk score of ≥4 or a score of 2 or 3 plus a plasma D-dimer level more than twice the upper limit of normal). The rivaroxaban regimen consisted of 10 mg once daily in patients with a creatinine clearance (CrCl) of >=50ml/min or 7.5 mg for patients with a CrCl of 30 to <50 ml/min. The first dose was given on the day of discharge and the last dose at Day 45. Patients were followed up for an additional 30 days. Baseline characteristics were well matched between groups and typical of a medically ill population. (more…)
Addiction, Author Interviews, Clots - Coagulation, NEJM / 27.09.2018

MedicalResearch.com Interview with: Dr. Amar Kelkar MD Clinical Fellow Division of Hematology & Oncology, Department of Medicine University of Florida College of Medicine, UF Health Shands Hospital MedicalResearch.com: What is the background for this study? What are synthetic cannabinoids? Response: Starting in March 2018, patients began reporting to hospitals and clinics with unexplained and prolonged bleeding symptoms, first in Chicago, Illinois, and then spreading to Peoria, Illinois and elsewhere. This gained a lot of press because the initial identifying factor was that all the patients had reported recent use of synthetic cannabinoids. As the matter was studied further, it was determined that these patients were likely exposed to an anticoagulant poison mixed in with the synthetic cannabinoids. Synthetic cannabinoids are lab-derived illicit drugs that target the cannabinoid receptors that are also targeted by marijuana. They go by many names including synthetic marijuana, K2, and Spice. (more…)
Author Interviews, Clots - Coagulation, Emergency Care, Pulmonary Disease, Stanford / 18.08.2018

MedicalResearch.com Interview with: Joseph Bledsoe MD, FACEP Clinical Assistant Professor of Emergency Medicine Stanford Medicine Director of Research Department of Emergency Medicine Intermountain Medical Center Murray, UT 84157 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with blood clots in the lungs (pulmonary embolism) (PE) are routinely admitted to the hospital for blood thinning medications in the United States. However, evidence from other countries has shown that with appropriate risk stratification patients may be safe for outpatient treatment for their PE. Our study is the largest prospective management study in the US to evaluate home treatment of patients with acute pulmonary embolism. We enrolled 200 patients and after risk stratification with the PE severity index score, leg ultrasounds and echocardiograms performed in the emergency department, patients were treated with blood thinning medications at home with routine outpatient follow up. During the 90 day follow up period we found only one patient suffered a bleeding event after a traumatic injury, without any cases of recurrent symptomatic blood clots or death.  (more…)