Annals Internal Medicine, Author Interviews, Clots - Coagulation, Heart Disease, Kidney Stones / 16.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50193" align="alignleft" width="84"]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 Dr. Badve[/caption] 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.
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 11.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49698" align="alignleft" width="200"]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 Prof. Sibbing[/caption] 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.
Author Interviews, Clots - Coagulation, Heart Disease, JAMA / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47707" align="alignleft" width="144"]Geoffrey Barnes, MD, MScAssistant ProfessorVascular and Cardiovascular MedicineUniversity of Michigan Dr. Barnes[/caption] 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. 
Author Interviews, Clots - Coagulation, J&J-Janssen / 05.12.2018

MedicalResearch.com Interview with: [caption id="attachment_46370" align="alignleft" width="200"]Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. Dr. Burton[/caption] 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. 
Author Interviews, JAMA, Thromboembolism, University of Michigan / 31.05.2018

MedicalResearch.com Interview with: Paul Grant, MD [caption id="attachment_41858" align="alignleft" width="125"]Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan Dr. Grant[/caption] Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation. In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model. Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital. 
Author Interviews, Heart Disease, JAMA, Stroke / 19.05.2018

MedicalResearch.com Interview with: Anna Gundlund, MD, PhD Herlev-Gentofte Hospital, Department of Cardiology Denmark  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atrial fibrillation increases a person’s risk of ischemic strokes up to 5-fold. Oral anticoagulation therapy lowers this risk effectively (>60%) and is therefore recommended for patients with atrial fibrillation and at least 1-2 other risk factors for stroke. Our study show, that oral anticoagulation therapy is still underused in patients with atrial fibrillation – even after a stroke event. In stroke survivors with atrial fibrillation, oral anticoagulation therapy were associated with better outcomes than no oral anticoagulation therapy. 
Author Interviews, NEJM, Stroke, University Texas / 16.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41746" align="alignleft" width="151"]Dr. S. Claiborne "Clay" Johnston MD, PhD Dean Vice President for Medical Affairs Frank and Charmaine Denius Distinguished Dean’s Chair Dell Medical School The University of Texas at Austin Dr. Johnston[/caption] Dr. S. Claiborne "Clay" Johnston MD, PhD Dean Vice President for Medical Affairs Frank and Charmaine Denius Distinguished Dean’s Chair Dell Medical School The University of Texas at Austin MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior studies have shown that the risk of a stroke or other ischemic events is high in the days to weeks after a TIA or minor stroke. We sought to test whether blocking platelet aggregation more effectively with clopidogrel plus aspirin could reduce this risk compared to aspirin alone.  We found that the combination did reduce risk of major ischemic events.  It also showed a small increase in risk of major hemorrhage, but for most people the benefits would outweigh the potential risk.
Author Interviews, Hematology, NEJM, Orthopedics, Thromboembolism / 22.02.2018

MedicalResearch.com Interview with: [caption id="attachment_40142" align="alignleft" width="200"]Dr. David R. Anderson, MD, FRCPC, FACP Faculty of Medicine Dean, Professor Dean, Faculty of Medicine Division of Hematology, Department of Medicine  & Nova Scotia Health Authority Dr. Anderson[/caption] Dr. David R. Anderson, MD, FRCPC, FACP Faculty of Medicine Dean, Professor Dean, Faculty of Medicine Division of Hematology, Department of Medicine & Nova Scotia Health Authority MedicalResearch.com: What is the background for this study? What are the main findings? Response: Blood clots in the lungs (pulmonary embolism) and veins of the legs (deep vein thrombosis) are well recognized complications following total hip and knee arthroplasty surgeries.  Prior to the routine use of antithrombotic prophylaxis, pulmonary embolism was the most common cause of death following these procedures.  Oral anticoagulants such as rivaroxaban are commonly prescribed for the indication of preventing blood clots following total hip or knee arthroplasty.  For maximal benefit these agents are continued following surgery for up to five weeks following total hip arthroplasty and for two weeks following total knee arthroplasty. There is evidence that aspirin has some benefit for the prevention of deep vein thrombosis and pulmonary embolism following total hip or knee arthroplasty.  However there is less evidence for its benefit than for oral anticoagulants.  We reasoned that aspirin would potentially be an attractive alternative for extended out of hospital prophylaxis following total hip or knee arthroplasty for patients who received a short course (5 days )of rivaroxaban following surgery.  Aspirin would be attractive for this indication because of its low cost, ease of use, and low rates of side effects. Our study demonstrated that in a randomized controlled trial involving a large group (over 3400) of patients undergoing total hip or knee arthroplasty that extended therapy with aspirin was comparable to rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism following surgery.  Low rates of complications (< 1%) were observed with both treatment arms.  We also found that rates of clinically important bleeding complications (the most common side effect with antithrombotic drugs) were uncommon and similar with the two agents.
Author Interviews, Heart Disease, JACC, Stroke / 13.02.2018

MedicalResearch.com Interview with: [caption id="attachment_40003" align="alignleft" width="200"]Normal rhythm tracing (top) Atrial fibrillation (bottom) Wikipedia image Normal rhythm tracing (top) Atrial fibrillation (bottom)
Wikipedia image[/caption] João Pedro Ferreira, MD, PhD & Faiez Zannad, MD, PhD National Institute of Health and Medical Research (INSERM)Center for Clinical Multidisciplinary Research 1433INSERM U1116University of LorraineRegional University Hospital of NancyFrench Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative–Cardiovascular and Renal Clinical Trialists, Nancy, France Department of Physiology and Cardiothoracic SurgeryCardiovascular Research and Development UnitFaculty of MedicineUniversity of Porto, Porto, Portugal MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is uncertain whether patients with a myocardial infarction with systolic dysfunction but without atrial fibrillation have increased risk for stroke. In this study including >22,000 patients and 600 stroke events we found a subgroup of patients at high risk for stroke despite not having atrial fibrillation. These patients are older, have worse renal function, frank signs of pulmonary congestion, hypertension and previous stroke history. We created a simple and “ready to use” score that allows the identification of these patients in routine clinical practice. 
AHA Journals, Author Interviews, Stroke / 07.02.2018

MedicalResearch.com Interview with: [caption id="attachment_39895" align="alignleft" width="160"]Todd C. Villines, M.D. FSCCT Professor of Medicine Uniformed Services University School of Medicine Director of Cardiovascular Research and Cardiac CT Cardiology Fellowship Program Director Walter Reed National Military Medical Center Bethesda, Maryland Assistant Professor of Medicine Georgetown School of Medicine Dr. Villines[/caption] Todd C. Villines, M.D. FSCCT Professor of Medicine Uniformed Services University School of Medicine Director of Cardiovascular Research and Cardiac CT Cardiology Fellowship Program Director Walter Reed National Military Medical Center Bethesda, Maryland Assistant Professor of Medicine Georgetown School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study was a retrospective, observational real-world analysis assessing the safety and effectiveness of novel oral anticoagulants (NOACs) among patients with non-valvular atrial fibrillation (NVAF) treated through the U.S. Department of Defense Military Health System. The study examined major bleeding and stroke rates in NVAF patients who had initiated treatment with dabigatran compared to those treated with rivaroxaban or apixaban. The study examined two cohorts: one that resulted in 12,763 propensity score matched dabigatran (150 mg bid) and rivaroxaban (20 mg daily) patients, and another that resulted in 4,802 propensity score matched dabigatran (150 mg bid) and apixaban (5 mg bid) patients. Dabigatran patients demonstrated lower rates of major bleeding compared to rivaroxaban patients (2.08 percent vs 2.53) percent and similar rates of stroke (0.60 percent vs 0.78 percent). In the exploratory analysis, dabigatran and apixaban patients showed similar rates of major bleeding (1.60 percent vs 1.21 percent) and stroke (0.44 percent vs 0.35 percent).
Author Interviews, Cancer Research, JAMA, Stroke / 13.01.2018

MedicalResearch.com Interview with: [caption id="attachment_39250" align="alignleft" width="200"]Babak B. Navi MD, MS Dr. Navi[/caption] Babak B. Navi MD, MS Department of Neurology Weill Cornell Medicine New York, New York MedicalResearch.com: What is the background for this study? Response: About 10% of patients with ischemic stroke have comorbid cancer and these patients face an increased risk of stroke recurrence. Many strokes in patients with cancer are attributed to unconventional mechanisms from acquired hypercoagulability. Therefore, many physicians recommend anticoagulation, especially low molecular weight heparins, for the treatment of cancer-associated stroke. However, hypercoagulable stroke mechanisms, such as nonbacterial thrombotic endocarditis, are rarely definitively diagnosed in cancer patients antemortem; while atherosclerosis, which is generally treated with antiplatelet medicines such as aspirin, is common in cancer patients. In addition, many historic indications for anticoagulation in ischemic stroke have been disproven by randomized trials because any reductions in stroke risk were offset by increased risks of bleeding. Given these considerations, we believed that a randomized trial comparing anticoagulation with enoxaparin to antiplatelet therapy with aspirin was necessary to determine the superior strategy, prompting implementation of the TEACH pilot randomized trial. The primary aim of TEACH was to determine whether the random assignment of different antithrombotic strategies to cancer patients with acute ischemic stroke would be sufficiently feasible and safe to proceed with a larger efficacy trial. 
Author Interviews, Heart Disease, Pharmaceutical Companies / 28.11.2017

MedicalResearch.com Interview with: https://www.verseon.com/ Anirban Datta, PhD Director Discovery Biology Verseon Corporation MedicalResearch.com: What is the background for this study? Response: Today’s anticoagulant market is dominated by the NOACs. These oral anticoagulants require less constant monitoring and have reduced drug and food interactions compared to their predecessors, warfarin and heparin. However, there is still a significant bleeding risk associated with the NOACs. This is particularly problematic when they are co-dosed with antiplatelet drugs. While life-long therapy combining an oral anticoagulant with one or two antiplatelet drugs is desired for the many patients suffering from both non-valvular atrial fibrillation and coronary artery disease, current treatment guidelines limit such therapy to a maximum of six months to a year due to safety concerns. At Verseon, we are developing a novel class of precision anticoagulants that combine efficacy comparable to the NOACs with a significantly reduced bleeding risk in preclinical testing. We believe that this profile can have a positive impact on the lives of the many patients in need of long-term anticoagulation-antiplatelet combination therapy. We are currently advancing two development candidates toward clinical trials in 2018. VE-1902, our first development candidate, is scheduled to enter phase I in the first half of the year.
Author Interviews, Boehringer Ingelheim, Surgical Research / 27.11.2017

MedicalResearch.com Interview with: [caption id="attachment_38546" align="alignleft" width="200"]Thomas Seck, M.D., vice president Clinical Development and Medical Affairs, Primary Care Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Thomas Seck[/caption] Thomas Seck, M.D., vice president Clinical Development and Medical Affairs Primary Care Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a new subanalysis of the phase III RE-VERSE AD™ study, which evaluated the safety and efficacy of idarucizumab, marketed in the U.S. as Praxbind®, in reversing the anticoagulant effect of Pradaxa® (dabigatran etexilate mesylate). This data assessed idarucizumab in a subset of patients requiring an urgent procedure or emergency surgery. The analysis found that idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98 percent of patients based on dTT. The median time between administration of idarucizumab and start of surgery was 1.7 hours for patients requiring abdominal procedures, 1.9 hours for orthopedic procedures, 1.4 hours for vascular procedures, 1.3 hours for drainage procedures and 1.2 hours for catheter procedures. Among these patients, periprocedural homeostasis was assessed as normal in more than 92 percent of patients, across all surgery types.
Author Interviews, Heart Disease / 07.11.2017

MedicalResearch.com Interview with: [caption id="attachment_34397" align="alignleft" width="138"]Nayan Agarwal MD Intervention Cardiology Fellow, University of Florida, Gainesville, FL Dr. Agarwal[/caption] Nayan Agarwal MD Intervention Cardiology Fellow University of Florida, Gainesville, FL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Optimal antiplatelet strategy post CABG remains controversial with guidelines still evolving. Though aspirin monotherapy is the therapy of choice, but some studies have suggested a benefit of dual antiplatelet (DAPT). Question also remains if choice of antiplatelet therapy strategy is influenced by clinical presentation (acute coronary syndrome [ACS] versus non ACS) or CABG technique ( off pump versus on pump). The current meta-analysis of 8 randomized control trials and 9 observational studies with a total of 11,135 patients demonstrated that at a mean follow up of 23 months, major adverse cardiac events (MACE) (10.3% versus 12.1%, RR 0.84, confidence interval (CI) 0.71-0.99); all-cause mortality (5.7% versus 7.0%, RR 0.67, CI 0.48-0.94) and graft occlusion (11.3% versus 14.2%, RR- 0.79, CI- 0.63- 0.98) were less with DAPT compared with aspirin monotherapy. There was no difference in myocardial infarction, stroke, or major bleeding between the 2 groups. Subgroup analysis demonstrated that benefit of DAPT was independent of clinical presentation (ACS versus non ACS) or CABG technique (off pump versus on pump).
Author Interviews, Cancer Research, JAMA / 06.11.2017

MedicalResearch.com Interview with: Gry Haaland, MD James Lorens PhD, Professor The Department of Biomedicine University of Bergen  MedicalResearch.com: What is the background for this study? Response: Antitumor activity of the common blood thinner warfarin has been reported in several experimental cancer model systems. We therefore considered whether warfarin is cancer protective. Using the comprehensive national health registries in Norway, we examined cancer incidence among a large number of people taking warfarin (92,942) and compared to those not taking warfarin (more than 1.1 million).
Author Interviews, Heart Disease, JAMA / 27.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37742" align="alignleft" width="200"]Elad Asher, M.D, M.H.A Interventional Cardiologist, Director Intensive Cardiac Care Unit Deputy Director Heart Institute Assuta Ashdod Medical Cent Dr. Asher[/caption] Elad Asher, M.D, M.H.A Interventional Cardiologist, Director Intensive Cardiac Care Unit Deputy Director Heart Institute Assuta Ashdod Medical Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy represents the standard care for treating ST elevation myocardial infarction (STEMI) patients. Given the higher risk of peri-procedural thrombotic events in patients undergoing primary percutaneous coronary intervention (PPCI), there is a need to achieve inhibition of platelet aggregation (IPA) more promptly. Although chewing ticagrelor has been shown to be more efficient for IPA in stable coronary disease and in patients with acute coronary syndrome (ACS)/non-ST elevation myocardial infarction (NSETMI), there are no studies that have specifically assessed the efficacy and safety of chewing ticagrelor in STEMI patients. Therefore, the aim of our study was to investigate whether chewing ticagrelor (180mg) loading dose is associated with more favorable platelet inhibitory effects compared with the conventional way of swallowing whole tablets loading dose in STEMI patients undergoing PPCI.
Author Interviews, Cognitive Issues, Heart Disease / 26.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37734" align="alignleft" width="200"]Dr. Leif Friberg MD, PhD Associate professor in cardiology Karolinska Institute Friberg Resarch Stockholm, Sweden  Dr. Leif Friberg[/caption] Dr. Leif Friberg MD, PhD Associate professor in cardiology Karolinska Institute Friberg Resarch Stockholm, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I have been doing research on atrial fibrillation and stroke risk for many years and knew that the very common heart arrhythmia is associated with a 40% increased risk of dementia. Considering that that 12-15% of 75 years olds have this arrhythmia, and even more at higher ages, the problem is significant to say the least. The mechanism behind stroke in atrial fibrillation is that blood clots are formed in the heart. When these are dislodged they travel with the blood stream and may get stuck in the narrow vessels of the brain where they stop blood flow causing brain infarction or stroke. Oral anticoagulant drugs like warfarin or the newer so called NOAC (new oral anticoagulant) drugs are highly efficient in preventing formation of these large blood clots and offer at least 70% risk reduction. Now, blood clots come in different sizes. There are also microscopic clots that do not cause symptoms of stroke but all the same eat away at the brain at a slow but steady pace. Imaging studies shows this after only a few months or even weeks of atrial fibrillation. Our hypothesis was therefore: If anticoagulants are so effective in protecting against large clots, will they not help against the small ones too?
Author Interviews, Clots - Coagulation, Genetic Research, JAMA, Surgical Research / 04.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37375" align="alignleft" width="140"]Anne R. Bass, MD Associate Professor of Clinical Medicine Weill Cornell Medical College Rheumatology Fellowship Program Director Hospital for Special Surgery New York, NY 10021 Dr. Bass[/caption] Anne R. Bass, MD Associate Professor of Clinical Medicine Weill Cornell Medical College Rheumatology Fellowship Program Director Hospital for Special Surgery New York, NY 10021 MedicalResearch.com: What is the background for this study? Response: Blood thinners are used after orthopedic surgery to prevent blood clots from forming in the legs and traveling to the lungs. They are also used in patients with certain heart diseases to prevent strokes. Blood thinners, like warfarin, are effective but can be associated with serious bleeding complications, especially if the wrong dose is given. Genetic testing can help doctors predict the right warfarin dose to use in an individual patient. In this trial, ≈1600 elderly patients undergoing hip or knee replacement were randomly assigned to receive warfarin dosing based on genetics plus clinical factors (like height, weight and gender), or based on clinical factors alone. The specific genes tested wereVKORC1, CYP2C9, and CYP4F2 which influence warfarin metabolism and the body’s ability to produce clotting factors.
Author Interviews, Boehringer Ingelheim, Columbia, Heart Disease, J&J-Janssen, Merck, NEJM / 14.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36919" align="alignleft" width="150"]Professor Christopher P. Cannon MD Executive Director, Cardiometabolic Trials, Baim Institute Cardiologist Brigham and Women's Hospital Baim Institute for Clinical Research Columbia University College of Physicians and Surgeons Dr. Cannon[/caption] Professor Christopher P. Cannon MD Executive Director, Cardiometabolic Trials, Baim Institute Cardiologist Brigham and Women's Hospital Baim Institute for Clinical Research Columbia University College of Physicians and Surgeons MedicalResearch.com: What is the background for this study? What are the main findings? Response: The trial explored whether a dual therapy approach of anticoagulation and P2Y12 antagonist - without aspirin - in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement would be as safe, and still efficacious, as the current standard treatment – triple therapy. For more detailed background on the study, readers may want to review the first paragraph of the article in the New England Journal of Medicine. Results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran, when compared to triple therapy with warfarin. In the study, the risk for the primary safety endpoint (time to major or clinically relevant non-major bleeding event) was 48 percent lower for dabigatran 110 mg dual therapy and 28 percent lower for dabigatran 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events.
Author Interviews, Boehringer Ingelheim, Heart Disease, PAD / 03.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36741" align="alignleft" width="150"]John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University Dr. Eikelboom[/caption] John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy. Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease.
Author Interviews, Heart Disease / 24.07.2017

MedicalResearch.com Interview with: Abhishek Sharma MD and Division of Cardiovascular Medicine State University New York Downstate Medical Center Dr.Sahil Agarwal M.B.B.S., M.D. Division of Cardiology St. Luke's University Health Network Bethlehem, Pennsylvania MedicalResearch.com: What is the background for this study?  Response: Prior randomized control trials (RCTs) and meta-analysis of these trials which have attempted to compare differences in outcomes between strategies of short (S) (3-6 months) and longer (L) (12-30 months) durations of dual anti-platelet therapy (DAPT) after drug eluting stents (DES) implantation have reported conflicting results. In general, the events rates in these studies were small, affecting statistical power. To overcome this limitation, we conducted an updated meta-analysis to compare the efficacy and safety of strategies of S-DAPT versus L-DAPT strategy after DES implantation by restricting inclusion to randomized studies with follow-up durations of 24 months or longer. The current meta-analysis is the first to compare outcomes between S-DAPT and L-DAPT in a meta-analysis restricted to trials with patient follow-up of 24 months or longer. We found no significant difference in the rates of mortality or of stent thrombosis with S-DAPT or L-DAPT. S-DAPT was associated with significantly lower risk of major bleeding but slightly higher risk of future myocardial infarctions.
Author Interviews, Heart Disease, JAMA, Stroke / 15.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35355" align="alignleft" width="110"]Gregory Y. H. Lip, MD Professor of Cardiovascular Medicine University of Birmingham, UK; Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark National Institute for Health Research (NIHR) Senior Investigator. Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK Visiting Professor of Cardiology, University of Belgrade, Serbia; Visiting Professor, University of Leeds, UK Honorary Professor, Chinese PLA Medical School, Beijing, China; Honorary Professor, Nanjing Medical University, Nanjing, China; Visiting Professor, National Yang-Ming University, Taipei, Taiwan Institute of Cardiovascular Sciences City Hospital Birmingham England UK Dr. Lip[/caption] Gregory Y. H. Lip, MD Professor of Cardiovascular Medicine University of Birmingham Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark National Institute for Health Research (NIHR) Senior Investigator. Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK Institute of Cardiovascular Sciences City Hospital Birmingham England UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: The randomized clinical trials comparing non-Vitamin K antagonist oral anticoagulants (NOACs) vs warfarin largely focused on recruitment of high risk atrial fibrillation(AF) patients with >2 stroke risk factors, with only the trials testing dabigatran or apixaban including a minority of patients with 1 stroke risk factor. Despite this, regulatory approvals of all NOACs have been for stroke prevention in AF patients with ≥1 stroke risk factors. No difference between NOACs compared to warfarin in risk of ischemic stroke/systemic embolism, was seen but for ‘any bleeding’, this was lower for apixaban and dabigatran compared to warfarin.
Author Interviews, BMJ, Heart Disease / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35317" align="alignleft" width="200"]Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD Institute of Applied Health Research Research Fellow University of Birmingham Dr. Adderley[/caption] Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD Institute of Applied Health Research Research Fellow University of Birmingham MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a major global public health problem. It is associated with a five-fold increase in risk of stroke. There are three types of AF – paroxysmal, persistent or permanent. In paroxysmal AF, episodes come and go, and usually stop without any treatment. With persistent AF episodes can last for periods of more than seven days and are treated with medication or a medical procedure called cardioversion. In permanent AF, the irregular heartbeat is present all the time and cardioversion has failed to restore a normal heart rhythm. All patients with AF, including paroxysmal AF, are at an increased risk of stroke. UK guidelines recommend anticoagulant treatment, such as the blood-thinning drug warfarin, for patients with all types of AF in order to reduce the risk of stroke. Our study aimed to determine whether patients with paroxysmal AF are less likely to be treated with anticoagulants than patients with persistent or permanent AF and to investigate trends in treatment between 2000 and 2015.
Author Interviews, Heart Disease, JACC / 21.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34759" align="alignleft" width="150"]Dr. Ion S. Jovin, MD, ScD Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center Director of the Cardiac Catheterization Laboratories and Site Director of the VCU Interventional Cardiology Fellowship Program at  McGuire V.A. Medical Center Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery Yale University, New Haven, CT Dr. Jovin[/caption] Dr. Ion S. Jovin, MD, ScD Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center Director of the Cardiac Catheterization Laboratories and Site Director of the VCU Interventional Cardiology Fellowship Program at McGuire V.A. Medical Center Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery Yale University, New Haven, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is still uncertainty regarding the best anticoagulant for patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) and especially PCI done via radial (as opposed to femoral) access. Our study compared outcomes of patients with STEMI treated with PCI done via radial access in the NCDR database who received one of the two main anticoagulants: bivalirudin and heparin. There is a large degree of variation in the use of the two anticoagulants in PCI and in primary PCI both within the United States but also in the world. We did not find a statistically significant difference between the outcomes of the two groups of patients, but we also found that a significant number of patients in both the heparin and in the bivalirudin group were also treated with additional medicines that inhibit platelet activation (glycoprotein IIb/IIIa inhibitors).
Author Interviews, Heart Disease, JAMA, Osteoporosis / 27.03.2017

MedicalResearch.com Interview with: Wallis CY Lau BSc Centre for Safe Medication Practice and Research Department of Pharmacology and Pharmacy Li Ka Shing Faculty of Medicine The University of Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Warfarin is a vitamin K antagonist (VKA) oral anticoagulant used for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), a common heart rhythm disorder. It works by interfering with vitamin K-dependent reactions in the process of blood clot formation. As these reactions also play a role in bone mineralization, there is concern that warfarin use may be linked with osteoporotic fracture. Despite the concerns for fracture risk, warfarin had been an inevitable treatment choice for over 50 years as there were no other alternatives available. Dabigatran is the first non-VKA oral anticoagulant (NOAC) approved for use in patients with NVAF. Recently, an animal study reported that use of dabigatran is associated with a better bone safety profile compared to warfarin in rats, suggesting a potential for a lower risk of osteoporotic fractures over warfarin. However, the actual risk of osteoporotic fractures with dabigatran use in human remains unclear. Therefore, we conducted a population-based cohort study to compare the risk of osteoporotic fractures in patients with NVAF treated with dabigatran and warfarin.
Author Interviews, Heart Disease, JAMA / 21.03.2017

MedicalResearch.com Interview with: [caption id="attachment_33174" align="alignleft" width="120"]Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research Dr. Eric Secemsky[/caption] Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research  MedicalResearch.com: What is the background for this study?  What are the main findings? Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events. The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting.
Author Interviews, Heart Disease, JAMA, Stroke / 14.03.2017

MedicalResearch.com Interview with: Dr. Ying Xian MD PhD Department of Neurology, Duke Clinical Research Institute Duke University Medical Center Durham, North Carolina MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation (AF) is the most common arrhythmia. AF increases the risk for stroke and accounts for 10% to 15% of all ischemic strokes. While the burden of AF-related stroke is high, AF is a potentially treatable risk factor. Numerous studies have demonstrated that vitamin K antagonists, such as warfarin, or non-vitamin K antagonist oral anticoagulants (NOACs), reduce the risk of ischemic stroke. Based on these data, current guidelines recommend adjusted-dose warfarin or NOACs over aspirin for stroke prevention in high-risk patients with Atrial fibrillation.
Alzheimer's - Dementia, Author Interviews, Brigham & Women's - Harvard, Geriatrics, Heart Disease, Stroke / 26.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32407" align="alignleft" width="200"]Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Instructor in Medicine, Harvard Medical School Dr. Ariela Orkaby[/caption] Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Instructor in Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atrial Fibrillation is a common heart rhythm that affects 1 in 25 adults over age 60 and 1 in 10 adults over age 80. The feared consequence of atrial fibrillation is stroke, leading to the prescription of blood thinning medications (anticoagulants such as warfarin) to prevent strokes. However, there is an underutilization of these life-saving medications in older adults, and particularly in those who have dementia. In part, this is due to a lack of research and inclusion of older adults with dementia in prior studies. In this study, we used clinical Veterans Administration data, linked to Medicare, to follow 2,572 individuals over age 65 who had atrial fibrillation and until a diagnosis of dementia. The average age was 80 years, and 99% were male. We found that only 16% remained on warfarin. We used statistical methods to account for reasons why a patient would or would not be treated with warfarin and found that those who continued to take warfarin had a significantly lower risk of stroke (HR 0.74, 95% Confidence interval 0.54- 0.99, p=0.47) and death (HR 0.72, 95% CI 0.60-0.87, p<0.01) compared to those who did not continue to take warfarin, without an increased risk of bleeding.
Author Interviews, Heart Disease, JAMA / 25.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32393" align="alignleft" width="200"]David Gaist, MD, PhD</strong> Department of Neurology Odense University Hospital University of Southern Denmark Odense, Denmark Dr. David Gaist[/caption] MedicalResearch.com: What is the background for this study? What are the main findings? Response: The incidence of subdural hematoma (SDH; a bleed located within the skull, but outside the brain) has been reported to be on the increase. Previous studies have shown an association between use of antithrombotic drugs and SDH. However, studies with updated estimates of this risk and with focus on current more complex and aggressive regimens of antithrombotic treatment are scarce. We therefore performed this study, where we identified 10,010 patients aged 20-89 years that were admitted with SDH in Denmark in 2000 through 2015. Preadmission use of antithrombotic drugs (low-dose aspirin, clopidogrel, vitamin K antagonist, e.g. warfarin, and direct oral anticoagulants) of these cases was compared to that of 400,380 individuals from the general population with no history of SDH (controls). We found that use of antithrombotic drugs was associated with an increased risk of subdural hematoma . The magnitude of this risk varied by type of antithrombotic, and was, e.g., low for use of low-dose aspirin, and highest for warfarin. Further, with a single exception (low-dose aspirin and dipyridamole), concurrent use of more than one antithrombotic drug was associated with higher risk of SDH, particularly if warfarin was taken along with an antiplatelet drug, e.g., low-dose aspirin or clopidogrel. Increasing use of antithrombotic drugs was observed in the study period. The incidence of subdural hematomas in the Danish population also increased markedly in the years 2000-2015, particularly among those aged 75+ years. Our study indicates that this increased incidence, can, at least partly, be explained by increased use of antithrombotic drugs.