Author Interviews, Clots - Coagulation, JAMA / 27.02.2018

MedicalResearch.com Interview with: Shyueluen Chang MD Phlebologist with Dermatologist background Vein Clinic, Department of Dermatology, Chang Gung Memorial Hospital Taoyuan, Taiwan MedicalResearch.com: What is the background for this study?   Response: Varicose veins are common, with about 23 percent of U.S. adults having the condition, but they are rarely thought to be associated with serious health risks. In contrast, venous thrombosis (DVT), pulmonary embolism (PE), and peripheral artery disease (PAD) are also vascular diseases that are associated with serious systemic effects. Not much is known about varicose veins and the risk of other vascular diseases. Elucidating potential associations between varicose veins and health-threatening diseases is important. (more…)
Author Interviews, Boehringer Ingelheim, Clots - Coagulation, Stroke / 05.10.2017

MedicalResearch.com Interview with: Craig Anderson | MD PhD FRACP Executive Director Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China MedicalResearch.com: What is the background for this study? What are the main findings? Response:  There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago.  The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design. The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain.  However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery. The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment.  We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain. The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups.  Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied. (more…)
Author Interviews, Clots - Coagulation, Genetic Research, JAMA, Surgical Research / 04.10.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, Thromboembolism / 29.03.2017

MedicalResearch.com Interview with: Paul Burton, MD, PhD, FACC Vice President, Medical Affairs Janssen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all. The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups. These results were presented at the American College of Cardiology's 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine. (more…)
Author Interviews, Clots - Coagulation, Electronic Records, JAMA, NYU, Surgical Research / 23.03.2017

MedicalResearch.com Interview with: Zachary Borabm, Research fellow Hansjörg Wyss Department of Plastic Surgery NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent studies have shown that health care providers perform poorly in risk stratifying their patients for venous thromboembolism (VTE) which leads to inadequate VTE prophylaxis delivery, especially in surgical patients. Computerized Clinical Decision Support Systems (CCDSSs) are programs integrated into an electronic health record that have the power to aid health care providers. Using a meta-analysis study technique we were able to pool data from 11 studies, including 156,366 patients that either had CCDSSs intervention or routine care without CCDSSs. Our main outcome measures were the rate of prophylaxis for VTE and the rate of actual VTE events. We found that CCDSSs increased the rate of VTE prophylaxis (odds ratio 2.35, p<0.001) and decreased the risk of VTE events (risk ratio 0.78, p<0.001). (more…)
Author Interviews, BMJ, Clots - Coagulation, Testosterone, Thromboembolism / 03.12.2016

MedicalResearch.com Interview with: Dr. Carlos Martinez Institute for Epidemiology, Statistics and Informatics GmbH Frankfurt, Germany, MedicalResearch.com: What is the background for this study? Response: A 10-fold increase in testosterone prescriptions per capita in the United States and a 40-fold increase in Canada in men has occurred over the first decade of this century, mainly for sexual dysfunction and/or decreased energy. Recognised pathological disorders of the male reproductive system remain the sole unequivocal indication for testosterone treatment but there has been increasing use in men without pathological hypogonadism. A variety of studies and meta-analyses have provided conflicting evidence as to the magnitude of the risk of cardiovascular events including venous thromboembolism in men on testosterone treatment. In June 2014, the US Food and Drug Administration and Health Canada required a warning about the risk of venous thromboembolism to be displayed on all approved testosterone products. Studies have reported contradictory results on an association between testosterone use and the risk of venous thromboembolism. The effect of timing and duration of testosterone use on the risk of venous thromboembolism was not studied and may explain some of these contradictory findings. (more…)
Author Interviews, CHEST, Clots - Coagulation, Surgical Research / 02.11.2016

MedicalResearch.com Interview with: William T. Kuo, MD, FSIR, FCCP, FSVM Director, Stanford IVC Filter Clinic Director, IR Fellowship Program Founding Director, IR-DR Residency Program Associate Professor, Interventional Radiology Stanford University Medical Center Stanford, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the USA, over 250,000 IVC filters are now implanted each year, and rising filter use has led to an increase in filter-related morbidity and recognition of the potential complications from indwelling IVC filters. Consequently, the FDA has issued two safety communications alerting all physicians caring for patients with IVC filters to consider removing the filter as soon as protection from pulmonary embolism is no longer needed: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm?so urce=govdelivery&utm_medium=email&utm_source=govdelivery Despite heightened awareness, up to 40-60% of IVC filters cannot be easily removed using standard methods alone, after the filter becomes firmly embedded. Additionally, many patients have undergone prior placement of a permanent-type filter not even designed for retrieval, leaving them with few options for safe device removal. Although all of these patients can develop filter-related morbidity especially after chronic implantation, there is currently no routine option for removing embedded IVC filters refractory to standard retrieval methods. Our 5-year first-in-human study of a novel procedure—laser-assisted filter removal— demonstrates the safety and efficacy of this technique to treat such patients. In a cohort refractory to standard retrieval methods and high force, endovascular laser-assisted retrieval was overall safe and successful in removing a variety of filter types including permanent filters, regardless of dwell time and without the need for open surgery. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC, Thromboembolism / 27.10.2016

MedicalResearch.com Interview with: Truven Health AnalyticsJay Margolis, PharmD Sr. Research Scientist Truven Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vitamin K antagonists (VKAs), most commonly warfarin, had been the only orally available anticoagulants available for the last 60 or so years. While highly effective, use of these agents was often problematic due to their narrow therapeutic index, need for routine coagulation monitoring, and interactions with food and other drugs. Recently introduced new oral anticoagulants (NOACs), particularly rivaroxaban, had been shown in clinical trials to provide comparable efficacy to the VKAs without the need for routine coagulation monitoring. There have been few studies outside of clinical trials showing benefits that translate to real-world populations. In our study using real-world data from a large sample of geographically and demographically diverse US hospitals, patients hospitalized for incident venous thromboembolisms (VTE) initiating oral anticoagulant treatment with rivaroxaban had significantly shorter hospital stays and lower hospitalization costs compared with warfarin-treated patients. (more…)
AHA Journals, Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, Clots - Coagulation, Heart Disease / 18.10.2016

MedicalResearch.com Interview with: Eric A. Secemsky, MD MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Fellow, Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown. Therefore, we used PCI data from a large, integrated healthcare system to determine current use of  oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy. (more…)
Accidents & Violence, Author Interviews, Clots - Coagulation, JAMA, Surgical Research, Thromboembolism / 03.10.2016

MedicalResearch.com Interview with: Charles A. Karcutskie IV, MD, MA Postdoctoral Research Fellow University of Miami Miller School of Medicine Department of Surgery Divisions of Trauma, Surgical Critical Care, and Burns MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our research group at the Ryder Trauma Center have recently done several studies showing various differences in outcomes and risk based on mechanism of injury. Additionally, venous thromboembolism (VTE) is another topic that our group has focused on in the past several years. Because trauma patients are inherently at a higher risk for VTE due to the nature of their injury, we questioned whether the most important risk factors for VTE were different after blunt or penetrating trauma. At our institution, we assess VTE risk with the Greenfield Risk Assessment Profile, which is a list of several risk factors that each have weight toward an overall risk score. We took these risk factors and analyzed them individually based on mechanism of injury. We found that the factors that contribute to the VTE risk are different based on injury mechanism: After blunt trauma, transfusion status, neurologic status, and pelvic fracture contributed most. After penetrating trauma, vascular injury, severe abdominal injury, and age 40-59 years contributed most. This tells us that mechanism of injury may need to be incorporated into the risk assessment in order to discover the highest risk patients. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, Stroke / 13.09.2016

MedicalResearch.com Interview with: Menno Huisman, MD, PhD Associate professor Department of Medicine Leiden University Medical Center The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotic agents in real-world clinical practice. The program is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different regimens for stroke prevention. At the ESC Congress 2016, we presented the first Phase II results of GLORIA-AF from approximately 3,000 NVAF patients, which showed that treatment with PRADAXA was associated with low incidences of stroke, major bleeding and life threatening bleeding. Less than 1% of PRADAXA-treated patients experienced a stroke over two years (0.63%). Major bleeding occurred in 1.12% of PRADAXA-treated patients and 0.54% experienced a life-threatening bleed. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC, Surgical Research / 30.08.2016

MedicalResearch.com Interview with: Gennaro Giustino MD Resident Physician - Department of Medicine The Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: A period of dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The pathophysiological rationale for DAPT after DES-PCI is predicated on the need to prevent stent-related thrombotic complications while vascular healing and platform endothelialization are ongoing, a process that seems to last between 1 and 6 months with new-generation DES. Whether to extend DAPT after this mandatory period in order to provide a broader atherothrombotic risk protection (for stent-related and non-stent-related atherothrombotic events) is currently a matter of debate. Current guidelines recommend at least 6 months of DAPT after PCI in patients with stable coronary artery disease (CAD) and at least 12 months of DAPT in patients presenting with acute coronary syndrome (ACS). While, several risk scores have been developed to guide clinical decision making for DAPT intensity and duration (namely the DAPT score and the PARIS risk scores) little attention has been payed so far to PCI complexity and the extent of CAD to guide duration of DAPT. In fact irrespective of clinical presentation, patients undergoing more complex PCI procedure (likely due to greater coronary atherosclerotic burden) may remain at greater risk for ischemic events and therefore may benefit of prolonged, or more intense, DAPT. (more…)
Author Interviews, Clots - Coagulation, Diabetes, Heart Disease, JACC / 12.08.2016

MedicalResearch.com Interview with: Raffaele Piccolo, MD Department of Cardiology Bern University Hospital University of Bern Bern, Switzerland MedicalResearch.com: What is the background for this study? Response: Over the past two decades, the prevalence of diabetes mellitus has doubled in Western countries and future projections are even worse by showing a 55% increase by 2035 when approximately 592 million of people are expected to live with diabetes all over the world. Acute myocardial infarction still represents the most common diabetes-related complication and its occurrence is associated with a higher risk of mortality. Timely recanalization of the occluded coronary vessel with primary percutaneous coronary intervention (PCI) represents the therapy of choice for acute ST-segment elevation myocardial infarction (STEMI). Our study investigated whether the direct application of an intracoronary bolus of abciximab, which is an antiplatelet drug blocking the glycoprotein IIb/III a receptor, at the time of primary PCI improves the outcomes at 1-year follow-up compared with the standard intravenous route. The study was in individual patient-level pooled analysis of 3 randomized trials including 2,470 patients, of whom 473 (19%) had diabetes. (more…)
Author Interviews, Clots - Coagulation, Lancet / 07.05.2016

MedicalResearch.com Interview with: Riyaz Bashir MD, FACC, RVT Professor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bashir: The use of compression stockings in the prevention of post thrombotic syndrome following an episode of deep vein thrombosis is common in clinical practice. However, the evidence to suggest its efficacy has been put into question by the recent publication of the SOX trial. Since this was the largest randomized controlled trial to date addressing this issue, it has led to clinicians questioning whether compression stockings should be used at all in these patients. The main finding of this meta-analysis was that in patients with deep venous thrombosis, use of elastic compression stockings does not significantly reduce the development of post thrombotic syndrome. However the current body of evidence is limited and we believe at present it is too early to give up on the use of this therapy, which may benefit many subgroups of patients. (more…)
Author Interviews, Clots - Coagulation, Genetic Research, Heart Disease, JACC / 23.02.2016

MedicalResearch.com Interview with: Professor Keith AA Fox Duke of Edinburgh Professor of Cardiology University of Edinburgh Medical Research: What is the background for this study? Prof. Fox: From previous reports, certain alleles of CYP2C19 are associated with reduced enzymatic function and reduced conversion of clopidogrel to the active metabolite. Patients carrying these reduced function alleles (reduced metabolizers) exhibit higher platelet reactivity when treated with clopidogrel, compared with patients without reduced-function alleles (extensive metabolizers). However, the relationship of CYP2C19 genotype and outcomes in medically managed patients with acute coronary syndromes (ACS) is not known. Medical Research: What are the main findings? Prof. Fox: There was no association between CYP2C19 metabolizer status (EM vs. RM) and the primary composite endpoint of cardiovascular death, myocardial infarction (MI), or stroke (hazard ratio [HR]: 0.86). EM and RM patients had similar rates of the primary endpoint whether treated with prasugrel (HR: 0.82) or clopidogrel (HR: 0.91; p for interaction non significant). (more…)
Author Interviews, Clots - Coagulation, Stroke / 21.02.2016

MedicalResearch.com Interview with: Thorsten Steiner, MD, PhD Klinikum Frankfurt Hoechst and Heidelberg University Hospital Germany Medical Research: What is the background for this study? What are the main findings? Dr. Steiner: Background of the study is intracranial hemorrhage (ICH) related to vitamin-K antagonists. The mortality rate is about 60%. Main reason for the high mortality rate is hematoma expansion which occurs in about 50% during the acute phase right after the start of symptoms. We performed an investigator initiated randomized controlled trial (RCT) and found that a 4-factor prothrombin complex (PCC) is superior to fresh frozen plasma (FFP) in normalizing the international normalized ratio (INR) and prevents hematoma expansion. This let to more deaths within 48 hours in the FFP-group but had no clinical impact at 3 months - but our study was powered to detect INR normalization and not a clinical endpoint. (more…)
Author Interviews, BMJ, Clots - Coagulation, Heart Disease, Stroke / 06.02.2016

MedicalResearch.com Interview with: Dr. Deborah Cohen Associate Editor BMJ BMA House, Tavistock Square London Medical Research: What is the background for this study? What are the main findings? Dr. Cohen: Anyone familiar with warfarin understands the critical role of INR values in determining the proper dose for warfarin patients. The INR value in an individual patient is the most important piece of information a doctor considers when determining the warfarin dose. If the doctor gives too little warfarin then the patient may be at undue risk of stroke; if too much, the patient may be at undue risk of a major bleed. The BMJ investigation revealed that the INR device used to manage the ~7,000 warfarin patients in the ROCKET trial (which served as the basis for approval of the non-valvular atrial fibrillation indication) was defective. As such – doctors were relying upon a defective device in determining the dose of the warfarin patients – which has a direct influence on the stroke and bleeding risk in that patient. Since this was a comparative trial – any deficiency in the performance of the comparator arm (warfarin) would skew the results in favour of the study drug (rivaroxaban). Since INR directly influences strokes and bleeds – the primary efficacy and safety endpoints – it very much questions, if not undermines, the overall results of this trial. (more…)
Author Interviews, Clots - Coagulation, FDA, Heart Disease, JAMA, Johns Hopkins / 12.01.2016

MedicalResearch.com Interview with:
Victor Serebruany, MD, PhD
HeartDrug Research, Towson, Maryland
Department of Neurology Johns Hopkins University Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings?

Dr. Serebruany: Missing data are common challenges to the validity of trial results, yet it is unclear how to characterize the extent of missing data.  We compared the published lost-to-follow-up rates to incomplete follow-up rates determined from subject records submitted to the FDA for major oral antithrombotic trials.  The 21 trials having both sets of rates included 270,089 patients followed for a median duration of 20 months.  The mean published lost-to-follow-up rates is 0.4% (median 0.3%, range 0.005% to 2%), consistently much lower than the FDA incomplete follow-up rates: mean 12% (median 13%, range 2% to 23%).  There is no correlation between the publication and FDA-calculated  rates (R 0.07, p = 0.76).   The FDA rates exceed greatly the endpoint rate differences: mean 1.3% (median 1,0%, range 0.2% to 3.0%). Medical Research: What should clinicians and patients take away from your report? Dr. Serebruany: That the FDA incomplete follow-up rates greatly exceed the endpoint rate differences raises questions of whether the endpoint differences may be due to differential follow-up rather than drug effect.  That they greatly exceed the measures routinely reported for trials, i.e., lost-to-follow-up rates, suggests that current trial reporting is inadequate.  Completeness of follow-up and other indicators of trial data quality should be considered when interpreting trial results. (more…)
Author Interviews, Cancer Research, Clots - Coagulation, Sloan Kettering / 16.12.2015

MedicalResearch.com Interview with: Luke V. Selby, MD Research Fellow, Department of Surgery Vivian E. Strong, MD FACS Associate Attending Surgeon, Department of Surgery Memorial Sloan Kettering Cancer Center Medical Research: What is the background for this study? What are the main findings? Response: There was strong concern at our institution about the safety of providing pre-operative Venous Thromboembolism (VTE) chemoprophylaxis (in addition to our standard peri and post-operative prophylaxis) was unsafe.  To answer this question we administered a single dose of either low molecular weight heparin or unfractionated heparin to all eligible surgical patients at our institution over a six month period. When compared to identically selected patients operated on during the preceding 18 months, patients who received the pre-operative VTE chemoprophylaxis did not have higher rates of bleeding complications and had lower rates of DVT and pulmonary embolism (PE). (more…)
Author Interviews, Clots - Coagulation, Infections / 19.11.2015

MedicalResearch.com Interview with: Professor Adam Cunningham PhD Institute of Immunology and Immunotherapy MRC Centre for Immune Regulation University of Birmingham Medical Research: What is the background for this study? Dr. Cunningham: Our original question was “Why do people die from Salmonella infections that spread beyond the gut”. Some reasons are known but these do not account for all. In particular infants in sub-Saharan Africa seem particularly prone to Salmonella infections that in the West do no more than cause a self-limiting gastroenteritis. A puzzling feature of many of infections in such infants is that they do not have many bacteria in the blood, probably <10 / ml of blood, yet this low density is a strong predictor of death. Therefore, we thought that it may be the host response to the infection that complicates its control and contributes. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, Stroke, University of Michigan / 10.11.2015

MedicalResearch.com Interview with: Geoffrey Barnes, MD, MSc Clinical Lecturer Cardiovascular Medicine and Vascular Medicine University of Michigan Health System Medical Research: What is the background for this study? Dr. Barnes: Although warfarin has been the primary anticoagulant used for stroke prevention in atrial fibrillation for over 60 years, four new direct oral anticoagulants (DOACs) have been introduced into the market since 2010. Dabigatran, which directly inhibits thrombin, was found to have better prevention of ischemic stroke and a significant reduction in hemorrhagic stroke (bleeding strokes) for patients with atrial fibrillation at intermediate and high risk of stroke.  Prior cost-effectiveness studies have shown that dabigatran is cost-effective from both the societal and payer (usually Medicare) perspectives.  However, none of those studies looked at the patient’s out-of-pocket costs and the impact of prescription drug coverage Medical Research: What are the main findings? Dr. Barnes: We found that patients with prescription drug coverage (Medicare Part D) had significant cost savings when choosing dabigatran over warfarin.  This is primarily because of the reduction in both types of stroke as well not needing to have frequent blood draws, as are required by warfarin.  However, when patients do not have prescription drug coverage, the costs for dabigatran are quite high.  (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 24.10.2015

H.A. (Hendrika) van den Ham PharmD Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University The Netherlands.MedicalResearch.com Interview with: H.A. (Hendrika) van den Ham PharmD Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University The Netherlands. Medical Research: What is the background for this study? What are the main findings? Dr. van den Ham: Atrial fibrillation (AF) is associated with a substantial risk of ischemic stroke and thromboembolism. The CHADS2 and the CHA2DS2-VASc risk scores are developed to guide the decision to prescribe anticoagulants. Recently a new clinically-based risk score, the ATRIA study risk score, was developed. We compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores in a large, independent, community-based cohort of Atrial fibrillation patients in the United Kingdom. We found that the ATRIA score more accurately identified low risk patients that the CHA2DS2-VASc score assigned to higher risk categories.  Such reclassification of stroke risk could prevent overuse of anticoagulants in very low stroke risk patients with Atrial fibrillation. (more…)
Author Interviews, Clots - Coagulation / 19.10.2015

MedicalResearch.com Interview with: Karl Minges, MPH PhD Candidate Yale Graduate School of Arts & Sciences Yale School of Nursing Research Associate | Yale-New Haven Hospital Center for Outcomes Research & Evaluation (CORE) McDougal Graduate Career Fellow | Yale Office of Career Strategy   Medical Research: What is the background for this study? What are the main findings? Response: Pulmonary embolism, caused by a sudden blockage in the lung artery, is thought to be among the most treatable and preventable causes of death. This has been precipitated by several recent diagnostic and therapeutic advancements that have broadened the range of options for diagnosis, treatment, and management for pulmonary embolism in the past decade. In fact, the public health burden of pulmonary embolism is so great that the U.S. Surgeon General issued a Call to Action to prevent venous thromboembolism, comprising deep vein thrombosis and pulmonary embolism in 2008. Despite recent diagnostic and therapeutic advances in pulmonary embolism treatment and prevention, little is known regarding the national trends of pulmonary embolism among older adults – a population that is adversely at risk. In this study, we identified the recent trends in pulmonary embolism hospitalizations and outcomes, such as in-hospital, 30-day and 6-month mortality using a 100% sample of Medicare beneficiaries from 1999 to 2010. We examined instances where pulmonary embolism was the primary or most serious reason for which the patient was in the hospital. Trends by age, sex, and race cohorts were also examined. (more…)
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Heart Disease, JACC / 16.10.2015

Laura Mauri, MD, MSc Division of Cardiovascular Medicine, Department of Medicine Brigham and Women’s Hospital Boston, MA 02115MedicalResearch.com Interview with: Laura Mauri, MD, MSc Division of Cardiovascular Medicine, Department of Medicine Brigham and Women’s Hospital Boston, MA 02115  Medical Research: What is the background for this study? What are the main findings? Dr. Mauri: The Dual Antiplatelet Therapy (DAPT) Study, the largest randomized controlled trial to date comparing different durations of dual antiplatelet therapy (thienopyridine plus aspirin) after coronary stenting, found that patients who were free from major ischemic or bleeding events at 1 year after coronary stenting (either drug-eluting [DES] or bare metal [BMS]), and who were compliant with their antiplatelet therapy, experienced significant reductions in stent thrombosis and myocardial infarction (MI) but increases in moderate or severe bleeding when treated with 30 months of thienopyridine plus aspirin, as compared with 12 months. We analyzed these outcomes in a post hoc analysis of the subset of patients who received everolimus-eluting stents (EES) in the DAPT Study, because EES were the most frequently used stent in the study, and because data suggest that EES may have lower rates of stent thrombosis when compared with paclitaxel-eluting stents. We found that 30 months of dual antiplatelet therapy after coronary stenting (compared to 12 months) was associated with reduced rates of stent thrombosis and MI, no difference in a composite outcome of death, MI and stroke, and increased rates of moderate or severe bleeding. As found in the primary analysis of the DAPT Study, 30 months of dual antiplatelet therapy was associated with increased all-cause mortality, largely due to increased non-cardiovascular mortality. Bleeding-related deaths accounted for a minority of these deaths, where as cancer-related deaths in patients with pre-existing cancer diagnoses accounted for the majority of the mortality difference. (more…)
Author Interviews, Clots - Coagulation, CT Scanning, Emergency Care, Geriatrics / 24.09.2015

MedicalResearch.com Interview with: Dr Lim Beng Leong MBBS, MRCS (A&E), FAMS Jurong Health Services Emergency Department, Singapore  Medical Research: What is the background for this study? What are the main findings? Dr. Leong: It is common in the emergency department to see patients with warfarin who suffer a minor head injury (HI) with GCS >13. It is standard practice according to international guidelines to perform a plain CT scan of the head. What is contentious in the literature is the subsequent management of those patients with a normal initial CT scan. Practice is heterogeneous and includes a mandatory second CT scan at 24 hours mark or observation and repeat CT scan at the discretion of the attending doctor. We have found in our study that the "observe and repeat CT scan for symptomatic cases" approach only was safe as abnormal second CT scans were rare (1 in 295 cases). We traced the patients' course 2 weeks post discharge and none of the patients were re-admitted for reasons of delayed intra-cranial hemorrhage (ICH). However, the cohort of patients consist largely of geriatric patients with falls. More than 50% of these patients were hospitalized for more than 3 days; the longest of 2-3 weeks. They were likely to have various reasons that required longer hospitalizations apart from observation for delayed ICH, such as assessing for risk, etc. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 21.09.2015

MedicalResearch.com Interview with: Renato Valenti, MD David Antoniucci, MD Cardiology Department; Careggi Hospital Florence; Italy Medical Research: What is the background for this study? Response: Previous data have shown that high residual platelet reactivity in patients receiving clopidogrel is associated with high risk of ischemic events and cardiac death after PCI at short-  and long-term follow-up. Clopidogrel nonresponders patients of  the  REsponsiveness to CLOpidogrel and StEnt thrombosis (RECLOSE-2) ACS study received an increased dose of clopidogrel or switched to ticlopidine under light transmittance aggregometry (LTA) adenosine diphosphate  (ADP) test guidance. Despite some decrease of ADP test after treatment adjustment, there was no improvement on clinical outcome. Currently no evidence exists that the achievement of an optimal platelet aggregation inhibition in clopidogrel nonresponders  modifies  the risk profile of  these patients. The RECLOSE-3  study invesigated if a new antiplatet therapy with prasugrel in clopidogrel nonresponders can modify the risk profile of these patients and improve the outcome in term of cardiac mortality. From the RECLOSE-3 registry we identified  302 consecutive  patients who were clopidogrel nonresponders.  Nonresponders  switched to prasugrel therapy.  Due to the nonrandomized study design the clinical outcome of clopidogrel nonresponders switched to prasugrel (from RECLOSE-3 study) was compared with the historical cohort of clopidogrel nonresponders of the RECLOSE-2 ACS (248 patients)  study. The primary endpoint of the study was cardiac mortality. The 2-year cardiac mortality rate was  4.0% in the RECLOSE-3 group and 9.7% in the RECLOSE-2 group (p=0.007). The difference in 2-year cardiac mortality remained also considering exclusively patients  with ACS on admission: 3.2% and 9.7%, respectively, p=0.023.At the final model of multivariable analysis, prasugrel treatment was inversely related to the risk of  2-year cardiac death (HR 0.32; p=0.036)  after adjusting for ACS and other well known covariates related to the outcome. Medical Research: What are the main findings? Response: The main finding of the RECLOSE-3 study is that nonresponsiveness to clopidogrel may be a “modifiable risk factor” for cardiac death after PCI. Prasugrel treatment overcomes nonresponsiveness to clopidogrel and results in thrombotic risk similar to the one of clopidogrel responders. (more…)
Author Interviews, Clots - Coagulation, Duke, Heart Disease, JACC / 09.08.2015

Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North CarolinaMedicalResearch.com Interview with: Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North Carolina Medical Research: What is the background for this study? What are the main findings? Dr. Hess: Guidelines recommend the use of anticoagulation for thromboembolic prophylaxis in atrial fibrillation and also recommend use of dual antiplatelet therapy to reduce cardiovascular events after myocardial infarction and percutaneous coronary intervention.  The use of triple therapy in patients with indications for DAPT and anticoagulation is challenging due to the increased bleeding risk associated with this regimen.  The optimal antithrombotic regimen in this population has not yet been defined. This study specifically focused on older patients, a population that is at greater risk for Atrial Fibrillation-related stroke and recurrent events after MI but also higher risk for bleeding. Despite a growing population of older patients with indications for triple therapy, these patients have been underrepresented in clinical trials and are therefore understudied. We found that relative to DAPT, patients on triple therapy had a similar risk of 2-year major adverse cardiac events but a significantly increased risk of bleeding requiring hospitalization, including greater risk of intracranial hemorrhage. (more…)
AHA Journals, Author Interviews, Clots - Coagulation, Outcomes & Safety, Surgical Research / 27.07.2015

Riyaz Bashir MD, FACC, RVTProfessor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140MedicalResearch.com Interview with: Riyaz Bashir MD, FACC, RVT Professor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140 Medical Research: What is the background for this study? Dr. Bashir: Catheter-based thrombus removal also known as Catheter Directed Thrombolysis (CDT) is a minimally invasive therapeutic intervention that has evolved over the past two decades to reduce the incidence of post thrombotic syndrome (PTS), a very frequent and disabling complication of proximal deep vein thrombosis (DVT). Catheter-based thrombus removal has been shown to reduce this lifestyle limiting complication of DVT and as a result we have observed a significant increase in the utilization rates of CDT across United States. Recent nationwide observational data suggests that higher adverse events such as intracranial hemorrhage rates and need for blood transfusions are seen with CDT use. Nonetheless specific reasons for these findings have not been explored prior to this study. Thread veins, also known as spider veins, are small veins which can appear on your face, thighs or calves and are an issue that many patients want help with. However, they are a cosmetic issue rather than a medical problem. People who suffer from the spider veins often feel that they affect their appearance and confidence and question why do we get thread veins? Medical Research: What are the main findings? Dr. Bashir: This study showed a significant inverse relationship between the institutional Catheter-based thrombus removal volumes and safety outcomes like death and intracranial hemorrhage. The institutions with higher volume of CDT cases annually (greater than or equal to 6 cases) were associated with lower in-hospital mortality rates and lower intracranial hemorrhage rates as compared to institutions, which performed less than 6 cases annually. This study also showed that at high volume institutions there was no difference in terms of death or intracranial bleeding rates between CDT plus anticoagulation versus anticoagulation alone. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 17.07.2015

Prof. Johan Bosmans Interventional cardiologist University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, BelgiumMedical Research Interview with: Prof. Johan Bosmans Interventional cardiologist University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium MedicalResearch: What is the background for this study? What are the main findings? Prof. Bosmans : Transcatheter aortic valve replacement (TAVR) has become standard of care for patients who cannot undergo surgery. With this, it is important to ensure that the risks associated with TAVR be fully understood, and if possible prevented. Even at this stage of the adoption of TAVR, large trials continue to provide information to the clinician about how to select the right patients to ensure the best possible outcomes. The ADVANCE Study is a prospective, multicenter study that evaluated the use of TAVR in 1015 patients at 44 experienced TAVR centers, which was designed to reflect routine clinical practice. We know that the risk of serious adverse events, such as stroke or transient ischemic attack (TIA), in post-TAVR patients can vary based on the timing before and after the procedure. A patient’s baseline demographics and medical history can affect their risk of procedure-related events as well as long-term outcomes. The manipulations required crossing the aortic valve and appropriately positioning any type of TAV has been thought to be related to procedural stroke events. Therefore, we performed a multivariable analysis looking for predictors of stroke – or stroke and TIA at 3 unique time periods (periprocedural, early and late) following TAVR. The most striking result from our analyses was that we were not able to identify any predictors of periprocedural (either during the procedure or on the day after) stroke, illustrating this very multifactorial etiology. We were able to show that being female, experiencing acute kidney injury or a major vascular complication positively predicted stroke during the early (2-30 days post procedure) time period. When we combined the outcome of stroke or TIA, we found that a history of prior atrial fibrillation (AF) was also a predictor. The only late predictor (day 31-730 post-procedure) of stroke was a history of coronary artery bypass grafting, which could reflect the patients’ risk of vascular disease. (more…)