Author Interviews, Clots - Coagulation, JAMA / 17.07.2018

MedicalResearch.com Interview with: David L. Brown, MD, FACC Professor of Medicine Cardiovascular Division Washington University School of Medicine St. Louis, MO 63110 MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is very little high quality data for use of IVC filters in general and no high quality data for using them in the population of patients who have had a DVT or PE and have a contraindication to anticoagulation. However, this is the patient population for which filters are most commonly placed. Using administrative, observational data, we found that IVC filter placement in this all-comer population was associated with an increased risk of 30-day mortality after adjusting for baseline differences and immortal time bias. (more…)
Annals Internal Medicine, Author Interviews, Emory, Endocrinology, Heart Disease, Sexual Health, Thromboembolism / 10.07.2018

MedicalResearch.com Interview with: Michael Goodman, MD, MPH Professor of Epidemiology Director, MD/MPH program Emory University School of Public Health Atlanta, GA  30322 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There is a concern that hormone therapy may be associated with higher risk of certain cardiovascular problems such as heart attacks, stroke and formation of blood clots (“venous thromboembolism”). To study this concern we examined data on 4,960 transgender and gender non-conforming people enrolled in Kaiser Permanente health systems in Georgia, Northern California, and Southern California. They were matched to 48,686 cisgender men and 48,775 cisgender women.  Below are the main findings
  • Rates of venous thromboembolism in all transwomen were approximately twice as high as the rates among cisgender men or cisgender women. The data for stroke and myocardial infarction demonstrated little difference between transwomen and cisgender men, but 80% to 90% higher rates among transwomen compared to cisgender women.
  • When the analyses focused specifically on transwomen who started therapy with female hormone estrogen at Kaiser Permanente, the incidence of both venous thromboembolism and stroke was more clearly elevated relative to either reference group.  There was evidence that incidence of both of these conditions among transwomen was particularly increased two to six years after estrogen initiation. By contrast, the association between estrogen therapy and myocardial infarction was less evident due to relatively few observed events.
  • Transmen did not appear to have significantly higher rates of venous thromboembolism, ischemic stroke, or myocardial infarction than their non-transgender counterparts, but this group was rather young and included a relatively small proportion of participants who initiated their hormone therapy during the study.
(more…)
Author Interviews, BMJ, Clots - Coagulation, Heart Disease / 07.07.2018

MedicalResearch.com Interview with: Yana Vinogradova, PhD, Research Fellow Division of Primary Care, School of Medicine University of Nottingham Nottingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: Anticoagulants are prescribed for treatment and prevention of thrombosis and stroke but may lead to major bleeding.  Unlike the older drug warfarin, newer direct oral anticoagulants do not require regular blood tests but their safety was shown only in selected patients and in trial conditions. The study found that Direct Oral AntiCoagulants (DOACs) are safer than warfarin in terms of bleeding risks with apixaban being the safest.  (more…)
Author Interviews, JAMA, Thromboembolism, University of Michigan / 31.05.2018

MedicalResearch.com Interview with: Paul Grant, MD 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.  (more…)
Author Interviews, Blood Clots, Cancer Research / 17.04.2018

MedicalResearch.com Interview with: Dr. Jens Sundbøll Department of Clinical Epidemiology Aarhus University Hospital Aarhus, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: The incidence of acute peripheral arterial occlusion is approximately 1.5 cases per 10,000 person-years. In comparison, the incidence rate of deep venous thrombosis is about 5-10cases per 10,000 person-years. It has been established previously that deep venous thrombosis in the lower limb and pulmonary embolism may be presenting symptoms of cancer and is associated with a poor cancer prognosis. However, whether arterial thromboembolism of the lower limb also can represent prodromal symptoms of occult cancer and worsen cancer prognosis has never been investigated. (more…)
Author Interviews, Circulation Issues, 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. Partner's note: Understanding the broader impact of vascular diseases can provide valuable insights into the risks associated with varicose veins. (more…)
Author Interviews, Hematology, NEJM, Orthopedics, Thromboembolism / 22.02.2018

MedicalResearch.com Interview with: 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. (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, Lancet, Lipids, Thromboembolism / 21.01.2017

MedicalResearch.com Interview with: Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab) Research Fellow/Epidemiologist Musculoskeletal Research Unit University of Bristol School of Clinical Sciences Southmead Hospital MedicalResearch.com: What is the background for this study? Response: Statins are well established for the prevention of cardiovascular disease and this is based on their ability to lower levels of circulating lipids in the blood. However, statins are also known to have pleotropic effects and these include potential protective effects on multiple disease conditions. Based on their anti-inflammatory and antithrombotic properties, there have been suggestions that statins may prevent venous thromboembolism (VTE) (which comprises of pulmonary embolism and deep vein thrombosis). The evidence is however uncertain. Several studies utilizing both observational cohort and randomized controlled designs have been conducted to evaluate whether statin therapy or use is associated with a reduction in the incidence of VTE, but the results have been inconclusive. In a recent review that was published in 2012, Rahimi and colleagues pooled the results of several randomized controlled trials (RCTs), but found no significant reduction in the risk of VTE with statin therapy [REF]. Given the publication of new studies since this study was published and the existing uncertain evidence on the effect of statins on VTE, we decided it was time to bring all the evidence together and evaluate if statin therapy really did have a protective effect on the risk of venous thromboembolism. (more…)
Author Interviews, NEJM, Orthopedics, Surgical Research, Thromboembolism / 06.12.2016

MedicalResearch.com Interview with: Suzanne C. Cannegieter, M.D., Ph.D. Einthoven Laboratory Leiden University Medical Center The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients who undergo arthroscopic knee surgery and patients who are treated with casting of the lower leg are at increased risk for venous thromboembolism (VTE). It is uncertain whether thromboprophylaxis is effective in these situations to prevent VTE. For both indications, several trials have been performed to evaluate the effectiveness of anticoagulant prophylaxis. However, an overall risk–benefit balance could not be established because of methodologic shortcomings; hence, there has been reluctance to establish international guidelines regarding the use of anticoagulant therapy for either of these indications. (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, Lancet, Outcomes & Safety, Thromboembolism, Transfusions / 28.11.2016

MedicalResearch.com Interview with: Mary A.M. Rogers, PhD, MS Research Associate Professor Research Director, Patient Safety Enhancement Program Department of Internal Medicine University of Michigan Ann Arbor, MI MedicalResearch.com: What is the background for this study? Response: Peripherally inserted central catheters (PICCs) are commonly used for vascular access in hospitalized patients. Previous studies have shown that PICCs of larger gauge (diameter) increase the risk of developing venous thromboembolism (blood clots in the deep veins that sometimes travel to the lung). Red blood cell transfusion is also known to increase the risk of venous thromboembolism. Because PICCs are often used to transfuse blood, we designed a study to investigate whether the method of transfusion delivery influences the risk of developing venous thromboembolism. (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, Blood Clots, CHEST, OBGYNE, Surgical Research, Thromboembolism / 27.09.2016

MedicalResearch.com Interview with: Marc Blondon, MD Division of Angiology and Hemostasis, Department of Specialties of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland Seattle Epidemiologic Research and Information Center, Department of Veterans Affairs Office of Research and Development, Seattle, WA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism, a condition including deep vein thrombosis (blood clots) and pulmonary embolism, is more common in older than younger patients. However, pregnancy and particularly the postpartum period are times at greater risk of blood clots in women. It is important to understand the risk and the risk factors for thrombosis in the postpartum period to guide the use of preventive measures such as heparin, an anticoagulant treatment, or leg compression devices. Our study summarizes the evidence on the link between C-sections and blood clots from the past 35 years. Our meta-analysis demonstrates that:
  • C-section carries a 4-fold increased risk of blood clots in the postpartum period, compared with vaginal deliveries ;
  • that this risk is most prominent but not restricted to emergency C-section ;
  • and that women who undergo elective C-section are also at higher risk than women who have a vaginal delivery.
  • Importantly, we estimated an absolute risk of blood clots after a C-section of 2-4 per 1000 pregnancies: on average, 3 out of 1000 women after C-section will develop a blood clot.
(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, Genetic Research, Opiods, Pain Research, Thromboembolism / 14.07.2016

MedicalResearch.com Interview with: Brian Meshkin Founder and CEO of Proove Biosciences Editor’s note: Proove Biosciences, Inc introduced three new evidence-based tests to support better clinical decision-making for difficult-to-treat conditions that are influenced by genetics. These conditions include substance abuse, fibromyalgia and venous thromboembolism. The tests are especially relevant in light of the House of Representatives passing the Comprehensive Addiction Recovery Act (CARA) bill on July 8, 2016 to combat the opioid epidemic. MedicalResearch.com: Would you update our readers on the significance and implications of the CARA Act? What is the role of genetics in addiction? What is the background for the Proove Addiction™ Profile? How does it aid in addiction management? Response: CARA is a national piece of legislation to expand access to treatment for drug overdoses and addiction. It also includes some other provisions meant to help address the opioid epidemic. However, there are some serious implications. First, it does not contain any funding, so it is a bit of a “Potemkin Village”. It is also a bit of a façade because it does not address 50% of the equation. According to the definition of addiction from the American Society of Addiction Medicine (ASAM) and the National Institutes of Drug Abuse (NIDA), about half of substance abuse is due to genetic factors. If you are studying for a test and ignoring half of the material, chances are you are not going to do well on the test. As doctors are confronted with the challenges of objectively assessing pain and knowing which patients are at risk for abuse, they must consider genetics. The Proove Opioid Risk test combines genetic markers and phenotypic variables into an algorithm to effectively identify patients at low, moderate and high risk for opioid abuse. By knowing this information, a physician can make better decisions about opioids. For low risk patients, a physician can safely prescribe and a patient does not need to fear the opioid prescription they are given – as this is about 50% of the population. For those at moderate risk, a physician can use a greater level of vigilance to monitor those patients with abuse-deterrent formulations, regular urine drug screens, opioid contracts, and other tools to monitor their use. For the small number of patients – less than 10% - that are at high risk, a physician can use alternative forms of pain relief such as interventional procedures or non-opioid analgesics to provide the needed relief to patients. The Proove Addiction Profile builds on this commitment, by providing genetic data points related to other disorders, such as addictions to alcohol, heroin, cocaine and others. Unfortunately, many patients who screen positive for aberrant behavior, such as having an illicit drug in their urine, are often discharged from care by their doctor. This just gets them lost in the system. By running the Proove Addiction Profile in addition to a urine drug screen, a doctor can better understand the genetic factors associated with the aberrant behavior and refer the troubled patient to an addiction specialist for treatment. (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, JACC, Thromboembolism, Yale / 01.03.2016

MedicalResearch.com Interview with: Behnood Bikdeli MD Department of Internal Medicine and Center for Outcomes Research and Evaluation (CORE) Yale University School of Medicine New Haven, CT 06510  Medical Research: What is the background for this study? What are the main findings? Response: The idea of closing the path of inferior vena cava (IVC) to prevent blood clots migrating to the pulmonary circulation and causing a pulmonary embolism (PE) has been around for over 150 years. We were aware than many practitioners might think of IVC filters for that reason, and specifically with the introduction of retrievable filters in recent years; that have made it more palatable for referring physicians. However, there is a paucity of high-quality data to suggest the efficacy of IVC filters. The two existing large trials did not show a mortality benefit from use of filters, and the guidelines have very narrow indications for use of IVC filters in patients who have already had a pulmonary embolism. Having said that, we wondered whether despite the absence of high-quality comparative effectiveness data, filters might be commonly used in patients with PE, particularly among older adults who are a vulnerable population (at higher risk of PE, at higher risk of PE complications; but also less likely to receive other advanced therapies for PE). Our study common use of IVC filters among older adults in the US; with over 75% relative increase in use of IVC filters from 1999 to 2010 (from ~5000 patients with PE in 1999 to ~9000 patients with PE in 2010). We also noted wide regional variations in the use of IVC filters (e.g. highest in the South Atlantic and lowest in the Mountain region). Such differences fundamentally persisted over time. In addition, we noted declining short-term and 1-year mortality rates in patients with pulmonary embolism over time, irrespective of whether or not they received an IVC filter. (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…)