Venous Thromboembolism Prophylaxis Over & Underutilized in Some Hospitalized Patients

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

Dr. Grant

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.  Continue reading

Oral Anticoagulants Still Underused in AFib Patients

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.  Continue reading

Benefits of Clopidogrel and Aspirin In Minor Stroke and High-Risk TIA

MedicalResearch.com Interview with:

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

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.

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Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty?

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

Dr. Anderson

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.

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Some Heart Attack Patients Without AFib Still at Increased Risk of Stroke

MedicalResearch.com Interview with:

Normal rhythm tracing (top) Atrial fibrillation (bottom) Wikipedia image

Normal rhythm tracing (top) Atrial fibrillation (bottom)
Wikipedia image

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.  Continue reading

Real World Studies Compares Dabigatran with Rivaroxaban or Apixaban in Nonvalvular AFib

MedicalResearch.com Interview with:

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

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). Continue reading

Could NOACs Be Better Option Than Warfarin To Prevent Ischemic Stroke?

MedicalResearch.com Interview with:

Taku Inohara MD Department of Cardiology, Keio University School of Medicine Tokyo, Japan Duke Clinical Research Institute, Duke University Medical Center Durham, NC 

Dr. Taku Inohara

Taku Inohara MD
Department of Cardiology, Keio University School of Medicine
Tokyo, Japan
Duke Clinical Research Institute, Duke University Medical Center
Durham, NC 

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

Response: Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly prescribed for high-risk patients with atrial fibrillation because they have fewer bleeding complications than warfarin. However, they still pose a risk of intracerebral hemorrhage (ICH). It was unclear if patients with preceding use of NOACs who experienced an ICH were at greater risk of death than patients with no oral anticoagulant (OAC)  or patients who received warfarin.

Using the GWTG-Stroke registry, we found that, while prior use of both NOACs and warfarin was associated with a greater risk of in-hospital mortality than no OAC, patients with prior use of NOACs were more likely to have favorable outcomes than patients with prior use of warfarin. In addition, the lower mortality in NOACs compared with warfarin was more likely to be prominent in patients with dual antiplatelet agents than those without antiplatelet therapy.

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

Response: High risk patients with atrial fibrillation have to be taking anticoagulation anyway, even ICH occurs, NOACs could still be a better option than warfarin to prevent ischemic stroke.

Physicians should consider NOACs as a safer anticoagulant strategy than warfarin in terms of the severity of their most devastating complication, despite lack of antidotes for current NOACs. 

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

Response: Our findings have the potential to inform future treatment selection when oral anticoagulation is warranted. Future study needs to clarify the temporal trend of OAC-related ICH in parallel of the implementation of NOACs and focus on how the widespread use of NOACs affect the outcome of patients experiencing OAC-related ICH.  

MedicalResearch.com: Is there anything else you would like to add?

Response: The GWTG-Stroke program is provided by the American Heart Association/American Stroke Association (AHA/ASA). This study is in part supported by the ARAMIS registry with research funding from Daiichi Sankyo, Inc., Genentech, Inc., and Janssen. 

Citations:

Inohara T, Xian Y, Liang L, Matsouaka RA, Saver JL, Smith EE, Schwamm LH, Reeves MJ, Hernandez AF, Bhatt DL, Peterson ED, Fonarow GC. Association of Intracerebral Hemorrhage Among Patients Taking Non–Vitamin K Antagonist vs Vitamin K Antagonist Oral Anticoagulants With In-Hospital Mortality. JAMA. Published online January 25, 2018. doi:10.1001/jama.2017.21917

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Feasibility of Anticoagulating Cancer Patients At Increased Risk of Stroke

MedicalResearch.com Interview with:

Babak B. Navi MD, MS

Dr. Navi

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.  Continue reading

Verseon’s Precision Anticoagulants Prevent Clotting Without Excess Bleeding Risk in Preclinical Studies

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. Continue reading

Idarucizumab – Praxbind – Reverses Anticoagulant Effect of Pradaxa Prior To Emergency Surgery

MedicalResearch.com Interview with:

Thomas Seck, M.D., vice president Clinical Development and Medical Affairs, Primary Care Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Thomas Seck

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.

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Dual Antiplatelet Therapy Found Beneficial Over Aspirin Alone Following CABG Surgery

MedicalResearch.com Interview with:

Nayan Agarwal MD Intervention Cardiology Fellow, University of Florida, Gainesville, FL

Dr. Agarwal

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).

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Anticoagulant Warfarin May Lower Cancer Risk

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).

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Chewing Loading-Dose of Ticagrelor Enhanced Platelet Inhibition in Heart Attack Patients

MedicalResearch.com Interview with:

Elad Asher, M.D, M.H.A Interventional Cardiologist, Director Intensive Cardiac Care Unit Deputy Director Heart Institute Assuta Ashdod Medical Cent

Dr. Asher

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.

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Dementia Incidence Lower For Atrial Fibrillation Patients Treated With Anticoagulation

MedicalResearch.com Interview with:

Dr. Leif Friberg MD, PhD Associate professor in cardiology Karolinska Institute Friberg Resarch Stockholm, Sweden 

Dr. Leif Friberg

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?

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Genetic Testing Reduces Risk Of Side Effects From Anticoagulation After Surgery

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

Dr. Bass

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.

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