Author Interviews, Heart Disease, Lipids, PAD, Women's Heart Health / 27.08.2020

MedicalResearch.com Interview with: First Author: Dhruv Mahtta, DO, MBA Cardiovascular Disease Fellow Baylor College of Medicine Houston, TX Senior & Corresponding Author Dr. Virani Salim S. Virani, MD, PhD, FACC, FAHA, FASPC Professor, Section of Cardiovascular Research Director, Cardiology Fellowship Training Program Baylor College of Medicine Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center Co-Director, VA Advanced Fellowship in Health Services Research & Development at the Michael E. DeBakey VA Medical Center, Houston, TX Investigator, Health Policy, Quality and Informatics Program Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation Houston, TX @virani_md MedicalResearch.com: What is the background for this study? What are the main findings? What do you think accounts for the gender differences? Response: We know that women with ischemic heart disease (IHD) have lower prescription rates for statin and high-intensity statin therapy. In this study, we assessed whether the same trends hold true for women with other forms of atherosclerotic cardiovascular disease (ASCVD) i.e. women with peripheral artery disease (PAD) or ischemic cerebrovascular disease (ICVD). Maximally tolerated statin therapy is a Class-I indication in patients with clinical ASCVD which includes PAD and ICVD. We also assessed statin adherence among men and women with PAD and ICVD. Lastly, we performed exploratory analyses to assess whether statin therapy, statin intensity, and statin adherence in women with PAD and ICVD were associated with cardiovascular outcomes and/or mortality. 
Author Interviews, Heart Disease, JAMA, PAD, Stroke / 19.07.2018

MedicalResearch.com Interview with: [caption id="attachment_42708" align="alignleft" width="143"]Dr. Michael Barry MD Director of the Informed Medical Decisions Program Health Decision Sciences Center at Massachusetts General Hospital Physician at Massachusetts General Hospit Professor of Medicine,Harvard Medical School Dr. Barry[/caption] Dr. Michael Barry MD Director of the Informed Medical Decisions Program Health Decision Sciences Center at Massachusetts General Hospital Physician at Massachusetts General Hospit Professor of Medicine,Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Peripheral artery disease—which is known as PAD—is a disease that reduces blood flow to a person’s limbs, especially the legs. PAD can cause leg and foot pain when resting or walking, wounds to not heal properly, and loss of limbs. Additionally, people with PAD are more likely to experience a cardiovascular disease event, such as heart attack and stroke. The U.S. Preventive Services Task Force looked at the latest research to see if screening people without signs or symptoms of PAD using the ankle brachial index (ABI) can prevent heart attack, stroke, or other adverse health effects. We found that more research is needed to determine if screening with ABI can help to identify PAD and/or prevent heart attack or stroke in people without signs or symptoms. Additionally, in a separate recommendation statement, we looked into the effectiveness of what we call nontraditional risk factors for assessing a person’s risk of cardiovascular disease. Clinicians typically check someone’s risk for cardiovascular disease using traditional risk factors, such as age, race, and smoking status. The Task Force looked at the current evidence to see if three additional, nontraditional risk factors can help prevent heart disease or stroke. The nontraditional factors considered were ABI measurements, an elevated amount of high-sensitivity C-reactive protein (hsCRP) in the blood, and an elevated amount of calcium in the coronary arteries (CAC score). In this recommendation, we also found that there is insufficient evidence to recommend for or against using nontraditional risk factors in addition to those normally used to assess cardiovascular disease risk in people without signs or symptoms. 
Author Interviews, Boehringer Ingelheim, Heart Disease, PAD / 03.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36741" align="alignleft" width="150"]John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University Dr. Eikelboom[/caption] John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy. Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease.
Author Interviews, Hematology, PAD / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28262" align="alignleft" width="175"]Michael P. Murphy, MD Dr. Michael Murphy[/caption] MedicalResearch.com: What is the background for this study? What are the main findings? Response: Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores, or gangrene.  Up to 30% of patients with CLI do not qualify for conventional interventions, such as a bypass or angioplasty, putting them at risk for amputation. The MOBILE trial (MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa in Subjects with Severe Peripheral ArteriaL DiseasE) was designed to assess the safety and efficacy of using autologous concentrated bone marrow aspirate (cBMA), cells derived from the patient's own bone marrow, to restore blood flow and prevent amputations in patients with CLI. MOBILE is a Phase 3, double-blind, randomized, placebo-controlled trial that evaluated 152 patients with CLI at 24 centers in the U.S. Patients were randomized to receive cBMA or placebo via injection at 40 sites on the symptomatic leg.  The cBMA was obtained from each patient using the MarrowStim PAD kit.  The placebo group underwent a sham bone marrow aspiration and received needle punctures in the index leg. The primary efficacy endpoint was amputation-free survival, defined as freedom from all causes of death and/or major amputation, at 52 weeks after treatment. Other endpoints included changes in blood flow in the leg, wound healing, measures of pain and quality of life, and distance walked in 6 minutes. The trial completed in June 2016, and a preliminary analysis found that cBMA demonstrated a meaningful improvement in amputation-free survival and a comparable safety profile to placebo.
Author Interviews, PAD, Surgical Research / 18.08.2016

MedicalResearch.com Interview with: [caption id="attachment_27111" align="alignleft" width="200"]George Adams, M.D., M.H.S., F.A.C.C., F.S.C.A.I. Director of Cardiovascular and Peripheral Vascular Research Rex Hospital Raleigh,North Carolina Dr. George Adams[/caption] George Adams, M.D., M.H.S., F.A.C.C., F.S.C.A.I. Director of Cardiovascular and Peripheral Vascular Research Rex Hospital Raleigh, North Carolina Summary: The early findings of a novel all-comers PAD study (LIBERTY 360°) suggest that ‘watchful waiting’ in Rutherford class 2-3 and ‘primary amputation’ in Rutherford class 6 may not be necessary. Peripheral vascular intervention can be successful in these patient populations as well. MedicalResearch.com: What is the background for this study?  Response: Approximately 18 million Americans have peripheral artery disease (PAD), and 2 million of these patients suffer from critical limb ischemia (CLI)1,2, the end stage of PAD3. CLI is highly prevalent in older patients with diabetes and/or end-stage renal disease4, and is associated with high risk of amputation and mortality5. Briefly, the LIBERTY 360° study6 is a prospective, observational, multi-center study with liberal inclusion criteria and few exclusions, meant to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD, including CLI. The study included any FDA-approved technology to treat claudication and CLI. Four core laboratories were utilized for independent analysis.
Author Interviews, PAD, Sleep Disorders / 29.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25722" align="alignleft" width="168"]Mako Nagayoshi, Ph.D, Assistant Professor Department of Community Medicine, Nagasaki University Graduate School of Biomedical Science Nagasaki Japan Dr. Mako Nagayoshi[/caption] Mako Nagayoshi, Ph.D, Assistant Professor Department of Community Medicine, Nagasaki University Graduate School of Biomedical Science Nagasaki Japan MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Sleep apnea is a common in the US adult population; approximately 13% of men and 6% of women have moderate to severe sleep apnea. Short sleep duration also is highly prevalent in the population. Numerous biological pathways linking sleep disturbances to atherosclerosis have been identified, such as insulin resistance, inflammation, hypertension, and endothelial dysfunction. Yet, the association of sleep apnea and sleep duration with peripheral artery disease (PAD) is not well characterized. This study provides some of first evidence that there is an association between sleep apnea and prevalent and incident PAD, with evidence for stronger associations with objectively measured sleep apnea and cross sectional PAD in blacks. In addition, short and long sleep duration were associated with PAD. These results identify sleep disturbances as a potential risk factor for PAD.
Author Interviews, Emory, PAD, Pharmacology / 15.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24373" align="alignleft" width="120"]Shipra Arya MD, SM Assistant Professor, Division of Vascular Surgery Emory University School of Medicine Assistant Professor of Epidemiology (Adjunct) Rollins School of Public Health Staff Physician, Atlanta VA Medical Center Director, AVAMC Vascular Lab and Endovascular Therapy Dr. Shipra Arya[/caption] Shipra Arya MD, SM Assistant Professor, Division of Vascular Surgery Emory University School of Medicine Assistant Professor of Epidemiology (Adjunct) Rollins School of Public Health Staff Physician, Atlanta VA Medical Center Director, AVAMC Vascular Lab and Endovascular Therapy  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Arya: Peripheral Arterial Disease is the next cardiovascular epidemic. It is poorly recognized and not adequately treated compared to heart disease – and research is lacking on the optimal use of statins for PAD patients. Very few randomized clinical trials have been done specifically in PAD patients to assess the impact of statins on cardiovascular outcomes and none on limb related outcomes. The 2013 ACC/AHA guidelines for cholesterol lowering medications recommends high intensity statins for PAD patients extrapolated from the level 2 and 3 evidence and empirically based on CAD and stroke data. In this study we looked at the amputation and mortality risk based on statin dosage in a large cohort of patients from the VA population and found that high intensity statins are associated with a significant reduction in limb loss (~30%) and mortality (~25%) in PAD patients followed by a smaller risk reduction [~23% for amputation risk reduction and 20% reduction in mortality risk] by low-moderate intensity statins as compared to no statin therapy.
AHA Journals, Author Interviews, Heart Disease, PAD, Surgical Research, University of Pennsylvania / 26.02.2016

[caption id="attachment_20701" align="alignleft" width="180"]Dr. Grace Wang MD FACS Assistant Professor of Surgery Division of Vascular and Endovascular Surgery Hospital of the University of Pennsylvania Dr. Grace Wang[/caption] MedicalResearch.com Interview with: Dr. Grace Wang MD FACS Assistant Professor of Surgery Division of Vascular and Endovascular Surgery Hospital of the University of Pennsylvania Medical Research: What is the background for this study? Dr. Wang: PAD is a major source of morbidity and mortality resulting in functional impairment, limb loss, as well as death. Despite epidemiologic studies which have contributed to our understanding of PAD prevalence and its association with traditional atherosclerotic risk factors, there have been conflicting studies published on the incidence of PAD and differences in treatment outcomes in women versus men. Patients with chronic kidney disease (CKD) are at particularly high risk for PAD. We set out to to define how the incidence of peripheral arterial disease (PAD) in chronic kidney disease (CKD) differs according to sex and age.
Author Interviews, Heart Disease, JAMA, PAD / 09.11.2015

MedicalResearch.com Interview with: Farzin Fakhry, MD PhD Candidate Depts. of Epidemiology & Radiology Erasmus MC Rotterdam, the Netherlands and Myriam Hunink MD, PhD Professor Professor of Radiology and Clinical Epidemiology Erasmus University Medical Center Rotterdam Adjunct Professor of Health Decision Science Harvard T.H. Chan School of Public Health, Boston Medical Research: What is the background for this study? What are the main findings? Response: Intermittent claudication is the classical symptomatic form of peripheral arterial disease (PAD) and affects approximately 20-40 million people worldwide. These patients experience significant functional disability resulting in a sedentary lifestyle and reduced quality of life. In the Endovascular Revascularization And Supervised Exercise (ERASE) study we compared a combination therapy of endovascular revascularization plus supervised exercise versus the recommended care of supervised exercise only as first-line treatment for patients with intermittent claudication. Results from the ERASE study showed that after one year follow up patients in both groups showed significant improvements in their treadmill walking distance and disease specific quality of life. Yet, patients receiving the combination therapy had more rapid and significantly greater improvement in their walking performance and disease specific quality of life compared to the patients following a supervised exercise program only.
AHA Journals, Author Interviews, Chocolate, PAD / 03.07.2014

MedicalResearch.com Interview with: Lorenzo Loffredo, MD and Francesco Violi, MD Department of Internal Medicine and Medical Specialties Sapienza University of Rome, Rome, Italy; MedicalResearch: What are the main findings of the study? Answer: Dark chocolate is rich of polyphenols; these natural substances exert antioxidant properties and, through an increase of nitric oxide, dilate arteries. Our research group applied this effect to enhance blood flow in a very common disease, the peripheral arterial disease. This disease is characterized by reduced blood flow to the limbs. There are not any drugs that improve this blood flow, but dark chocolate could. Our study suggest that dark chocolate, and only dark chocolate, could reduce oxidative stress and improve blood flow and walking autonomy in patients with peripheral arterial disease. We observed no effect on blood flow, oxidative stress and on walking autonomy in PAD patients after milk chocolate assumption. This lack of effect was probably due to the low concentration of polyphenols in milk chocolate.
Author Interviews, Cost of Health Care, PAD / 13.09.2013

MedicalResearch.com Interview with: Nasser Malyar, MD Division of Vascular Medicine Department of Cardiovascular Medicine University Hospital Muenster Albert-Schweitzer-Campus 1, A1 48149 Muenster, Germany MedicalResearch.com: What are the main findings of the study? Dr. Malyar: The main findings of the study were that 1) PAD as a main or co-diagnosis is common among in-hospital treated patients 2) The prevalence of PAD among hospitalized patients is disproportionately increasing, particularly in the subset with critical limb ischemia 3) Despite all efforts and increasingly use of endovascular and surgical revascularization procedures PAD patients still have a poor in-hospital outcome in terms of limb amputation and in-hospital mortality 4) Last but not least the reimbursement costs for in-hospital treatment of patients with PAD are markedly increasing.