Author Interviews, CDC, JAMA, Stroke, USPSTF / 11.02.2021

MedicalResearch.com Interview with: Aaron B. Caughey, M.D., M.P.P., M.P.H., Ph.D. Professor and Chair Department of Obstetrics and Gynecolog Associate dean for Women’s Health Research and Policy Oregon Health & Science University    Portland, OR. Founder and Chair Centers for Disease Control and Prevention–funded Oregon Perinatal Collaborative MedicalResearch.com: What is the background for this study? What are the main findings? Response: Stroke is a leading cause of death and disability in the United States and can be devastating to those affected. One of many risk factors for stroke is carotid artery stenosis (CAS), which is the narrowing of the arteries that run along the sides of the neck and supply blood to the brain. The Task Force wants to help prevent people from having a stroke, but evidence shows that screening for CAS in people without symptoms does not help prevent strokes and can actually lead to harmful events such as stroke, heart attack, or death. Since the harms of screening greatly outweigh the benefits, the Task Force continues to recommend against screening for CAS among adults who do not have any signs or symptoms of a blocked artery in the neck. (more…)
Author Interviews, JACC, Stroke, Surgical Research / 03.05.2017

MedicalResearch.com Interview with: Jay S. Giri, MD, MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine Penn Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed data from 6,526 patients in the 5 most recent randomized trials comparing carotid artery stenting to carotid endarterectomy.  These procedures are performed to prevent long-term stroke in patients with severe narrowings of their carotid arteries.  We learned that the procedures are equally effective in preventing stroke over the long-term.  However, the procedures have quite different safety profiles, defined as adverse events that the patients experienced within 30 days of their procedure. Carotid artery stenting was associated with a higher risk of stroke in the initial 30 days after the procedure.  Carotid endarterectomy was associated with greater risks of myocardial infarction (heart attack) and cranial nerve palsy, a variable condition that most often results in difficulty with swallowing or speaking, over this timeframe. (more…)
AHA Journals, Author Interviews, Duke, Geriatrics, Heart Disease, Surgical Research / 03.05.2016

MedicalResearch.com Interview with: Jessica J. Jalbert PhD From the Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine, Brigham and Women’s Hospital Harvard Medical School, Boston, MA LASER Analytica New York, NY MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Jalbert: Landmark clinical trials have demonstrated that carotid artery stenting (CAS) is a safe and efficacious alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. Clinical trials, however, tend to enroll patients that are younger and healthier than the average Medicare patient. We therefore sought to compare outcomes following CAS and CEA among Medicare patients. MedicalResearch.com: What are the main findings? Dr. Jalbert: We found that outcomes among real-world Medicare patients undergoing CAS and CEA were similar. While our results were inconclusive due to small sample size, we also found some evidence suggesting that patients over the age of 80 and those with symptomatic carotid stenosis may have better outcomes following carotid endarterectomy than CAS. (more…)
AHA Journals, Author Interviews, Duke, Outcomes & Safety, Stroke, Surgical Research / 04.11.2015

MedicalResearch.com Interview with: Soko Setoguchi-Iwata, M.D MPH Adjunct Associate Professor Department of Medicine Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting vs Carotid Endarterectomy in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated  Carotid Artery Stenting proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with an mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.   (more…)
Author Interviews, Heart Disease, JACC, Stroke, University of Pennsylvania / 25.04.2015

Jay Giri, MD MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine University of PennsylvaniaMedicalResearch.com Interview with Jay Giri, MD MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine University of Pennsylvania MedicalResearch: What is the background for this study? What are the main findings? Dr. Giri: Carotid artery stents are placed by vascular surgeons or interventional cardiologists to decrease the risk of long-term stroke in patients with severe atherosclerotic disease of the carotid artery.  When these procedures are performed, there is a risk of releasing small amounts of debris into the brain’s circulation, causing a stroke around the time of the procedure (peri-procedural stroke).  In order to mitigate this issue, embolic protection devices (EPD) have been developed to decrease the chances of small debris reaching the brain. Two types of EPD exist.  The first is a small filter meant to catch the debris released by placement of the carotid stent (distal filter EPD). The second is a more complex device type that leads to transient halting of blood flow to the brain in the carotid artery being stented (proximal EPD). Debris-containing blood is removed from the body prior to allowing normal blood flow to proceed back to the brain after stent placement. Our prior research has shown that nearly all (>95%) of domestic carotid stenting procedures are performed with utilization of one of these devices.  We sought to compare important clinical outcomes of stroke and death between these 2 device types within a large national sample of patients undergoing carotid stenting. Some small prior studies have investigated whether the total amount of debris reaching the brain is less with proximal embolic protection devices.  These studies have shown mixed results.  However, no prior study has investigated important clinical outcomes of stroke and death in relation to these devices. We found that overall uptake of proximal embolic protection devices utilization in America has not been robust.  Less than 7% of all domestic CAS procedures are performed with this technology.   Our analysis showed that in-hospital and 30-day stroke/death rates with proximal EPD and distal filter EPD were similar (1.6% vs. 2.0%, p = 0.56 and 2.7% vs. 4.0%, p = 0.22, respectively). (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations. (more…)