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…)
Author Interviews, Heart Disease, Surgical Research / 20.04.2017

MedicalResearch.com Interview with: Emmanouil S. Brilakis, MD, PhD Director, Center for Advanced Coronary Interventions Minneapolis Heart Institute Minneapolis, Minnesota 55407 Adjunct Professor of Medicine University of Texas Southwestern Medical School at Dallas MedicalResearch.com: What is the background for this study? What are the main findings? Response: Calcification in the coronary arteries might hinder lesion crossing, equipment delivery and stent expansion and contribute to higher rates of in-stent restenosis, as well as stent thrombosis. In this project we sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a contemporary, multicenter registry. We analyzed the outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients between 2012 and 2016 at 11 US centers. Data collection was performed in a dedicated online database (PROGRESS CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, Clinicaltrials.gov Identifier: NCT02061436). (more…)
Author Interviews, Heart Disease, JAMA / 21.03.2017

MedicalResearch.com Interview with: Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research  MedicalResearch.com: What is the background for this study?  What are the main findings? Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events. The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting. (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…)
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…)