Author Interviews, Heart Disease, Technology / 03.04.2024
Coronary In-Stent Restenosis: Paclitaxel-Coated Balloon vs Uncoated Balloon – AGENT DCB Trial Results
MedicalResearch.com Interview with:
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Dr. Sathananthan[/caption]
Dr. Janarthanan Sathananthan M.D.
Chief Medical Officer for Interventional Cardiology Therapies
Boston Scientific
MedicalResearch.com: What is the background for this study?
Response: Despite significant improvements in the drug-eluting stents that are used to treat patients with coronary artery disease, 10% of the percutaneous coronary interventions (PCIs) in the U.S. today address in-stent restenosis (ISR), which is when a previously stented section of a coronary artery becomes obstructed or narrowed by plaque or scar tissue. These patients require additional intervention to avoid potential complications. In the multicenter, randomized AGENT IDE trial, we evaluated whether the AGENT™ Drug-Coated Balloon (DCB), a balloon catheter coated with anti-restenotic paclitaxel, is superior to an uncoated balloon in patients for treating ISR. The AGENT DCB is currently available in countries outside the U.S. Our goal is to bring this technology to market in the U.S. and finally provide physicians with an alternative to traditional ISR treatments, such as placing additional layers of stents or radiation, which may not provide ideal outcomes in some cases.
In October 2023, at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, we presented the primary endpoint data from our AGENT IDE randomized controlled trial evaluating clinical outcomes in patients with ISR undergoing treatment with the AGENT DCB or conventional balloon angioplasty. The positive results in this primary analysis cohort supported the device’s U.S. Food and Drug Administration (FDA) approval, which we announced on March 1, 2024. Just a few months later, data from the full cohort of 600 patients were published in the Journal of the American Medical Association (JAMA) and shared in a late-breaking presentation at Cardiovascular Research Technologies (CRT) 2024 meeting.
Dr. Sathananthan[/caption]
Dr. Janarthanan Sathananthan M.D.
Chief Medical Officer for Interventional Cardiology Therapies
Boston Scientific
MedicalResearch.com: What is the background for this study?
Response: Despite significant improvements in the drug-eluting stents that are used to treat patients with coronary artery disease, 10% of the percutaneous coronary interventions (PCIs) in the U.S. today address in-stent restenosis (ISR), which is when a previously stented section of a coronary artery becomes obstructed or narrowed by plaque or scar tissue. These patients require additional intervention to avoid potential complications. In the multicenter, randomized AGENT IDE trial, we evaluated whether the AGENT™ Drug-Coated Balloon (DCB), a balloon catheter coated with anti-restenotic paclitaxel, is superior to an uncoated balloon in patients for treating ISR. The AGENT DCB is currently available in countries outside the U.S. Our goal is to bring this technology to market in the U.S. and finally provide physicians with an alternative to traditional ISR treatments, such as placing additional layers of stents or radiation, which may not provide ideal outcomes in some cases.
In October 2023, at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, we presented the primary endpoint data from our AGENT IDE randomized controlled trial evaluating clinical outcomes in patients with ISR undergoing treatment with the AGENT DCB or conventional balloon angioplasty. The positive results in this primary analysis cohort supported the device’s U.S. Food and Drug Administration (FDA) approval, which we announced on March 1, 2024. Just a few months later, data from the full cohort of 600 patients were published in the Journal of the American Medical Association (JAMA) and shared in a late-breaking presentation at Cardiovascular Research Technologies (CRT) 2024 meeting.
Dr. Solgama[/caption]
Jay P. Solgama
Medical Student
Department of Medical Education
Geisinger Commonwealth School of Medicine
Scranton PA
MedicalResearch.com: What is the background for this study?
Response: The opioid crisis in the United States continues to escalate, with opioid-related deaths increasing by over 800% since 2000. Prescription opioids, particularly oxycodone, have been a contributor to this crisis, with substantial variations in their distribution observed across different states [1,2,3].
Against this backdrop, the study conducted by researchers from the Geisinger Commonwealth School of Medicine aimed to characterize the distribution of oxycodone across US states from 2000 to 2021. By analyzing data from the Drug Enforcement Administration’s comprehensive Automation of Reports and Consolidated Orders System (ARCOS) and the Centers for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research (WONDER) databases, the study sought to identify trends and patterns in oxycodone distribution and their potential implications for opioid-related deaths [4,5].
Dr. Thomas Robert[/caption]
MedicalResearch.com Interview with:
Thomas Robert, MD, AIX
Associate Professor of Nephrology
APHM (Assistance Publique - Hopitaux de Marseille)
Marseille, Provence-Alpes-Côte d'Azur, France
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Dr. Letavernier[/caption]
Prof. Emmanuel Letavernier, MD PhD
Nephrologist at Tenon Hospital
Paris, France
MedicalResearch.com: What is the background for this study?
Response: Our work was prompted by emerging concerns surrounding the potential nephrotoxic effects of hair-straightening products containing glyoxylic acid. This inquiry was instigated by a patient who experienced three repeated acute episodes of kidney injury in June 2020, April 2021, and July 2022, each occurring shortly after a hair-straightening procedure. Notably, these episodes resolved with hydration.
Upon examining the composition of the hair product used by the patient, which contained glyoxylic acid, and considering the patient's report of painful ulcer scalp during application and subsequent scalp scarring, we suspected a potential link between exposure to glyoxylic acid and kidney injury. Consulting with my colleague, Professor Emmanuel Letavenier, a specialist in crystalline nephropathy at Paris, confirmed this suspicion.
In summer 2023, cases series have been reported by an Israeli team (
Dr. Cortese[/caption]
Marianna Cortese, MD, PhD
Senior Research Scientist
Dr. Fangqun Yu[/caption]
Dr. Fangqun Yu PhD
Senior Research Faculty
Atmospheric Sciences Research Center University
Albany, State University of New York
Dr. Arshad Nair[/caption]
Dr. Arshad Arjunan Nair PhD
Postdoctoral Associate
Atmospheric Sciences Research Center
University at Albany, State University of New York
Skilled
Dr. Magruder[/caption]
Matthew Magruder, MD PGY3
Orthopaedic Residency Program
Department of Orthopaedic Surgery and Rehabilitation
Maimonides Medical Center
MedicalResearch.com: What is the background for this study?
Response: The prevalence of obesity and diabetes mellitus has reached epidemic proportions. Approximately 37.3 million people in the United States, accounting for 11.3% of the total population, have diabetes, and 100.1 million, or 41.9%, of all US citizens are obese. Furthermore, these numbers are only projected to increase in the coming decades. This is an issue for orthopaedic surgeons because diabetes and obesity have consistently been demonstrated to be risk factors for complications following total joint replacements, especially total hip replacements. Therefore, we are in desperate need of new and more effective tools in mitigating the risk of poor outcomes in our joint replacement patients.
Semaglutide, and other GLP-1 agonists, are potentially a new tool that can be used to help decrease the risks following joint replacement surgery. Initially a medication to treat diabetes, semaglutide has recently been approved by the FDA to treat obesity as well, as randomized controlled trials have consistently demonstrated significant weight loss with minimal side effects. The purpose of our study was to see what effect the use of semaglutide had on total hip arthroplasty patient outcomes.
Dr. Akefe[/caption]
Isaac O Akefe DVM, PhD
Clem Jones Centre for Ageing Dementia Research
Queensland Brain Institute
The University of Queensland St Lucia
Academy for Medical Education, Medical School
Brisbane QLD Australia
MedicalResearch.com: What is the background for this study?
Response: The brain is the body’s fattiest organ, with fatty compounds called lipids making up 60% of its weight. Fatty acids are the building blocks of a class of lipids called phospholipids.
In our study, we first showed that levels of saturated fatty acids increase in the brain during neuronal communication and long-term memory formation, but we didn’t know what was causing these changes.