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Three-year SAPPHIRE and US carotid feasibility trials demonstrate durability of carotid stenting
October 19, 2005Preliminary three-year data from the SAPPHIRE and final three-year data from the U.S. Carotid Feasibility Study (USFS) presented at the 2005 Transcatheter Cardiovascular Therapeutics meeting, demonstrate the long-term durability of carotid artery stenting (CAS) for the prevention of stroke versus carotid endarterectomy (CEA) in high risk surgical patients.
Three hundred thirty-four patients in the SAPPHIRE trial were randomized to either CAS or CEA. Patients who received CAS with the PRECISE® Nitinol Self-Expanding Stent and ANGIOGUARDTM XP Emboli Capture Guidewire System maintained a low incidence of stroke after the first 30 days for the duration of the three-year follow-up in the USFS and SAPPHIRE. In the SAPPHIRE trial, at 36 months the incidence of stroke was virtually identical for both CAS and CEA (7.1% for CAS and 6.7% for CEA, P = 0.945). The 3-year incidence of stroke across the randomized and non-randomized CAS treatment groups in SAPPHIRE and the USFS had only an average increase of 4.0% over the 30-day stroke rate. Cordis Corporation, a Johnson & Johnson company, sponsored the SAPPHIRE and USFS clinical trials.
Jay S. Yadav, M.D., the Cleveland Clinic Foundation, and a principal investigator for the SAPPHIRE trial said, "The SAPPHIRE trial demonstrated CAS was non-inferior to CEA. This is important new data which suggests the long-term durability of CAS in this patient population."
An analysis of target lesion revascularization (TLR) with follow up to three years in the randomized arms of SAPPHIRE showed reintervention rates of 3.0% for CAS and 7.1% for CEA, P = 0.084. Three-year TLR rates for CAS were similar in the USFS.
Additional Carotid Stenting Data
Data from the SAPPHIRE, USFS, and CASCADE clinical trials also were presented in two poster sessions highlighting CAS involving ANGIOGUARD. The data suggests emboli protection is effective in preventing major strokes during carotid stenting. 30-day stroke rates were 8.6% for the 266 patients treated with stenting alone and 2.6% for the 116 patients treated by stenting with ANGIOGUARD. In addition, no patients treated with an ANGIOGUARD in CASCADE, USFS or in the treated randomized portion of SAPPHIRE had a major stroke. Approximately two-thirds of the minor ipsilateral strokes that occurred in these trials resolved with time.
Edelman Public Relations
An analysis of target lesion revascularization (TLR) with follow up to three years in the randomized arms of SAPPHIRE showed reintervention rates of 3.0% for CAS and 7.1% for CEA, P = 0.084. Three-year TLR rates for CAS were similar in the USFS.
Additional Carotid Stenting Data
Data from the SAPPHIRE, USFS, and CASCADE clinical trials also were presented in two poster sessions highlighting CAS involving ANGIOGUARD. The data suggests emboli protection is effective in preventing major strokes during carotid stenting. 30-day stroke rates were 8.6% for the 266 patients treated with stenting alone and 2.6% for the 116 patients treated by stenting with ANGIOGUARD. In addition, no patients treated with an ANGIOGUARD in CASCADE, USFS or in the treated randomized portion of SAPPHIRE had a major stroke. Approximately two-thirds of the minor ipsilateral strokes that occurred in these trials resolved with time.
Edelman Public Relations
Carotid Stenting Current Events and Carotid Stenting News RSSStudy shows safety and efficacy of blood flow reversal system used during carotid stenting
Results of a study on an embolic protection system during carotid stenting that uses a novel blood flow reversal system was reported today during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).
Study reveals embolic neuroprotection system reduces risk of cardiac events
Results of a study on the use of the FiberNet® Embolic Protection System in carotid artery stenting were reported today during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).
SAPPHIRE trial shows long-term benefit of carotid stenting as alternative to surgery
Carotid artery stenting is an effective option for high risk patients who are not eligible for surgery, according to a long-term study published in this week's New England Journal of Medicine. Carotid artery disease, which involves clogging of the arteries in the neck that provide blood to the brain, is a significant risk factor for stroke, making these study results important for the estimated 200,000 Americans each year who would otherwise not be candidates for the treatment.
Research sheds light on carotid artery stenting risk in elderly
Dr. Hernan Bazan, Assistant Professor of Surgery, Section of Vascular Surgery, at Louisiana State University Health Sciences Center New Orleans' School of Medicine, is the lead author of a research paper which may help physicians decide which patients with carotid artery occlusive disease should have carotid surgery or carotid stenting.
2 carotid artery stenting studies show results comparable to AHA guidelines
Two carotid stenting trials examining patient outcomes demonstrated results that are comparable to guidelines established by the American Heart Association (AHA) for patients treated with carotid artery surgery.
Broad-based group of physicians calls for improvement in stroke treatment
A coalition of physicians representing a wide range of medical specialties has issued a call to action to improve the treatment of stroke.
Cerebral embolic protection and carotid stent systems
High-risk surgical patients in community hospital settings can safely benefit from the use of new embolus-removing and stent-inserting systems, according to a study presented today at the American College of Cardiology's Innovation in Intervention: i2 Summit in New Orleans, La.
Carotid stenting the new anti-depressant?
Inserting a stent to open a narrowed carotid artery has been found to reduce symptoms of depression that may be associated with carotid stenosis, according to a study in the August issue of Radiology.
Training on virtual 'patient' improves carotid angiography skills
Cardiologists can learn to perform risky catheter procedures such as carotid angiography on a virtual patient simulator, rather than on real patients, according to a new study in the May 2, 2006, issue of the Journal of the American College of Cardiology.
New generation of cardiac interventions, therapies optimize heart disease care
Research presented today at the American College of Cardiology's 55th Annual Scientific Session and the inaugural Innovation in Intervention: i2 Summit 2006 in Atlanta, Ga., highlights critical advances in the treatment of cardiovascular disease.
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Carotid Artery Stenting: The Basics (Contemporary Cardiology) by Jacqueline Saw (Editor) Over the past three decades, carotid artery stenting has evolved to become a promising and viable alternative to carotid endarterectomy, especially for patients deemed to have high surgical risks. In Carotid Artery Stenting: The Basics, Jacqueline Saw and a panel of international experts on carotid artery stenting discuss in depth the details of all contemporary aspects of carotid stenting, while reviewing supporting studies, guidelines, technical perspectives, and peri-procedural management. This textbook serves as a learning resource on the multifaceted management of patients with carotid artery stenosis, with the key focus on extracranial carotid artery stenting. Additional sections detail the specifics of setting up and maintaining a laboratory and discuss the preparation of the... |
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Carotid Artery Stenting Current Practice And Techniques by Lippincott Williams & Wilkins Carotid Artery Stenting Current Practice and Techniques : Carotid Artery Stenting Current Practice and Techniques Pub Date: June 2004 Product Type: Print Author/s: Nadim Al-Mubarak MD; Gary S Roubin MD, PhD; Sriram S Iyer MD; Jiri J Vitek MD, PhD Written by internationally recognized experts in interventional cardiology, this comprehensive clinical reference on carotid artery stenting provides illustrated, step-by-step descriptions of techniques and details on indications, contraindications, patient selection, complications, technology, and clinical trials. The first section reviews clinical results and experience, including the CAVATAS trial findings on stroke prevention. The second section describes stenting techniques and includes information from major trials on... |
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Carotid Artery Stenting: Current Practice and Techniques by Nadim Al-Mubarak (Editor), Gary S Roubin (Editor), Sriram S Iyer (Editor), Jiri J Vitek (Editor) Written by internationally recognized experts in interventional cardiology, this comprehensive clinical reference on carotid artery stenting provides illustrated, step-by-step descriptions of techniques and details on indications, contraindications, patient selection, complications, technology, and clinical trials. The first section reviews clinical results and experience, including the CAVATAS trial findings on stroke prevention. The second section describes stenting techniques and includes information from major trials on design and application of devices. The third section presents guidelines and current regulations on establishing a carotid stenting program. The book concludes with a preview of future directions. | |
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Practical Carotid Artery Stenting by Sumaira Macdonald (Editor), Gerry Stansby (Editor) In the management of vascular disease, there has been an inexorable drive towards less invasive endovascular treatments. This has substantially altered the attitudes of patients, clinicians and health care providers. Endovascular treatment of carotid stenosis for stroke is no exception. Several trials are running concurrently; these are comparing carotid endarterectomy (CEA) with the less invasive alternative, carotid stenting (CAS). There is already evidence that CAS may be preferable in certain patient populations i.e. those deemed to be at high surgical risk. Furthermore both procedures have comparable benefits in terms of survival free of ipsilateral stroke between three to five years post-procedure. State-of-the-art CAS (with regards use of all available... |
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