Navigation Links
NEJM study demonstrates carotid stenting with embolic protection is comparable to surgery
Date:4/10/2008

WARREN, N.J., April 9, 2008 According to a study published in The New England Journal of Medicine this week, three-year data from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study in patients with severe blocked carotid arteries, the main blood vessels in the neck leading to the brain, who underwent carotid artery stenting (CAS) with the PRECISE Nitinol Stent and the ANGIOGUARD Emboli Capture Guidewire were comparably protected from stroke, heart attack, death, and repeat revascularization procedures as patients who underwent surgery (endarterectomy).

SAPPHIRE is a multicenter, prospective, randomized study that evaluated the safety and performance of the PRECISE Nitinol Stent and ANGIOGUARD Emboli Capture Guidewire, compared with endarterectomy, in 334 patients with high-grade carotid artery stenosis. The prespecified major secondary endpoint at three years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke (occurring on the same side) between 31 days and three years.

At three years, data were available for 260 patients, 85.6 percent of patients (143 of 167) in the stenting group and 70.1 percent of patients (117 of 167) in the surgery group. The pre-specified major secondary endpoint occurred in 41 of the 167 patients who underwent stenting (cumulative incidence, 24.6 percent) and in 45 of 167 patients who underwent endarterectomy (cumulative incidence, 26.9 percent). There was no statistical significance between these groups. A procedure to re-open the blocked arteries (target-vessel revascularization) was infrequent in both groups.

It is important to know the protection of carotid revascularization against future stroke and other ischemic events was maintained at three years and there was no significant difference in the cumulative incidence of major cardiovascular events between carotid revascularization and carotid surgery, said Donald E. Cutlip, M.D., Executive Director of Clinical Investigation, Harvard Clinical Research Institute, Harvard Medical School. Dr. Cutlip currently serves as an investigator in the Cordis-sponsored SAPPHIRE study.

SAPPHIRE is the first, longest-term randomized study comparing the safety and efficacy of carotid stenting with embolic protection to those undergoing endarterectomy or surgery in patients considered at a high surgical risk. Carotid artery stenting is a minimally invasive procedure that involves placement of a stent, a wire mesh device used to open a narrowed artery, up to the neck through a catheter near the leg. To reduce the chances of small pieces of plaque breaking off and entering the bloodstream during this process, SAPPHIRE researchers used an emboli-protection device to catch these small particles. The PRECISE Stent and ANGIOGUARD Guidewire are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA) -- a surgical treatment for removing arterial plaque from the carotid artery.

These long-term study results are important to the approximately one-third of patients who have severe carotid artery stenosis and require a less invasive, but effective treatment option because they are poor candidates for surgery, said Sidney Cohen, M.D., Ph.D., Vice President, Clinical Research, Cordis Corporation. Results show that stenting with the PRECISE Nitinol Stent combined with the ANGIOGUARD distal protection device offers these patients a safe and effective alternative to carotid surgery.


'/>"/>

Contact: Amy Meshulam
amy.meshulam@edelman.com
323-202-1028
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 2016 , ... Stephanie Hebert Insurance Agency, serving families of ... charity campaign. As part of their ongoing community involvement program, funds are now ... children deserve a voice, and in the spirit of neighbors helping neighbors in ...
(Date:2/8/2016)... , ... February 08, 2016 , ... A man who has struggled to quit smoking, ... Laser Therapy , was determined to find solutions to his problems – and he did. ... Digest is ready to introduce his breakthrough inventions to the world and better people's ...
(Date:2/8/2016)... York, NY (PRWEB) , ... February 08, 2016 , ... ... are too much to handle, you are not alone. According to the Center for ... include heart disease, stroke, type 2 diabetes and certain types of cancer, some of ...
(Date:2/8/2016)... Hilton Head Island, SC (PRWEB) , ... February 08, 2016 , ... ... Head and surrounding areas with a vital new community enrichment program, has teamed up ... to local women and children suffering from intimate abuse. To support all those victimized ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local ... the greater Venice, FL area, has initiated a fundraiser for a two year ... just four days after Christmas. To support this beautiful child who is facing ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Cardiovascular Surgery Devices - Medical Devices Pipeline Assessment, ... report, "Cardiovascular Surgery Devices - Medical Devices Pipeline ... Devices currently in pipeline stage. ... comprehensive information on the pipeline products with comparative ... development. The report reviews major players involved in ...
(Date:2/8/2016)... 2016  Labvantage Lx, a newcomer to the ... sexual enhancement product, EnduramenT. Setting a new standard ... a patented biomedical breakthrough molecule that promotes the ... responsible for many biological functions including erectile function. ... Forgoing the use of prescription medications, scientists working ...
(Date:2/8/2016)... TOKYO and FAIRFIELD, N.J. ... (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that ... exclusive development and commercialization rights for OPA-15406 in the ... agreement also provides manufacturing rights.  OPA-15406 is a topical, ... for atopic dermatitis. --> ...
Breaking Medicine Technology: