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:12/7/2016)... Orleans, LA (PRWEB) , ... December 07, 2016 ... ... technique used to treat wrinkles and deep lines by smoothing and tightening the ... minimally invasive techniques out there to address facial aging with very little downtime, ...
(Date:12/7/2016)... ... 2016 , ... It is vital for any lab to secure funding, and ... team at Beckman Coulter has designed Kaluza, templates with advanced analytical tools to streamline ... operate in a GLP (Good Laboratory Practice) fashion. , With features designed to simplify ...
(Date:12/7/2016)... ... ... to blow out his candles on his 14th birthday, Estefano Reano had only one wish: ... Joe DiMaggio Children’s Hospital surprised his family with a phone call that made his wish ... was playing at home, when we got the phone call telling us there was a ...
(Date:12/7/2016)... ... December 07, 2016 , ... One of two inventors from Glen Burnie, ... is painful for her. "This is why the co-inventor and I have designed a ... They then created a prototype of the patent-pending AV-AIR, a device that serves as ...
(Date:12/7/2016)... Honolulu, HI (PRWEB) , ... December 07, 2016 ... ... Dermatology is proud to announce that its fully redesigned website, which launched October ... well as a sleek responsive design and easy-to-navigate layout. Visitors and patients can ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... FALLS, N.J., Dec. 8, 2016 CANTEL MEDICAL CORP. ... income of $18,800,000, or $0.45 per diluted share, on a ... first quarter ended October 31, 2016. This compares with net ... of $153,779,000 for the first quarter ended October 31, 2015. ... first quarter ended October 31, 2016 to $21,323,000, or $0.51 ...
(Date:12/8/2016)... , Dec. 8, 2016   Mederi Therapeutics Inc . has announced regulatory ... Therapy, a non-surgical treatment for chronic gastroesophageal reflux disease (GERD). ... ... and broadcast during the Chinese Congress of Digestive Endoscopy, by Professor Jun Liu, Director ... , , "We are very ...
(Date:12/8/2016)... BEIJING , and SAN DIEGO , ... genomic services and solutions with cutting edge next-generation sequencing and ... biotechnology company; and the Genome Institute of ... (NovogeneAIT) – a new joint venture between Novogene and AITbiotech ... at Biopolis, Singapore .   ...
Breaking Medicine Technology: