Navigation Links
Drug-Eluting Peripheral Stent Continues to Show Positive Data at Two Years
Date:5/7/2010

SAN DIEGO, May 7 /PRNewswire/ -- Patients treated with the Zilver® PTX™ Drug-Eluting Peripheral Stent maintained clinical improvement at two years, according to interim results from the Zilver® PTX™ Global Registry presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd Annual Scientific Sessions. The prospective, single-arm study is ongoing to evaluate the drug-eluting stent for the treatment of peripheral artery disease (PAD). Results of a separate pivotal randomized study in a similar cohort of patients are expected to be available later this year.

In the meantime, this analysis includes 12-month follow-up data from 721 patients and 24-month follow-up data from 447 patients who received the Zilver® PTX™ paclitaxel-coated stent in the superficial femoropopliteal artery (SFA), a major artery above the knee. The registry study was designed to evaluate stent integrity, event-free survival and freedom from target lesion revascularization.

PAD affects more than eight million people in the U.S. and, if not treated, can limit the ability to walk and exercise, as well as place patients at risk for limb loss. PAD patients also have a greater chance of heart attack, stroke and death.

Although use of DES is common in the coronary arteries, the peripheral arteries, including those in the legs, experience different types of stress caused by walking and other movement. In some instances, blockages in these arteries are very difficult to treat, and may ultimately lead to limb amputation. The study is the third to evaluate the effectiveness of a drug-eluting stent outside of the coronary arteries, but the first to suggest clinical efficacy. The Zilver® PTX™ is an investigational device.

The characteristics of the 787 patients who were enrolled and treated included restenosis of previously treated lesions in 24 percent, in-stent restenosis in 14 percent, and total occlusions in 38 percent; 22 percent of patients had lesions longer than 15 cm. The mean lesion length was 10.0 +/- 8.2 cm, the mean percent diameter stenosis was 84.6 +/- 16.4 percent, with an average of 2.2 Zilver® PTX® stents used per patient.

At 12 months, the event-free survival rate was 87.0 percent, and freedom from target lesion revascularization was 90.5 percent. X-ray evaluation found a very low rate of stent fractures, 1.5 percent of patients at 12 months. Patients available for 24-month follow-up had an event-free survival rate of 80.0 percent, and freedom from target lesion revascularization was 83.3 percent.

This low rate of target lesion revascularization translated into meaningful clinical improvement for the majority of patients, with both the average walking distance and average walking speed more than doubling following Zilver PTX stent implantation, and being sustained to two years. In addition there was a very good safety profile, and a very low rate of stent fractures.

"These interim data suggest this device is safe and efficacious for the treatment of SFA lesions," said William A. Gray, M.D., FSCAI, who presented the study data and is associate professor of clinical medicine and director of endovascular services at Columbia University Medical Center/New York Presbyterian Hospital. "Prior attempts to demonstrate drug-eluting stent effectiveness using sirolimus or its analogues have fallen short, but the use of a paclitaxel-coated, non-polymeric stent appears to have improved the outcomes for patients who received this study stent. If these results are confirmed in the separate randomized study using the same device, it will be welcome news to patients who suffer from this disease."

Dr. Gray reports no conflicts of interest related to this study. He will present the study "Two-year interim results from the single-arm clinical study of the Zilver® PTX® drug-eluting peripheral stent" during the Main Session on Friday, May 7, at 11:30 a.m. (Pacific Time).

About SCAI

Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty. SCAI's patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.seconds-count.org.


'/>"/>
SOURCE SCAI
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Positive Long Term Data Presented at ACC 2010 Demonstrate Sustained Safety and Efficacy Advantages of the Cypher(R) Sirolimus Drug-Eluting Stent Over the Endeavor(R) Zotarolimus-Eluting Stent
2. Major Health Care Reforms in China Supported Growth of More Than 20% in the Drug-Eluting Stent Market in 2009, According to Millennium Research Group
3. Long Term Data Presented at EuroPCR 2009 from Randomized Study Attest to Durability of Results of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) Compared to Drug-Eluting Stents
4. Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent
5. Adoption of PCI in AMI Patients to Drive Drug-Eluting Stent Use
6. HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS(R) Drug-Eluting Stents in Heart Attack Patients
7. Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
8. Data Presented at Annual Meeting of Japanese Society of Interventional Cardiology Demonstrate OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) Has Better Outcomes When Compared to Drug-Eluting Stents
9. Multiple Clinical Data Presentations at EuroPCR 2008 Support Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) as Safe Alternative to Drug-Eluting Stents
10. Study Finds Taxus(R) Drug-Eluting Stent Beneficial in Treatment of Large Vessels
11. CardioMind Launches First-in-Human Trial of Small Vessel, Drug-Eluting Stent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... 2016 Jazz Pharmaceuticals plc (Nasdaq: ... Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), ... Inc. ("Celator"; Nasdaq: CPXX ) expired effective ... As previously announced on May 31, 2016, ... agreement under which Jazz Pharmaceuticals has commenced a tender ...
(Date:6/24/2016)... June 24, 2016  Consumers have taken a ... have placed more emphasis on patient outcomes. ... programs in the pharmaceutical industry have evolved beyond ... pharmaceutical companies are focusing on becoming more patient-oriented ... products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... ... ... makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum ... by 2020 and then adjusting it yearly to increase at the same rate as the ... wage floor does not erode again, and make future increases more predictable. , The company ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):