Navigation Links
Drug-coated balloon overcomes in-stent restenosis
Date:3/31/2008

CHICAGO, Ill. (March 31, 2008) An angioplasty balloon coated with a drug that reduces renarrowing of the coronary arteries appears to be more effective than a drug-eluting stent in treating an unwanted build-up of tissue inside a bare-metal coronary stent. After six months, the newly expanded artery remained more widely open within the stent after treatment with the paclitaxel-eluting balloon when compared to a paclitaxel-eluting stent, according to the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II-In-Stent Restenosis (PEPCAD II-ISR) study. Additional data suggested that at one year, rates of major cardiac events were also lower with the drug-coated balloon.

The PEPCAD II-ISR study is being reported today at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

This drug-eluting balloon clearly qualifies for consideration as an alternative to drug-eluting stents for the treatment of restenosis inside bare-metal stents, said Martin Unverdorben, MD, PhD, an associate professor of medicine at the University of Frankfurt/Main, Germany. However, two to three years more data are required before making a definitive statement.

In-stent restenosis remains a challenge, despite the availability of drug-eluting stents. Approximately 25 percent of patients treated with a bare-metal stent and about 10 percent of patients treated with a drug-eluting stent develop an overgrowth of vascular tissue and renarrowing inside the stent, or in-stent restenosis.

Treating in-stent restenosis with a drug-eluting stent is a complex procedure that adds another layer of metal to the artery and can create mechanical problems. The Sequent Please drug-eluting balloon may offer a simpler alternative. This drug-eluting balloon is coated with paclitaxel, the same medication that coats the Taxus stent. The balloon is inflated for about 30 seconds inside the narrowed artery, and the paclitaxelwhich has a natural attraction to cellsquickly moves from the surface of the balloon into the arterial cells.

Not only does the drug-eluting balloon avoid a second layer of metal inside the artery, the carrier that is used to bind paclitaxel to the balloon is iopromide, a commonly used contrast agent. This avoids concerns about the arterys reaction to the polymers used to bind paclitaxel and other anti-restenosis medications to drug-eluting stents.

The study was conducted at the Center for Cardiovascular Diseases in Rotenburg an der Fulda, Germany. Dr. Unverdorben and his colleagues recruited 131 patients with restenosis in a bare-metal stent, randomly assigning them to treatment with the Sequent Please drug-eluting balloon (DEB) or the Taxus drug-eluting stent (DES). Five patients were excluded for protocol violations, and four patients in the stent group were actually treated with the drug-eluting balloon. This left, for the as-treated analysis, 66 patients in the DEB group and 60 patients in the DES group.

The researchers initially analyzed the data according to each patients original treatment assignment (the intention-to-treat analysis). After an average of six months of follow-up, late-lumen lossthe amount of tissue that grew from the vessel wall into the arterial lumenwas significantly less in the patients treated with the DEB (0.20 mm vs. 0.45 mm, p=0.02). When the data were analyzed according the treatment each patient actually received, the results were even more promising. Late-lumen loss remained significantly better with the drug-eluting balloon. In addition, a finding of significant renarrowing in the treated segment was less common in the DEB group (3.4 percent vs. 20.4 percent, p=0.007), as was the need for a repeat procedure to re-treat the target lesion (3.1 percent vs. 16.7 percent, p=0.02). Combined rates of major cardiovascular events, defined as heart attack, repeat procedure to treat the target lesion and cardiac death were 4.7 percent and 18.3 percent, respectively (p=0.02).

Between six and 12 months, two patients in the DEB group needed PCI in another artery, and one patient (1.5 percent) needed yet another PCI to treat the original target lesion. In the DES group, two patients died of noncardiac causes, and three patients (5 percent) needed repeat target-lesion PCI. No new patients experienced a major cardiac event.

At 12 months, there was a trend toward better event-free survival in patients treated with the DEB in the intention-to-treat analysis. The difference was statistically significant (p=0.01) when the analysis was done according to the as-treated analysis.

Dr. Unverdorben will present the results of the "Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II-In-Stent Restenosis (PEPCAD II-ISR) study on Monday, March 31 at 9:00 a.m. CDT in the Grand Ballroom, S100.


'/>"/>

Contact: Kathy Boyd David
pr@scai.org
717-422-1181
Weber Shandwick Worldwide
Source:Eurekalert

Related medicine news :

1. Drug-Coated Balloons Keep Leg Arteries Open: Study
2. Drug-Coated Stents Better Than Bare-Metal Ones in Complex Cases
3. Drug-Coated Stents No Riskier in Long Run Than Bare Metal Ones
4. Study Finds Benefits With Drug-Coated Stents
5. Drug-Coated Stents Go Head to Head
6. Balloon catheter-based sinus surgery radiation exposure very low, safe
7. Balloon Valve May Be Alternative to Open-Heart Surgery
8. Sun Safety Awareness Reaches New Heights at Plano Hot Air Balloon Festival
9. Sun Safety Outreach to Families Takes Flight at the Plano Hot Air Balloon Festival
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa ... contributed a medical article to the newly revamped Cosmetic Town journal ... the hair transplant procedure known as Follicular Unit Extraction (FUE). , ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... named one of Michigan’s 2017 Best and Brightest in Wellness® by Best and ... Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... of $3,296 in property taxes a year. In some states—like New York, New ... , By contrast, many overseas retirement havens have extremely low property-tax rates, which ...
(Date:10/12/2017)... Washington, D.C. (PRWEB) , ... October 12, 2017 ... ... Company, Cal Dining at the University of California Berkeley, and other leading institutions ... leverages the buying power of institutions to change the way animals are raised ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Denmark , Oct. 2, 2017 The Rebound ... in the struggle to reverse the tide of prescription drug ... for regulating their medicine intake and stepping down their dosage ... set to launch in December 2017; the first 100,000 people ... Learn more at http://www.rebound-solution.com/ ...
(Date:9/27/2017)... , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global ... that its MyDario product is expected to appear on The Dr. Oz ... Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked ... The segment features ...
(Date:9/22/2017)... Sept. 22, 2017  As the latest Obamacare repeal ... Bill Cassidy (R-LA) and Lindsey Graham ... the medical device industry is in an odd place. ... the 2.3% excise tax on medical device sales passed ... want covered patients, increased visits and hospital customers with ...
Breaking Medicine Technology: