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:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... OAKLAND, N.J. , June 24, 2016 /PRNewswire/ ... in the design, development and manufacturing of collagen ... and regeneration announced today that Bill Messer ... Sales and Marketing to further leverage the growing ... surgery medical devices. Bill joins the ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
Breaking Medicine Technology: