Navigation Links
Biolimus still comparable to everolimus in year 2 of stent match-up
Date:3/31/2014

WASHINGTON (March 31, 2014) A new stent covered with biodegradable coating continues to show statistical equivalence to Japan's market leader in cumulative second-year data and subgroup analyses, according to research from the NEXT trial presented at the American College of Cardiology's 63rd Annual Scientific Session. NEXT is the largest head-to-head randomized study of these two stents the novel biolimus-releasing model with the degradable coating (BES) and the everolimus-releasing standard with a durable polymer (EES).

Polymer coatings contain the drugs in drug-eluting stents, and slowly release agents to keep the stent clear of new lesions called intima neointima formations that lead to target lesion revascularization a second procedure to restore blood flow to the blocked artery after a stent is in place. Drug-releasing stents have become standard treatment, but the permanent polymer that holds the helpful drug can cause late clinical problems.

First year results for 3,235 patients randomly assigned to BES (1,617 patients; 2,059 lesions) or EES (1,618 patients; 2,010 lesions) demonstrated statistically equivalent outcomes for the efficacy endpoint of target lesion revascularization and the composite safety endpoint of death from all causes and heart attack. The track record of non-inferiority continued with year-two data: BES 7.8 percent compared to EES 7.7 percent for safety endpoints; BES 6.2 percent compared to EES 6 percent for the efficacy endpoint. Landmark analysis at one year showed no difference in safety (BES 2.5 percent vs. EES 2.4 percent) or efficacy (BES 2 percent vs. EES 1.5 percent). Subgroup analysis for target lesion revascularization in patients with diabetes, insulin-treated diabetes, patients 75 years or older, hemodialysis, and multi-vessel angioplasty revealed no significant differences in cumulative incidence.

"Recent network meta-analyses suggested that drug-eluting stents with a biodegradable polymer had an excess risk for stent thrombosis or heart attack compared with second-generation everolimus stents with a durable coating," said Masahiro Natsuaki, M.D., Kyoto University Graduate School of Medicine's Cardiovascular Medicine Department. "However, we found no significant differences between the BES and EES groups. There was no apparent signal suggesting either improvement or impairment of clinical outcomes with one stent or the other."

Natsuaki cautioned that underreporting of adverse events, especially stent thrombosis, is possible because study participants were not fully monitored. But angiograms in patients with target vessel revascularization were rigorously evaluated for blood clots at an angiographic core laboratory, and "adjudication of death and heart attack events was conducted very carefully" to rule out stent thrombosis, he said.

Because the BES biodegradable polymer takes up to a year to disappear, any differences in outcome between the two stent types will be evident only after the first year. "The advantage of polymer degradation and no permanent polymer in the vessel wall could emerge with longer-term follow up," Natsuaki said. If year-three results confirm that outcomes with BES are at least equal to EES, patients with complex lesions requiring heart bypass surgery could be candidates for additional studies, he said.


'/>"/>

Contact: Beth Casteel
bcasteel@acc.org
202-375-6275
American College of Cardiology
Source:Eurekalert

Related medicine news :

1. Men Can Still Ask for PSA Test, and Some Should, Doctors Say
2. Fewer Stillbirths Among Pregnant Women Vaccinated Against Flu
3. Many Still Tanning, Despite Dangers, Survey Finds
4. Once-Obese Women Still Face Stigma, Study Finds
5. Smallest, Largest Fetuses at Higher Risk of Stillbirth
6. People With Darker Skin Still at Risk for Melanoma
7. In-Person Bullying Still Bigger Problem Than Cyberbullying: Expert
8. More Americans Walking, But Still Not Enough, CDC Says
9. PSA Tests Overall Benefit Still Unclear: Study
10. Wayne State researchers say adolescent smoking prevention programs still critical
11. Smokers Are Still High Schools Cool Kids, Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2017)... ... May 27, 2017 , ... In any business, follow ... the talent of your dental team at presenting treatment, there will always be some ... lot of time and money on best practices when it comes to presenting treatment. ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... week to review more than eighty-nine grant submissions all vying for nearly $1,000,000 ... in the Parkinson’s field.     , The American Parkinson Disease Association (APDA) is focused ...
(Date:5/26/2017)... ... May 26, 2017 , ... Somnoware, a ... portable sleep monitor with its Somnoware Sleep Device Interface (SDI). Somnoware SDI is ... device operations. With this platform, initializing devices and importing studies are just one-click ...
(Date:5/26/2017)... , ... May 26, 2017 , ... On May 24, ... which narrowly passed the U.S. House on May 4, would result in 23 million ... under continued implementation of the 2010 Patient Protection and Affordable Care Act (ACA). ...
(Date:5/26/2017)... ... May 26, 2017 , ... Rob Lowe acts as ... production of the series is on hiking in American. Viewers can reconnect with America ... great benefits of hiking. , Many consumers have looked for an inventive new place ...
Breaking Medicine News(10 mins):
(Date:5/8/2017)... 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO)., has completed ... a health care service center company based in ... in relationship management programs for leading pharmaceutical manufacturers and ... WRB will join Envoy Health Management, LLC ... manufacturers, biotech firms, and other service companies. Together, WRB ...
(Date:5/4/2017)... 2017  A recent study published in the ... light as a means of disinfection anesthesia workstations ... bioburden on anesthesia workstations. In the study, UVC ... medical equipment surfaces contaminated with three (3) organisms ... study further validates the body of literature supporting ...
(Date:5/4/2017)... --  BioLife Solutions , Inc. (NASDAQ: BLFS ... clinical grade hypothermic storage and cryopreservation ... that the Company,s first quarter 2017 financial results will ... 2017, and that the Company will host a conference ... afternoon. Management will provide an overview of the Company,s ...
Breaking Medicine Technology: