Study examines use of stent with bioabsorbable polymer

Sep 21, 2010

Three-year data demonstrated that satisfactory clinical and safety outcomes of sirolimus eluting stents with a biodegradable polymer were sustained in a real world setting. The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

"The three-year data from the CREATE study is further evidence that biodegradable polymers represent the future of stent design," said Yaling Han, MD, the lead investigator and Director in the Department of Cardiology, Shenyang Northern Hospital (Shenyang, China.) "This study demonstrates sustained clinical safety and efficacy of based sirolimus eluting stents when used with 6 months of dual antiplatelet therapy in a 'real-world' setting."

The CREATE study was a post-marketing surveillance multi-center registry that demonstrated satisfactory angiographic (at 9 months) and clinical (at 12 and 18 months) outcomes of biodegradable polymer-based sirolimus eluting stents for real world patients. The aim of the study was to evaluate the 3-year clinical safety and efficacy outcomes in patients enrolled in the CREATE trial.

A total of 2077 patients, exclusively treated with EXCEL stents at 59 centers from 4 countries, were enrolled in the CREATE study. The recommended antiplatelet regimen was clopidogrel and aspirin for 6 months followed by chronic .

The cumulative rates of major adverse cardiac events (MACE) were 2.7% at 1 year and 4.5% at 3 years. The rate of stent thrombosis with Academic Research Consortium definitions was 0.83% at 1 year and 1.53% at 3 years. At 6 months to 3 years, prolonged therapy (> 6 months) was not beneficial in reducing cumulative hazards of MACE (5.2% vs. 4.6%, log rank p=0.629) or stent (1.5% vs. 0.6%, log rank p=0.052).

3-year outcome data will be presented during the Poster Abstracts Sessions in the Lower Level of the Washington Convention Center.

Explore further: Early detection and transplantation provide best outcomes for 'bubble boy' disease

Provided by Cardiovascular Research Foundation

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Best use of drug-eluting stents

Sep 02, 2008

Compared with bare metal stents, drug-eluting stents substantially reduce the risk of angiographic and clinical recurrence but do not affect mortality or the short term or long term risk of myocardial infarction. The use ...

Recommended for you

New malaria vaccine candidates identified

11 hours ago

Researchers have discovered new vaccine targets that could help in the battle against malaria. Taking a new, large-scale approach to this search, researchers tested a library of proteins from the Plasmodium fa ...

User comments : 0