News Column

Reports Summarize Biodegradable Polymers Study Results from Columbia University

May 26, 2014

By a News Reporter-Staff News Editor at Clinical Trials Week -- Data detailed on Biodegradable Polymers have been presented. According to news reporting from New York City, New York, by NewsRx journalists, research stated, "In the TARGET I randomized controlled trial, the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions. This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population (including patients with small vessels, long lesions and multi-vessels), and at validating the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent."

The news correspondents obtained a quote from the research from Columbia University, "TARGET II was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. Patients were grouped by tertiles of SS (6 to 12). All patients were exclusively treated with the FIREHAWK stent and were followed up at 1, 6, and 12 months, and annually thereafter up to five years. A total of 730 patients were included in this registry study. The 12-month incidence of TLF was 4.4% and the incidence of TLF components were, cardiac death 0.5%, TV-MI 3.2%, and TLR 2.2%. One definite/probable stent thrombosis was observed at 12-month follow-up. Mean SS was 10.87 +/- 6.87. Patients in the SS >12 tertile had significantly higher TLF (P=0.02) and TLR (P

According to the news reporters, the research concluded: "SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients."

For more information on this research see: Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the TARGET II trial. Chinese Medical Journal, 2014;127(6):1027-1032. Chinese Medical Journal can be contacted at: Chinese Medical Assoc, 42 Dongsi Xidajie, Beijing 100710, Peoples R China. (Chinese Medical Association -; Chinese Medical Journal -

Our news journalists report that additional information may be obtained by contacting B. Xu, Columbia University, Medical Center, Cardiovasc Res Fdn, New York, NY, United States. Additional authors for this research include Y.L. Zhao, Y.J. Yang, R.Y. Zhang, H. Li, C.S. Ma, S.L. Chen, J.A. Wang, Y. Huo, M.B. Leon and R.L. Gao (see also Biodegradable Polymers).

Keywords for this news article include: Pharmaceuticals, Drugs, Therapy, Sirolimus, Macrolides, New York City, United States, Biodegradable Polymers, Immunosuppressive Agents, North and Central America, Clinical Trials and Studies

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Source: Clinical Trials Week

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