A pooled patient-level analysis of Boston Scientific’s PERSEUS and TAXUS ATLAS clinical trials data has demonstrated differences in safety and efficacy outcomes favoring the next-generation ION Platinum Chromium (PtCr) Paclitaxel-Eluting Stent System (TAXUS Element) compared to the currently available TAXUS Liberte Paclitaxel-Eluting Stent System.
The study compared pooled patient-level data from 2,298 patients enrolled in the PERSEUS (ION Stent) and TAXUS ATLAS (TAXUS Liberte Stent) trials.
The PERSEUS clinical program compared the ION (TAXUS Element) Stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.
The PERSEUS Workhorse trial demonstrated positive safety and efficacy outcomes in workhorse lesions for the ION Stent System compared to the TAXUS Express2 Stent System.
The TAXUS ATLAS program compared patients with de novo coronary lesions treated with the TAXUS Liberte Stent to a historical case-matched TAXUS Express Stent control group.
Principal investigator of the PERSEUS clinical program Dean Kereiakes said although the ION and TAXUS Liberte Stents employ the same drug and polymer, the ION Stent demonstrated significantly lower rates of major adverse cardiac events (MACE), target lesion failure (TLF) and myocardial infarction (MI) in this case-matched analysis of nearly 2,300 patients
"This study demonstrates that alloy composition, stent design and strut thickness may influence angiographic and clinical outcomes following drug-eluting stent deployment," Kereiakes said.
Boston Scientific Cardiology, Rhythm and Vascular executive vice president and group president Hank Kucheman the ION Stent’s advanced alloy, stent architecture and delivery system, coupled with a proven drug and polymer combination, provide interventional cardiologists with improved acute performance in treating patients with coronary artery disease.
In the US, the TAXUS Element Stent System will be commercialized as the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System.
The company expects to launch the ION Stent System in the US by mid-2011.
The TAXUS Element Stent System received CE mark approval in May 2010.
In the US, the ION Stent System is an investigational device, limited by applicable law to investigational use only and not available for sale.