Boston Scientific Corporation (NYSE: BSX) today announced results from a pooled patient-level analysis of its PERSEUS and TAXUS ATLAS clinical trial data, demonstrating 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. Results were presented at the American College of Cardiology Annual Scientific Sessions by Dean Kereiakes, M.D., Medical Director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati and Principal Investigator for the PERSEUS clinical program.
"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," said Dr. Kereiakes. "This study demonstrates that alloy composition, stent design and strut thickness may influence angiographic and clinical outcomes following drug-eluting stent deployment."
The study compared pooled patient-level data from 2,298 patients enrolled in the PERSEUS (ION Stent) and TAXUS ATLAS (TAXUS Liberte Stent) trials. Propensity score matching was performed to adjust for differences in patient and lesion characteristics between the groups, and clinical follow-up was conducted out to 12 months. Propensity-matched results in 1,326 patients revealed that the ION Stent achieved significantly lower rates of MACE (7.5 percent vs. 12.0 percent)
"These results reinforce the relative clinical benefits of the PtCr Stent Series we have observed through physician experience in Europe and other approved markets," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "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."
The ION Stent System features an innovative PtCr alloy and new stent design to offer greater strength, enhanced deliverability and exceptional visibility. The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. The advanced low-profile delivery system facilitates precise delivery of the stent across challenging lesions.
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 reported 12-month results in March 2010, demonstrating 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.
In the U.S., 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 United States by mid-2011. The TAXUS Element Stent System received CE Mark approval in May 2010.
In the U.S., the ION Stent System is an investigational device, limited by applicable law to investigational use only and not available for sale.
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