Next-Generation Stent Shows Strong Performance in Pooled Analysis
April 6, 2011 – Results from a pooled patient-level analysis favored a next-generation paclitaxel-eluting stent. Data from the PERSEUS and TAXUS ATLAS trials compared Boston Scientific’s Ion Platinum-Chromium (PtCr) to the Taxus Liberte Paclitaxel-Eluting Stent System.
Results were presented at the American College of Cardiology (ACC) 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. Kereiakes is also 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 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, p=0.007) and TLF (5.5 percent vs. 8.5 percent, p=0.04). This was largely driven by a reduction in myocardial infarction (1.8 percent vs. 3.9 percent, p=0.02). A numerically lower but not statistically different rate of target vessel revascularization (TVR) was also observed in favor of the Ion stent (6.5 percent vs. 8.8 percent, p=0.12), supported by significantly lower late loss at nine months (0.33 plus/minus 0.52 mm vs. 0.42 plus/minus 0.56 mm, p=0.04).
"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 system features a 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.
In the United States, the Taxus Element Stent System will be commercialized as the Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System. The Company expects to launch it by mid-2011. It received CE Mark approval in May 2010.
For more information: www.bostonscientific.com