Boston Scientific Corporation (NYSE: BSX) today announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS® Element™ Paclitaxel-Eluting Stent System compared to the TAXUS® Express2™ Paclitaxel-Eluting Stent System. The results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the TAXUS Element Stent compared to a historical control group of patients receiving the Express® bare-metal stent.
Analysis of the data was presented at the American College of Cardiology Annual Scientific Sessions during a late-breaking trial session by Dean Kereiakes, M.D., Medical Director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati and the Principal Investigator for the PERSEUS clinical program.
"We are very encouraged by the one-year data demonstrating positive safety and efficacy outcomes for the TAXUS Element Stent and its innovative platinum chromium alloy," said Dr. Kereiakes. "In my experience, the TAXUS Element Stent offers increased flexibility, visibility and deliverability compared with currently available products. The PERSEUS data confirm that the proven TAXUS drug and polymer combination has been successfully transferred to the Element platform with excellent performance and comparable safety."
The TAXUS Element Stent is designed specifically for coronary stenting. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.
"Boston Scientific continues to build on its legacy of drug-eluting stent leadership through the development of our third-generation TAXUS Element Stent System," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "In addition, we remain the only company to offer customers a choice of two drugs."
The PERSEUS clinical program compares the TAXUS Element Stent to prior-generation stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.
Workhorse trial
The pivotal PERSEUS Workhorse trial is evaluating the safety and efficacy of the TAXUS Element Stent compared to Boston Scientific's first-generation TAXUS Express Stent in 1,262 patients with de novo lesions.
The prospective, randomized (3:1) trial met its primary endpoint of non-inferiority for target lesion failure (TLF) at 12 months with rates of 5.6 percent for the TAXUS Element Stent and 6.1 percent for the TAXUS Express Stent. The secondary endpoint of in-segment percent diameter stenosis at nine months as measured by quantitative coronary angiography (QCA) was also met.
The Workhorse results also demonstrated similar safety for the TAXUS Element Stent as demonstrated by low rates of Major Adverse Cardiac Events (MACE) and stent thrombosis. All components of MACE, including cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) were similar to the TAXUS Express Stent control. A numerically lower rate of non-Q-wave MI for the TAXUS Element Stent resulted in lower overall MI (2.2 vs. 2.9 percent,>
Small Vessel trial