A Medical Device Daily

Two-year results from the ENDEAVOR-IV clinical trial show that the Endeavor drug-eluting stent (DES) from Medtronic (Minneapolis) is associated with statistically fewer heart attacks than Boston Scientific's (Natick, Massachusetts) Taxus DES.

Martin Leon, founder and chairman emeritus of the TCT-sponsoring Cardiovascular Research Foundation (New York) and principal investigator of ENDEAVOR-IV, presented the results at the TCT meeting as part of a late-breaking clinical trials session.

"Through two years of follow up in the ENDEAVOR-IV clinical trial, the Endeavor drug-eluting stent has proven to be statistically safer than Taxus on the important measure of myocardial infarction, and no different in terms of efficacy as measured by the need for repeat procedures," said Leon. "The latest data clarify the comparative safety and efficacy of these two drug-eluting stents beyond one year. As importantly, the data also show that Endeavor is associated with numerically fewer instances of very late stent thrombosis."

The latest update to an independently conducted pooled data analysis shows the Endeavor DES is distinguished by persistently strong safety benefits for patients with coronary artery disease. Called ENDEAVOR-Safety, the analysis now includes more than 1,100 patients followed to four years.

Compared to a bare-metal stent (n=596), the Endeavor DES (n=2,132) has been shown at four years to be associated with numerically lower rates of death, cardiac death, major adverse cardiac events (MACE), myocardial infarction (MI) and stent thrombosis, with the differences in rates of cardiac death and MI between the two devices reaching statistical significance in this retrospective analysis.

Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute, an interventional cardiologist at Brigham and Women's Hospital (Boston) and principal author of the ENDEAVOR-Safety analysis, said: "These data are truly remarkable when you remember that we're not comparing Endeavor to another DES but to a bare-metal stent. The stent thrombosis figures alone present a compelling case. Despite more than 70% of Endeavor patients being off dual-antiplatelet therapy at 12 months, the cumulative incidence of ARC-defined (Academic Research Consortium) stent thrombosis at four years is only 0.7%, almost half the rate observed for the bare-metal stent [1.5% (p=0.071)]."

In other news from TCT:

• Boston Scientific reported 12-month left main and three-vessel disease subset data from its SYNTAX trial comparing percutaneous coronary intervention (PCI) using the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System to contemporary coronary artery bypass graft (CABG) surgery.

The results reinforced previously reported data demonstrating no overall statistically significant differences between PCI and CABG in rates of death or myocardial infarction. The company also presented an analysis of the data based on the SYNTAX Score, a new tool that seeks to provide guidance to physicians on optimal treatment options for this high-risk group of patients, showing similar safety and efficacy outcomes for two thirds of SYNTAX randomized patients.

The SYNTAX trial is the first large-scale, randomized, controlled clinical trial comparing PCI using drug-eluting stents (DES) to CABG in patients with left main disease and three-vessel disease.

"The data announced today will provide important additional information for doctors as they evaluate treatment options for complex coronary patients," said Keith Dawkins, MD, associate chief medical officer of Boston Scientific.

"The comparable safety and efficacy outcomes with PCI and CABG in patients with left main disease in this trial indicate PCI is a good treatment alternative for this patient population," he said. "Physicians will also be able to consider the SYNTAX Score analysis, demonstrating no difference in safety and efficacy outcomes between PCI and CABG in approximately two-thirds of the SYNTAX patient population, when assessing the appropriate treatment for their patients."

• GE Healthcare (Waukesha, Wisconsin) and Boston Scientific have reported a collaboration that enables improved intravascular ultrasound (IVUS) workflow between the GE Healthcare Innova cardiovascular X-ray system and the Boston Scientific iLab ultrasound imaging

Built on GE's Innova digital detector, the Innova system helps physicians clearly visualize fine vessels, precisely place stents and successfully perform critical procedures.

Cardiologists in the cardiac cath lab use it when performing procedures to view and treat potential coronary artery blockages that could cause heart attacks or other serious cardiovascular damage. The system is designed to provide cardiologists with more information than ever before, resulting in better diagnosis and treatment of cardiovascular disease.