A Medical Device Daily

At this year’s edition of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, running through Friday, volumes of data are scheduled to be presented and new products will be introduced, and there will undoubtedly be a large focus on the safety of drug-eluting stents (DES) and their utility in real-world conditions.

A presentation Monday focused on this real world issue. Boston Scientific (Natick, Massachusetts) reported one-year results from its TC-WYRE (Taxus Express2 Stent vs. Cypher Stent: What’s Your Real-World Experience?) study, which it said showed the Taxus Express2 paclitaxel-eluting coronary stent to be superior to Johnson & Johnson ’s (J&J; New Brunswick, New Jersey) Cypher sirolimus-eluting coronary stent in diabetic patients in a head-to-head study.

This study of 1,558 patients was designed to retrospectively compare one-year clinical outcomes in real-world practice among consecutive, unselected patients in 19 centers across the U.S.

The study’s primary endpoint was target vessel revascularization (TVR) at one year. The two stents demonstrated comparable TVR rates of 3.2% for the Taxus stent and 4.4% for the Cypher stent. This trend towards lower TVR in the Taxus stent group was statistically significant in the complex diabetic patient population (2.8% for the Taxus stent compared to 8.5% for the Cypher stent).

“These low re-intervention rates are consistent with those we’ve seen in the STENT registry in the Unites States,” said William O’Neill, MD, University of Miami , and national principal investigator in the TC-WYRE study. “The data are particularly compelling because they represent the patients physicians treat every day in a real-world setting. These patients often present with multiple complexities physicians may not see in a randomized controlled trial setting — complexities such as diabetes, small vessels, tortuous anatomy and more.”

The company also noted that the TC-WYRE study demonstrated excellent safety outcomes consistent with previous U.S. studies. The major adverse cardiac event (MACE) rates were comparable for the Taxus stent at 7.2% and the Cypher stent at 7.3%. In addition, the two groups demonstrated low and comparable overall stent thrombosis rates of 0.9% for Taxus and 0.8% for Cypher, with an identical late-stent thrombosis rate of 0.1 percent reported for both stents.

“While some smaller, single-center studies have suggested significant differences between the Cypher stent and the Taxus stent, these differences have not been borne out by the broader body of clinical data and have been inconsistent with what physicians tell us about their daily practice experience,” said Paul LaViolette, chief operating officer of Boston Scientific. “TC-WYRE was designed to capture the real experience physicians are having with the two stents and it corroborates the positive findings on the TAXUS stent from significant studies such as the STENT registry and from the REALITY trial — the two largest studies of their kind to evaluate Taxus and Cypher stents head-to-head.”

In other TCT conference news:

• ev3 (Plymouth, Minnesota) reported a worldwide fracture-free guarantee in support of its new EverFlex family of stents. In the event that an EverFlex stent should fracture within two years of implantation, ev3 said it will provide a free replacement product to the medical facility, subject to the terms and conditions of the program.

“While advances in stent technology have greatly improved treatment options for patients, industry data has shown that the potential for stent fracture remains a real clinical challenge,” said Jim Corbett, president and CEO of ev3. With the EverFlex stent, we have directly responded to this challenge with a unique product design that we believe will withstand even the most challenging clinical situations. And we are standing behind that belief with our new fracture-free product guarantee.”

In simulated fatigue testing conducted by ev3 and an independent testing facility, ev3’s EverFlex stent demonstrated a five-to-10 times improved resistance to fracture compared to the five competitive stents tested.

The EverFlex is indicated in the U.S. for the palliative treatment of malignant neoplasms in the biliary tree. ev3 also obtained CE mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery.

ev3 is focused on catheter-based technologies for the endovascular treatment of vascular diseases and disorders.

• CardiacAssist (Pittsburgh) reported that it will feature its recently FDA-approved TandemHeart Escort Controller in booth 345 at the conference.

The new Escort Controller is one of three primary components that make up the TandemHeart PTVA percutaneous circulatory support system from CardiacAssist.

The TandemHeart system provides up to five liters per minute (lpm) of circulatory support through a cardiac catheterization procedure in as little as 30 minutes. It is FDA approved for extracorporeal circulatory support for up to six hours for procedures not requiring full cardiopulmonary bypass.

At TCT 2006, The TandemHeart system is the subject of a case presentation by Alan Heldman, MD of Johns Hopkins Hospital (Baltimore), titled, “CardiacAssist TandemHeart Device: Device Description, Indications, and Clinical Studies” today, at 8:15 a.m.

The system is also the subject of a poster presentation, “The Role of Percutaneous Ventricular Assist Device (TandemHeart) in High-Risk Coronary Artery Intervention” by Annapoorna Kini, MD, et al., Mt. Sinai Medical Center (New York).

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