Medtronic, Boston Sci Stents Similar In Diabetes -Study

Mar.30, 2008 in Market Outlook

CHICAGO (Dow Jones)–Medtronic Inc.’s (MDT) Endeavor drug-coated stent heart
device performed similarly to Boston Scientific Corp.’s (BSX) Taxus stent after
one year in tough-to-treat diabetic patients, according to new data from an
Endeavor study released Sunday.

The details came from within the 1,548-patient, Medtronic-sponsored Endeavor IV
randomized trial on the company’s heart device, which the Food and Drug
Administration approved two months ago. One-year data on 477 patients with
diabetes that took part in the study were released during the American College of
Cardiology’s annual conference.

Data on another set of patients, meantime, showed that Endeavor patients whose
heart arteries were imaged with an angiogram after angioplasty were more likely
to have a repeat procedure than patients with a Boston Scientific stent. But the
rate of repeat procedures for Endeavor was much lower - and similar to the Taxus
rate - for the larger set of patients who didn’t have the imaging done.

Stents are tiny devices implanted via catheter during angioplasty procedures to
prop open clogged arteries, and coated stents such as Endeavor and Taxus use
medication to help combat renarrowing in the vessel. Diabetic patients represent
at least one quarter of angioplasty procedures, and are more likely to endure
complications and need repeated procedures.

In the data from Endeavor IV, the Medtronic and Boston Scientific stents posted
similar results when it came to avoiding overall mortality, death related to
heart problems, heart attacks, stent-related clots, certain measures of
re-treatment and a composite measure of serious events including re-treatment.
For all of these categories, the difference in performance between the stents
wasn’t considered statistically significant.

Boston Scientific has been highlighting the performance of its Taxus stents in
diabetic patients. In December, the company’s Taxus Liberte stent, on sale
outside the U.S. and awaiting approval for the U.S. market, won approval in
Europe for diabetic patients. The stent makers don’t have specific FDA approval
to market their devices for people with diabetes in the U.S.

The patients in the Endeavor IV diabetic set were divided about evenly between
Endeavor and Taxus. Among the statistics, there was a 0.9% rate of heart attacks
with both stents. There was a 0.9% rate of stent-related clots among diabetic
patients with Endeavor, verses a 0.4% rate for Taxus patients.

The rate of repeat procedures in the already-treated area was 6.9% with Endeavor
and 6.8% with Taxus. On a broader measure of repeat procedures in the
already-treated vessel, Endeavor had an 8.6% rate verses 9.4% for Taxus.

Meantime, separate data showed that Endeavor patients were more likely to be
re-treated if they were examined with an angiogram.

The first 328 patients in the Endeavor IV trial had an angiogram right after
their procedure and again in eight months. Among those patients the rate of
repeat procedures for the problem area of the vessel was 8.5% among Endeavor
patients compared with 3% among Taxus patients. In the next 1,200 patients that
weren’t checked with an angiogram, though, the rate of repeat procedures was 3.6%
with Endeavor and 3.3% with Taxus.

The results follow signs in other studies, including the overall Endeavor IV
data, that Endeavor hasn’t performed as well as other coated stents when it comes
to late loss, which is a measure of renarrowing. But Medtronic has argued that
this measure doesn’t have an impact on clinical outcomes.

Medtronic said in a release that the results showed the “artificial impact of
routine angiography on revascularization rates.”

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