Setback for Taxus Liberte Stent

-WSJ

09/24/2009 - SAN FRANCISCO—Heart stents made by market leader Boston Scientific Corp. took a scientific drubbing at a big cardiology conference, after rival products from Medtronic Inc. and Abbott Laboratories appeared safer in several studies.

Some doctors predicted the findings would spur movement toward Abbott and Medtronic stents. Tens of thousands of cardiologists are gathered here at the Transcatheter Cardiovascular Therapeutics meeting, where the results were announced.

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Stents Perform Well, Studies Demonstrate (9/22)In a statement, Boston Scientific's chief medical officer, Donald Baim, said 4.6 million Taxus stents had been implanted and that the product had a decade-long safety record. "Before discounting this experience based on these recent contradictory new trial results, further analysis is warranted," Dr. Baim said.

Stents are tiny scaffolds that prop open clogged arteries. Total sales were about $5 billion last year. Boston Scientific's flagship model, Taxus Liberte, has about 20% of the U.S. market. Boston Scientific also resells a model from Abbott, called Xience V, under its own brand.

In a trial of 1,800 patients at the Maasstad hospital in Rotterdam, the Netherlands, Xience appeared markedly safer than Taxus Liberte. About 5.4% of patients with Boston Scientific`s stent had a nonfatal heart attack in the first year, compared with 2.8% of those with Xience. The results, presented Wednesday, attracted attention because Taxus Liberte hadn't previously been tested in a controlled medical study, considered to be the most rigorous scientific test.

There was no difference in the percentage of deaths, but patients with Abbott's stent needed fewer returns to the operating room for a repeat operation to reopen a reclogged artery. Taxus Liberte patients were more likely to develop a blood clot inside the stent—at 2.6% within one year, compared with 0.7% for Xience.

"I'm not going to use Taxus anymore," said Pieter C. Smits, the cardiologist who led the study. His hospital has received grants from Boston Scientific and Abbott.

Earlier in the week, a study funded by Medtronic found that its Endeavor stent resulted in a 3.6% rate of deaths and heart attacks after three years, versus 7.1% for an older Boston Scientific product, Taxus Express. A study funded by Abbott measuring the same occurrences found a 2.8% rate for Xience versus 4.1% for Taxus Express after one year.

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