Boston Scientific's Taxus stent endures challenge by rival J&J

ORLANDO -- Several medical studies presented yesterday at a scientific conference here boosted the prospects for cardiac stents made by Johnson & Johnson but failed to deliver the knockout scientific blow the company was hoping to land on rival Boston Scientific Corp.

Doctors and investors had expected that the biggest head-to-head trial to date of the two companies' new drug-coated stents, which prop open clogged arteries, might simplify an ongoing debate over the relative merits of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher device.

Johnson & Johnson funded the 1,386-patient study known as Reality to prove Cypher is a safer and more effective product. The data failed to do that, researchers said, fulfilling a prediction made by Boston Scientific last week and providing ammunition to help the Natick company maintain its lead in the $5 billion annual market.

''There's not enough data to select one stent instead of the other," said principal investigator Marie-Claude Morice, of France's Institut Hospitalier Jacques Cartier. She was speaking to reporters here at the annual scientific meeting of the American College of Cardiology. ''For me, as a doctor, it will not make me change any prescription for patients."

Reality and other trials did raise some concerns about the effectiveness of Taxus, such as in certain hard-to-treat patients such as diabetics. Campbell Rogers, a cardiologist at Brigham and Women's Hospital, said the new data will make it harder for Boston Scientific to claim its stents are best for diabetic patients.

Stents are wire-mesh tubes that prop open arteries after they have been cleared of blockages through a procedure called angioplasty. The latest versions from both firms are coated with drugs to prevent the growth of scar tissue that can re-block arteries, a process known as restenonsis.

A third stent maker, Medtronic Inc., said it had encouraging results in a clinical trial of its own drug-coated stents. These haven't yet been approved for sale by regulators, but the positive results may boost its prospects and provide more competition for the two incumbents. A fourth big stent player, Guidant Corp., is being purchased by Johnson & Johnson.

Specifically, Morice found that eight months after the stenting procedure, roughly the same number of patients showed signs of restenosis who were treated with the Taxus stent, 8.3 percent, as in the Cypher group, 7 percent, a statistically insignificant difference. Complication rates were also similar between the two devices.

Morice said one unexpected outcome was data suggesting patients treated with Taxus were more prone to develop potentially dangerous blood clots, or thrombosis. But she agreed with other doctors who argued the Reality trial wasn't designed to scrutinize this phenomenon and lacked the patient numbers to prove it.

''No firm conclusions regarding stent thrombosis should be drawn," said Eberhard Grube, a German physician commenting on the Reality trial just after Morice presented it to several thousand cardiologists assembled here.

Morgan Stanley analyst Glenn Reicin said the Reality results could still be worrisome for Taxus when combined with other studies that were presented. For instance, another European study, funded independently, concluded Cypher had superior performance in diabetic patients. When treated with Taxus these patients needed repeat procedures more often than with Cypher, concluded the study.

Additionally, a smaller European head-to-head trial of the two stents found better results for Cypher than Taxus, Dow Jones reported. And a study known as Taxus V, sponsored by Boston Scientific, also raised concerns about whether diabetic patients could handle several stents well.

''There's a preponderance of evidence here that Taxus has got safety and efficacy issues, compared to Cypher," Reicin said in an interview. ''The impact on sales will depend on how quickly J&J can get the word out."

Several doctors disagreed, or at least used much softer terms to describe the studies' cumulative impacts. Gregg Stone, principal investigator for Taxus V, paid for by Boston Scientific, said plenty of other studies offered count-arguments against the issues raised.

Ross Kerber can be reached at kerber@globe.com.