Expensive Heart Drug Not Helpful in Most Procedures

      WASHINGTON, Oct. 19 (UPI) -- An expensive drug doesn''t add any benefit when administered to heart-attack victims undergoing implantation of stents, or tiny coils, to prop open their blood vessels, doctors said Thursday.

      Abciximab, manufactured by drug company Centocor in Malvern, Penn., was originally designed to reduce complications during heart procedures. It costs about $1,000 per procedure.

      In a presentation of a clinical trial that looked at how well abciximab performed in patients undergoing angioplasty -- a heart procedure in which clogged heart arteries are mechanically opened -- the drug failed to improve patients'' outcomes if those patients also had tiny coils called stents implanted.

      Stents help keep clogged blood vessels from shutting down. Studies have shown their use can reduce risk of later complications or, in the case of heart attacks, minimize damage to the heart muscle.

      Dr. Gregg Stone, course director for the Transcatheter Cardiovascular Therapeutics meeting in Washington at which the data was announced, said there was no difference in outcome between patients receiving stents and those who got both the stent and abciximab.

      In patients receiving angioplasty without a stent, the trial appeared to show a benefit for use of the drug.

      More than 700,000 angioplasty procedures are performed each year in the United States, and more than 80 percent of these procedures now include use of the stents, said Dr. Donald Baim, professor of medicine at Harvard School of Medicine, Boston.

      Baim said the study, known as CADILLAC, positions the use of abciximab as a secondary treatment. -- for the small number of patients who are not going to receive a stent in the angioplasty procedure and for those patients who may be at high risk for other complications of the procedure.

      "There is no down side to the use of abciximab," said Stone, "aside from the cost."

      Abciximab has shown that it can reduce complications by as much as 50 percent in patients undergoing some procedures, but this trial involved more than 2,500 patients who were being treated for an acute heart attack.

      About one fourth of the patients received angioplasty alone; an equal group received angioplasty and abciximab; another group got angioplasty and a stent; and the final group received angioplasty, a stent and abciximab.

      Stone said there were still many patients that he would still treat with abciximab, although probably less than 50 percent of those undergoing angioplasty.

      Dr. Elliott Barnathan, Centocor''s senior director of cardiovascular clinical research, said the results of the study showed that using the drug appeared to reduce mortality, blood flow and the risk of blood clots. He said that further analysis of the CADILLAC data might also find that use of the drug helps preserve heart function. Stone said those analyses will be reported at a later date.

      "This was a very damaging study for abciximab," said Baim. "If you design a good study -- such as CADILLAC -- you''ve got to live with the results."

      Abciximab is a drug known as a IIb/IIIa inhibitor and was designed to prevent formation of clots, especially common during mechanical interventions in blood vessels. The drugs have not done well in recent clinical trials.

      Baim said the companies "deserve" the disappointing results because "they have marketed well ahead of the evidence...telling doctors ''there''s nothing left to prove'' and ''it''s malpractice not to use them.'' The interventional community has not, by and large, adopted these drugs in their practice and studies like this demonstrate that their skepticism was appropriate."

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