Sept. 2 (Bloomberg) -- A Swedish study found no increased risk of death among patients getting drug-coated stents made by Boston Scientific Corp. and Johnson & Johnson, reversing an earlier finding.

The initial result, an 18 percent increase in deaths among patients getting the tiny metal mesh tubes to prop open heart arteries, fueled concern about the products earlier this year and helped trigger a plunge in sales worldwide. Now, researchers are saying the effect didn't hold up when they analyzed a larger group of patients treated for a longer period.

The new findings, presented at the European Society of Cardiology meeting in Vienna, show patients getting the drug- coated stents weren't more likely to die or have a heart attack than those given the older, bare-metal stents. The results may reassure doctors and patients that they can benefit from the technology while controlling the risks.

``This registry, which was one of the ones that caused significant concern, is now less concerning and might be reassuring,'' said Spencer King, chair of interventional cardiology at Piedmont Hospital in Atlanta. ``This registry helps remove some of the fear of drug-eluting stents.''

Largest Ever Study

The observational study is the largest ever to compare the long-term safety of drug-eluting stents compared to bare-metal versions, said Stefan James, the researcher from the Uppsala Clinical Research Center in Sweden. It wasn't clear why the death rates fell, he said. The risk that appeared with patients who underwent procedures in 2003 and 2004 disappeared with the longer follow-up, which included patients treated in 2005, he said.

The reversal may be attributable to more sophisticated stents, longer use of Sanofi-Aventis SA's and Bristol-Myers Squibb Co.'s Plavix and better operating techniques, he said.

It is critical that the devices are used correctly, King of the Piedmont Hospital said in an interview. Selecting patients most likely to benefit, using the device that is best suited to their condition and ensuring people take drugs such as Plavix to prevent clots are key, he said.

The drug-coated devices cost about $3,000, more than 10 times the price tag on the older bare-metal stents. Doctors need to ask whether the benefits are worth the additional cost and the risk of taking anti-clotting drugs for at least a year, said Steven Nissen, chair of cardiology at the Cleveland Clinic Foundation in Ohio, in an interview.

`Not an Answer'

``For something that's used in millions of people around the world, we need the evidence to make rational decisions,'' Nissen said. ``This is a clue, it's not a definitive answer.''

About 8 percent of patients getting bare-metal stents had a renarrowing of the arteries, compared with only 4 percent of those getting the drug-eluting stents, the study found. That didn't translate into fewer deaths or heart attacks, he said.

The registry included all patients in Sweden who received the devices to prop open heart arteries from 2003 through 2005, including almost 14,000 given the drug-coated stents and 21,000 given the older, bare-metal versions.

Extended use of Plavix, also known as clopidogrel, may explain some of the change in the data, said Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston, in an interview. Doctors and patients were starting to realize the drug was needed for longer periods to prevent clots toward the end of the study, perhaps improving patient care, he said.

Extending Drug Use

``Extended clopidogrel may clear up the issue with stent thrombosis with drug-eluting stents,'' Cannon said. ``From that point of view, tracking all these data and paying attention to the clopidogrel issue is a real win out of all the hullabaloo from last year.''

Stents keep arteries open after doctors have cleared clogged vessels with tiny inflatable balloons. To suppress growth of scar tissue that can block the blood vessel, device makers started coating stents with drugs used to suppress the immune system or prevent cell division.

U.S. demand for drug-coated stents made by Johnson & Johnson and Boston Scientific has fallen 40 percent since researchers last September found a link between the devices and potentially fatal clots. Doctors reduced their use of the devices and returned to the older, bare-metal versions to reduce risks in patients not prone to a reclosure of the blockages.

``We welcome the updated results of the SCAAR registry showing the benefits of drug-eluting stents compared to bare-metal stents,'' Johnson & Johnson spokesman Christopher Allman said.

Real World

The results aren't enough to trigger a resurgence in the use of drug-eluting stents, doctors said. The study was a registry that tracked all patients treated with stents, providing a real world experience with the devices. The fact that they weren't randomly assigned, as is the case in tests done for regulatory approval, could have altered the results, doctors said.

``These data don't change substantially the evidence we've had in the past year,'' said Raymond Gibbons, a cardiologist at the Mayo Clinic in Rochester, Minnesota. ``I don't think we can place too much emphasis on these data until we understand why it happened.''

More than 8 million people worldwide have been given the drug-coated stents since they became available in 2003, primarily Boston Scientific's Taxus and Johnson & Johnson's Cypher.

Medtronic Inc.'s Endeavor was introduced later and the demand for it is still low in Sweden, James said. Overall use of drug- eluting stents has plunged to less than 20 percent in Sweden in the past two years, down from about 60 percent, he said. In the U.S., less than 70 percent of stents are now drug-coated, down from almost 90 percent.

Novartis AG's Rasilez lowered a biological marker for heart failure, a finding that may point to a new use for the blood pressure medicine, researchers said at the conference today. Merck & Co.'s experimental niacin drug Cordaptive improved cholesterol levels with reduced facial flushing, a side effect that has limited use of the market leader, Abbott Laboratories' Niaspan, according to another study released in Vienna today.

To contact the reporter on this story: Michelle Fay Cortez in Vienna at mcortez@bloomberg.net; Eva von Schaper in Vienna at evonschaper@bloomberg.net.

Last Updated: September 2, 2007 09:45 EDT