The health care giant is reacting to new research showing that patients given drug-coated stents after an acute heart attack are nearly 5 percent more likely to die a year or more later than those with bare-metal stents. The two-year analysis of 2,300 patients in 14 countries adds further
uncertainty over the safety of the drug-coated models, including J&J's Cypher.
Doctors at the European Society of Cardiology said the finding showed the need to be very selective about giving drug stents to the right patients. Gabriel Steg of the Hospital Bichat-Claude Bernard in Paris followed patients who were given stents after suffering the most deadly kind of heart attack.
For the first six months, those on drug stents did as well as those on bare ones. But after 180 days, their paths diverged and the drug stent patients were 4.7 percent more likely to die. Steg said the trend probably reflected the high thrombosis risk in this group of patients, who represent an estimated 10 to 20 percent of coronary stent procedures.
"The results...are inconsistent with the findings of all of the currently available randomised controlled trials comparing drug-eluting stents to bare metal stents in a wide range of patients, including patients with acute myocardial infarction (heart attack)," J&J's Cordis unit says in a statement. "In addition, these results are substantially different from other real world all-comer registry data." J&J also issued a statement disputing the latest research.
Stent sales have dropped this year due to safety concerns, which was a key reason cited this summer when J&J disclosed restructuring plans that include eliminating more than 4,300 jobs.
Drug stents carry a small risk of blood clots after the first year, occurring in less than 1 percent of patients but killing nearly half of those affected. "I still believe there is room for (DES) drug-eluting stents in many patients and I disagree with the concept of banning DES altogether," Steg told Reuterse. "There are candidates for DES, but these happen to not be STEMI patients."
UPDATE: J&J issued another press release this morning, claiming its Cypher stent reduces the risk of blood clots.