That editorial comment accompanied five articles and two commentaries published online yesterday by The New England Journal of Medicine in response to controversy in the past year about the risk of deadly clots forming in the drug-coated stents. The package is the most comprehensive peer-reviewed summary since a controversy began over safety data from major trials.
The editorial stressed that doctors should be aware of the new consensus that patients receiving the drug-coated devices needed daily doses of aspirin and Plavix, an anticlotting medication, for at least a year. No one knows yet if the clotting risk persists indefinitely or whether taking the drugs longer than a year would reduce it.
“We really wanted to put this information out there as a guide for future research,” said Dr. Gregory D. Curfman, a cardiologist who is executive editor of the journal. “We also wanted to reassure people with stents that the risk is small.”
The journal’s package summarized and in a few cases elaborated on information presented in early December to a panel of expert advisers brought together by the Food and Drug Administration to review the stent safety controversy.
While some doctors say the bigger concern may be whether stents of all types are being used too frequently on patients who should be receiving drugs or bypass surgery instead, the panel review and the journal articles focused on the narrower question of comparing the drug-coated stents with the bare metal stents they have largely supplanted.
Nearly a million Americans received stents last year to treat chest pain, shortness of breath and heart attacks, according to Wall Street analysts. The $6 billion worldwide stent market has stumbled in the last nine months because of rising fears about stent safety.
Recent earnings reports from Boston Scientific and Johnson & Johnson, the two market leaders, suggest that total stent use has leveled off and may even be declining. In addition, cardiologists have shifted enough patients from drug-coated to bare metal stents to cut the drug-coated share to 73 percent, from last spring’s peak of about 88 percent.
The device companies are heavily reliant on doctors continuing to use the devices “off label” — that is, in patients with more complicated health problems than those tested in clinical trials — because such uses now account for as much as 60 percent of the market. The Food and Drug Administration has said such uses are linked with higher risks and has refused to endorse them.
Ina podcast accompanying the journal articles, Dr. Donald S. Baim, chief medical and scientific officer of Boston Scientific, called the label “artificially narrow” based on recent trial data. He said future trials of drug-coated stents in complicated patients should focus exclusively on comparisons with surgery rather than with bare metal stents.
That view was challenged in the podcast by Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic Foundation and current president of the American College of Cardiology, who cited the journal article looking back at the outcomes for nearly all 20,000 Swedes who received stents in 2003 and 2004. The Swedish data was not based on randomized trials but suggested that bigger clinical trials comparing the two types of stents were needed, he said.
“If the Swedes are right, we will regret putting these devices into individuals,” Dr. Nissen said of the drug-coated stents.
Stents are implanted after angioplasty, a procedure in which a balloon is temporarily inflated inside a constricted coronary artery to widen it. Angioplasty patients frequently return for follow-up procedures because the artery rapidly recloses. Bare metal stents cut the reclogging rate in half. When drug-coated stents were introduced in 2003, reclogging rates were cut another 50 percent.
No one is certain why but the drug-coated stents seem slightly more likely to promote clotting long after implantation — about one extra case for every 200 to 250 patients, according to various studies. The trial data suggests that there is no difference in death and heart attack rates after four years. One theory is that the higher number of repeat procedures with bare metal stents leads to enough deaths and heart attacks to offset any higher clotting risk in the drug-coated devices.
