Late stent use may not help after heart attacks
Nov 14, 2006
CHICAGO (MarketWatch) -- A new study showed that balloon angioplasty plus the use of stent heart devices failed to reduce major complications in stable patients when performed three to 28 days after a heart attack, a result that could reduce the use of such procedures for stable patients.
The intervention to open blocked arteries has shown to be beneficial in patients when performed within 12 hours of a heart attack, and sometimes within 36 hours, but an estimated one-third of patients don't receive treatment that quickly. The so-called Occluded Artery Trial, or "OAT", was designed to see whether the late opening of blocked arteries would still provide a long-term benefit for stable heart-attack survivors, as doctors still tend to intervene in those cases.
The trial of 2,166 people is the largest and longest study of its kind, and was funded by the National Heart, Lung, and Blood Institute. Results were released Tuesday at the American Heart Association's annual Scientific Sessions conference here.
"It is critical to seek medical care very early after symptoms that could be a heart attack," said Dr. Judith Hochman, of the Clinical Research Center at the New York University School of Medicine, who presented the results at an AHA press conference.
However, "if you are a stable patient there is no benefit to opening that artery late, days to weeks after the heart attack."
That advice seems to be contrary to the assumptions of doctors who often perform late angioplasty/stenting in stable heart-attack survivors. Indeed, many centers didn't want to participate in the trial amid concerns about not opening blocked arteries.
"Until this trial was completed, we didn't know it was an unnecessary procedure," Hochman said during the press conference.
Results from the trial showed there was no statistically significant difference in the occurrence of major events such as death, heart attacks or heart failure between patients who received angioplasty and a stent and patients who received medication. Additionally, researchers also found "an unsettling trend toward more heart attacks" in the angioplasty/stent group, according to a press release.
This rate of repeat heart attacks didn't reach the level of statistical significance, but is worrisome, Hochman said.
"Our findings should lead to lower rates of unnecessary coronary interventions in this specific group of stable patients, which should result in substantial health-care cost savings," she said in a press release. The group in question is stable patients who survived a heart attack and didn't have certain complications. They weren't considered high risk patients.
Hochman also noted in the press conference that, despite the trial results, no one should be confused about the benefit of this therapy when it's performed quickly after heart attacks.
The randomized, clinical study followed patients for three years, and among patients who received stents, they received both bare-metal and drug-coated devices. Most patients did not receive a drug-coated stent, although these are by far the most widely used stents in the U.S. The study was performed in the U.S. and several other countries.
The two drug-coated stent makers in the U.S. are Boston Scientific Corp. (BSX) and Johnson & Johnson (JNJ), while Abbott Laboratories Inc. (ABT) is the largest maker of bare-metal stents.
A subset study of the OAT trial was also presented Tuesday, and it showed that angioplasty/stenting did effectively restore blood flow through blocked arteries, but didn't improve the heart's pumping ability after one year, when performed in patients three to 28 days after a heart attack.
The Total Occlusion Study of Canada, or "TOSCA-2", included 381 Canadian and international patients who were enrolled in the larger OAT trial. TOSCA-2 found that 93% of heart-attack related arteries could be reopened with late angioplasty/stenting in that side of the trial, and that 83% of the arteries in question remained open after one year. In the medication side of the trial, 25% of arteries remained open.
Still, a common measure of the heart's pumping ability, called ejection fraction, was similar for both groups after a year. Researchers in the TOSCA-2 trial also concluded that routine, late angioplasty/stenting shouldn't be performed in stable patients after a heart attack.
http://content.nejm.org/cgi/content/abs ... JMoa066139