THURSDAY, Oct. 9, 2008 (HealthDay News) -- Artery-opening procedures can be safely done in some cases without using the anti-clotting drug heparin, reducing the risk of excess bleeding, Italian cardiologists report.
Participants in the trial were chosen carefully, according to a report in the Oct. 7 issue of the Journal of the American College of Cardiology by doctors at the University of Turin. The 700 people who had the procedure were in no immediate danger of a heart attack, had single blockages of a heart artery, and were already taking two clot-preventing drugs, aspirin and thienopyridine.
The incidence of heart damage and bleeding events was lower in those who got no heparin, and there was a lower risk of death, heart attack, or blood vessel problems in that group, the report said, but it ended on a decided note of caution: The no-heparin approach "probably could not be applied to all patients, even stable ones, and certainly not to patients with complex lesions in acute coronary symptoms."
"Unless a large multi-center trial is performed that confirms these findings, this paper is not intended to provide false reassurance for an operator who decides to try this approach," the report concluded.
That caution is decidedly warranted, said Dr. Harold L. Dauerman, director of the cardiac catheterization laboratory at the University of Vermont, who wrote an accompanying editorial comment.
"It is an interesting approach to decrease bleeding complications beyond the usual level of pharmacological reduction we would use," Dauerman said. "But using absolutely no heparin at all is a really bold step and could be dangerous in the wrong situation."
The Italian cardiologists were careful to pick the lowest-risk participants for their trial, "and even in these low-risk patients, I was surprised that there were so few complications," he said.
The average time that angioplasty took in the trial was also very short, about 15 minutes, Dauerman noted. The procedure often can take as long as an hour to perform, and, in that case, "would be beyond the bounds of what was done in this trial," he said.
Giving heparin during angioplasty is standard procedure, although excess bleeding is always a concern. A study reported earlier this year said that a newer anti-clotting drug, bivalirudin, did not reduce the incidence of deaths, heart attacks and blood vessel complications but did lower the incidence of major bleeding events.
Because excess bleeding is a major concern, bivalirudin now is being used in 30 percent to 40 percent of artery-opening procedures in the United States, said Dr. Magnus Ohman, a professor of cardiovascular medicine at Duke University.
The Italian study is welcome, "because you always try to push the envelope a bit," Ohman said, but he agreed that more work is needed to confirm the results.
"I would like to see a multi-center trial with many different investigators, somewhat larger than this," Ohman said. Such a trial would allow enrollment of a wider variety of people undergoing angioplasty, he said. But even if such a trial was done successfully, heparin-free procedures probably would not be recommended for more than about 10 percent of people having angioplasty, Ohman said.
"Pushing the envelope like this doesn't mean conversion of practice," he said.
Much of the heparin used in the United States is manufactured in China. Heparin was in the news earlier this year, because batches contaminated by the chemical chondroitin sulfate caused 86 deaths and hundreds of illnesses in American recipients.
The artery-opening procedures formally called percutaneous coronary interventions are described by the American Heart Association.