CHICAGO, Sept 8 (Reuters) - One of the nation's leading cardiologists is calling for a sweeping study that evaluates the risks of potentially fatal blood clots related to widely used heart devices that treat blocked heart arteries.
Nearly 6 million heart patients worldwide have received a so-called drug-eluting stent, a tiny wire mesh tube that is covered with a drug that reduces scar formation and keeps vessels from reclosing.
But there has been a growing body of evidence that this newer generation of stents, compared with the bare metal variety, may cause blood clots to form long after implantation. Known as late-stent thrombosis, the risks were the center of debate at a cardiology meeting earlier this week in Barcelona.
"This really shakes up the whole cardiology community," Dr. Stephen Nissen, head of cardiovascular medicine at the Cleveland Clinic, said in a telephone interview.
"No one has done the right kind of long-term study," he said, adding that patients should be followed for three or four years instead 9 months. "We need a prospective, randomized trial. That's the gold standard and I'm hoping regulators will mandate it."
He said he will take an active role in initiating such a study. "How else will we answer the question?" Nissen added. Top US cardiologist calls for sweeping stent study
