The broad use of drug-coated heart stents in unapproved patients came under scrutiny today as US advisers weighed the risks of the tiny tubes implanted in millions to keep arteries open.
Blood clots have appeared months later in some patients treated with drug-coated stents sold in the United States by Johnson & Johnson and Boston Scientific causing some doctors to return to older, bare-metal versions. Clots can kill or cause heart attacks.
An estimated 60 per cent or more of drug-coated stents have been placed in patients outside the narrow group approved by the US Food and Drug Administration.
An FDA advisory panel is considering the risks of using the devices in patients with acute heart attacks, multiple blocked vessels and other conditions that may raise their risk of complications.
Less research is available in those types of patients, making it difficult for doctors to know the best way to treat them, some physicians told the panel.