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Efficacy of heart stents called into question

Mar 27, 2007 | Financial Times

A seven-year US study has called into question whether doctors are overusing heart stents, the blockbuster tiny wire mesh tubes used to prop open narrowing coronary arteries.

The results of the study, called Courage, added more uncertainty to a stent market that recently has been thrown into flux over questions of safety, appropriate usage and new competition.

This flux was also highlighted by a 7 per cent fall in the share price of Boston Scientific, a leading US stent maker, because new data showed a forthcoming stent by rival Abbott Laboratories could be better than its most important product, Taxus.

Debate has swirled among the medical community, regulators and device-makers, raising questions over the past year on whether medical devices have been used too soon and too aggressively.

Drug-coated stents, whose coating helps keep arteries from scarring and closing again, have been at the centre of that debate as one of the most widely used devices.

Medical devices are increasingly feeling scrutiny, akin to that seen with pharmaceuticals, from doctors and US regulators concerned with potential emerging questions about long-term safety.

In addition, as use of expensive devices has increased markedly, more scrutiny has fallen on the relative benefit of new medical devices. For instance, a recent Food and Drug Administration panel recommended against approval of a implantable heart data monitor by Medtronic, a US group, that could transmit patient data to a doctor via the internet.

The Courage study, presented on Monday at the annual American College of Cardiology meeting, looked at whether people receiving stents and drug therapy had fewer deaths or heart attacks than those with drug therapy alone.

Importantly, the study sought to find out if stents in patients with stable coronary artery disease whose life was not acutely threatened  reduced risk of death and heart attacks because such a benefit "had not been shown".

The study said that, in 2004, more than 1m stents were implanted in the US and 85 per cent were done so in patients with stable disease.

The Courage study found "no significant differences" by using bare-metal stents as compared with drug therapy alone, in death, heart attacks or stroke. It did find that patients with stents had fewer chest pains.