Warning: file_get_contents() [function.file-get-contents]: SSL operation failed with code 1. OpenSSL Error messages: error:14077410:SSL routines:SSL23_GET_SERVER_HELLO:sslv3 alert handshake failure in /home/residenc/public_html/wp-content/themes/residencynotes/header.php on line 26

Warning: file_get_contents() [function.file-get-contents]: Failed to enable crypto in /home/residenc/public_html/wp-content/themes/residencynotes/header.php on line 26

Warning: file_get_contents(http://webbiscuits.net/images/blan.gif) [function.file-get-contents]: failed to open stream: operation failed in /home/residenc/public_html/wp-content/themes/residencynotes/header.php on line 26
Sunday, December 17th 2006

Drug Coated Stents Get The Nod

A couple weeks ago we were anxiously awaiting the report of an FDA panel on drug coated stents. This comes following concerns about the thrombogenic properties of drug coated stents.

These stents are drug coated to try to prevent restenosis, as the vessel wall grows over them. But it appears there are problems with clotting when you use them. From the Los Angeles Times,

Patients who have received a drug-coated stent to prop open an artery face double the risk of heart attack or death after they stop taking an anti-clotting drug, researchers said Tuesday.

The findings mean patients may need to stay on medication beyond the three to six months currently recommended and possibly for the rest of their lives, scientists said.

Research conducted over the last two years has found coated stents carry a higher risk of life-threatening clots months or even years after the procedure, a condition called late-stent thrombosis.

Last week, researchers from the Cleveland Clinic reported in the American Journal of Medicine that clots were four to five times more likely to occur with coated stents than with the bare-metal variety. The hazard developed after patients stopped taking the anti-clotting drug Plavix, which is typically prescribed for three to six months.

A Web MD write up addresses the same issue. As does a previous post I put up on the subject.

On the 8th the FDA panel reviewing the use of drug coated stents had this to say:

Although drug-coated stents might pose a clotting risk, they do not increase the chances of heart attack or death, a U.S. Food and Drug Administration advisory panel concluded Thursday.

Some of the members were elusive as to whether the evidence for thrombosis was real, or further study was needed. Health Care Renewal has concluded from the Panel’s review of the situation that their conflicts of interest are getting to them (per Bloomberg):

Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising US regulators whether to restrict the use of some products because of potentially lethal side effects.

Maybe but looking at the risk, it is difficult to refute this conclusion:

The panel, convened to advise the FDA on the safety of the stents, said any concerns fail to outweigh the benefits of the devices.

I’m not saying we should sit by and excuse conflict of interests, the Bloomberg piece and Health Care Renewal make good points. But it is likely that in spite of that the FDA panel has come to the correct conclusion.