FDA Panel Adds Little to Stent Discussion – So Far

The big expensive panel convened to decipher the risks of drug-eluting versus bare metal stents, has so far done little to clarify issues regarding management of patients with drug eluting stents for cardiologists. So far, the meeting seems more like a PR meeting to reassure the public that industry-sponsored experts are confident in the safety of stents.

Cardiologists already know this. In days of old before drug-eluting stents, cardiothoracic surgeons were still pretty busy helping to manage patients who would return with re-narrowing (re-stenosis) of their bare metal stents after cardiologists could do little to intervene. But now, cardiothoracic surgeons are busy finding other things to do, like atrial fibrillation ablations, since multi-vessel angioplasty and stenting has become commonplace due to the effectiveness of drug-eluting stents. Cardiologists have pushed the indications beyond treatment of simple vessel narrowings, tackling branch-vessel narrowings that are much more complicated. In fact, the FDA estimates that 60% of these devices are used outside manufacturers’ labeling.

What cardiologists want to know (and other doctors who manage these patients) are management issues: in what situations should a patient NOT receive a drug-eluting stent? Should these stents be used in off-label complicated branch-vessels in an off-label, side-by-side fashion known to be higher risk for clotting? How long do patients need clopidogrel (Plavix)? What do we do with patients who require surgery and have drug-eluting stents to minimize their risk of in-stent thrombosis?

Instead we were treated yesterday to a feel-good session on the safely of stents by cardiologists who receive (either personally or for their institution) significant funds from the stent manufacturers.

While it is good to allay the concerns of the millions of people out there with drug-eluting stents, I hope we get to hear more “meat” today about management and follow-up of our patients, or at least, about plans to organize prospective trials to address some of these questions.

-Wes