Anyone who expected the long awaited FDA panel on drug-eluting stents to finally solve the growing dilemma over what to do about DES must be disappointed this week. (Read about the panel's deliberations here and here.) The problem, of course, has been the recent realization that DES - invented to address the problem of early restenosis seen with bare metal stents - will occasionally occlude quite suddenly, most often a year or more after stent placement, due to the formation of blood clots (thrombosis). The risk of late stent thrombosis can be reduced with the blood thinners clopidogrel (Plavix) plus aspirin, but these drugs carry their own risks, and do not actually eliminate the risk of thrombosis.
Throughout the summer and fall, concern about the safety of DES has grown, and has become quite public, and much hope was invested in the FDA panel resolving those concerns. Specifically, many prayed that the panel would utter definitive pronouncements on a) the safety of DES (relative to other therapies for coronary artery disease), and b) how long patients should stay on Plavix after having a DES placed.
The panel did the best they could given the state of the available data, but neither question was put to rest. When used for "on-label" indications (i.e., for relatively uncomplicated coronary artery blockages), the panel decided that DES seem to yield results that are comparable to those achieved with bare metal stents. Considering that DES were developed with the specific goal in mind of improving post-stent outcomes, one might consider this conclusion to be a bit of a disappointment. However, given the heightened fears that had built up over the past several months, most proponents of DES seemed to consider this conclusion a victory. For the "off-label" use of DES - and up to 75% of DES are used for the more complex, off-label coronary artery blockages - the panel showed considerably more concern, and seemed to indicate that cardiologists should curtail, at least to some degree, the use of DES in at least some types of complex coronary artery disease.
Regarding the use of Plavix, the panel noted the lack of information that would be necessary for them to reach a definitive conclusion. A more-or-less compromise position was reached, recommending that Plavix be continued for 12 months after DES placement, when practicable. Long-term randomized data will be required, the panel pointed out, before more concrete conclusions can be made. Such data, unfortunately, will be years in coming.
What this means to patients
For anyone who gets their coronary artery disease 5 or 10 years from now, these issues will undoubtedly be resolved - more data will be available to guide medical decisions, and new technology will be available that will reduce or eliminate late stent thrombosis. So if you can reduce your risk factors sufficiently to buy yourself a few more years of health, do so.
For those of you who can't wait 5 years for the medical science to sort itself out, keep a few things in mind. First, stents are not the only treatment for coronary artery disease. For patients with stable angina and 1 or 2 coronary artery blockages, stents have never been shown to be better than aggressive medical therapy. In fact, medical therapy (like stents) has advanced significantly over the past decade or so. The aggressive use of beta blockers, ACE inhibitors, and especially statins threatens to significantly improve the "natural history" of coronary artery disease. Furthermore, for those with more extensive coronary artery disease, bypass surgery is a very good choice. In fact, bypass grafting has been shown to be better than stenting for many patients with diffuse or critical coronary artery disease. DrRich has the impression that their supreme confidence in DES has led many cardiologists to tackle coronary artery disease with stents that, according to available randomized data, would be better served with surgery. If this is the case, perhaps reconsideration of the "routine" is now in order.
Second, if stenting is the treatment of choice, make sure you discuss with your doctor the issue of bare metal stents vs. DES. If DES is clearly a better choice for you, discuss with your doctor his/her plan regarding Plavix. How long do you have to take it, and if you need to stop it temporarily for some reason (such as discovering a colon polyp that must be removed), what is his/her strategy for managing Plavix therapy? Your doctor probably won't have answers that are any more definitive than those offered by the FDA panel, but you should make sure he/she has fully considered these issues and has a plan in mind. If the doctor cannot articulate a reasonable Plavix strategy, you ought to question whether the decision to recommend a DES is a truly well-thought-out one.
