Thursday, January 18, 2007

Euphoria to Panic, the story of DES

I implanted my first DES, a Cypher, on May 28th 2002. Since that period of euphoria, we have seen a descent in the fortunes of DES to considerable trials and tribulations.

Initially there was a period of euphoria spanning 2002. After that, we started to see problems with the Cypher stent in the form of thrombosis. Bad news sells, predictably, the mass media picked it up. JnJ Cordis called upon their expert panels who came out to make the right reassuring noises and all was calm for a while.

Like a bad movie, a calm can only mean one thing, an impending storm. Storm it did when the Cypher stent picked up in popularity. Suddenly JnJ Cordis went from defending the Cypher to trying to figure out how to churn out more of the things because they just couldn't keep up with demand. Centers started to ration the usage of Cypher. In hindsight this was probably a good thing, usage of Cypher was rationed and bare metal stents picked up the rest of the slack resulting in more usage.

Next the FDA approved the use of Taxus. After about a year or so reports started coming out that Taxus stent balloons were not deflating. Unfortunately, some patients suffered heart attacks and a few did not make it. Boston Scientific pro-actively withdrew the affected batches and issued statements of reassurance. The stents seemed to work well after this (around 2004).

In 2005 Dr Virmani sounded off about potential dangers of DES. She had become an expert in studying necropsy specimens of DES failures. She began to warn us that DES caused terrible reactions in the coronary arterial wall, including inflammatory responses which looked like allergy, inadequate expansion of DES with arterial wall malapposition, and of course the all important stent thrombosis. We all thought that of the millions of DES placed, these reports were the results of 40 necropsy specimens. We heard but paid only cursory attention to the information.

However, at meetings we began to hear of reports of stent thrombosing after 1 year of implantation. Until then, we thought that stent thrombosis was a problem of the first six months or 1 year of implantation.

In Yr 2005, we heard the presentation of the "Late Basket Trial " by the Swiss workers who warn that there seemed to be more late stent thrombosis (stent thrombosing after 1-2 years of implantation) in DES. Then came Barcelona in September 2006, with the reports of Dr Camezind and Normad, who did the meta-analysis that warned use of the dangers of late stent thrombosis.

Bad news continued to sell and the mass media was there to document every horrid detail. This is a natural result of a smaller, flatter world where the inevitable flow of information leads to greater transparency. Post Vioxx, we learnt an important lesson - come clean early, coming clean late could result in very expensive lawsuits.

This brings us to the present. I spoke in Langkawi last year at the ICF 2006 to local interventional cardiologist on this subject. I concluded by saying that through all the trials and tribulations, we learned the following :-

1. Use DES only when it is indicated, and not simply for convenience of style and that the patient can afford it

2. There is still a place for bare metal stents (BMS), especially in patients who may be allergic to plavix, patients who may be scheduled for non-cardiac surgery (plavix may have to be discontinued), in large coronary vessels where DES or BMS made no medical difference

3. That Plavix (or ADP receptor blockers, including ticlopidine) is absolutely important, and should not be discontinued for 1 year at least after implantation, if not 2 years (as in Harvard's Peter Bringham).

In my practice, patients are advised not to stop their plavix without telling me. This then is the situation till December 2006. Who knows what Yr 2007 will bring.


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Bernard said...

Dr Ng.. i included this post in the blogrounds.

Important info for us people who don't follow the cardiology scene.

Steven said...

Steven said...
DES good?.. hardly... not if you are the one who is suffering from ACS literally every day for 5.5years as a result of a DES... I am finding that Celebrex is a bit helpful (suggested by head of a cath lab at different hospital than the one mine was placed in) ... and looking for natural methods, top fish oil, herbs etc., anyting to stop this daily severe and dangerous vascular inflammation and pain. It has been a 10 of pain almost every day since the day after I had a large Cypher DES placed in my Osteum of LAD. Also thousands are all over the web complaning about significant post stent chest pain/angina with completely patent DES stents... really getting quite common. Every middle aged man I have met with a DES has the problem like mine. Older people don't complain, because the doctors tell them "it your heart", you are old and sick, or "not right in the head". There are also dozens of articles and studies on post stent pain, inflammation, allergy, especially for the DES... yet interventionists are still in (monetary) denial... Surgeons however are now speaking up for the first time about stents (especially DES) heated arguments are going on in hospitals. The DES is junk, dangerous... careful ballooning, followed by rest and the many available medicines and strict change in diet, untimately later excercise, all far preferable... and if need be, a bare metal in the most dire of proven cases. Otherwise forget the DES, until they invent something that does not first "harm" the patient... I am suffering every day, and have tried everything to no avail... some courageous interventionists are suggesting Celebrex, with increasing aspirin; next choice Prednisone (a dangerous choice, but what else to do) by some interventionists. Some articles and studies on the various "treatments" are on the web. But most interventionists are just blowing off the patients. Some other interventionists however are also suggesting antihistamines, and various immune altering drugs, but this is dangerous. Antihistamines did not help me at all... good idea though... only Celebrex helps me, and only a little bit, at 400mg per day. I am left to experiment on myself as many thousands of others are, suffering from "stent-osis"... far worse than arteriosclerosis, as there in apparently nothing you can do to cure stent-osis, not vigorous exercise, nothing, and the vessel just gets more inflammed the more you exercise or do anything. Bypass and removal of stent becomes all the more dangerous with stents in the way, having been inflammed in the vessel, etc. My advise: never, ever, ever allow any doctor to put a DES in you heart, ever...

10:13 PM