Thursday, November 30, 2006

Drug coated balloons

When DES (Drug eluting stent) was first announced to the world in 2001, it was touted as a revolutionary advancement in PCI. This advancement would solve all problems of percutaneous coronary intervention for CAD. At that time, little did we all realise that altthough DES did solve the problem of re-stenosis, it created a new problem of late stent thrombosis, first highlighted to us by the Swiss in the Late Basket Trial, and now openly announced and debated in ESC/WCC in September in Barcelona and later again debated in TCT/Washington in October. This is now widely seen as the inter-Atlantic Stent-war.

It looks like there is an issue, a problem of late stent thrombosis with DES (much as the Washington Americans would not agree). It does look like the fact the DES lessens and delays re-endothelialisation, this fact actually promotes stent thrombosis, making deployment technique and the role of plavix, absolutely vital. Of course the patient mix is also important.

With that long intro, the latest issue of the New England Journal of Medicine, had an article by a group of Germans interventionist (I must say that this are the lesser known Germans in our circle), who studied 52 patients with in-stent restenosis following bare metal stents, who received treatment witha paclitexal coated balloon. They compared their results with the control group who were tretaed with plain old balloon angioplasty (POBA). Lo and behold, the paclitaxel coated balloon group had restenosis of about 5% as compared with the POBA-treated group who had a restenosis rate of 43%. POBA is one of the ways of treating restenosis of bare metal stents in the days before DES.

What is amazing is that a drug coated balloon, inflated over a lesion for about 1 min, can affect tissue reaponse in such a significant manner. Of course, we are all holding our breathes to see if we can achieve this good result in native, virgin lesions. We must note that an in-stent restenosis lesion is not like a native, virgin atherosclerosis lesion.

This paper is very interesting and I am sure that other groups will begin to do the same and perhaps a large scale clinical trial will result, either confirming or disputing this findings. What was also intriging for me was that this work was not broadcast on the world stage of TCT Washington.

We should probably also take some time on this blog to comment on the industry news that JnJ Cordis has acquired Conors (the owners of the Costar technology).

1 comment:

Steven said...

Steven said... Drug coated balloons sounds interesting... but not sure it is, if they leave any stent, whether this is a good plan, balloon only if at all possible, no stent, then deal with things later for the patient, carefully... origionally the DES was thought to be good... but is a
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"... while the top doctors just give nice speeches in nice places... stent-osis is 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. Calcium Channel blockers, Ace block/inhibitors/statins/ Plavix, all useless, tried them all... nothing stops the vascular/stent inflammation, except Celebrex, and only a tiny bit. All drugs have been useless... post to me if you have had success with any remedy... My advice: never, ever, ever allow any doctor to put a DES in you heart, ever...

10:13 PM