COURAGE from ACC 2007
The biggest news from from ACC 2007, New Orleans (at least if the normal talking heads on the internet are to be believed) is the "Courage" trial.
Courage stands for "Clinical Outcomes Utilising Revascularisation and Aggressive Drug Evaluation". This trial was originally scheduled for 27th March (last day of the ACC) but had to be brought forward because a speaker (Dr Martin Leon) at the earlier weekend symposium seemed to have broken the embargo not to discuss the trial before it was formally presented. Once the results were leaked the press honed in like hungry sharks, nothing leads better than bad news and this one bled all the way to the columns above the fold, the ones with big big fonts. The organizers felt that they had to bring forward the presentation by one day.
Make no mistake. COURAGE is an important landmark because it will influence the practice of interventional cardiology. COURAGE enrolled 2287 patients from 1999 to 2004, and had mean followup of 4.8 years. The PI is Dr William Boden of Buffalo GH. They compared patients with CAD treated with PCI + optimal medical therapy against patients who only received optimal medical therapy. After a mean followup of 4.6 years, they showed that there was no difference in death, heart attacks and strokes. There was a difference in chest pain control (more of the PCI group had less chest pains).
This study findings is not really surprising. Angioplasty has never been shown to reduce death or MI especially in the assymptomatic population. PCI does reduce death and MI in certain subsets like unstable angina (currently called acute coronary syndrome). This trial is not without flaws. Remember the physicians were not blinded. How can you blind against angioplasty. It could be that more severely ill patients received PCI.
Anyway "COURAGE" is interesting. What are the implications of this trial results (if you believe in evidence based medicine).
1. Checking out assymptomatic individuals, diagnosing CAD by MSCT and reacting to it with angiogram and angioplasty, is not supported by this trial result. You need chest pains or inducible ischemia, to justify intervention. Assymptomatic patients with high calcium scores, should receive optimal medical therapy.
2. That after coronary angiogram in assymptomatic patients, interventionist will have no basis to go on to PCI (oculo-stenotic reflex), without giving a period of optimal medical therapy.
3. Those who treat assymptomatic patients aggressively with medical therapy know that they are supported by the "COURAGE" study. They are medico-legally protected.
4. Maybe MSCT company shares and interventional company shares will fall. Clinical guidelines, will have to be amended. I am sure that non-interventionist will accuse interventionist of "dilating for bread" . Perhaps they are right. I am sure that more is to come, on this subject.
Courage stands for "Clinical Outcomes Utilising Revascularisation and Aggressive Drug Evaluation". This trial was originally scheduled for 27th March (last day of the ACC) but had to be brought forward because a speaker (Dr Martin Leon) at the earlier weekend symposium seemed to have broken the embargo not to discuss the trial before it was formally presented. Once the results were leaked the press honed in like hungry sharks, nothing leads better than bad news and this one bled all the way to the columns above the fold, the ones with big big fonts. The organizers felt that they had to bring forward the presentation by one day.
Make no mistake. COURAGE is an important landmark because it will influence the practice of interventional cardiology. COURAGE enrolled 2287 patients from 1999 to 2004, and had mean followup of 4.8 years. The PI is Dr William Boden of Buffalo GH. They compared patients with CAD treated with PCI + optimal medical therapy against patients who only received optimal medical therapy. After a mean followup of 4.6 years, they showed that there was no difference in death, heart attacks and strokes. There was a difference in chest pain control (more of the PCI group had less chest pains).
This study findings is not really surprising. Angioplasty has never been shown to reduce death or MI especially in the assymptomatic population. PCI does reduce death and MI in certain subsets like unstable angina (currently called acute coronary syndrome). This trial is not without flaws. Remember the physicians were not blinded. How can you blind against angioplasty. It could be that more severely ill patients received PCI.
Anyway "COURAGE" is interesting. What are the implications of this trial results (if you believe in evidence based medicine).
1. Checking out assymptomatic individuals, diagnosing CAD by MSCT and reacting to it with angiogram and angioplasty, is not supported by this trial result. You need chest pains or inducible ischemia, to justify intervention. Assymptomatic patients with high calcium scores, should receive optimal medical therapy.
2. That after coronary angiogram in assymptomatic patients, interventionist will have no basis to go on to PCI (oculo-stenotic reflex), without giving a period of optimal medical therapy.
3. Those who treat assymptomatic patients aggressively with medical therapy know that they are supported by the "COURAGE" study. They are medico-legally protected.
4. Maybe MSCT company shares and interventional company shares will fall. Clinical guidelines, will have to be amended. I am sure that non-interventionist will accuse interventionist of "dilating for bread" . Perhaps they are right. I am sure that more is to come, on this subject.
1 comment:
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"... 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 if you have had success with a remedy... My advice: never, ever, ever allow any doctor to put a DES in you heart, ever...
10:13 PM
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