The prestigious NEJM published a study that showed a dose of radiation can help keep heart arteries wide and clear after artery-clearing angioplasty. The benefits of the treatment were so dramatic in one study, the researchers call for head-to-head trials comparing radiation to stents, the wire mesh tubes that are now routinely used to keep arteries open after angioplasty.
About 30% to 40% of heart disease patients who undergo angioplasty end up with restenosis -- a reclosure of the clogged artery. While stents can help prop the artery open, restenosis is still a risk. Usually, the re-closure is due to the overgrowth of new cells in the artery, which can be triggered by the angioplasty, a procedure in which a balloon-tipped catheter is used to squash fatty plaque against artery walls.
Fortunately, the system used in the study is not approved for use in the United States.
About 5% of patients in the radiation group experienced blood clots late in the study, compared with less than 1% of patients in the placebo group.
This rise in blood clots was linked to an increased rate of heart attacks, which was more than twice as high in radiation-treated patients.
The study was funded by Cordis, the New Jersey-based manufacturer of the technology.
Several of the researchers have served as consultants or received funding from companies involved in the development of radiotherapy.
The New England Journal of Medicine 2001;344:243-256, 295-299
This is the most ridiculous and idiotic study I have ever seen published in a real journal. I almost fell off my chair backwards when I read it. It is almost unbelievable that this was even considered for a trial, let alone published.
This is an important issue as ore than 500,000 angioplasties are performed every year in the US and blockages occur in one-third within six months.
I guess we are beginning to see the results of the new editor that was installed at NEJM last year.
There are a number of illustrative and very interesting points in this study.
The study was funded by the devices's manufacturer.
All the investigators were paid consultants for the manufacturer.
Do you think that there might have been the slightest bit of bias in this study?
The follow-up was only for nine months and even that limited time there was a doubling of the heart attack rate due to an increase in blood clots.
Both beta-radiation and gamma-radiation sources have been studied. Beta radiation takes the form of electrons, or particulate energy, and has limited tissue penetration. Most of the therapeutic effect of beta radiation occurs 2 to 3 mm from the radioactive source. The gamma radiation used in this device takes the form of photons and penetrates well beyond 10 mm. This will absolutely increase the person's risk of developing a future cancer.
The answer to prevention of the artery blockages is to follow the diet and exercise. One also needs to consider factors like homocysteine
Ferritin and other blood risk factors.
If the blockage becomes more severe it would be wise to consider EDTA chelation which has helped tens of thousands of patients. It is not a magic bullet, but it is far more effective than bypass as it addresses all the miles of blood vessels in the body, not just the two inches of arteries on the heart.
The dangerous issue here is that on November 3, 2000, the Food and Drug Administration (FDA) granted approval for two devices to deliver this radiation. Given this approval, it is possible that there will be widespread dissemination of this technique before its safety and efficacy have been established.
Just remember you read it here first, this therapy is utter nonsense and should be avoided like the plaque, it has no place in the management of this problem.