February 2005 Archives
February 28, 2005
Sunday! Sunday! Sunday!
It's all happening this Sunday at the Orlando
speedway! No, I don't mean NASCAR. I'm talkin' REALITY. This coming
Sunday evening, March 6, Johnson & Johnson/Cordis is holding
a special "Scientific Forum" at the start of the 54th
Annual American College of Cardiology meeting in Orlando, Florida.
In a 90-minute program, Drs. Marie Claude Morice (France), Antonio
Colombo (Italy/NY), David R. Holmes, Jr. (Mayo Clinic) and Jeffrey
W. Moses (NY) will present a program, titled "The New
Body of Evidence for the CYPHER® Sirolimus-eluting Coronary
Stent" and will present the much-anticipated REALITY
trial results. REALITY is a "real-world" comparison of
the two currently-approved drug-eluting stents: the CYPHER (J&J/Cordis)
and the TAXUS (Boston Scientific). J&J decided to mount this
study in order to determine which stent is best. From J&J's press
release of a year ago:
Investigators describe the REALITY Trial as
expressly designed to compare performance differences between
the two drug-eluting stents, particularly in high-risk patient
group subsets, such as diabetics and patients with long lesions
and small-diameter vessels. Diabetics represent 32 percent of
the study's population.
"The REALITY trial is significant for
two reasons," said principal investigator, Marie-Claude
Morice, M.D., head of Interventional Cardiology at the Institut
Hospitalier Jaques Cartier, Massy, France. "Not only is
it the first direct comparison of two drug-eluting coronary stents,
but it is also the first drug-eluting stent trial to include
a high percentage of diabetic patients. Until now, the subsets
of diabetic patients in these trials have been very small, making
it difficult to draw meaningful conclusions on the efficacy of
one drug-eluting stent versus another in treating diabetic patients.
The REALITY trial offers us our first opportunity to get a true
picture of the relative performance of these products in a very
challenging population."
High stakes, non? Considering that drug-eluting
stents have in effect replaced bare-metal stents in most situations
and that the worldwide market is gigantic, the Oscar in this match-up
may well go to the "Five-Billion-Dollar-Baby". (Okay, I'm
mixing metaphors -- I started off with race-cars and transitioned
to the movies...).
Anyway here's my prediction...(drum roll, please)...the
winner is...BOTH the Cypher and Taxus will be best!
Not to be facetious, but the magic here is in how
you define success. There are a number of measurements with lots
of acronyms, like TVR (Target Vessel Revascularization) or LLL (Late
Lumen Loss) and more. And it only makes sense that the two stent
manufacturers will spin the data from REALITY to make their stent
look, if not better, at least equivalent to the competition. I mean
there's so much at stake, wouldn't you?
But seriously, it's my own feeling that there's
not going to be a massive discrepancy between the two technologies
and, as I've written in a number of articles on our website, Angioplasty.Org,
it's the patients who will benefit most because all these
new improvements represent a quantum leap in the efficacy and durability
of interventional solutions to the problem of arterial blockage.
During this week, I'll be addressing the various
acronyms, what they are, what their meaning is, etc. so when the
stent Oscars are announced, you'll understand better what they're
for.
February 16, 2005
This Search Brought To You By...
Admittedly search engines are terrific.
We like them: our site Angioplasty.Org is
among the top "hits" on most search engines for words
like "angioplasty" and "stents" and the vast
majority of our almost 60,000 monthly users come to us through
internet searches (which studies have shown is the primary method
used by people who use the internet to get health information)..
But then there are the "sponsored links" --
you know, the mini-ads that come up on the right side or the top
of the page. These are triggered by keywords in your search and the
ads also are distributed to many other web sites that partner with
the search engine, like the New York Times, etc. The difference is
that while you can't "buy" true search engine placement,
which is based upon several criteria (popularity, links to your site
from other sites, etc.) you CAN buy sponsored links -- and you don't
need to be a major corporation. Got a credit card and something to
sell? Sign right here.
It sounds democratic and it can be very helpful
in helping internet users find targeted information quickly (our
site uses these ads) but you can find some definite oddities as well.
For example, Google the word "angioplasty" and you get
over a million "finds". The first two "real" hits
are our site, Angioplasty.Org -- and correctly so -- we are the most
comprehensive public site on the Net for this subject. But among
the sponsored links on the right is "Yourticker.com" --
a site promoting a drug called "Angioprim" that supposedly
dissolves the nasty calcium in your arteries.
What is Angioprim? Well, according to YourTicker,
this "miracle cure" was discovered by the uncredited author
of the site, who refers to himself as a "bio-molecular scientist" who
had been through both bypass surgery and angioplasty with no relief
of his angina. In his career, he had developed a chemical stain remover
for calcium in swimming pools. Knowing that calcium was one of the "chemicals" that
blocked arteries, he had an inspiration and one day, he writes:
"I decided to risk my life in an effort
to improve my health. I reasoned, maybe the stain remover might
work to break down the calcium scale and plaque in my arteries
? The stain remover was a food grade additive and used as a preservative
for bread. I had no idea of the amount to use, so I thought I
would start with just a little bit. I mixed it with orange juice
and drank it up. In less than a minute, my stomach was in such
pain it was like I was kicked by a horse. I was vomiting and
had diarrhea at the same time. After I lost most of the fluids
in my body, I crawled into bed and was in pain all night. I got
a little sleep and when I awoke. I went to the bathroom and brushed
my teeth. I looked in the mirror and my mouth was flowing red
with blood. I thought to myself, "I've done it now, I killed
myself. Surprising, I rinsed my mouth and no more blood. I went
upstairs and when I reached the top I realized I wasn't out of
breath, this was a miracle and my legs weren't fatigued, Holy
Buckets the remedy worked."
Holy buckets, Batman, indeed! I'll take a dozen!
Turns out there are several web sites, all promoting the same amazing
cure: angioprim.com, anginacure.com, americanheartcouncil.com (a "non-profit" organization
that "only endorses companies that have shown proven non-surgical
treatments methods" -- the only product they currently endorse
is...Angioprim) -- you get the idea. If you do a little research,
you'd find that they all point back to Orange County CA entrepeneur
Jack Slocumb, of Slocumb & Associates (on
his website, he unabashedly posts his "family pics" of
birthdays, Thanksgivings and fishing trips) or to his "former
salesman" who he states abscounded with the secret formula and
now markets an "inferior product" called Cardiorenew,
which one can also often find listed in the "sponsored links".
It's amazing what you can find on the Net.
February 14, 2005
Drug-Eluting Whats?
I've visited
this issue before, but when it comes to medical reporting of
studies concerning interventional procedures, too many sites are
still "partying like it's 1999" -- by that I mean that
they report on outcomes, etc. without factoring in treatments that
have come into use in the past few years -- in this case, the use
of drug-eluting stents.
To whit, Friday's email contained HeartCenterOnline's
weekly newsletter, featuring an item titled, "New
scale helps decide: angioplasty or bypass surgery?" Their
news piece refers to the PCI vs. CABG study I wrote about yesterday but
completely fails to discuss the impact (or existence) of drug-eluting
stents. Even the AHA study itself mentions that it used data from
the pre-drug-eluting stent era. I explored those important implications
in yesterday's entry, but according to HeartCenterOnline, "Patients
at intermediate or high risk of restenosis are referred for bypass
surgery." Period. Which is NOT what
the study concludes, and I quote:
Conclusions -- The relative
health status benefits of CABG surgery compared with PCI increase
as the risk of restenosis increases. Although selecting CABG
or PCI is complex, preprocedural restenosis risk should be considered.
It should also be tested as a means for considering drug-eluting
as opposed to bare metal stents in PCI. (read
the abstract in Circulation)
"Selecting...is complex" and "should
be considered" are a bit different than "you go
here" and "you go there"; the study does
not say that "patients
at intermediate or high-risk of restenosis are referred for bypass
surgery". The study also clearly links the better outcomes
seen with surgery to the 25-30% restenosis rates historically
associated with angioplasty and bare metal stenting -- patients
do report more relief when the procedure is more durable. With
restenosis rates now being reduced to single digits and PCI becoming
more "durable" via drug-eluting stents, one would have
to assume that the patients will be faring better as well. Most
interventional cardiologists I know think so. Why doesn't HeartCenterOnline?
February 13, 2005
PCI vs. CABG: a "SLOW" study
Bypassing for the moment (yes, pun intended)
the whole question of whether either Coronary Artery Bypass Graft
(CABG) surgery or Percutaneous Coronary Interventions (PCI) prevent
heart attacks or even prolong life (this very large subject I'll
deal with in future entries) -- a study
released in last week's Rapid Access Circulation did
two things. First, it used patient data to stratify the risk of
reclosure (restenosis) in each case by awarding points for various
pre-procedural conditions. For example, four points were awarded
to diabetics, a patient population known for high restenosis rates,
while blockage in more than one artery only garnered a single point.
The patients were then placed in one of three categories for restenosis
risk:
Risk of Restenosis
|
category
|
Score
|
% Risk
|
low
|
1-4
|
15%
|
intermediate
|
5-8
|
23%
|
high
|
8+
|
44%
|
Secondly, the study measured the outcomes,
both in relief of pain and quality of life, for each restenosis
risk group level, separating them into treatment with CABG or PCI
(angioplasty). The study found no difference in patient-perceived
outcomes between angioplasty and surgery in the low restenosis
risk group, so here the less-invasive angioplasty or PCI was the
clear winner because of the reduced recovery time, cost, etc. However,
the intermediate group showed significantly better outcomes in
terms of pain relief for the patients who had bypass surgery, with
the difference even more pronounced in the high risk group. By
the way, 83% of the PCI patients received stents, but they were
bare metal stents -- the study used patient data from 1999-2000.
So while this report may be very helpful
in stratifying patients for the proper treatments, here's why it's
a candidate for my SLOW classification (that's SLOW: Study Limited
to Old Ways)
-- it's now 2005; these data are from six years ago and pre-date
drug-eluting stents. Both brands of drug-eluting stents now approved
in the U.S., the TAXUS and the CYPHER, have been shown to reduce
restenosis by something like 60-70% -- i.e. restenosis rates that
approached 30% are now down to single digits. Preliminary studies
on diabetics alone show even greater reductions in restenosis rates.
So theoretically the point-scale criteria have changed with the
advent of a new technology because diabetics may no longer warrant
a four point score, etc.
If the drug-eluting stent studies presented
to date are correct, use of these devices would significantly change
the percent of risk in the above table, bringing all of the
intermediate and at least half of the high risk populations
down into the low risk category, and thus making PCI a better alternative
to far more patients. The key word is, of course, "theoretically".
Until actual studies are done, we won't know. But by the time a
study of drug-eluting stents vs. CABG is completed, there will
probably be another new technology, rendering it obsolete as well.
Not that I am in any way saying that the
study in Circulation is obsolete -- it's just SLOW....
The authors (John A. Spertus, MD et al from
the Mid America Heart Institute in Kansas City) are not unaware
of this and specifically discuss that their risk scale will be
of benefit in assessing which patients could be treated with less
expensive technology, i.e. bare metal stents instead of drug-eluting
types, which are currently 3-4 times as expensive.
Again I would apply the word "theoretically",
because show me an inrterventional cardiologist who will tell his/her
patient that they're going to save the insurance company a couple
thousand dollars by implanting a bare metal stent instead of the
latest and greatest drug-eluting stent that will reduce the risk
of reclosure by more than half. Just asking....
What I find very important in this study, however,
is that the measurements of success in the procedures were based
on the patients' perceptions of how they fared -- what their
quality of life was. As quoted in the AHA article, Dr. Spertus states, “This
is part of an overall push to re-craft health care to be more patient-centered.
By really starting to understand patients’ experiences, we
can be more attuned to providing the things that will benefit our
patients most.” Hear, hear!
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