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:

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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