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November 17, 2009 -- 11:30pm EST PPIs and Plavix -- Confusion Reigns Supreme In the past a number of observational studies (namely from Medco and the Veterans Administration) have shown that patients who take PPIs and Plavix experience an increased risk of adverse events, such as heart attacks. However, other studies have shown no clinical effect. In fact it was only a short while ago that a panel of cardiologists, commented during this year's TCT meeting on the COGENT trial (COGENT examined the clinical results of taking Plavix with PPIs). The panel exclaimed quite pointedly that the COGENT study, a randomized clinical trial (not a retrospective observational study) was THE study that revealed the truth -- and that truth was that there was NO increase in adverse clinical events when PPIs were taken with Plavix. They even did a Colbert-like "wag of the finger" to the medical news outlets that published inflammatory headlines about the non-existent danger. So it was a bit of a shock to these and other cardiologists assembled at the American Heart Association Annual Scientific Sessions in Orlando to read today's warning from the FDA:
This warning also mentioned other drugs to be avoided when taking clopidogrel, such as esomeprazole (Nexium), cimetidine (Tagamet) and so on. In addition, yet another observational study about PPIs and Plavix was presented yesterday at the AHA meeting. This retrospective study, which looked at patient records from Mt. Sinai in New York, showed an increase in adverse events. These two provided a double whammy to the results of the COGENT trial.
The difference between a randomized clinical trial (RCT) and a retrospective observational study is an important one here in understanding the different results. An RCT is a carefully-designed scientific test of a hypothesis -- patients are randomized to two different treatments in a way that negates differences in ages, states of health, and other "confounding" data. An observational study looks at patient data that already exists. Attempts can be made to normalize the patient groups for comparison's sake, but the results are not necessarily accurate when measuring two treatments, for example. This is why the FDA normally requires that an RCT be done before a new treatment is approved. Observational studies, however, can point to possible problems, or can generate hypotheses for future randomized scientific trials. They can show associations, but not necessarily prove cause and effect. This is, in effect, what happened with PPIs and Plavix, and why the COGENT trial was done: to answer the questions raised by the early observational studies. Dr. Chet Rihal, director of the catheterization lab at Mayo Clinic put it another way (as quoted in HealthDay):
Indeed, one explanation for these different results is that patients who are having gastric distress and require Prilosec may be sicker or older patients, thus skewing the results of any observational study against the group taking PPIs -- they may have worse outcomes because they started off sicker or older -- and the worse outcomes are not "caused" by the PPIs. As for the FDA warning, which involves a label change to the drug clopidogrel, Dr. Cannon noted to me that it was more carefully worded, and did not claim that PPIs caused more adverse events, only that PPIs have been shown to reduce the antiplatelet effect, something that was shown in a small study last year, titled OCLA (Omeprazole CLopidogrel Aspirin) -- a study conducted by Dr. Deepak L. Bhatt, Cannon's colleague at Brigham and Women's in Boston. Dr. Cannon continues:
So should you stop taking your Prilosec or Nexium with your clopidogrel? Most doctors say no -- in fact suddenly stopping either medication could cause serious problems. However, you should call or see your cardiologist and ask him or her about these studies. Meanwhile the FDA has placed this issue on the agenda for the November meeting of its Drug Safety Oversight Board and HealthDay reports that new AHA/ACC recommendations on the use of PPIs with Plavix will be announced tomorrow (Wednesday) during the American Heart meeting. « permalink » « send comment » « back to top »
September 24, 2009 -- 11:45am PDT Prilosec and Plavix Together Again! This translates to an immediate and important message to patients: it is safe to take your Prilosec (and other similar drugs, such as Nexium, Prevacid and Protonix) with your Plavix! In fact, one of the reasons these two drugs have been prescribed together is that the PPIs can allay gastric problems and bleeding that may be a side effect of Plavix -- something which can have an important beneficial effect. The COGENT Study, subtitled "A Prospective, Randomized, Placebo-Controlled Trial of Omeprazole in Patients Receiving Aspirin and Clopidogrel" was just presented by Dr. Deepak L. Bhatt at the TCT 2009 meeting in San Francisco and there will be a full report of that study later on Angioplasty.Org. As I have reported previously, there have been a number of conflicting studies of this issue, one of the most recent being a major report from Medco Health, which was presented at the recent SCAI annual meeting. But this was an observational study -- large populations of patients were looked at via prescription records, etc. However, lacking a definitive trial, this and other studies have caused patients to stop taking these drugs together. So the panel of physicians at this morning's press conference was quite vocal and joined in a strong opinion that true scientific evidence can only be discerned in a randomized clinical trial (RCT). As Dr. Christopher Cannon stated:
More to come.... « permalink » « send comment » « back to top »
September 22, 2009 -- 1:20pm PDT SRO at the Wrist Angioplasty Seminar -- Transradial is Hot
Organizers have told me that Thursday night's satellite symposium on Transradial already has 400 people signed up. Transradial (wrist) angioplasty is performed 40-50% or more around the world, but less than 5% in the U.S. From the interest being shown, especially at this year's TCT, this situation will soon change...and more quickly than expected, I predict. For more information about the transradial technique, check out the "Radial Access Center" on Angioplasty.Org.
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September 17, 2009 -- 2:00pm EDT Angioplasty Comes Home to San Francisco So next week thousands of interventional cardiologists will gather in San Francisco for the TCT, the largest meeting about angioplasty, stents and related procedures in the world. It's usually held in Washington, DC, but this year, it's SF. But what most of these cardiologists don't realize is that they will be coming home -- "home" being where the first coronary angioplasties were done. Many know that Andreas Gruentzig performed the first PTCA (coronary angioplasty done in a cath lab from a small incision in the leg artery) in Zurich in September of 1977. But earlier in the year he spent time with Dr. Richard Myler at St. Mary's Hospital in San Francisco, doing intraoperative angioplasties, performed during open heart bypass graft surgery, as a way of testing whether his novel idea might work. The story below, told by Richard Myler and Maria Schlumpf (Gruentzig's assistant) -- excerpted from my documentary, "PTCA: A History":
Richard Myler went on to perform the first PTCA in the U.S. in his cath lab in spring of 1978 -- on the same day, Simon Stertzer performed the procedure in his cath lab at Lenox Hill Hospital in New York. The two later joined forces at the San Francisco Heart Institute where I had the honor of working with them to produce live demonstration courses. Back then a good audience was 500 cardiologists. Next week over 10,000 will come home to San Francisco! « permalink » « send comment » « back to top »
September 16, 2009 -- 6:25pm EDT Transradial Angioplasty at TCT « permalink » « send comment » « back to top »
September 15, 2009 -- 8:50pm EDT Drug-Eluting Stents: Looking Ahead The top cardiologists in the world will be presenting at the DES Summit, so anyone who sits through these sessions will come away with a rich understanding of the current status of these devices. We'll try to bring our readers the highlights of these sessions. But some of the major issues that will be aired are:
More next week.... « permalink » « send comment » « back to top »
August 22, 2009 -- 3:10pm PDT Drug-Eluting Stents: Looking Back
Quite so. After all, DES usage (at the time a $5 billion per year business) fell from 90% to 58% in a matter of months. Financial analysts were quite fixated on documenting those numbers. As were the discussions during subsequent cardiology meetings, such as the October 2006 TCT (see "Stent Wars Across the Atlantic: USA vs. Europe") reaching a peak in December at a special two-day Stent Safety Panel, convened by the FDA. I remember sitting in the hotel conference room in Gaithersburg, watching PowerPoint after PowerPoint about drug-eluting stent trial results, listening to the Swedish cardiologists present the SCAAR study which significantly ramped up fears about stent thrombosis, anecdotally referring to DES as the "death stent". I watched the executives and medical directors of the stent manufacturers being grilled by the FDA panel and saw panel members' incredulous reactions to the fact that there really wasn't very good data on long-term use of antiplatelet therapy or on "off-label" indications. I listened to the constant clacking of keyboards, as reporters from NBC, Wall Street Journal, New York Times instantly launched the speakers' words into cyberspace. I also testified to the panel on behalf of patients who were confused and scared about the "tiny time bombs" in their hearts. And I remember stopping Daniel Schultz, head of FDA's device division, in the parking lot and thanking him for convening this important meeting. So much for fond remembrances. Two weeks ago Daniel Schultz announced he was resigning his position "by mutual agreement". He'd been criticized for being too close to industry and with the change that's occurred in Washington, the FDA and...well, thank you very much, time to be on my way. (BTW, my observation at the 2006 Stent Safety Panel from the looks on the faces of the various industry execs, was that this had not been a happy pro-industry session!). However, some of the questions raised then have been answered (others not, but that's another column). The Swedish SCAAR Registry team totally reversed itself a year later (as predicted by Marty Leon and Gregg Stone). When longer time periods and more data were analyzed, there was absolutely no difference in mortality between drug-eluting and bare metal stents. (Sorry 'bout that!) Since the 2006 firestorm, two new 2nd generation drug-eluting stents have been introduced to the U.S. market (Abbott's XIENCE and Medtronic's Endeavor) promising greater efficacy and possibly increased safety. And the recent meta-analysis of DES and BMS in over a quarter of a million patients concluded:
In fact, David Kandzari now estimates that DES usage is back up -- now around 75% and will probably level off at 75-80%. But somehow we haven't been reading headlines about these reversals of fortune. I guess "About those tiny time bombs in your heart -- never mind" doesn't quite capture the headline writers' imaginations. Makes one pine for the good ol' days of 2006.... « permalink » « send comment » « back to top »
August 19, 2009 -- 5:45pm PDT FALSE: Stents Denied to Patients Over 59
Totally wrong! This lie has been circulated worldwide in an anonymous email and somehow has found its way into articles, such as the one mentioned, op-ed pieces, etc. and is clearly part of an organized campaign to scare elderly citizens into opposing health care reform. I am not going to get into the pros and cons of the overall plan here, but I do feel the need to publicize true facts over false rumors regarding stents and angioplasty.. The British National Health Service does not deny stents to patients over 59. This is an absurd claim, since it is specifically patients over 59 who are the prime beneficiaries of angioplasty, stents and interventional procedures. My sources are Dr. Peter Weissberg, medical director of the British Heart Foundation, as quoted in The Guardian, which states about the claim:
Also responding to this assertion was British Health Secretary Andy Burnham, who stated in an email to Dr. Hisham Rana's medical blog:
Stents and heart bypass surgery are fully available in the England, as they are and would continue to be in the U.S. It's possible that somehow, somewhere, someone picked up on a possible two-year-old hypothetical recommendation by the British National Institute for Health and Clinical Excellence (NICE) that drug-eluting stents might not be cost-effective. (We covered that topic in detail here -- and that recommendation was never adopted!) However, if you really want to discuss denial of health services, go to our Forum Topic titled, Financial Assistance for Plavix. Here you will read many stories from patients in the U.S. who received drug-eluting stents (most of them were insured for the procedure) but who were then denied reimbursement by their insurance companies for the recommended one-year-to-life prescription drug therapy of clopidogrel (Plavix) -- which is almost $1,500 annually. Many have stopped taking the drug because they cannot afford it. It is well-documented that premature cessation of antiplatelet therapy results in increased heart attacks and mortality. This is the true current status quo and to paraphrase the ophthamologist, "this situation in its present form might be lethal for you." « permalink » « send comment » « back to top »
July 29, 2009 -- 10:30pm PDT Is Radioactive Isotope Shortage an Opportunity
for CT Scans to Shine? Because of the two-part test and the various injections of technetium, etc., the test takes several hours to complete. The patient is also exposed to radiation. If the test is negative, the cardiologist assumes that there is no coronary artery disease (CAD), although there are definitely situations where false negatives can occur. If the blood flow to the patient's heart shows a deficit, then CAD is a prime suspect and the patient is usually sent to the cardiac catheterization lab for a diagnostic invasive angiogram and possible intervention (angioplasty or stent). The accuracy of the nuclear test is good, but 37% of patients sent for diagnostic angiograms show no disease -- indicative of a fairly high rate of false positives for the nuclear screening test, especially in women. Enter the Cardiac Computed Tomography Angiogram (CCTA).
Many in the imaging establishment have been using nuclear stress exams for many years, and the newer, more accurate CCTA has been fighting an uphill battle. But now, as reported in the New York Times, reactors in Canada and The Netherlands that produce technetium have shut down, for a while anyway, resulting in an emergency shortage of the isotope. The gravity of the situation is conveyed by Dr. Michael M. Graham, president of the Society of Nuclear Medicine -- “This is a huge hit,” he proclaimed to the Times. And Dr. Andrew J. Einstein of Columbia University College of Physicians and Surgeons pointed out that since this isotope is used to determine if a patient has a coronary blockage requiring an angioplasty or stent, those invasive procedures would be performed on some who did not need them. (He doesn't discuss the fact that this same isotope-based test sends many patients needlessly to the cath lab for an invasive angiogram -- a test that results in vascular complications about 3% of the time.) Nowhere in the article is the more accurate alternative test of CCTA mentioned. In fact, Dr. Einstein has been critical of CCTA in the past. Perhaps the shortage of technetium will drive more cardiologists to send patients for this newer test. Perhaps the diagnostic value of CCTA will be recognized as a result of the shortage of technetium. And it will shine...not glow... « permalink » « send comment » « back to top »
July 10, 2009 -- 1:50pm PDT Prasugrel / Effient Approved by FDA
Effient is manufactured by Eli Lilly and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd. Late Update: Here's part of the statement from the FDA:
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July 5, 2009 -- 4:30pm PDT Stents: An Insider's Look
Currently two main companies are developing this technology: Volcano Corporation of San Diego, and LightLab, based in Massachusetts. To learn more about the growth of this imaging technology, read my exclusive interview with Dr. Guagliumi. « permalink » « send comment » « back to top »
May 26, 2009 -- 5:45pm EDT Breaking News -- Texas Senate Passes Calcium
Scoring Bill Late update: Leaders of the Society for Heart Attack Prevention and Eradication (SHAPE) have issued a press release explaining how this legislation will benefit patients and reduce costs. They are urging Texas Governor Rick Perry to sign the bill into law « permalink » « send comment » « back to top »
May 26, 2009 -- 12:05am EDT Women's Heart Health at Stanford
One specific area where Dr. Tremmel recently has made changes, and this was the focus of our interview, was in the vascular access site she uses in catheter-based procedures. She notes that women have higher rates of bleeding complications than men when the femoral (groin) access site is used -- and it is used in more than 90% of procedures in the U.S. This increased bleeding risk prompted Dr. Tremmel to examine, learn and utilize the radial (wrist) approach to angioplasty. She now tries to perform 100% of her procedures through the wrist and, as a result, has had virtually no complications. More information about Women's Heart Health at Stanford can be found here. My full interview with Jennifer Tremmel can be found here. « permalink » « send comment » « back to top »
May 6, 2009 -- 4:05pm EDT Plavix PPI Study Released But a study released today at the SCAI annual meeting showed a greater than 50% increase in major adverse cardiac events in stent patients who were taking both clopidogrel and a PPI. The message was that PPIs have probably been over-prescribed for this particular patient population. The recommendation to patients was to consult their cardiologists, and not unilaterally change their drug regimen (and specifically not to stop taking Plavix -- early cessation of clopidogrel carries an increased risk of stent thrombosis which can lead to heart attack or death). The recommendation to physicians was to look more carefully at why each individual patient might or might not benefit from a PPI, but probably not to give it prophylactically -- and also to return to an earlier class of drugs, called histaminergic (H2) blockers (Zantac, Tagamet) or even common antacids. Of course, a reader of an earlier posting on this blog, D.B. who is a pharmacist in California, already figured this out for himself. Oddly enough, the incidence of gastrointestinal bleeding that required hospitalization was very low across the board, but numerically lower in patients who were not taking PPIs. « permalink » « send comment » « back to top »
May 4, 2009 -- 12:45pm EDT Effectiveness in Stenting
Huennekens' piece was titled, "Obama effectiveness proposal: a tool for finding faster, less expensive medical solutions? " and he details why he agrees with and supports President Obama's decision to study "comparative effective research" -- primarily because there are a number of ways that new technologies, many of them (of course) manufactured by his company, will be useful for interventional cardiology.
Another is Fractional Flow Reserve (FFR) which can measure whether or not a blockage seen to be significant on an angiogram is in fact obstructing blood flow, and how much. The recently published FAME study, detailed in our piece, "Better Outcomes for Stents When Fractional Flow Reserve (FFR) is Used", showed 28% reduction in major cardiac events when FFR was used to determine which blockages to stent and which to leave alone. Also one-third less stents were used: more effective therapy and more cost-effective too. We continue to cover other areas where the effectiveness of catheter-based therapy can be improved. Our Transradial Access Center details the ways in which bleeding complications can be reduced, just by changing the access site for diagnostic and interventional procedures. And we're closely following the use of other imaging modalities, like Cardiac CT angiography (CCTA) which shows promise in eliminating a significant number of invasive diagnostic caths by accurately ruling out coronary disease -- and Optical Coherence Tomography (OCT) which may help in determining stent strut coverage and whether it is safe for the patient to stop taking antiplatelet drugs, such as Plavix. Innovation in medicine may not only be cost-effective, it may be profitable as well. In an excerpt from The Wall Street Transcript's annual Medical Device issue, Matt Dolan of ROTH Capital Partners predicts that, counter to some companies, Volcano is looking at a continued growth rate of 20%. Very effective, indeed. (By the way, the photo posted with Scott Huennekens' op-ed on the Washington Times web site is NOT Huennekens, but Montana Senator Max Baucus -- go figure.... Huennekens is pictured correctly at the top of this article.) « permalink » « send comment » « back to top »
May 1, 2009 -- 4:30pm EDT Comparative Effectiveness Research and
The Patient But in the short term, here are a few quick looks. In March we posted an article about the SYNTAX study which compared bypass surgery to stenting in multivessel disease. The results were not a "yes or no", but more nuanced. Surgery was still the preferred treatment for patients with severe multivessel disease. But for patients with less severe situations, stenting was just as effective ("comparative effectiveness") -- in fact, the authors cited patient preference as an important decision factor. We quoted Dr. Elizabeth Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI):
This concept of a partnership between the patient and physician is echoed in an op-ed piece in today's Baltimore Sun by Ruth R. Faden and Jonathan D. Moreno. Titled "Power for Patients: Comparative effectiveness research will help people make better health choices", the article emphasizes the importance of patients' control over their treatment, but in tandem with their physicians, and based on the most current information:
We at Angioplasty.Org concur. Each month, 30,000 readers visit our Cardiology Patients' Forum, looking for the latest information to help them make complex decisions. We always encourage those readers who post questions to discuss the information they find with their physicians. One thing we have found, and this is backed up by research:
That is why, at Angioplasty.Org, all of our articles are available to all readers, whether patients or healthcare professionals -- to help foster the partnership that is so critical for "effective" treatment. Comparatively speaking, that is. « permalink » « send comment » « back to top »
April 21, 2009 -- 5:15am EDT CT Scans for Strokes It's an important topic, and one which Dr. Nick Hopkins, head of the Toshiba Stroke Center, discusses in more detail during our interview, posted in Angioplasty.Org's Imaging and Diagnosis Section. Stroke has been called a "heart attack in the brain". If only it were that simple. A heart attack is caused by a sudden stoppage of blood to the heart -- the treatment: open up the blockage. But strokes can have two different causes -- and the treatments for these two different types of stroke are totally opposite. An ischemic stroke, the "heart attack in the brain" type, is treated with clot-busting drugs, and/or a clot-retrieval device, threaded to the brain via a catheter, not unlike angioplasty. But the second type of stroke is caused by an aneurysm or other type of bleeding complication. Giving a clot-buster in this situation would be disastrous. Luckily, a CT scan of the brain immediately tells the physician which type of stroke the patient is having. And luckily again, CT scans can be done very quickly in an Emergency Department set up for this type of diagnostic procedure. Furthermore, as Dr. Hopkins points out, there's yet another advantage to the CT scan -- it also shows the viability of the brain tissue. If significant parts of the patient's brain tissue have died, attempting to reperfuse (increase circulation) in those parts may cause even worse complications, such as hemorrhage. The controversy detailed in Burton's article is over official guidelines for the use of CT, with implications for reimbursement. I won't get into the details, because you should read his piece, but this is just one more issue where advances in imaging, being able to see, have profound implications for being able to treat. « permalink » « send comment » « back to top »
April 18, 2009 -- 10:45pm EDT Plavix and PPIs: Update So earlier today reader D.B., a pharmacist in California, sent in this:
In fact, there are two recent updates. One is a study in the current issue of Thrombosis and Haemostasis, an official publication from the European Society of Cardiology. The article, "Impact of proton pump inhibitors on the antiplatelet effects of clopidogrel", shows a definite effect in the inhibition of clopidogrel's antiplatelet function when using omeprazole (a.k.a. Prilosec) but, interestingly enough, the other PPIs tested showed no such effect. However, it was a study that measured platelet reactivity and not clinical results, so the other PPIs are still not out of the woods. In fact an editorial in the same issue recommends against the use of PPIs with Plavix (clopidogrel) which goes against the recommendations of the American societies. The second update (or future update) may clear some of this up in a few weeks. New results from the Medco study are scheduled to be presented at the annual SCAI meeting in Las Vegas May 6-9, so we'll be reporting on that when it breaks. It will be interesting to see if guidelines and recommendations will change as a result. As for H2 blockers (like Pepcid) they were by and large replaced when PPIs hit the market. There is question how effective they are in this situation, and they also had some side-effects, but were never shown to inhibit antiplatelet drugs like Plavix. « permalink » « send comment » « back to top »
April 6, 2009 -- 10:00pm EDT Cardiology Sites Taking Notice of the Radial
Approach to Angioplasty and Stenting (PCI) This is interesting on several levels: one, this poll has been posted and open for voting on theheart.org considerably longer than previous polls; two, as of this morning (see graphic above) over 500 votes have been tallied from healthcare professionals who read theheart.org (this is a lot of votes for a typical poll on their site!); and three, the vote is 50/50! -- and has been so over the past couple of months, sometimes going up to 52/48 in favor of radial. This last point, the vote results, is even more interesting because the most recent data from the NCDR database shows that less than 3% of angioplasties done in the U.S. are done via the radial artery in the wrist; the mainstay of catheter-based procedures in this country remains the femoral artery in the leg/groin. (Not so around the world, where 50% or greater is the norm. In fact those cardiologists who are proficient with the radial technique tend to use it in 70-80% of their cases.) So if less than 3% of PCIs are done via the wrist, why is the vote 50/50? Is it because many cardiologists from outside the U.S. have been voting? Or is it because many cardiologists feel that radial should be the preferred access site -- but they just don't practice it themselves? Or, more likely, aren't trained in it? For two years now, Angioplasty.Org has been offering a special section on this technique, our Transradial Access Center, offering information to both physicians and patients about the advantages of the radial approach: less complications, greater patient comfort, cost-effectiveness, etc. And we've also been listing training opportunities, U.S. hospital centers where radial is practiced, interviews with key cardiologists who use it. And we've seen increasing interest in the radial approach as a result. In fact, today the weekly poll on another "professionals only" cardiology site, CRTonline.org, asks the question:
Only 64 votes have been cast at present, and almost half are saying "less than 20%", so it will be "interesting" to see how this goes as the week progresses. So...to you radialists out there, go vote!! Late Update: Alas! theheart.org has taken down its poll -- glad I got a screenshot of the final tally. Later Update: The poll at theheart.org -- is back online!
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Patients
taking Plavix (a.k.a. clopidogrel) -- and that would be all stent
patients -- sometimes experience a side effect of gastric upset,
heartburn or even bleeding. So they are given a Proton Pump Inhibitor
(PPI) with a brand name of Prilosec, Nexium, Prevacid or Protonix
to alleviate these symptoms.
So
earlier today I asked Dr. Christopher Cannon about this new study
(two months ago he stated in no uncertain terms that the COGENT study
proved that there was no increased risk for patients when taking
Plavix and PPIs). Dr. Cannon is the senior investigator of the Thrombolysis
in Myocardial Infarction (TIMI) Study Group, and has led some of
the most well-known practice-changing guidelines in the treatment
of heart disease He replied:
Breaking
and big news for heart patients: 
So
I'm standing outside of Room 120 at the TCT in San Francisco, where "
(Late
Update at 2:25pm): So many people in the corridor that TCT opened
up another room to handle the overflow. No one could get through
the radial crowd to get into the other meetings. The original room
held 130 people. Estimated total attendence: 375.)
There's
a long list of opportunities to learn about the transradial technique
(catheter access via the wrist) at this year's TCT meeting in San
Francisco. I've 
As
a companion to my last post "
This
past month has offered an odd bit of reminiscence about an object
of ongoing interest: the drug-eluting stent (DES). First a study
from Duke was published in 
A
false meme has been circulating that the British National Health
Service (NHS) denies stents to patients older than 59...and that
Obama's health care reform will follow the NHS guidelines. I first
read this ridiculous assertion in a 
The
standard cardiac test for a symptomatic patient, one experiencing
chest pain, is usually a 
The
test is visual: a direct look at the coronary arteries. The test
does not involves exercise and stress, that in some patients is difficult.
The test takes less than 15 minutes to prep and complete. And with
modern equipment operated by technicians trained in the latest low-dose
protocols, the radiation exposure is less than that of a nuclear
test. And then there is the accuracy: 99% negative predictability
-- if the CCTA show no disease, you have no disease.
After
a year-and-a-half of review, amid concerns over potentially serious
bleeding complications, the FDA today approved Eli Lilly's blood
thinner Prasugrel as a drug "to reduce the risk of blood clots
from forming in patients who undergo angioplasty" (it will be
marketed in the U.S. as Effient). Prasugrel will now be an alternative
to Bristol-Myers Squibb's Plavix, although the FDA approval comes
with a "black box warning" to physicians to be aware of
potentially fatal bleeding complications -- this warning would ostensibly
alert physicians to monitor patients carefully. 
It
remains to be seen what the availability of prasugrel will mean
for stent patients. Currently, patients receiving drug-eluting
stents are given Dual AntiPlatelet Therapy (DAPT) which is aspirin
for life and Plavix for a year or more. There have been a number
of studies regarding the optimum length for DAPT: some have shown
no benefit beyond six months, others indicate increased benefit
and protection against late stent thrombosis; one observational
study from the VA even noted that that there may be a "
I
recently talked at length with 
Dr.
Guagliumi reported results from the 
Back
in January, I 
Aside
from stents themselves, there's a whole toolbox of devices and techniques
that are candidates for "comparative effectiveness" in
that they may be able to increase the success of interventional procedures
-- or even target patients who need these procedures more accurately.
As Volcano Corp.'s CEO Scott Huennekens wrote in a 
Among
them is intravascular ultrasound (IVUS) which shows more accurate
information about stent placement and expansion than can be seen
on an angiogram. Last July Angioplasty.Org posted an article titled, "
More
than a billion dollars has been allocated to "Comparative Effectiveness
Research" in the U.S. Federal government's stimulus package,
yet the term continues to be confused with "cost-effectiveness".
They are not the same, and in an attempt to clarify the difference,
Angioplasty.Org will be posting a number of articles and interviews
in the near future about these issues: specifically how they impact
the field of interventional cardiology.
Two
months ago,