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January 2012 Archives:
January 27, 2012 -- 5:14pm EST Stent Pioneer Gary Roubin Leaving Lenox Hill
Interventional cardiology pioneer, Dr. Gary Roubin, is leaving Lenox Hill Heart & Vascular Institute in New York, where he has served as chair of Interventional Cardiac & Vascular Services for almost a decade. Dr. Roubin confirmed his departure to Angioplasty.Org and stated that he is "moving on to bigger and more challenging projects." Dr. Roubin's departure was first reported yesterday by Shelley Wood of theheart.org. Roubin told me that he feels he has "much more to contribute to the field of cardiovascular medicine", although looking through his list of accomplishments, one might think that difficult to top because so many of those accomplishments start with the word "First", as in: First abstract on balloon angioplasty in multivessel disease (with Andreas Gruentzig, inventor of the procedure); First balloon expandable coronary stent; First carotid bifurcation stent; First intracranial stent. And speaking of "Firsts", both Dr. Roubin and Lenox Hill figure enormously in the story of angioplasty and stenting. Lenox Hill Hospital is where, in April 1978, the First balloon angioplasty in the U.S. was performed by Dr. Simon Stertzer, on the same day that Dr. Richard Myler performed one at St. Mary's Hospital in San Francisco. And Lenox Hill is where I got involved in this field as well, when I made the First film (ever) on coronary angioplasty in 1979 with Stertzer -- and where I produced the First live demonstration course on the Sones approach to angioplasty. And, yes, Mason Sones himself was in attendance.
I subsequently traveled down to Emory Hospital in Atlanta to work with Dr. Andreas Gruentzig, the inventor of coronary balloon angioplasty, and there I met Gary Roubin, whom Andreas had recruited from Australia. A decade later, the very first coronary stent was approved by the FDA -- it was designed by Gary Roubin and radiologist Cesare Gianturco. Here's an early news report of Roubin's accomplishment:
As fate would have it, Roubin eventually wound up at Lenox Hill Hospital where, for the past decade, he has continued innovating and evangelizing for endovascular solutions to vascular problems -- in particular the use of carotid stenting and the multidisciplinary approach to vascular therapy, where surgeons, interventionalists and clinical cardiologists work together towards the same end: the best and most appropriate treatment for patients. He lectures all over the world on these and many other subjects and, never forgetting the lessons of the "master", he formed and still heads the International Andreas Gruentzig Society. In 2007, he and co-chair, Dr. Bernhard Meier, organized a wonderful and moving event to celebrate the 30th anniversary of the first angioplasty. Having worked closely over the years with Dr. Roubin, including producing a live course with him on carotid stenting (and so, as is the title of this blog, I have been "The Voice in His Ear") I can say that among his many accomplishments, angioplasty pioneer, co-inventor of the first FDA-approved coronary stent, etc., one of his most important contributions has been to carry forth the principles of Andreas Gruentzig in the treatment of patients, not just "blockages", in the care and accuracy of recording and reporting procedural outcomes and in the responsible use of this minimally invasive treatment of coronary artery disease. « permalink » « send comment » « back to top »
January 21, 2012 -- 8:05pm EST FAME II Is Not the "Anti-COURAGE": Stents and Angioplasty in the Spotlight
So is this, as several analysts have suggested, a reversal of the COURAGE trial results? Not according to the principal investigators of both the FAME II trial AND the COURAGE trial, whom I have spoken with in the past 48 hours. I will be posting an in-depth article in the next couple of days about this issue, which is extremely important to the interventional cardiology community. But suffice it to say that both Dr. William Boden, PI for the COURAGE trial, and Dr. Bernard De Bruyne, PI for FAME II agree that the two trials do not negate each other at all, because the patient populations are not the same. FAME II only enrolled patients who had ischemia, documented via Fractional Flow Reserve (FFR). In that population, PCI (a.k.a. stenting or angioplasty) was shown to be the best option. In COURAGE, a much broader patient group was enrolled, using angiographic evidence of blockage of 70% or more. FFR was not used. And in COURAGE, there was no difference in outcomes between patients who had PCI plus OMT, or those who had OMT only. The important finding here is that, when FFR is used as a guide to therapy, PCI is validated as the best option -- without question! But when visual imaging via angiography is the only diagnostic tool, the value of stenting can be debated -- as it has been in numerous controversial cases in Maryland (Dr. Mark Midei, etc.) and Pennsylvania and in many other hospitals. The conclusion, for us at Angioplasty.Org, is that FFR should be used as a mandatory part of all angiograms: in order to clearly document ischemia. Why subject the patient to a catheter-based procedure, with all of the possible adverse events that are seen, and not spend a few minutes performing an FFR measurement -- one which will validate the future course of therapy? Comments? « permalink » « send comment » « back to top »
January 18, 2012 -- 6:30pm EST Does FAME II Trump COURAGE? FFR: Key to Stents and Angioplasty
Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.
Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That's pretty big news! What about the findings of the 2007 COURAGE Trial which were interpreted to show quite a different picture: namely that in stable patients, stenting added nothing more than costs. Although those results were hotly contested by the interventional cardiology community and questions were raised about the inclusion criteria and other aspects of COURAGE, the study had a significant impact on the treatment of stable patients and the use of stents dropped precipitously over the next year. In fact anyone following "Stent News" for the past couple of years would see that the main issues in the headlines have to do with appropriateness of PCI, cardiologists accused of over-stenting, etc. So what is one to make of today's news? Is this a reversal of COURAGE? (And possibly a "reversal of fortune" for stent manufacturers?) The answer is well, sort of: not so much a reversal, but rather a refinement. The real answer has to do with something that I and Angioplasty.Org have been advocating and evangelizing about for years now: better decision-making tools. If you visit our "Intravascular Guidance Center", you'll see many articles on the issue of FFR and how its use can improve patient outcomes AND reduce costs at the same time. One of my most recent pieces is, "FFR: Why Isn't everyone Using It?" -- and that's a great question. And now it seems an ethical question, as well. So, back to COURAGE. In COURAGE, the decision to treat was guided by angiography alone, what Dr. Gary Mintz has called a "silhouette-o-gram." Patients with a 70% or greater blockage, as seen on the angiogram, were eligible for randomization to either OMT or to OMT plus PCI. The results showed no difference in outcomes between the two therapies, leading the medical community to conclude that stenting added nothing in the treatment of stable patients. I've often quoted the then-President of the American Heart Association proclaiming, "Hundreds of thousands of patients may be getting unnecessary stents." Got the picture? Two years later, Nico Pijls and his team showed in FAME that using FFR to measure the severity of the lesion, instead of angiography, led to 1/3 better outcomes and 1/3 less stenting! So FAME II was devised to mash up these two studies: in effect FAME II would be COURAGE using FFR to decide on stenting, rather than angiography. And the result? Well today's news shows pretty strongly that FFR-guided PCI is safer, better and, by extension, cheaper. It's also the opinion of many, including several Wall Street analysts, that these data are going to strengthen the interventional approach to the treatment of coronary artery disease. For example, Larry Biegelsen of Wells Fargo stated:
And Leerink Swann's Rick Wise wrote in a note:
FFR catheters are manufactured by two companies: St. Jude Medical (NYSE:STJ) and Volcano Corporation (NASDAQ:VOLC). The market is pretty much split 50/50 and this is great news for both companies -- Volcano's stock rose 6.75% today; St. Jude's was up 1.68% -- Volcano is a smaller company and FFR constitutes a much greater piece of their pie. Positive for companies, but what about patients? Well, as of right now, the use of FFR can help eliminate the concern over "unnecessary stenting". If the FFR shows a significant blockage in the artery (measured by the intracoronary pressure, and not guessed at by looking at a 2-dimensional shadow X-ray image) then the physician and patient can be reassured that stenting can be beneficial. Of course, this is very preliminary data and compiled analysis will not be presented until later this year at a cardiology meeting TBD. And the FAME II patients will be followed for up to five years. This follow-up data will be very important because it may (and I stress "may") show a mortality difference between PCI and OMT, when guided by FFR, that is. For now, I have a big question. If, as was announced today, the Safety Board judged that it would be unethical to continue randomizing patients to OMT alone, once FFR showed a significant blockage, is it "ethical" to be subjecting patients to invasive angiography and NOT use FFR? Did you know that FFR is used in less than 20% of cases? FFR is currently rated as a Class 1A decision tool in the European Guidelines, but only a Class 2A in the U.S. Perhaps these new data will provide the push needed to upgrade FFR as a treatment tool -- and then, most importantly, to fully reimburse its use: something that may clearly save money AND benefit patients. Sounds perfect, eh? Well, stay tuned.... « permalink » « send comment » « back to top »
January 17, 2012 -- 10:15pm EST AAA Stent Graft Revisited The AAA procedure is definitely more complex than a simple coronary stent procedure, and the catheter incision is larger. But refinements are occurring all the time. For example, today Medtronic received the CE Mark for its newest version of the Endurant II AAA stent graft, reducing the catheter size from 20F to 18F, and introducing other refinements.
But back to the patients. Kevin Morgan (who can be found on Twitter at @FitOldDog) received a stent graft a year-and-a-half-ago. Prior to that, he competed in Ironman triathlons. So, in case you thought that he might be slowed down by this medical condition, check out his blog, athletewithstent.com, where Kevin shares all kinds of thoughts about life after getting an AAA stent graft. And yes he has continued to compete. Now Kevin has launched a new website, "Old Dogs in Training", where he hones in on the whole issue of exercise and training for older folk. (By the way, Kevin is 68 and he notes with pride that he is the first AAA stent graft recipient in the world to finish an Ironman race...pride deserved!) Although Kevin Morgan is a stand-out example, there are many many patients who resume active lives, and become even more active, after a brush with coronary artery disease. Angioplasty.Org's Patient Forum hosts a Topic on "Exercise, Sport, Physical Activity After Stent" and a separate topic just on "Abdominal Aortic Aneurysm (AAA) Stent Grafts", one we started with Kevin Morgan. I urge all patients to browse through these stories, and to send in their own, in an effort to spread the word to others that a diagnosis of CAD or AAA does not necessarily signal an ending, but could be a new beginning...so much depends on how you approach it. « permalink » « send comment » « back to top » |
Last year at this time, I wrote about a patient who had been posting in our