I’m in shock. Dr. Nortin Hadler of the University of North Carolina has proclaimed that the era of coronary angioplasty is over.
Poor, poor angioplasty…you were barely 36 years old, but you’re no longer needed. Guess we’re going to have to find a new name for our web site!
Of course, my first thought upon seeing this Op-Ed piece posted today on The Health Care Blog was that it was yet another article railing against the overuse of stents in patients with stable angina. Whenever I encounter this line of reasoning, I point to the fact that, according to the National Cardiovascular Data Registry (NCDR) 71% of the 600,000 angioplasties performed annually in the United States are done urgently: that is, for patients in the midst of a heart attack or acute coronary syndrome. Virtually every practitioner in the field of heart disease agrees that the gold standard treatment for ST-elevated Myocardial Infarction (STEMI) is angioplasty.
But, as I continued to read the article, I saw that Dr. Hadler’s premise is that angioplasty may not be necessary even in these severe cases, that clot-busting drugs could achieve the same outcomes at less expense and less risk for the patient. He spends most of his article discussing the recent STREAM study. I’ll get back to Dr. Hadler in a minute, but first a little background on STREAM, which I first heard presented at the American College of Cardiology meeting in March and which was subsequently published in the New England Journal of Medicine.
The STREAM (Strategic Reperfusion Early after Myocardial Infarction) study compared Primary PCI (angioplasty as the initial treatment for STEMI) with fibrinolytic therapy (clot-busters) followed by diagnostic angiography and, if deemed necessary, angioplasty — but non-urgent angioplasty, done up to 17 hours later. Almost 2,000 patients in 15 countries were enrolled in the STREAM study. Very importantly, these were patients who were not able to undergo Primary PCI within one hour after ambulance pickup or presentation at the Emergency Room.
In other words, these were patients outside the optimal therapeutic window in which angioplasty is known to be the best way to stop a heart attack. These were patients who were not near a PCI-capable hospital and had to be diagnosed at a local Emergency Department and then transported to a hospital with a cath lab. Half of these patients received clot-busters before transport. If they arrived at the PCI-capable hospital and the clot-busters had not opened up the blocked artery, they underwent urgent angioplasty. This was the case in 36% of the clot-buster cohort. This is an important figure to remember when I get back to discussing Dr. Hadler which, I promise, will be in a minute.
The results of STREAM at 30-days were that there was no difference in outcomes for the two therapies. There was one difference actually: in the beginning of the study, older patients (over 75) in the clot-buster group experienced significantly higher rates of intracranial hemorrhage, a serious type of stroke caused by the drugs. Once discovered, the researchers halved the dose of the clot-busters and the excessive bleeding risk was lowered.
Are Reports of PCI’s Demise Greatly Exaggerated?
Yes. To say that the STREAM trial supports Hadler’s conclusion that angioplasty may be replaced by fibrinolytic therapy is completely incorrect. The population studied was very specific and excluded a significant number of STEMI cases (for example, those who could get an angioplasty quickly). Even the authors of the study wrote, “This trial was designed as a proof-of-concept study. All statistical tests were of an exploratory nature.” And, oh yes, the clot-busters didn’t work in 36% of the patients who received them.
An excellent commentary accompanying the study in NEJM was written by Dr. Deepak Bhatt of the VA Boston Healthcare System, Brigham and Women’s Hospital, and Harvard Medical School. In his editorial, titled “Timely PCI for STEMI — Still the Treatment of Choice,” Dr. Bhatt makes an important point: the clot-buster strategy was judged to be non-inferior. It was not better than PCI; it just was not worse. There was also the increase in intracranial hemorrhage in elderly patients, even though the dosage was altered during the trial (this is not news — elderly heart attack victims are rarely given clot-busters for this reason). Most importantly, why not strive “to design systems that allow patients to receive rapid PCI uniformly” since that is known to be superior?
These seem like obvious points. But instead Dr. Hadler seems intent on targeting angioplasty as an unnecessary and overused treatment and he makes over-the-top statements such as:
“If angioplasty, with or without stenting, was a pharmaceutical instead of a procedure (device), is there any regulatory agency that would license it without a randomized controlled trial demonstrating adequate efficacy?…If some august governmental body were to declare interventional cardiology and cardiovascular surgery for coronary artery disease a failed experiment that should no longer be supported, I would applaud and display the scientific basis for the shift in policy.”
Of course, Dr. Hadler, the author of a number of books and a highly respected academic clinician in the field of musculoskeletal disorders, quotes several other sources to support his opinion, and you should read his piece (and by all means post your opinion in the comments below). But my guess is that the millions of people whose heart attacks have been stopped by stents, who lives have been saved and who are able to live full and productive lives without the morbidity imposed on them by a severely damaged heart muscle, my guess is that they might have a somewhat different opinion.
Of course, Hadler’s article is just an Op-Ed on The Health Care Blog, certainly not the largest circulation journal — and I’m probably giving it even more readership by posting this on my blog. However, of more import and concern is the fact that Hadler recently provided the team at Bloomberg News (they have much much higher circulation) with some juicy anti-angioplasty thoughts for their series on over-stenting. (He seems to be one of the “go-to” sources on this subject.)
I’ll be writing soon and in more detail about the Bloomberg series, but I would like to point out that in two weeks, 12,000 interventional cardiologists from around the world will be gathering in San Francisco at the 25th Annual TCT meeting, where they will spend 5 days discussing studies, parsing data and attempting to refine the practice of interventional cardiology, without doubt one of the most data-driven specialties in medicine today. Unfounded pronouncements such as today’s obit for angioplasty not only insult this professionalism, but do a disservice to patients by dissuading or delaying them from seeking the most immediate and best treatment for their heart attack.
And such a delay can cost lives. And that’s not just my opinion….