Yesterday’s edition of USA Today carried an article by Peter Eisler titled, “Six common surgeries often done unnecessarily” — and, you guessed it, angioplasty and stents were at the top of the list of “six common surgeries that carry significant risks of being done without medical necessity, according to federal data and independent studies.”
I was a bit taken aback because I was not aware of any new study, federal or independent, that concluded stents were being vastly over-used. And it turns out that there wasn’t one. Continue reading
Click to enlarge flow chart
Best medical practices for angioplasty and stent placement are a moving target because no sooner than a guideline is published it can be changed by the results of a more recent study. And the SCAI Ad Hoc PCI Consensus Statement posted online just three days ago is no exception. Continue reading
Cardiologist talks to a patient “on the table” in cath lab
Something that is “on the table” is defined as an item that is “up for discussion.” And this week The Society for Cardiac Angiography and Interventions (SCAI) issued a consensus statement about the proper use of “ad hoc PCI” — and the patient was definitely on the table, up for discussion, part of the conversation.
Since we’re into definitions, ad hoc PCI is the scenario in which a diagnostic catheterization is followed in the same session by PCI (angioplasty and stents). And this is a common scenario: in New York State, for example, 80% of all angioplasties are done in the same session as the diagnostic angiogram, although the vast majority of these are emergency or primary angioplasties, where a patient in the midst of a heart attack (or close to it) is brought into the cath lab and the blockage is opened up, saving the heart muscle and possibly the patient’s life. Continue reading
Artist illustration of the iFR “Wave Free Period”
As previously reported on Angioplasty.Org, a new method for the functional measurement of intracoronary pressures and the severity of blockages has been developed by researchers at Imperial College in London. One of the main advantages of this new method, called Instant Wave-Free Ratio™ (iFR), is that, unlike standard fractional flow reserve (FFR), it does not require injection of a vasodilator drug, such as adenosine, to induce stress on the heart. The result is that the procedure is more comfortable for the patient and potentially useable in clinical scenarios where vasodilation is not feasible, such as acute coronary syndromes, infarctions, unstable patients, patients with breathing problems; it may also be somewhat quicker, easier to use, and more cost-effective. Continue reading
Earlier today, the opening day of EuroPCR, Dr. Bernard De Bruyne presented preliminary results from the FAME II trial which tested the diagnostic power of Fractional Flow Reserve to guide PCI (stenting) of the coronary arteries. I wrote about FAME II back in January, when enrollment in the trial was halted for ethical reasons because the results of the ongoing FAME II trial were showing that the outcomes for stents in patients with stable angina were clearly superior to those in patients who were being treated with medications (a.k.a. Optimal Medical Therapy or OMT) alone. An independent Data Safety Monitoring Board advised that continuing the randomization would not change the findings and so, it was unethical to withhold the option of stents from this patient population. Continue reading
There’s been much talk this week in the interventional cardiology community (and among stock market analysts) about stents and angioplasty, given the news that the FAME II clinical trial ended enrollment early, due to ethical concerns that were generated by the fact that patients randomized to Optimal Medical Therapy (OMT) alone were returning to the hospital in significant numbers for “urgent revascularization”, i.e. stenting!
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. Continue reading
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! Continue reading