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
Forgive the perverse Shakespearean pun in the title but, as the Bard wrote: “What’s in a name? That which we call a rose by any other name would smell as sweet.” My topic is pretty much the polar opposite of roses, but the whole concept of labels and what we call things has become increasingly important. It’s one that I touched on in my post over last weekend about the impending CMS audits of stent procedures: namely, that the “official” terms used to describe treatment of a blocked artery are flawed when it comes to proper use of the English language.
The official “Appropriate Use Guidelines” place stent and angioplasty procedures into three categories: Appropriate, Uncertain and Inappropriate. Any patient, potential patient or, for that matter, anyone not steeped in the minutiae of interventional cardiology, would look at those terms and assume that any doctor putting a metal coil into someone’s heart when the procedure was labeled “uncertain” or “inappropriate” should be fined or fired or both. Continue reading
A major study of a half-million angioplasties, published today1 in the Journal of the American Medical Association (JAMA), refutes two major myths about angioplasty and stent use in the United States: myth #1, that angioplasty is vastly overused and unnecessary in most cases; and myth #2, that most angioplasty is used in stable patients and therefore has little or no benefit over drugs in reducing death or heart attacks.
Titled “Appropriateness of Percutaneous Coronary Intervention“, this paper is the first comprehensive look at how closely interventional cardiologists in the U.S. are adhering to the practice guidelines for PCI (angioplasty and stenting) most recently published by the professional cardiology and surgical societies in January 2009. Continue reading
A lost story this past couple of weeks has been an “admission” by the American Heart Association that the number of angioplasties performed in the United States is actually half of what the AHA has been saying all these years.
In their most recent 193-page Heart Disease and Stroke Statistics 2011 Update, published on December 15, the AHA now states that 622,000 percutaneous coronary interventions (PCI) were performed in 2007 (the most recent period for which stats have been compiled). Previously the AHA reported an annual volume of around 1.3 million — double the number. Continue reading
Monday’s 172-page Senate Finance Committee Staff Report on the overuse of coronary stents by Dr. Mark Midei at St. Joseph’s Hospital in Maryland has been all over the news — over 300 articles to date, claiming fraud, malpractice, pig roasts, threats to reporters — all of which serve to rekindle the “anti-stent” sentiment that followed on the heels of the COURAGE study back in 2007. In fact, Dr. William Boden, principal investigator for COURAGE, was interviewed for the Senate report, which characterized him as follows: Continue reading