Category Archives: Clinical Trials / Studies

January 21, 2012 · 8:05 pm

FAME II is Not the “Anti-COURAGE”: Stents and Angioplasty in the Spotlight

Cath LabThere’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 →

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Filed under Clinical Trials / Studies, COURAGE, FAME I / FAME II, FFR

January 18, 2012 · 6:30 pm

Does FAME II Trump COURAGE? FFR: Key to Stents and Angioplasty

Fame II QuestionsPositive 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 →

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Filed under COURAGE, FAME I / FAME II, FFR, Stent

December 7, 2011 · 2:15 pm

A Stent By Any Other Name

Stent and RoseForgive 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 →

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Filed under Appropriate Use Criteria (AUC), COURAGE, Media Coverage, Stent

July 5, 2011 · 4:15 pm

Angioplasty and Stents Inappropriate Only 4% of the Time

Are Stents Appropriate?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 →

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Filed under Appropriate Use Criteria (AUC), COURAGE, Media Coverage

April 8, 2011 · 6:50 pm

Transradial Wrist Angioplasty RIVALs Femoral

Transradial procedureThe European cardiologists don’t understand all the fuss in the U.S. about wrist vs. groin, radial vs. femoral. They use the wrist artery for angioplasty, stents and catheter access at least half the time (many 80-90% of the time) and they can’t understand why, in the United States, it’s only used in 5% of cases.

That may be changing as a result of an important study presented this week at the American College of Cardiology Annual Scientific Session (the 60th! — Happy Birthday ACC — in 5 years you can qualify for Medicare, assuming it still exists!)

For a comprehensive review of the study, dubbed RIVAL (RadIal Vs. FemorAL Access for Coronary Intervention Study), read my article on Angioplasty.Org, “Angioplasty and Stenting from the Wrist Safe and Effective: The RIVAL Trial“.

There was some disappointment when the RIVAL results showed that one method was not superior to the other. You see, “radialists”, as they call themselves, are very evangelical about the advantages of the wrist as the access site for diagnostic and interventional procedures. (They call those doctors who dismiss the wrist and are “addicted” to the leg, “femoral-holics”.) So the title of this new study, RIVAL, is apt. Continue reading →

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Filed under ACC, Clinical Trials / Studies, Innovators, Transradial Approach

March 29, 2011 · 4:30 pm

Will a Heart Stent from the Wrist RIVAL One from the Leg?

Transradial angioplasty from the wristAt Angioplasty.Org, we are about to mark the fourth anniversary of our Transradial Access Center, where we have been evangelizing an approach used around the world for catheter-based diagnostic and interventional procedures: using the radial artery in the wrist for catheterizations and PCI (angioplasty and stents) instead of the femoral artery in the leg. It’s an approach that is used 50% or more of the time in other countries, but is still in the single digits (pun intended) here in the United States. You can read why the U.S. has been behind the curve in our many articles on the subject of the transradial approach.

But all this soon may be changing, if the results of an important study, being presented at this year’s American College of Cardiology meeting, support the investigators’ hypothesis: Continue reading →

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Filed under ACC, Clinical Trials / Studies, Interviews, Transradial Approach

March 23, 2011 · 6:50 pm

Smoking After Sex: A Double Heart Attack Risk?

The Bed by Toulouse-LautrecOkay. Now that I have your attention…. Sure, we all know that smoking significantly increases the risk of having a heart attack…but sex? Well a study, published in this week’s Journal of the American Medical Association (JAMA) looks at this topic, in an article titled, “Association of Episodic Physical and Sexual Activity With Triggering of Acute Cardiac Events“. And it’s a topic that a not insignificant number of readers writing into Angioplasty.Org’s Patient Forum are concerned about. Continue reading →

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Filed under Clinical Trials / Studies, Heart Attack, Patients