Category Archives: COURAGE

COURAGE: Does 15-Year Data Have Any Clinical Relevance?

pills_vs_stent_140sqThis past week saw publication of an update to the 2007 COURAGE trial which compared optimal medical therapy (OMT) to stenting (PCI) as the initial management strategy for stable coronary artery disease. (Please note the phrase “initial management strategy.” This will not be the last time you see it in this post.)

Appearing in the New England Journal of Medicine and titled “Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease,” this study, performed by Dr. Steven P. Sedlis and other COURAGE trial investigators, is described as “an extended survival analysis to examine the potential long-term survival benefit from initial PCI among the patients with stable ischemic heart disease who were followed for up to 15 years after initial enrollment in the COURAGE trial.”

This new analysis concluded: “…we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease.” This also was the finding of the original COURAGE trial at five years. Continue reading

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Filed under Appropriate Use Criteria (AUC), Bare Metal Stents, Clinical Trials / Studies, COURAGE, Drug-Eluting Stents, FAME I / FAME II, FFR, Intravascular Guidance, IVUS, OCT, Optimal Medical Therapy, Stent

George W. Bush Gets Angioplasty and Stent – Was It Necessary?

George W BushFormer President George W. Bush received an angioplasty and stent this morning at Texas Health Presbyterian Hospital Dallas. The stent was recommended by Bush’s doctors to open a blockage in one of his coronary arteries, found yesterday during what was described by Bush spokesman Freddy Ford as his annual physical exam at the Cooper Clinic in Dallas. Continue reading

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Filed under Angiograms, Appropriate Use Criteria (AUC), Cardiac CT, Celebrity Patients, COURAGE, Drug-Eluting Stents, FFR, Imaging, Media Coverage, Non-Invasive Testing, Optimal Medical Therapy, Stent

USA Today Claims Stents and Angioplasty “Often Unnecessary”

Coronary StentYesterday’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

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Filed under Appropriate Use Criteria (AUC), Clinical Trials / Studies, COURAGE, FAME I / FAME II, Heart Attack, Media Coverage, Shared Decision-Making, Stent

Ad Hoc Angioplasty: The Patient Is On The Table

Cardiologist and patient in cath lab

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

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Filed under COURAGE, FAME I / FAME II, FFR, Heart Attack, History, Optimal Medical Therapy, Patient Empowerment, Patients, Shared Decision-Making, Stent

FAME II: Should Fractional Flow Reserve (FFR) Be Mandatory?

Should Fractional Flow Reserve (FFR) Be Mandatory?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

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Filed under Appropriate Use Criteria (AUC), COURAGE, FAME I / FAME II, FFR

Stents vs. Pills — Summer Re-run in February

Pills vs. StentI’m looking at this morning’s news and I’m seeing headlines like these: “Stents Overused in Stable Heart Patients” (WebMD), “Pills as good as stents for stable heart patients” (Reuters), “No Extra Benefits Are Seen in Stents for Coronary Artery Disease” (New York Times), and “Stents no better than pills for some heart patients” (MassDevice) — and I think I have time-traveled half a decade back to March 2007 when the results of the COURAGE study were presented at the American College of Cardiology Annual Meeting. Continue reading

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Filed under Clinical Trials / Studies, COURAGE, Media Coverage, Stent

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