Category Archives: Optimal Medical Therapy

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

Plavix and Aspirin After Stent: 8 Years Later – Is Longer Better?

plavix_and_stentNo one thought it would take quite so long to get this information, but in just a couple hours results from the Dual Antiplatelet Therapy (DAPT) Study will be presented at the American Heart Association Scientific Sessions 2014. The question to be answered: Is there a benefit to extending dual antiplatelet therapy (aspirin plus a thienopyridine, such as clopidogrel/Plavix, prasugrel/Effient, etc.) beyond one year after stenting?

This is a question asked back in 2006, during a special two-day FDA hearing, convened to discuss all known issues with drug-eluting stents and prompted by the “ESC firestorm” over the problems of increased incidence of late stent thrombosis in drug-eluting stents. (See “Problems Resurface with Drug-Eluting Stents” – September 9, 2006.) Continue reading

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Filed under Antiplatelet Medications, Bare Metal Stents, Clinical Trials / Studies, Drug-Eluting Stents, Global Trends, Meetings & Conferences, Optimal Medical Therapy, Stent Thrombosis

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

Fractional Flow (Chart) Reserve

Flow Chart from Ad Hoc PCI Consensus Statement

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

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Filed under FAME I / FAME II, FFR, Non-Invasive Testing, Optimal Medical Therapy

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

Did I (Cough!) Say ACE Inhibitors? (Cough! Cough!)

Vasotec - ACE InhibitorA study in the current issue of The American Journal of Medicine confirms what we’ve been telling heart patients on Angioplasty.Org’s Patient Forum for a while now: a well-known side effect of ACE inhibitors is a dry cough. The provocatively-titled study is “Angiotensin-Converting Enzyme Inhibitor Associated Cough: Deceptive Information from the Physicians’ Desk Reference“.

It is a provocative article because of the word “deceptive” in the title: the word indicates that patients and physicians are not being adequately informed about the incidence of a side effect of ACE inhibitors: the cough. And is that ever the case! Continue reading

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Filed under Clinical Trials / Studies, Optimal Medical Therapy, Patient Alert, Patient Experience, Patients

Plavix After Stents: How Long?

Dr. Eric Topol

Dr. Eric Topol

I recently interviewed Dr. Eric Topol for Angioplasty.Org about current efforts to determine the optimal duration of dual antiplatelet therapy (a.k.a. DAPT or clopidogrel plus aspirin) after drug-eluting stent placement. My first question was what had we learned about this issue since the 2006 FDA stent safety hearings? And his answer was “Unfortunately, we don’t know anything more…“.

Sort of shocking. A major study was supposed to come out of those hearings, but the DAPT study just began recruiting last summer and won’t be completed for four years. This massive study, sponsored by all the major stent makers, as well as the manufacturers of antiplatelet meds, will enroll 20,000 patients and test them at 12 and 30 months to determine the rates of MACCE (death, heart attack and stroke) stent thrombosis and major bleeding complications. It will be performed with all drug-eluting stent brands and will not compare one to another. What will this teach us? Dr. Topol has an opinion about the DAPT study:

“The notion that we should treat all patients for X duration is totally crazy. It completely goes against all the evidence that every patient is an individual with a separate biologic story, and a risk of bleeding. And then there is obviously a big expense. The drug companies would love it to be 30 months or 30 years. But to try to generalize from a trial like that, I’m amazed that it’s going forward.”

Dr. Topol (who, by the way, was an invited panel member at those 2006 FDA hearings) is currently Director of the Scripps Translational Science Institute (STSI) where he is conducting research on the genomics of coronary artery disease. The bottom line is that all patients are not the same — and they respond to antiplatelet therapy differently. So Dr. Topol believes that the “one-size-fits-all” concept of thrombosis prevention just doesn’t apply.

Another concept is that all drug-eluting stents aren’t the same. Because of the metal structure, polymer coating or drug itself, each device has different characteristics and different healing properties. This was seen clearly in the ODESSA trial, where Dr. Giulio Guagliumi used OCT intravascular imaging to measure stent coverage at six months. He found significant incomplete coverage in the CYPHER and TAXUS stents, but complete healing in the ENDEAVOR.

As a result of these findings and other clinical data, two trials, involving only Medtronic’s ENDEAVOR stent, are currently starting up: SEASIDE, which Dr. Topol is involved in, will measure the outcomes of patients who receive and only get six months of DAPT; and OPTIMIZE, being conducted in Brazil by Dr. Fausto Feres, which is stopping DAPT at three months.

Rather than testing if DAPT is more effective at longer durations, such as 12 and 30 months, these studies are testing to see if it is just as effective at shorter periods, when used with a DES that has a greater healing profile, like the ENDEAVOR. The advantages of a shorter DAPT duration are several:

  • less risk of bleeding complications (inherent in the use of antiplatelet drugs);
  • less cost (Plavix costs $4/day — the difference of a year or two is significant — newer antiplatelet drugs like prasugrel cost even more);
  • less problems deferring surgery (in order to perform surgery of any sort, for example knee replacement, etc., antiplatelet therapy must be stopped).

The short back story here is that when drug-eluting stents first came on the market in 2003-2004, the FDA recommended six months of DAPT to keep the blood from clotting in and around the stent (a.k.a. stent thrombosis). Within a couple of years, reports surfaced about a small number of patients who suffered late stent thrombosis (six months or more after stenting). A flurry of concern arose and the 2006 FDA stent safety hearings resulted in recommendations to extend DAPT to 12 months or more — the current guidelines. But, as Dr. David Kandzari, co-principal investigator for the SEASIDE trial told Angioplasty.Org:

“Current treatment guidelines are based principally on consensus opinion and intuition rather than hard evidence that extending DAPT reduces the risk of late and very late ST. In fact, in more recent trials, patients experiencing very late ST are more commonly on DAPT than off.”

Dr. Kandzari explores this issue in detail in his Viewpoint article in December’s JACC: Interventions, “Identifying the ‘Optimal’ Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Revascularization

For more information, read my interview with Dr. Topol and keep up with the latest news in our StentCenter.

 

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Filed under Antiplatelet Medications, Clinical Trials / Studies, Drug-Eluting Stents, Imaging, Innovators, Interviews, Optimal Medical Therapy, Stent Thrombosis