Optimal medical therapy

I was re-reading some of the details behind the recently announced COURAGE Trial comparing angioplasty/stent in 1100 people compared to "optimal" medical therapy in another 1100. You'll recall that no difference was found.

In particular, over approximately 5 years, 20% of participants in each group died, experienced heart attacks, or strokes. Of those treated with "timal" medical therapy, 32% ended up getting a procedure like stents or bypass anyway due to deteriorating symptoms.

What is "optimal" medical therapy? I bring this up again because the study investigators in COURAGE, as well as in similar trials, say this with a straight face. Optimal medical therapy means aspirin and/or Plavix (the anti-platelet, aspirin-like blood thinner); "aggressive" statin drug therapy to reduce LDL cholesterol to 60-85 mg/dl; and "anti-ischemic" therapy (that reduces angina and the phenomena of poor coronary blood flow) using nitroglycerin preparations, beta blockers, and other drugs.

I do give credit to the investigators for having the courage to perform this trial in a world hell bent on doing procedures and still reporting the neutral outcome. But the notion of "optimal" medical therapy begs for comment.

Indeed, this is regarded as optimal by most practitioners. Some would even argue excessive, based on the low LDL target achieved. Would you be satisfied with a 20% likelihood of heart attack, stroke, or death or 5 years, a 1 in 5 roll of the dice? I would not. Recall that we aim for near-total elimination of risk.

What could have been further "optimized"? Plenty. For instance:

--What is the real LDL, not the fabricated, calculated LDL? The two can be commonly 100 mg/dl different.

--How about raising HDL to 60 mgd/?

--What about reducing the proportion of small LDL particles? After all, small LDL is the number one cause of heart disease in the U.S., not high LDL.

--What is Lp(a)? If you treat LDL with a statin drug, Lp(a) is unaffected and continues to trigger huge plaque growth. You will fail if this is not identified and corrected.

--What is vitamin D3? One of the most powerful facilitators of plaque reversal I know of.

--What are triglycerides? Triglycerides create hidden particles in the blood like intermediate-density lipoprotein, potent triggers for coronary plaque growth. Speaking of intermediate-density lipoprotein, that's another very important pattern to identify, the after-eating persistence of dietary fats.

--Why aren't they taking fish oil? With a 28% reduction in heart attack and 45% reduction in sudden death from heart attack, this alone would have halved the number of "events" in the "optimal" medical treatment group.

Of course, there's more. But the idea that aspirin, statins, and anti-ischemic therapy is somehow optimal is silly and sad at the same time. But that's the bias. The COURAGE Trial does represent a step forward, a step away from the "stent everyone and everything" mentality that motivates my colleagues, aided and abetted by their co-conspirators, the hospitals. But you and I know better. "Optimal" medical therapy, in truth, can mean a far better approach that can dramatically reduce, perhaps eliminate, risks for events like heart attack. The conventional "optimal" medical therapy will suffice only if you're content with a 20% likelihood of heart attack, death or stroke, or a 32% likelihood of an urgent procedure in your future.

Comments (6) -

  • David

    4/9/2007 8:54:00 PM |

    A year ago I had what was termed  a "minor cardiac incident". An angioplasty procedure identified 95% blockage in one coronary artery (at the back of the heart), and another 35% blockage in another coronary artery. A stent was implanted in the back artery.
    Your observations on the COURAGE Trial has caused me to question my treatment decision. Does 95% blockage in one coronary artery represent a necessary condition for stenting, as opposed to say, following clogging prevention therapy and a diet regimen that includes fish oil and D3?
    There must be a certain point in plaque conditions beyond which intrusive treatment (ie a stent) is considered essential to survival.

    I appreciate your blog. It's provided lots of valuable informtion.

  • Dr. Davis

    4/10/2007 12:57:00 AM |


    The fact that you had what you called "a minor cardiac incident" might suggest that you did not fit into the criteria of the people who were entered in the COURAGE Trial, who had stable symptoms. I suspect that your "incident" means that you released "cardiac enzymes" into the blood, meaning that your artery may have closed momentarily. This is an entirely different situation, a blood clot driven event that is different than the disease we focus on with heart scanning (and reversal) and the COURAGE Trial.

    Nonethleless, now is the time to 1) identify your causes, and 2) correct them, so that it doesn't happen again. With conventional therapy, it will.

  • warren

    4/11/2007 1:46:00 AM |

    I have often wondered the same thing as david - I had what was described as a 95% blockage in the right coronary artery.  For me, what got me in to the doctor was shortness of breath while playing my regular racquetball partner or hiking uphill strenuously.  The rest of the time, I had no symptoms.  If I am correct, these were stable symptoms, right?  But in my case, the symptoms were interfering with my ability to exercise the way I want to exercise.  That was a few months ago, and I am back to my routine and symptom-free for now (and also following the Track Your Plaque program).

    I was given the choice, but the momentum of the system's bias pushed me forward toward having the stent put in.  Before going in for the angioplasty, I asked a lot of questions.  I never really asked if the procedure was necessary or would save my life - that was just assumed.  The questions and answers all revolved around what would happen if I needed a stent or an operation, the different types of stents, the concerns about re-clogging, and references to treating any blockages that were not stented afterward with medication.  

    Everything happened in one day - from the stress test to the angioplasty to the stent.  It was all quite dramatic and all the professionals were very concerned, and the sense I got was that this procedure was necessary to save my life and prevent the artery from closing up completely.  But when I look back, I realize that nobody ever really came right out and said so.  It was just assumed and implied.

    Dr. Davis, how do you feel about implanting stents in cases like mine, where the primary benefit is relief of stable symptoms?

  • Dr. Davis

    4/11/2007 12:08:00 PM |

    Hi, Warren--

    There are some issues here which allow me to comment only superficially on your situation, e.g., the actual appearance of your "blockage," over what period of time your symptoms developed, its pattern, etc.

    However, I will say that stenting is a superior way to obtain immediate relief of symptoms. That is probably the only substantial difference.

    As COURAGE showed and many of us suspected, stenting only prevents heart attacks as they occur, or are about to occur. Stable plaques without blood clot-promoting activity can usually be managed "medically." I have to give credit to the investigators in COURAGE for using the lame tools they did in the "optimal medical therapy" arm and sticking to it. Personally, their brand of optimal medical therapy really makes me nervous because of its obvious and glaring inadequacies.

    Look on the bright side: Following the Track Your Plaque program makes another stent highly unlikely.

  • David

    4/16/2007 10:59:00 AM |

    In your reply to warren, you say "Stable plaques without blood clot-promoting activity ....". I'd appreciate your elaborating on what activity this refers to? From your blog, you've clearly provided valuable information on activity that promotes unhealthy plaque buildup, but "clog-promoting activity" is less clear (at least to me). TIA

  • Dr. Davis

    4/16/2007 12:53:00 PM |

    As lame as it seems, the decision about how actively a specific plaque is triggering blood clots is usually made by 1) the pattern of symptoms, with increasing or easy to provoke symptoms more likely to mean more blood clot-prone, and 2) the appearance of the plaque surface at time of angiogram. Occasionally, it can be made with examination of the plaque with intracoronary ultrasound.

    Unfortunately, these are observations that generally require your cardiologist's judgement. I am a big fan of providing people with tools for self-empowerment, but this is not something you can decide for yourself. Hopefully, you do it with the assistance of a trustworthy cardiologist.