Optimal Medical Therapy with or without PCI for Stable Coronary Disease

[viostorm]

I could really use some insightful discussion of this article if you all would be intrested. What exactly is this saying and how does it apply to managment.

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Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D., Robert A. O'Rourke, M.D., Koon K. Teo .........

Volume 356:1503-1516 April 12, 2007 Number 15

ABSTRACT

Background In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.

Methods We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).

Results There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).

Conclusions As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov] .)

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[turkleton]

Probably would need a cardiologist to back this up, but when I read this a few months, I'd say this falls in the category of landmark trial mostly because of the overwhelming number of cath cases which are for stable angina.

Basically, what the COURAGE trial suggests is that for chronic stable angina- therefore not ACS, STEMI- there is no benefit on mortality, or CV endpoints in treating a patient with aggressive, optimal medical management (BP <140/90, LDL <70, A1C at 7, anti-smoking and a few others) versus optimal medical management PLUS taking the patient to cath and placing a stent in the diseased artery. That's huge.

Now I've heard several criticisms of this trial, particularly the sample size versus the initial screening pool, the real life difficulty in achieving the "optimal" medical management w/o a dedicated research nurse etc etc and I'm sure people will chime in. There is also the issue of initial symptomatic improvement of angina, but the medical arm catches up in 5 year f/u.

Regardless, I think this was interesting stuff, and I'd be curious to hear the interventionalist and non-interventionalist take on it. How will this change our practice? How will this change our w/u of new stable angina? Do we no longer take the high risk people directly to cath?

 

[JayneCobb]

turkleton has it summed up nicely. It definitely emphasizes the importance of Optimal medical therapy for stable CAD. I think the key to catch here is that it appears that this trial was on those with STABLE CAD. It's yet another big hammer to use to hammer home to patients that they need to be compliant and that prophylactic stents do not seem to convey any benefit. And probably more importantly, since there is no obvious benefit, then this would be fiscally unsound to keep placing stents in asymptomatic patients.

But it lends itself to the question which was brought up at the end of the trial "Screening asymptomatic diabetic patients for coronary artery disease prior to renal transplantation." So, even if we screen all these people, what are we going to do about it and what effect will that have on M&M rates?

And very good article choice to bring up. For some reason NEJM isn't working for me, or I'd post the whole article so we could get a better feel of the methodology and look for potential sources for bias.