Small Trial Leads To Big Concerns

There has been this ongoing debate about percutaneous coronary intervention (PCI), be it balloons and/or stents. Is it truly being overused ? As cardiologists, are we too quick to jump to intervention ? As an interventionist,I can say without a doubt that in the throngs of a heart attack OR unstable angina( known as Acute Ischemic Syndromes) that prompt intervention is life saving. But what about those with chronic symptoms who are clinically stable? We've known from previous studies that such patients do fine on medical therapy. Enter the recent ORBITA trial. This was a small study comprised of 200 patients with clear-cut blockage in a coronary artery.All patients underwent intensive medical therapy for 6 weeks. In the 2nd phase of the study, they were randomized to undergo the real deal (stenting of the affected artery) or a sham procedure in which the artery was left alone.(without the patient's knowledge) The outcome in both groups was the same. There was no difference in symptoms of chest pain , or differences in exercise stress testing..

So should we leave behind a significant blockage that we discover by invasive testing vs. stent it since we are already there? Are we too quick to bring patients to the cardiac cath lab? What constitutes optimal medical therapy anyway? With multiple drugs come multiple risks and costs. Fortunately in my office we offer EECP which is a FDA approved treatment for coronary artery disease. This is a great adjunct to those on medical therapy.


The bottom line is that there are too many variables that this study fails to address. Expect to hear a lot of debate about this trial in the coming weeks and months.


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Howard Elkin MD