Saturday, April 12, 2008


At the just ended American College of Cardiology Annual Scientific meeting in Chicago, Dr Han Yaling, a prominent interventional cardiologist from China, presented the CREATE study. It studied 2077 patients who had a China made DES implanted. The China made DES is called EXCEL and has a biodegradable polymer, on a stainless steel platform. In fact, the Chinese also have a new generation, biodegradable polymer DES on a cobalt chromium platform. This study is interesting because, in 2006, at Barcelona, we learned that DES had a problem of late stent thrombosis. Many workers in this field believed that part of the reason for the late stent thrombosis may be the vessel wall reaction to polymer-coating on the first generation DES. So we were awaiting Dr Han's registry study to see if DES with biodegradable polymer will do well.

The results presented, for the 1 year follow up with 9 months angiographic follow up were , in short, too good to be true. When it was so good, the discussant, when discussing, agreed that the results were outstanding, but chose to comment that they doubt the consistency of events reporting. Dr Omiston, who was discussing, asked if the events were under-reported, because the clinical follow up data were not to his satisfaction. I suppose there is some truth there, that the 59 Chinese hospitals who took part in the study, were diagnosing AMI events clinically.

I wondered also whether first world countries, in the 21st century, have problem accepting good clinical research done in developing countries. By this we mean research originating in developing countries and not research run by white men where brown or yellow men take the risky medicine. One cannot deny that DES with biodegradable polymer may indeed do better, short term. My comment on the CREATE study would be that this study is great, showing that the EXCEL stent is good at 1 year, but surely, the test comes at 3-5 years. That is when we separate the good DES from the average, and the bad ones, at least as far as late stent thrombosis is concern.

Kudos to Dr Han and group for a good piece of work, but we need to wait another three years to really see if the EXCEL is as good as she says it is. In the meantime everyone deserves at least a fair hearing regardless of origin.

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