Author + information
- Spencer B. King III, MD, MACC, Editor-in-Chief, JACC: Cardiovascular Interventions⁎ ()
- ↵⁎Address correspondence to:
Spencer B. King, III, MD, MACC, Saint Joseph's Heart and Vascular Institute, 5665 Peachtree Dunwoody Road NE, Atlanta, Georgia 30342
The advice to think about the big picture, but to act on the situation at hand, has been applied to politics, business, and other fields. It is also applicable in medicine. When we obtain evidence that seems globally compelling, how do we apply it to the local situation? ST-segment elevation myocardial infarction (STEMI) is a case in point. The guidelines on both sides of the Atlantic are very clear that primary percutaneous coronary intervention (PCI) is the treatment of choice; but when it is not available, it is useless to lecture about how it is to be done in all cases. Other approaches to local problems which exist in much of the world must be perfected, and there are many examples.
Often I find myself asked to give lectures on various topics including the choice of therapy for patients with diabetes. I have been interested in this subject ever since we saw a trend in favor of better outcomes with surgery in the EAST trial and were subsequently convinced by the BARI trial that this was a real problem for balloon angioplasty. As a member of the Steering Committee of the BARI 2D and FREEDOM trials, I have tried to explain how the evidence obtained should be used to inform practice. Sometimes practice changes and the global thinking is applied to the local situation, and sometimes not. Is failure to get with the guidelines always a failure?
I recently returned from the China Interventional Therapeutics (CIT) meeting in Beijing. Among my assignments were a couple of lectures on the choice of revascularization for patients with multivessel coronary disease and diabetes. PCI is exploding in China, as are many other things, but bypass surgery is not one of them. There are superb surgical centers in China but they are not widely distributed and, for many reasons, PCI is strongly favored by the physicians and the patients. I was keenly aware of that, but facts are facts, and the FREEDOM trial results are what they are. The various risk scores being developed to predict outcomes using the evidence we have, including FREEDOM and the diabetic subset of SYNTAX, point to the growing interest in including this data and in informed consent discussions. How should the 5-year actuarial data from FREEDOM—showing an expected mortality of 16.3% with PCI and 10.9% with coronary artery bypass grafting (CABG)—be used in determining treatment choices? The use of this global data will be modified by the local situation, but it cannot be ignored. (It is on the Internet for all to see.) Nuances about the trial and other data will continue to evolve, but that is not the point. We have evidence from a large international trial, and the question is: “what will we do with this evidence?”
As I discussed this issue with colleagues from China and elsewhere over beers in the bar, it became evident that the response to such evidence cannot be uniformly applied. Surgery for multivessel disease patients with diabetes is not going to become the standard of care in China in the near term. What is the reason? Is the evidence collected outside China valid for Chinese patients? Probably so. Are other advances such as second-generation drug-eluting stents or functional guidance of interventional procedures going to reverse the evidence? Hopefully these techniques will improve survival of the patients, but that is just speculation at this point. The real reason that surgery is not the default strategy for diabetic patients with extensive multivessel disease in China is the fact that CABG surgery is rarely performed in hospitals in China. Whereas making surgery the default strategy for such patients may be attractive in the locales that made up the global results of the FREEDOM trial, this will not be the case where surgery is not well established. It occurs to me that since the easy solution, i.e., “send them all to surgery,” is not going to happen everywhere, there is an opportunity to learn much from these “local” experiences. The fact remains that from BARI to FREEDOM, expert CABG surgery has set the gold standard for outcomes in diabetic patients with extensive coronary artery disease. In locales where PCI is to remain dominant for these patients, the challenge will be to replicate these surgical results. Can it be done with more careful selection, meticulous techniques, enhanced surveillance, or better secondary preventive therapy? I do not know, but the only way that we will know is for these patients to be carefully characterized in prospective registries with long-term follow-up. Is it a cop-out to advocate registries when many would say that a randomized controlled trial is the only way to establish whether therapeutic improvements are having an effect? Certainly randomized controlled trials are beginning to be performed in China, and there is rapid progress in the infrastructure to perform these studies. However, the surgical penetration outside of a few major centers will limit the application of evidence obtained to the real-world practice. It is conceivable that new knowledge of how to improve the outcome of diabetic patients will come from locales where default surgery is not available and where the “necessity” of challenging the gold standard of surgery is “the mother of invention” of new nonsurgical therapies. There certainly will be no shortage of subjects for this investigation as China and India vie for the dubious title of “diabetic capital of the world.”
- American College of Cardiology Foundation