Some European doctors recently backed away from the findings of a major study that found bypass surgery and stents are equally effective at preventing heart disease deaths when a major heart artery is clogged. There has been growing preference for stents as they allow for patients to recover far faster. Many still question, however, if stenting is as good as bypass surgery over the long run when the left main coronary artery is blocked. A medical association dropped new standards based on a English television show.
Reuters Health recently reported on this growing conflict within the medical profession. The EXCEL study followed almost 1,900 volunteers for five years, recently reported in the New England Journal of Medicine. Although stent death rates were a little higher than surgery (13% and 9.9% respectively), from the vantage of only heart disease, it turns out both were equally safe.
Major Organizations Advanced their Guidelines
As a result of the EXCEL study and two other studies, the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Medical Oncology (ESC) both changed their guidelines.
BBC News Spooks Some Physicians in Europe
However, a BBC Newsnight show covering the EXCEL study commented on a data leak revealing that if a “Universal Definition” is used to define a heart attack then stent recipients are 80% more likely to have one, hence making the surgery by far the favored choice. As it turns out, the EXCEL researchers used a popular standard for defining a heart attack—one developed by the Society for Cardiovascular Angiography and Interventions—but not the “Universal Definition” label, reports Reuters Health Gene Emery.
Concealed Data from the Study?
Apparently, Domenico Pagano, EACTS secretary general, felt that based on the information from the BBC, “Some of the results in the EXCEL trial appear to have been concealed.” Consequently, EACTS promptly advised doctors to ignore the updated guidelines for such patients. However, ESC didn’t budge and stuck with the new guidelines, noting that the data points were derived not just from EXCEL but also other studies.
The EXCEL Team Position
The entire EXCEL team, according to the Reuters Health reporting, stood by the Universal Definition benchmark reporting standard. This included the surgeons who actually conducted cardiac bypass feeling the term “was not suitable” for comparing the two techniques. As it turns out, the Universal Definition uses a very sensitive blood test for monitoring heart muscle damage—in fact, the test is so sensitive, reports Mr. Emery, it may detect minor damage done by the procedure itself. And many doctors disregard use of the test on patients undergoing stenting or bypass surgery.
Politics over Science?
The EXCEL study group was categorically emphatic that there wasn’t any concealment of any data. Rather, from this point of view, EACTS immediatly rejected the guidelines without even a probe for clarification. Literally, it would appear a television show made up their mind for them.
Because the Universal Definition necessitates heart attack assessment of data not consistently collective from study patients, the researchers suggested any data leaked to the BBC with the claim to show heart attack rates under the Universal Definition couldn’t be accurate.
Interestingly, Mr. Emery and the Reuters Health team attempted to get the BBC side of the story and to send the data they used to make their claims and they refused the request. It would seem like EACTS could take the time to meet with the EXCEL study team and collectively vet the data from the BBC.
Lead Research/Investigator of EXCEL Study
· Gregg W. Stone, MD, Columbia University
· Patrick W. Serruys, MD, Erasmus Medical Center
· Joseph Sabik, MD, Cleveland Clinic
· A Peter Kappetein, MD, Erasmus Medical Center