Do to an investigation carried out by the BBC that led to the withdrawal of EACTS support from the latest coronary revascularization guidelines, the authors of the EXCEL study (indicated by this research) provided the following answers.
-Defining Peri-Procedural Infarction:
All researchers involved (including surgeons) agreed that the universal definition of infarction was not right for this study. This was because the universal definition criteria are different for PCI and surgery. Furthermore, their association to prognosis has not been shown. The EXCEL protocol criteria are uniform, and they have certainly been linked to prognosis.
The BBC investigation claims the research criteria were modified, which is absolutely incorrect.
-Peri-procedural infarction rates were deliberately omitted:
Using the universal definition of infarction was one of the 35 exploratory secondary end points. The universal definition is based on troponins and, unfortunately, this data was missing in most patients. Therefore, there were no infarction reports using the universal definition criteria. Nevertheless, researchers were planning to report infarction rate according to multiple definitions, including of course the universal definition.
-All cause mortality rate was not emphasized enough:
All-cause mortality was a secondary end point and the sample had no statistical power to show anything. The modest difference in mortality between the groups was not adjusted, which made it impossible to draw any conclusions. Besides, mortality was caused mainly by sepsis and cancer several years after randomization, according to an events committee. A meta analyzis with 4394 patients from 4 randomized studies on PCI with DES vs. CABG (including the EXCEL) did no show differences in mortality at 5 years between the revascularization strategies.
Not even SYNTAX data at 10 years showed differences in mortality.
Unfortunately, the difference between all-cause and cardiovascular mortality was not mentioned in the BBC investigation.
-The safety committee issued alerts that were not taken into account:
The independent safety monitoring committee often followed up on raw data and suggested staying on track as planned, with no amends.
-The ESC/EAPCI/EACTS guidelines are not safe:
Guidelines are written based on a stack of evidence from multiple studies carried out by independent experts. The current guidelines (based partly on the EXCEL) suggest PCI can be considered a viable alternative for select patients with left main disease.
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