Study challenges CABG mortality benefits over stenting

A new registry analysis study is challenging the benefits of coronary artery bypass grafting over percutaneous coronary interventions using everolimus-eluting stents in patients with diabetes mellitus and multivessel disease.

Results from the 16,000+ patient analysis, published July 8 in Circulation: Cardiovascular Interventions, did not support previous results that suggested that CABG treatments resulted in lower mortality rates than PCI .

The analysis of New York State registry data aimed to examine the comparative effectiveness of the 2 treatments, and results opposed those of the 5-year 2012 Freedom trial. The 1,900-patient Freedom trial previously reported that the CABG arm had fewer adverse events and lower mortality rates than the PCI cohort.

“There was a debate after Freedom, mostly about the applicability of Freedom to what we do today. These trials take such a long time to be done and by the time you have the final results, the stents that were used in the trial are no longer used. So there is the question of how [the results] translate to current-day practice,” lead investigator Dr Sripal Bangalore told heartwire.

In the U.S. and Europe, CABG has a class 1 indication primarily based on data from the Freedom study, which reported a 30% lower mortality rate in those treated with CABG versus PCI.

“The reason it is a class 1 indication is that there was also a mortality benefit with CABG compared with PCI. We wanted to see whether there would be a mortality benefit if we compared CABG with newer-generation stents. The way PCI and CABG treat coronary artery disease is completely different, and I don’t think that at any point in time PCI would be better than CABG, but at least we might be able to bridge the gap between CABG and PCI with the newer stents,” Bangalore told heartwire.

The analysis found that PCI reduced mortality risk by 42% in the first 30 days, and reduced the risk of stroke by 86% after 30 days, compared with CABG. Mortality differences faded over the long-term, but PCI was still associated with a 24% lower risk of stroke, according to the analysis. However, PCI treatment resulted in a significantly increased risk of myocardial infarction over the first 30 days.

In the Freedom trial, PCI 5-year mortality rate was 16.3%, significantly higher than the 10.9% reported in the CABG arm.

“It was interesting in the sense that if you look at the primary end point of our study, which was all-cause mortality, there was actually no difference in mortality long-term. Freedom showed a mortality benefit with CABG, but we did not. Freedom also found an increased risk of stroke with CABG, and that’s exactly what we found in our analysis,” Bangalore told heartwire.

Freedom trial investigator Dr. Michael Farkouh of the University of Toronto told heartwire that he was skeptical of the results, and didn’t think they contradicted data from the Freedom trial.

“You need 4 or 5 years before the mortality signal emerges,” Farkouh told heartwire. “To me, this is completely consistent with Freedom. You have more MIs in the PCI group, more stroke in the CABG group, but mortality is the real driver, and the problem is you haven’t followed the people long enough for the mortality signal to emerge.”

Newer stents might be providing some advantage over the stents used in the earlier trial, Farkouh said.

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