In diabetes and multivessel CAD, CABG is still better than PCI.

 

CHICAGO - A presentation at the American Heart Association Scientific Sessions said that the last long-term follow-up report from the landmark FREEDOM trial confirms that patients with diabetes who have multivessel CAD live longer with CABG than with PCI with drug-eluting stents. The liberty Follow-On study, which followed up on 943 patients from the original FREEDOM trial for an average of 7.5 years, found that those who had CABG had a lower risk of dying from all causes and a higher chance of living compared to those who didn't. 1.32; 95% CI, 0.97-1.78), Valentin Fuster, MD, PhD, MACC, director of Mount Sinai Heart and doctor-in-chief of The Mount Sinai Hospital, said during the presentation. All-cause death for all of the patients in the cohort, which was followed for three years. Eight years had passed since the first trial, and the number of people who stuck with it longer in FREEDOM Follow-On was also lower with CABG vs. Fuster said that in the extended follow-up cohort, the survival factor for CABG was good for patients younger than 65 years old at the time of randomization, and there was a trend toward favoring CABG across subgroups.

 

Fuster said during the presentation, "In patients with diabetes and advanced CAD, CABG remains better than PCI with DES in reducing all-cause mortality at an eight-year follow-up." The results of the original FREEDOM trial, which were published in the New England Journal of Medicine in 2012 and presented by Fuster at that year's AHA Scientific Sessions, showed that CABG was more effective than PCI at reducing all-cause deaths, MIs, and strokes by a median of three. Eight years when compared to PCI with sirolimus- or paclitaxel-eluting stents in this patient population (18.7% vs. "The death rate in the PCI group was 16.3% and the death rate in the CABG group was 10.9%, with a P value of.049.," he said. During his talk, Fuster brought up his discussion of the problems with the original FREEDOM trial from his first presentation of the data in 2012. At one point, he said that for a disease that lasts a long time, 3.8 years of follow-up was a fairly short study.

 

He did find, though, that following up on coronary revascularization trials after five years is rare because there isn't enough money and it's hard to do. He said, "The goal of the FREEDOM Follow-On study was to look at long-term all-cause mortality in patients with diabetes and multivessel infection who took part in the FREEDOM trial." Twenty-five facilities with 943 patients agreed to take part in FREEDOM Follow-On. This is 49.6% of the 1,900 people in the cohort. "Rather, these are 25 institutions that have agreed to adopt outpatients in a randomized way," he said. Even though FREEDOM Follow-On was made to deal with the problem of shorter-term follow-up in the specific trial, Fuster said that this long-term study did have some problems. "After the freedom trial, newer types of stents were made," he said. Fuster also said that the evaluation of FREEDOM Follow-On did not include information about revascularization or unusual endpoints, such as MI and stroke.

 

Alice K. Jacobs, MD, from Boston University School of Medicine and Boston Medical Center, said that there are a lot of things to think about when judging or reading the quality of a randomized medical trial. For example, you should think about whether the question is important and new, the layout, the size of the sample, the endpoints, the conclusions, and how you can use the results. "The question is important in FREEDOM, but it's not new," she said at some point during a talk about the freedom Follow-On effects. She also said that the design could be biased because only about half of the original cohort took part in the long-term follow-up study. But this is lessened by a number of things, like the fact that the follow-up was done with facilities and not with patients, says Jacobs. Jacobs said that the study might not be strong enough in terms of sample size, but that this problem is lessened by the fact that the information from FREEDOM Follow-On participants was similar to that of the whole cohort.

 

She also said that the liberty effects are important and help with modern science. "The long-term results of FREEDOM add to the existing evidence that CABG is the best treatment for people with diabetes and multivessel CAD," Jacobs said. "It's not clear if the constant change of the DES era will lessen the benefits of CABG, but it seems less likely if the success of CABG is mostly due to the myocardium's safety against new diseases. LBS.06: Late Breaking Clinical Science in Coronary Revascularization, by Fuster V., et al. Presented at the American Heart Association Scientific Sessions, which were held in Chicago from November 10-12, 2018. J Am Coll Cardiol. Farkouh ME, et al. Disclosure: Fuster studies no related financial disclosures. Jacobs, she has gotten help with her studies from Abbott Vascular. The freedom Follow-On data back up our recommendations and suggestions that surgical revascularization is better for patients with diabetes and multivessel infection in the long run. I think this is especially true for this group, since 98% of them had left anterior descending artery disease. It is very important for these people to be able to get an artery bypass to the LAD. We think that the fact that almost all of these people had LAD disease is one of the most important factors in how well they do in the long run. If the patients didn't have LAD disease, the results could have been a lot closer. FREEDOM Follow-On is a long-term look at the results of a well-done study. Some criticisms could also be based on the fact that 50% of patients stayed in the long-term study. With third-generation stents, some people might say that our methods have changed. But I think the training is pretty stable, and those findings will keep our tips from changing.

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