Bypass scores over stents in diabetics with heart problems: FREEDOM trial

Diabetics with multiple clogged heart arteries have a long-term survival if they undergo bypass surgery rather than getting their blood vessels reopened with stents, according to a new study published in the Journal of the American College of Cardiology and subsequently presented at American Heart Association's annual meeting, in Chicago.

Patients treated with coronary-artery bypass surgery survive about three years longer than those who have their blood vessels propped open with stents.

The findings are the final long-term follow-up to the landmark FREEDOM trial. (FREEDOM stands for Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease).

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Valentin Fuster, director of Mount Sinai Heart in New York City, and colleagues conducted the study to determine whether coronary artery bypass grafting (CABG) confers a survival benefit after an extended follow-up period.

That's important news for about one-quarter of patients now receiving stents, because they are diabetic with many blocked arteries and would benefit more from bypass surgery, said Dr. Fuster.

"It's a huge high-risk population in which we now can say much more categorically, we are affecting their risk of mortality," Fuster said. "This is not a trivial issue."

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In 2012, the first FREEDOM results showed that diabetics with many blocked arteries had fewer heart attacks and strokes and were less likely to die if they underwent bypass surgery instead of getting a stent.

The initial trial involved 1,900 patients who randomly underwent either stenting or bypass surgery between 2005 and 2010.

Twenty-five centers (out of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range, 0 to 13.2).

Key Findings:

• Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On).


• The all-cause mortality rate was significantly higher in the percutaneous coronary intervention with drug-eluting stents (PCI-DES) group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths].


• Of the 943 patients with extended follow-up, all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group.


• Both men and women and all races saw a survival benefit from bypass surgery, but the greatest benefit was in patients younger than 65.

"The results are quite significant in terms of mortality," Fuster said. "They're not borderline anymore."

Current guidelines already call for bypass surgery in these patients, said Dr. Michael Valentine, president of the American College of Cardiology.

"I think what this does is it solidifies our current recommendations and guidelines," said Valentine, a senior cardiologist at the Stroobants Cardiovascular Center of Centra Health in Lynchburg, Va.

Stents can clog over time, and don't address widespread hardening of the arteries in these patients, Valentine and Fuster said.

"The vessels stay open longer with an arterial bypass," Valentine said.

Fuster agreed. "When you use the bypass, you bypass everything. It is a safe mechanism. It is a pipe that overcomes everything," he said.

"In patients with diabetes and multivessel coronary disease (MVD), coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up," concluded the authors.

For further reference log on to 10.1016/j.jacc.2018.11.001