Editor’s note: The embargo on FREEDOM was lifted early after a press release was published by mistake.)
Diabetics with multivessel disease do better with CABG than PCI, according to FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at the American Heart Assocation in Los Angeles and published simultaneously in the New England Journal of Medicine.
The study was designed to evaluate the relative worth of the two revascularization procedures in diabetics with multivessel disease. Although many studies, including BARI, ARTS, CARDia, and SYNTAX, suggested that CABG was more effective than PCI in this population, PCI has remained a popular procedure in this group. Now, many experts agreed here in Los Angeles, FREEDOM may well dampen enthusiasm for PCI in this group.
In the trial, 1900 patients were randomized to either PCI with a drug-eluting stent or CABG. After followup for at least two years the primary outcome– the composite of death, nonfatal MI, or nonfatal stroke– occurred more often in the PCI group. There were more deaths and MIs in the PCI group but more strokes in the CABG group:
Here are the 5-year event rates:
Composite endpoint: 26.6% in the PCI group versus 18.7% in the CABG group (p=0.005)
- Deaths: (16.3% versus 10.9%, p=0.049) but more strokes in the CABG group
- MI: 13.9% versus 6%, p<0.001)
- Stroke: 2.4% versus 5.2%, (p=0.03)
The results in favor of CABG were consistent across all the prespecified subgroups, including severity of disease as assessed by the SYNTAX score.
In an accompanying editorial, Mark Hltaky discussed the resistance of many cardiologists to accepting that CABG is superior to PCI in this patient population. Previous studies were dismissed because they were outdated, an argument that Hlatky labels “a catch-22, since long-term studies are needed to compare hard outcomes, but evidence from long-term studies may be ignored if therapies are evolving.” In particular, PCI advocates have proposed that the use of drug-eluting stents would close the gap between PCI and CABG.
Now, he writes, 17 years after the NHLBI issued a clinical alert based on the results of the BARI trial, FREEDOM “provides compelling evidence of the comparative effectivesness of CABG versus PCI.”
“The results of the FREEDOM trial suggest that patients with diabetes ought to be informed about the potential survival benefit from CABG for the treatment of multivessel disease. These discussions should begin before coronary angiography in order to provide enough time for the patient to digest the information, discuss it with family members and members of the heart team, and come to an informed decision.”
At an AHA press conference, David O. Williams said that FREEDOM “provides meaningful information to help” cardiologists choose the best therapy for their patients and that it will cause “a definite change in practice.”
At the same press conference, Alice Jacobs said that FREEDOM might result in CABG receiving a class 1 recommendation in the guidelines. Now, she said, “one would think long and hard” about offering PCI to diabetics with multivessel disease.
Mandatory YouTube Link for this trial:
Click here to read the AHA press release…