Letters To The Editor

The FREEDOM trial

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To the Editor: We would like to raise the following points about the paper by Dr. Aggarwal et al1 interpreting the Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) trial.2

The patients enrolled in the FREEDOM trial do not in our opinion completely reflect the real patients that we meet in our daily “real-world” practice.2 The patients in the FREEDOM trial did not have a high-risk profile. Rather, the mean European System for Cardiac Operative Risk Evaluation score (EuroSCORE) was 2.7 ± 2.4 in the percutaneous coronary intervention (PCI) group and 2.8 ± 2.5 in the coronary artery bypass grafting group—whereas a score of 5 or more on the EuroSCORE is associated with decreased rates of survival.2

Furthermore, patients with left main coronary artery stenosis were completely excluded from the FREEDOM trial,2 but this type of stenosis, with different grades, is found in about 30% of diabetic patients with multivessel coronary artery disease, a fact that may significantly influence the decision regarding the revascularization strategy (bypass grafting or PCI), especially in a clinical setting such as acute coronary syndrome.3–5

In addition, the authors did not clearly highlight that diabetes mellitus is an independent risk factor for coronary lesion progression, coronary bypass graft occlusion, and cardiac mortality after bypass grafting surgery.6–8 Clinical outcomes after bypass grafting in diabetic patients are worse than in nondiabetic patients; diabetic patients have higher rates of morbidity (deep sternal instability, wound infection, stroke, renal dysfunction, and respiratory problems), longer intensive care unit and hospital stays, and poorer postoperative physical functioning and quality of life.6–8

The authors correctly explain the reasons for the superiority of coronary artery bypass grafting vs PCI in diabetic patients, either by the ability to achieve complete revascularization or by using more arterial grafts, and especially the left internal thoracic artery.1 However, clarifying details on the strategy of revascularization in the FREEDOM trial are scarcely provided.2 All we know from the provided details in this regard is that “for CABG surgery, arterial revascularization was encouraged” and 94.4% of the patients undergoing bypass grafting received left internal thoracic artery grafts.2

In addition, whereas off-pump coronary artery bypass grafting surgery is superior to conventional bypass grafting in terms of lower rates of death and major adverse cardiac and cerebrovascular events in diabetic patients with multivessel coronary artery disease,3 only 165 (18.5%) of the 893 patients who underwent bypass grafting in the FREEDOM trial underwent an off-pump procedure.2,3

Therefore, all these considerations should be taken into account as the physician team discusses the therapeutic options (PCI and bypass grafting surgery) with diabetic patients who have multivessel coronary artery disease.

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