In reply: The FREEDOM trial

In Reply: We appreciate the comments of Dr. Saeed and colleagues . As stated in our article, given that the patients included in the FREEDOM trial represent a select group with diabetes and multivessel coronary artery disease, they may not represent all patients encountered in a real-world setting. We highlighted that only 10% of the patients screened were included for randomization, which limits the generalizability of the results. Also, the overall patient population may not be at high risk, as evidenced by low mean EuroSCORE and SYNTAX scores and by the low proportion of patients with ejection fractions less than 40%. However, patients with left main coronary artery disease (even without diabetes) have been shown to have better outcomes with coronary artery bypass grafting than with PCI, although a head-to-head trial in a diabetic subgroup is currently not available. ^1,2 In addition, it is important to realize that the FREEDOM trial deals with stable angina; therefore, the results may not extend to patients with acute coronary syndrome wherein primary PCI remains the most feasible option in most cases.

Diabetes mellitus is independently associated with complex, accelerated, and multifocal coronary artery disease. Therefore, outcomes after revascularization (with bypass grafting or PCI) are worse in diabetic patients than in those without diabetes. However, this association does not prove the superiority of PCI over bypass grafting.

As we stated in our paper, the FREEDOM trial did not clearly define the strategy for arterial grafts in patients undergoing bypass grafting. The mean number of coronary lesions in the bypass grafting group was high (mean = 5.74), but the average number of grafts used was only 2.9, and data were not provided on the use of sequential grafting and multiple arterial conduits. Lastly, it is true that the FREEDOM trial had relatively fewer patients (18.5%) that underwent off-pump bypass grafting surgery; however, this approach has never been shown to be superior in large randomized trials. ^3,4

In conclusion, no randomized trial should replace clinical judgment to define the targeted revascularization strategy for an individual patient. Rather, results from the FREEDOM trial should help support clinical decision-making in the context of the patient and the institution.