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The FREEDOM trial
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.
- Aggarwal B, Goel S, Sabik JF, Shishehbor MH. The FREEDOM trial: in appropriate patients with diabetes and multivessel coronary artery disease, CABG beats PCI. Cleve Clin J Med 2013; 80:515–523.
- Farkouh ME, Domanski M, Sleeper LA, et al; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012; 367:2375–2384.
- Emmert MY, Salzberg SP, Seifert B, et al. Is off-pump superior to conventional coronary artery bypass grafting in diabetic patients with multivessel disease? Eur J Cardiothorac Surg 2011; 40:233–239.
- Perrier S, Kindo M, Gerelli S, Mazzucotelli JP. Coronary artery bypass grafting or percutaneous revascularization in acute myocardial infarction? Interact Cardiovasc Thorac Surg 2013 Aug 20 [Epub ahead of print]
- Sabik JF, Blackstone EH, Firstenberg M, Lytle BW. A benchmark for evaluating innovative treatment of left main coronary disease. Circulation 2007; 116(11 Suppl):I232–I239.
- Lu JC, Grayson AD, Jha P, Srinivasan AK, Fabri BM. Risk factors for sternal wound infection and mid-term survival following coronary artery bypass surgery. Euro J Cardiothorac Surg 2003; 23:943–949.
- Ji Q, Mei Y, Wang X, Feng J, Cai J, Sun Y. Impact of diabetes mellitus on old patients undergoing coronary artery bypass grafting. Int Heart J 2009; 50:693–700.
- Stevens LM, Carrier M, Perrault LP, et al. Influence of diabetes and bilateral internal thoracic artery grafts on long-term outcome for multivessel coronary artery bypass grafting. Eur J Cardiothorac Surg 2005; 27:281–288.
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.
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.
- Aggarwal B, Goel S, Sabik JF, Shishehbor MH. The FREEDOM trial: in appropriate patients with diabetes and multivessel coronary artery disease, CABG beats PCI. Cleve Clin J Med 2013; 80:515–523.
- Farkouh ME, Domanski M, Sleeper LA, et al; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012; 367:2375–2384.
- Emmert MY, Salzberg SP, Seifert B, et al. Is off-pump superior to conventional coronary artery bypass grafting in diabetic patients with multivessel disease? Eur J Cardiothorac Surg 2011; 40:233–239.
- Perrier S, Kindo M, Gerelli S, Mazzucotelli JP. Coronary artery bypass grafting or percutaneous revascularization in acute myocardial infarction? Interact Cardiovasc Thorac Surg 2013 Aug 20 [Epub ahead of print]
- Sabik JF, Blackstone EH, Firstenberg M, Lytle BW. A benchmark for evaluating innovative treatment of left main coronary disease. Circulation 2007; 116(11 Suppl):I232–I239.
- Lu JC, Grayson AD, Jha P, Srinivasan AK, Fabri BM. Risk factors for sternal wound infection and mid-term survival following coronary artery bypass surgery. Euro J Cardiothorac Surg 2003; 23:943–949.
- Ji Q, Mei Y, Wang X, Feng J, Cai J, Sun Y. Impact of diabetes mellitus on old patients undergoing coronary artery bypass grafting. Int Heart J 2009; 50:693–700.
- Stevens LM, Carrier M, Perrault LP, et al. Influence of diabetes and bilateral internal thoracic artery grafts on long-term outcome for multivessel coronary artery bypass grafting. Eur J Cardiothorac Surg 2005; 27:281–288.
- Aggarwal B, Goel S, Sabik JF, Shishehbor MH. The FREEDOM trial: in appropriate patients with diabetes and multivessel coronary artery disease, CABG beats PCI. Cleve Clin J Med 2013; 80:515–523.
- Farkouh ME, Domanski M, Sleeper LA, et al; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012; 367:2375–2384.
- Emmert MY, Salzberg SP, Seifert B, et al. Is off-pump superior to conventional coronary artery bypass grafting in diabetic patients with multivessel disease? Eur J Cardiothorac Surg 2011; 40:233–239.
- Perrier S, Kindo M, Gerelli S, Mazzucotelli JP. Coronary artery bypass grafting or percutaneous revascularization in acute myocardial infarction? Interact Cardiovasc Thorac Surg 2013 Aug 20 [Epub ahead of print]
- Sabik JF, Blackstone EH, Firstenberg M, Lytle BW. A benchmark for evaluating innovative treatment of left main coronary disease. Circulation 2007; 116(11 Suppl):I232–I239.
- Lu JC, Grayson AD, Jha P, Srinivasan AK, Fabri BM. Risk factors for sternal wound infection and mid-term survival following coronary artery bypass surgery. Euro J Cardiothorac Surg 2003; 23:943–949.
- Ji Q, Mei Y, Wang X, Feng J, Cai J, Sun Y. Impact of diabetes mellitus on old patients undergoing coronary artery bypass grafting. Int Heart J 2009; 50:693–700.
- Stevens LM, Carrier M, Perrault LP, et al. Influence of diabetes and bilateral internal thoracic artery grafts on long-term outcome for multivessel coronary artery bypass grafting. Eur J Cardiothorac Surg 2005; 27:281–288.