Randomized Comparison of PCI With CABG in Diabetic Patients
Objectives The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease.
Background CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization.
Methods The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available.
Results At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p = 0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p = 0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p = 0.82), respectively.
Conclusions The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154)
Diabetic patients make up at least one-fourth of all patients referred for revascularization. Their risk of complications from all types of revascularization procedures are higher than that in patients without diabetes, and their long-term prognosis is worse. The pattern of coronary artery disease in diabetic patients is often complex, with multiple lesions and widespread disease, making effective revascularization difficult.
The BARI (Bypass Angioplasty Revascularization Investigation) compared percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel disease, with a primary end point of mortality at 5 years. The analysis of the subset of 353 diabetic patients showed that after 5 years of follow-up, patients initially treated with PCI had double the mortality of those randomized to CABG. CABG was already established as the standard revascularization strategy in nondiabetic patients with left main stem coronary artery disease or 3-vessel coronary disease and impaired LV function, and the BARI subgroup results led to this being extended to all patients with diabetes and multivessel disease. However, the BARI was conducted before bare-metal stents (BMS) and glycoprotein IIb/IIIa inhibitors were available. In addition, PCI has evolved further with the introduction of drug-eluting stents (DES) and new oral antiplatelet strategies There have also been developments in surgery, including increased arterial revascularization and off-pump techniques, but their impact on outcome has been less dramatic. In the context of the continuing refinement in treatment strategies and an increase in the number of diabetic patients requiring revascularization, there is a need to continually assess the role of contemporary PCI compared with CABG. Accordingly, the CARDia (Coronary Artery Revascularization in Diabetes) trial was undertaken to compare PCI plus stenting with CABG in patients with diabetes and multivessel coronary artery disease.
Abstract and Introduction
Abstract
Objectives The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease.
Background CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization.
Methods The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available.
Results At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p = 0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p = 0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p = 0.82), respectively.
Conclusions The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154)
Introduction
Diabetic patients make up at least one-fourth of all patients referred for revascularization. Their risk of complications from all types of revascularization procedures are higher than that in patients without diabetes, and their long-term prognosis is worse. The pattern of coronary artery disease in diabetic patients is often complex, with multiple lesions and widespread disease, making effective revascularization difficult.
The BARI (Bypass Angioplasty Revascularization Investigation) compared percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel disease, with a primary end point of mortality at 5 years. The analysis of the subset of 353 diabetic patients showed that after 5 years of follow-up, patients initially treated with PCI had double the mortality of those randomized to CABG. CABG was already established as the standard revascularization strategy in nondiabetic patients with left main stem coronary artery disease or 3-vessel coronary disease and impaired LV function, and the BARI subgroup results led to this being extended to all patients with diabetes and multivessel disease. However, the BARI was conducted before bare-metal stents (BMS) and glycoprotein IIb/IIIa inhibitors were available. In addition, PCI has evolved further with the introduction of drug-eluting stents (DES) and new oral antiplatelet strategies There have also been developments in surgery, including increased arterial revascularization and off-pump techniques, but their impact on outcome has been less dramatic. In the context of the continuing refinement in treatment strategies and an increase in the number of diabetic patients requiring revascularization, there is a need to continually assess the role of contemporary PCI compared with CABG. Accordingly, the CARDia (Coronary Artery Revascularization in Diabetes) trial was undertaken to compare PCI plus stenting with CABG in patients with diabetes and multivessel coronary artery disease.
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