Clinical trials of stents versus CABG involving diabetic patients

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Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI)

The Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI) was one of the largest trials of PTCA versus CABG and had follow-up over a 4-year period (Kurbaan etal., 2001). Complete revascularisation was mandatory, and in the percutaneous group new devices such as atherectomy or stents were allowable at the operator's discretion. A total of 1054 subjects, of whom 125 (12%) had diabetes, were randomised to CABG or PTCA; 37% of the CABG group received an

IMA graft. Diabetic patients had a higher mortality rate than non-diabetic patients. Diabetic patients randomised to PTCA had a higher mortality rate than diabetic patients randomised to CABG (CABG vs. PTCA: 8/63(12%) vs. 14/62(23%)). Post-revascularisation angiographic evidence of residual CHD was consistently significantly greater in PTCA than in respective CABG subgroups.

Arterial Revascularisation Therapy Study (ARTS)

The Arterial Revascularisation Therapy Study (ARTS) trial randomised 1205 patients with multivessel coronary artery disease to stent implantation (n = 600; diabetic = 112(19%)) or CABG (n = 605; diabetic = 96(16%)) (Abizaid etal., 2001). At 1 year the event-free survival overall was 74% in the stented group and 88% in the surgical group, largely due to a higher rate of revascularisation in the stented group (17% vs. 4%). Interestingly, 40% of the major adverse events in the first 30 days after intervention were due to stent thrombosis. In the future, the incidence of this problem might be expected to fall with a greater use of new adjunctive therapies, such as clopidogrel and glycoprotein IIb/IIIa inhibitors, neither of which were used in this trial.

At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63%) because of a higher incidence of repeat revascularisation (typically CABG) as compared with both diabetic patients treated with CABG (84%) and non-diabetic patients treated with stents (76%). This difference was largely due to a higher rate of incomplete revascularisation in patients who underwent PCI (70%), compared to those who had a CABG (84%). Conversely, diabetic and non-diabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84% and 88%). Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or non-diabetics treated with stenting. Alternatively, diabetic patients had an increased risk of stroke with CABG versus PCI (4% vs. 0%).

Other studies

At least three additional trials have compared PCI with bare metal stents versus bypass surgery in patients with multivessel CHD (Rodriguez etal., 2001; Sedlis etal., 2002; Sigwart etal., 2002; Rodriguez etal., 2003). The SOS (Stent or Surgery) trial showed less repeat revascularisation with CABG than with PCI overall at 2 years, but the diabetic group was not analysed separately (Sigwart etal., 2002). The other trials showed mixed results.

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