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Abstract
Background The optimal form of revascularisation in diabetic patients with multivessel coronary disease has been controversial since the subset analysis of BARI (Bypass Angioplasty Revascularisation Investigation) in 1996. The CARDia (Coronary Artery Revascularisation in Diabetes) Trial primary endpoint results were presented at the ESC in 2008. It is the first study in patients with diabetes and complex coronary disease comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with abciximab and stents.
Aims The main purpose of the CARDia trial was to compare PCI and CABG in patients with diabetes. Bare metal stents (BMS) were used at the beginning of recruitment in the PCI arm accounting for 29% of patients. Once drug-eluting stents (DES) became available these were used as the main stent technology in the other 71%. The aim of this analysis is to compare the subsets of BMS versus DES in terms of repeat revascularisation.
Methods The trial recruited patients between January 2002 and May 2007. Patients who received BMS were recruited early in the trial and those receiving DES were recruited in the middle and later (from 2003 onwards). The recruitment of patients into the trial was undertaken initially with BMS. Once DES became available it was decided to make a subrandomisation between BMS and DES once a patient had been randomly assigned to PCI. This lasted only a few months as the steering committee agreed that all patients recruited into the PCI arm from then on should have DES.
Results The results show no significant difference in the primary endpoint of death, myocardial infarction or cerebrovascular accident (see table). Although the BMS versus DES comparison was not randomised, baseline characteristics were broadly similar. There was an advantage with DES in terms of repeat revascularisation 17.3% versus 7.3%, p = 0.023 (see fig).
Conclusion Although these comparisons have been prespecified they are also subset analyses and non-randomised and therefore should be considered exploratory and hypothesis generating. They are consistent with data in trials comparing BMS and DES in patients with diabetes whether dedicated diabetes trials or in diabetic subset analyses. It is worth noting that CARDia is the only study with such a comparison that has been undertaken in patients with almost exclusively multivessel disease. In terms of repeat revascularisation, there is an advantage with DES versus BMS in patients with diabetes and multivessel disease.
MS, bare metal stent; DES, drug-eluting stent.
Comparison of BMS vs DES