Aims: Percutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES).
Methods and results: The Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n=129 pts) or BMS (n=96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P=.003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P=.003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P=.005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P=.05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P=.13), MACE was 18.6% in DES vs. 13.2% in PEB (P=.29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P=.14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18)
Conclusions: Diabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.
Copyright © 2012 Elsevier Inc. All rights reserved.