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Results from the DiabEtic Argentina Registry (DEAR) published ahead of print in Cardiovascular Revascularization Medicine Journal

Date: 2012/09/12

One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies

Eurocor’s DIOR® DEB shows remarkable performance in diabetic patient popularization

The Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomized, open-label study and enrolled patients with Diabetes Mellitus (DM). Results were compared retrospectively with previous outcomes in patients with DM treated with DES or BMS in clinical studies conducted in the catheterization laboratories from the Cardiovascular Research Centre (CECI) in three hospitals in Buenos Aires, Argentina. The 12 months’ data are now published ahead of print in Cardiovascular Revascularization Medicine Journal. The aim of the registry was to assess major adverse coronary events (MACE) when a Paclitaxel-eluting balloon (DIOR®) and a stent are used to treat coronary lesions in a diabetic population. The outcome in this challenging group of patients is a low single digit target lesion revascularization (TLR) rate of 6.6 per cent. The study was performed by the Principal Investigator Dr. Alfredo Rodriguez.

The primary clinical endpoint to be evaluated for the success of the registry was MACE at nine months, one year and two years follow up. Patients between the ages of 18 to 85 years, suffering from diabetes mellitus I or II, with a positive stress test, with stable or unstable angina including non-STEMI and those who were eligible for PCI with stent implantations were included. The enrollment started in April 2009 in 3 Argentinean centers. 91 patients complying with the inclusion and exclusion criteria were enrolled in the DEAR Registry. Of these, 74.7 per cent patients suffered from multiple vessel disease.

Dr. Alfredo Rodriguez compared the outcomes of the DEAR Registry with the outcomes from other CECI trials that used BMS or DES in 92 and 129 diabetic patients, respectively. The data show that the use of DIOR® is effective in the treatment of de novo lesions in diabetics leading to significantly lower rates of TVF and MACE in comparison to the use of BMS. The one-year outcome shows a TVF rate of 30.2 per cent for BMS, 18.6 per cent for DES and 11.0 per cent for DIOR®, which is remarkable. MACE could be observed in 32.3 per cent of patients in the BMS-group, 18.6 per cent in the DES-group and only 13.2 per cent in the DIOR® DEB-group.

Dr. Rodriguez commented: “Diabetics with coronary lesions are a high-risk group of patients. The use of DIOR® DEB to treat these patients seems to be safe as it delivers low incidence of TVF and MACE. DIOR® DEB could be the right alternative treatment for these patients.”

Dr. Rembert Pogge von Strandmann, Clinical Director, Eurocor GmbH commented: “The results of the DEAR study confirm that the DIOR® DEB is a recommended treatment option for high risk patients that suffer from diabetes. We are glad to see ever more positive outcomes from various trials and registries for our DIOR® DEB as for example the Valentines Trial I and II or the Spanish Registry.”

Press Release: DEAR Registry published online ahead of print