First data at 12 months of the DEAR Registry presented at TCT

[Note: Clinical abbreviations expanded at the end of article.]

Bonn, GERMANY and San Francisco, CA --On the occasion of the Transcatheter Cardiovascular Therapeutics Conference (TCT) San Francisco, USA the first 12 months’ data from the Argentinean Registry of the DIOR balloon in diabetic patients, called DEAR registry, have been presented. The aim of the registry is to assess major clinical events 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 very low single digit TLR rate of 6.6 per cent. The data was presented by Dr. Alfredo E. Rodriguez, MD, PhD [Cardiovascular Research Centre (CECI), Head of Cardiology Department at Otamendi Hospital, Argentina] at an international breakfast symposium that was dedicated to current experiences with drug-eluting balloons (DEB), arranged by Eurocor GmbH, Bonn (Germany) on Thursday.

The primary clinical endpoint to be evaluated for the success of the registry was MACCE at nine months, one year and two years follow up. Patients between the ages of 18 to 85 years, suffering from diabetes mellitus I and 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. Rodriguez also compared the outcomes of the DEAR Registry with the outcomes from other CECI trials that used BMS (on 96 diabetics) and DES (on 129 diabetics). The data shows that the use of DIOR® is effective in the treatment of de novo lesions in diabetics leading to significantly lower rates of TVF and MACCE in comparison to the use of BMS. The outcome at 12 months showed a TVF rate of 30.4 per cent for BMS, 18.6 per cent for DES and only 11 per cent for DIOR®, what is remarkable. On the point of MACCE, the outcome shows 32.6 per cent for BMS, 18.6 per cent for DES and only 13.2 per cent for DIOR® DEB.

Dr. Rodriguez commented: “Diabetics with coronary lesions make for a high-risk group of patients. The use of DIOR® DEB to treat these patients, at midterm outcome, seems to be safe as it delivers low incidence of TVF and MACCE.  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.

Abbreviations

BMS - Bare Metal Stent

DEB - Drug-eluting Balloon

DES - Drug-eluting Stent

MACCE - Major Adverse Cardiac & Cerebrovascular Events

PCI - Percutaneous Coronary Intervention

TLR - Target Lesion Revascularization

TVF - Target Vessel Failure

TVR - Target Vessel Revascularization

Source: Eurocor