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DIOR® DEB shows remarkable performance in diabetics with coronary lesions

Date: 2011/05/31

First data at 9 months of the DEAR Registry presented at EuroPCR

[Note: Clinical abbreviations expanded at the end of the press release]
      
Bonn, May 31, 2011 - On the occasion of EuroPCR the first nine months’ data from the Argentinean Registry of the DIOR® balloon in diabetic patients, called DEAR registry, have been presented at one of the leading cardiovascular congresses worldwide in Paris. 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 a symposium that was dedicated to current experiences with drug-eluting balloons (DEB), arranged by Eurocor.

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 92 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 nine months showed a TVF rate of 30.4 per cent for BMS, 18.8 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.”
      
The EuroPCR (12, 567 attendees in 2011) contributes to the promotion of education and information on existing and developing techniques in interventional cardiology. The objective of this annual course is to inform physicians of the latest technological developments and offer practical tips that help interventional cardiologists and cardiac surgeons make the right ethical choice for each individual patient.

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

PR Eurocor’s DIOR® DEB shows remarkable performance in diabetics with coronary lesions

PM DIOR® DEB zeigt hervorragende Ergebnisse bei Behandlung von Diabetikern

Presentation A. Rodriguez DEAR Registry EuroPCR