1. Preliminary results of the Elutax SV Italian registry
B Cortese, R Fetiveau, A Carrera, S Blengino, V Balian, R Rogacka, C Lettieri,
A Pavei, C Pierli, M Crenna, S Tresoldi, F Buffoli, A Poli.
Bernardo Cortese
Intv’ Cardiology, A.O. Fatebenefratelli
bernardocortese.com

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse have had a financial interest/arrangement or affiliation with the organizations listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Movi, AB Medica, Medtronic
Cardionovum, Abbott Vascular, Concept Medicals, Acilia, The Medicines Company

3. Newer generation DCBs -higher deliverability
-improved tech’s to deploy PTX on the balloon
-improved retention of PTX in the vessel wall (3-8 weeks)
-same safety

4. Elutax SV balloon

5. Elutax SV balloon

6. Italian Elutax SV registry – methods 1
RETROSPECTIVE REGISTRY
Inclusion criteria:
-any type of symptomatic/asymptomatic (with objective ischemia) CAD treated effectively with the device.
-no exclusions/consecutive enrollment
Exclusion criteria:
-any (retrospective analysis)

7. Italian Elutax SV registry – methods 2
Enrollment period:
2012 (release of Elutax SV)-2014
NO intention-to-treat, all patients with effective DCB use were enrolled.
A minimum of 6 months follow up required.
Coronary interventions were performed following the GISE Italian Position paper on DCB-PCI published in 2014.

8. Italian Elutax SV registry – methods 3
MILANO FBF
MILANO S. LUCA
DESIO
SIENA
MANTOVA
LEGNANO
CONEGLIANO VENETO
BUSTO ARSIZIO

9. Italian Elutax SV registry – methods 4
PRIMARY ENDPOINT
Target lesion revascularization at the longest available follow up.
SECONDARY ENDPOINTS
Cardiac Death, total Death, Myocardial Infarction
No angiographic follow up scheduled

10. results

11. results

12. results Follow up: average 225 days, I.Q. ranges 67 days
11 patients (4.5%) lost at follow up
-1 MI (other vessel)
-1 heart failure
-2 malignancies
-2 ICH

13. Italian Elutax SV registry – limitations
-absence of central adjudication of events;
-absence of angiographic follow up;
-clinical follow up: high number of patients lost (4.5%);
-mid-term follow up

14. conclusions
In this consecutive series of patients, treatment with a new generation of DCB was found safe and associated with low TLR rates, at mid-term follow.