Author + information
- Bernardo Cortese1,
- Gaetano di Palma2,
- Simonetta Blengino3,
- Massimo Fineschi4,
- Renata Rogacka5,
- Corrado Lettieri6,
- Andrea Pavei7 and
- Pedro Silva8
- 1ASST Fatebenefratelli-Sacco Milano, Milano, Milan, Italy
- 2Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli, Milan, Milan, Italy
- 3ospedale s. luca milano, Milan, Milan, Italy
- 4AZIENDA OSPEDALIERA UNIVERSITARIA SENESE SIENA, Siena, Siena, Italy
- 5Desio Hospital, Merate, Lecco, Italy
- 6Ospedale Carlo Poma, Mantova, mantova, Mantua, Italy
- 7Civil Hospital Conegliano, Conegliano, Venice, Italy
- 8FBF hospital, Milan, Milan, Italy
drug-coated balloons (DCB) have an acknowledged role for the treatment of in-stent restenosis (ISR), and there is some initial evidence of their efficacy for treatment of de novo lesions, especially in small coronary vessels. In the last years several new generation DCB have been developed, with improved trackability and drug deliverability to the vessel wall. We here report a sub-analysis of the Italian Elutax SV registry (DCB RISE), comparing the performance of Elutax SV DCB (Aachen Resonance, Germany) for de novo lesions vs. ISR.
between 2012-2015 all patients treated with Elutax S) at 9 italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow up. Secondary endpoint was the occurrence of device-oriented adverse cardiovascular events (DOCE), a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and TLR. A minimum of 6-month clinical follow up was required.
We enrolled 544 consecutive patients, 282 with ISR and 262 with de novo lesions. Procedural success was obtained in 97.5% of the patients. At the longest available clinical follow up (average 12.9±6 months), we observed a TLR rate of 10% vs. 3.2% (p=0.006) in the ISR and de novo groups respectively. DOCE were significantly higher in the ISR group (12% vs 3.2%, p=0.001), while no significant statistical difference was observed in terms of cardiac death, TV-MI and stroke.
this registry on the performance of a new generation DCB showed good procedural success in both ISR and de novo lesions, and a significantly lower rate of TLR in patients treated for de novo lesions at mid-term clinical follow up.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery