Pls read the TCTMD article, on the primary endpoint presentation of PICCOLETO II, at TCT 2019.
Currently we are running the following studies on the drug-coated balloon technology:
-A randomized controlled trial of new-generation DCB vs new generation DES for the treatment of small coronary vessel disease: a spontaneous, multicenter clinical trial. You can find the study protocol in this page.
-the Falcon Registry: a prospective registry on the In.Pact Falcon (Medtronic) DCB, for any coronary clinical indication. This is a multicenter international registry. I am the Italian P.I. for this study. You can find the study protocol in this page.
-The Italian Elutax SV all-comers Registry: a retrospective multicenter registry on the use of the Elutax SV DCB for coronary applications. We are the coordinating center for this national study.
-The DCB Restore Registry: a retrospective multicenter registry on the use of the Restore DCB for coronary applications. We are the coordinating center for this study. I have the dream of running it internationally, and I’m working on this item.
Save the date!!!
During the upcoming TCT, the primary endpoint of the PICCOLETO II study will be released.
Stay tuned!!SAVE THE DATE_elutax_TCT
I am really proud to share the news on the publication of the DCB Book, edited by Springer U.S..
This is the most updated DCB textbook you can ever find. A panel of the most important experts worldwide participated to the project. I am really proud to share this extremely qualified group of physicians:
Patrick. W. Serruys, Kuniaki Takahashi, Dario Buccheri, Carlo Zivelonghi, Pierfrancesco Agostoni, Freek Nijhoff, Marco Ferrone, Juan F. Granada, Manish Doshi, Prakash Sojitra, Dinesh Shah, Sameer Dani, Alexandre Abizaid, Serdar Farhan, Birgit Vogel, Roxana Mehran, Fernando Alfonso, Javier Cuesta, Fernando Rivero, Marcos García Guimaraes, Teresa Bastante, Mostafa Elwany, Anouar Belkacemi, Pieter R. Stella, Gaetano Di Palma, U. Wickramarachchi, Simon C. Eccleshall, Donato Gerardi, Arturo Alfani, Giovanni Esposito, Eugenio Stabile, Dario Pellegrini, Roberto Nerla, Fausto Castriota, Alberto Cremonesi, Antonio Micari, Damiano Regazzoli, Marco Bruno Ancona, Pier Pasquale Leone, Azeem Latib, Satoru Mitomo, Richard J. Jabbour, Antonio Colombo.
I am proud to inform that FASICO NATIVES has been accepted for publication in the Journal of Cardiovascular Medicine.
After FASICO and NANOLUTE’ this is a crucial piece for the assessment of the safety and efficacy of Magic Touch sirolimus-eluting DCB. In this study, which will be available soon for the readers, we have conducted a core-lab assessment of the angiographic outcome of SCB for native coronary vessel disease.
With more than one third of patients showing late lumen enlargement (just like the top-in-class paclitaxel DCB), the average LLL was 0.09mm in this cohort of consecutive small-vessel-disease patients.
Core lab analysis was performed by Cardialysis (Rotterdam, NL).
…waiting for the interim analysis of the EASTBOURNE study, 1043 patients, to be presented at EuroPCR 2019 as late breaking clinical trial!
Recently, a meta-analysis by Katsanos et a. showed an increase in late mortality after paclitaxel administration (either with DES or DCB) in the peripheral field (SFA).
The topic is hot and deserves a deep analysis of the available data. For the moment, our position regarding DCB is that the technology, if used in expert hands and following the available position papers, is safe and effective for the treatment of lower extremity disease.
Please, take a look at the recently published editorial of F Fanelli, T Zeller and myself in the Journal of Endovascular therapy.
The DCB book is on the go…
This is the short presentation for the DCB Course held in Birmingham, UK. This course, whose Director was S. Eccleshall, gathered the most experienced DCB-players worldwide. We shared our experiences and had fun – top experiences and science for the DCB fans!
A new pubblication about “Nuove tecnologie e applicazioni per il pallone medicato nel 2017” has been published on G Ital Cardiol 2017.
Authors: Bernardo Cortese (1,2), Gaetano Di Palma (1), Roberto Nerla (3), Antonio Micari (3)
(1) Cardiologia Interventistica, ASST Fatebenefratelli – Sacco, Milano
(2) U.O. Cardiologia Diagnostica e Interventistica, Fondazione “Gabriele Monasterio”-Regione Toscana – CNR, Massa
(3) Laboratorio di Cardio-Angiologia Diagnostica e Interventistica, Maria Cecilia Hospital, Cotignola (RA)
I DCB sono in grado di superare alcune importanti limitazioni degli stent senza perdere la capacità di inibizione della proliferazione neo-intimale, ma deve essere chiaro che questi costituiscono una componente della strategia di rivascolarizzazione ottimale per i nostri pazienti, sempre più complessi, piuttosto che un’alternativa ai DES. Mentre il loro ruolo nella ISR è ormai ben defnito, il trattamento di lesioni de novo, specie nel distretto coronarico, è la nuova frontiera e presenta ad oggi dati incoraggianti, ancorché preliminari. In ambito periferico, tali risultati sembrano non subire effetto di catch-up a 2-3 anni e si possono estendere sia a lesioni TASC A/B sia alle più complesse TASC C/D, così come alle sottopopolazioni di pazienti con lesioni severamente calcifche, dove l’aterectomia costituisce un valido alleato del DCB, o la ISR.
I diversi DCB attualmente in commercio differiscono per la tecnologia che ne è alla base e, pertanto, hanno fornito risultati differenti in termini di effcacia a lungo termine, il che suggerisce l’assenza di un “effetto di classe” per i DCB in generale. Ogni differente tecnologia ha l’obbligo di dimostrare la sua effcacia e sicurezza in studi di adeguata ampiezza, qualità e rigore che possano confermare l’utilità nella pratica clinica dei dispositivi che entreranno in commercio da qui in avanti.
Here is the full article:
9 DCB review GIC 2017
During the EuroPCR 2017, I have presented theOne year clinical outcome of percutaneous treatment with Sirolimus eluting balloons: Results from Nanolute prospective registry.
Prospective, Multi‐center clinical registry real world, all comers patients at various indian Interventional Cardiology Sites. Clinical Follow-up at 1,6 and 12 Months.
SCB might constitute a new therapeutic option, considering the overall complexity of modern-era interventional cardiology.
The results of this registry, performed in indian patients, are encouraging, but deserve more complete clinical assessment in broader patients populations.
A synergistic DCB use with new-generation DES is intriguing
Here’s the presentation of the meeting4 NANOLUTE' presentation
During the EuroPCR 2017, I met 45 PI of the EASTBOURNE Registry to talk about the end point and the trend of the Study. There were PI from all around the world (Spain, China, Italy, Japan, England, India, etc.).
The EASTBOURNE Registry, thE All-comers Sirolimus-coaTed BallOon eURopeaN rEgistry, has been created to observe and evaluate the performance of a Sirolimus-
eluting Drug-Coated Balloon (SCB) for the treatment of any type of coronary lesions, including native vessel disease and in-stent restenosis.
The Registry has the following characteristics:
•Prospective, multicenter, spontaneous clinical registry
•real world, all comers patients
Here’s the presentation of the meeting1 EASTBOURNE Investigator Meeting
Fernando Alfonso, MD, head of Cardiology at Hospital La Princesa in Madrid, just confirmed that his center is ready to enroll patients at PICCOLETO II, that thereafter today becomes international!
The scientific validity of the RCT study PICCOLETO II, EES vs. Elutax SV for the treatment of small coronary arteries, is confirmed by the patronage recently obtained by the Italian Scientific Society of Interventional Cardiology GISE.patrocinio-studio-non-profit-2016
Great news-a few days ago I had the chance to use a sirolimus-coated balloon for coronary PCI in the first european patient (to say the truth, the first patient of the western world)!!
This very promising device just obtained the CE Mark for this application. A long way is ahead and I am really excited to be part of this adventure in designing a strict scientific program on the matter. In fact, no one wants to repeat the mistakes of the paclitaxel-eluting technology, that has only now reached a reliable scientific background.
A couple of weeks ago, I had the pleasure to be invited at the CLIC, a cardiovascular meeting organized by Dr Amico in Caltanissetta. The event had the scientific background of some renown physicians from the group of Prof Tamburino in Catania, and I had the pleasure to be the only “continental” physician invited!
The meeting was of high scientific level and the discussion was interactive and interesting.
I contributed with a speech entitled “Incomplete revascularization and drug-coated balloons”, a setting where DCB may have a specific role. I also gave some contributions regarding biovascular scaffolds during the discussion. Give a look at the nice pics.
Which is the most valuable treatment for recurrent in-stent restenosis, namely the ISR of 2 already implanted stents? We investigated the role of drug-coated balloons in this setting, and our findings seem to show how this strategy should be considered.
A few months ago, an expert panel lead by our group published the International Positioning Document on DCB use in peripheral interventions. The document was published in the European Heart Journal.
A few weeks ago, our study on DCB in native coronary vessels left with a dissection was published in JACC Int, and we had the honor of receiving a dedicated Editorial from 2 experts on the field: R Byrne and M Joner. Their conclusion was different from ours from several points of view, so we deemed necessary to underline further aspects and we wrote a Letter to the Editor.
This important paper from our group was just published in JACC Interventions, and commented on TCTMD.
Please see comments here:
This is the link for my interview at CX Vascular News, one of the world leading websites on cardiovascular medicine.
The interview has been just released. It is a sort of personal opinion on drug-coated balloons. Enjoy the reading!!
For the current year, the Scientific Research at the cardiac Dpt. will have the following actors:
Head of cardiovascular research: Bernardo Cortese, MD
Assistant at research: Roberto Latini, MD
Fellows: Davide Piraino, MD, Dario Buccheri, MD
Data Manager: Elena Galfrascoli, Pharm D, Sophia Campbell, Pharm D (pic)
Data Monitor: Lorenzo Cagliani, Eng