JIM 2020: Primary outcome of PICCOLETO II trial — Dr Bernardo Cortese

Dr Bernardo Cortese (San Carlo Clinic, Milan, IT) discusses the 6-month primary outcomes of the PICCOLETO II randomized clinical trial.
 
Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment (PICCOLETO II) is one of the latest trials to show drug-coated balloons (DCB) as a potential alternative to drug-eluting stents (DES) in patients with small-diameter lesions. 
 
Questions:
1. What was the PICCOLETO II study design and what did it aim to assess?
2. What are the key outcomes and how do they compare to studies such as BASKET-SMALL II?
3. Were there limitations with PICCOLETO II?
4. In your opinion, how should PICCOLETO II influence practice?
5. What questions remain unanswered that require further research?
 
Filmed on location at the JIM 2020.
 
Interviewer: Ashlynne Merrifield
Videographer: Dom Woodruff
 

Transcript Below :

Question 1 : What was the PICCOLETO II study design and what did it aim to assess?

PICCOLETO II is a [Inaudible] sponsored study, it is an investigator-driven study, multicenter, randomised clinical study of comparison between Elutax SV also called Emperor in some countries and Xience EES in a small vessel disease setting, which means vessels up to 2.75. 

Question 2 : What are the key outcomes and how do they compare to studies such as BASKET-SMALL II?

Well, when we designed the PICCOLETO II study, we hypothesised the non-inferiority of this DCB eluting Paclitaxel versus ions. And we were really surprised in finding and in seeing the results of the core lab analysis of the primary endpoint, which is late lumen loss because in segment and in lesion lumen loss show the superiority of this device as compared to the-best-in class drug-eluting stents, namely Xience EES The difference with BASKET-SMALL II is that the BASKET-SMALL II is a study whose primary endpoint is clinical surrogate endpoints putting together different endpoints, namely MACE Major Adverse Cardiovascular Events. So the study is larger, however, the comparison arm was made of 75% of the cases with Xience about 25% with Taxus and paclitaxel eluting stents. So this is a little bit confusing. There are two big studies, two important studies, both of them showing at least the non-inferiority or even the angiographic superiority like the PICCOLETO II study of drug-coated balloon in a small-vessel disease setting. 

Question 3 : Were there limitations with PICCOLETO II?

First of all, we don't have, we have clinical data obviously but with the study is not powered in order to have a definite superiority or non-inferiority of this device in terms of clinical endpoints. And the second limitation is that for the moment, we have the one-year follow-up, which at which I presented today, but we will need at least a two-year follow-up in order to see if these results will be maintained by DCB or if there will be a late catch up phenomenon, in terms of restenosis. 

Question 4 : In your opinion, how should PICCOLETO II influence practice?

This is a final answer when you should decide what to use in a small-vessel disease. We know that if we use even the best- in-class drug eluting stent in small-vessel disease, we still have a 10 to 12% target lesion failure after one or two years, and is too much. So now we have the data regarding the safety and the efficacy of an alternative to drug eluting stents in this setting. 

Question 5 : What questions remain unanswered that require further research?

We would need like Roxana Mehran, which moderated our session today, we would like to have a big randomised clinical trial, with clinical endpoints, one devices drug-coated balloon, later generation drug-coated balloon and one latest generation drug-eluting stent. We would like to have these, probably designing with just one single clinical endpoint. That will be wonderful. It would be tough because we would need the 2,000 or 2,500 patient study, but that would be great.