- I am Dr. Praveen Chandra from Medanta, Medicity Hospital in Delhi, India. And today I'm going to share with you the new developments in the field of drug-coated balloons.

Study Rationale

The rationale of this study was to show and prove the safety and efficacy of a three microgram dose of sirolimus with the new micro-reservoir technology and show it in terms of the results on patients.

Micro-Reservoir Technology

So the micro-reservoir technology works like this, that it takes the drug inside the vessel and then the drug stays there as it used to do with the drug-eluting stents over a period of time, up to 90 days. And that is why we expect that the results will be much better and same almost same as drug-eluting stents.

Study Design and Patient Cohort

The patient cohort was including both De novo and restenotic lesions. And this cohort was not pre-selected. It was, you know, just a day to day cases, which were taken up in this registry and these patients were treated and then followed up for a period of one year.

Key Findings

The key findings are very encouraging in these 54 patients and there was no incidents of late restenosis. There were no incidents of acute occlusion of the vessels and no major adverse cardiac events. So we are very excited with this small study though and the patients showing no adverse outcomes.

Take-Home Messages

The key take home message from this study is that this dose of three microgram was absolutely safe, efficacious. And now we can use this technology drug eluting balloons for lesions, which are either Denovo or restenotic and get almost good results as we saw or even better than drug-eluting stents.

Next Steps

The next steps is that, you know, now since we know that these results are encouraging we will use it in our day to day basis. The technology is getting approved all over the world and maybe there will be some randomised controlled trials with drug eluding stents in even proximal vessel disease.