In this third episode of a special five-part series on the history of DCBs, Jos van den Berg (Lugano, Switzerland) moderates a Vascular News roundtable discussion where he is joined by John Laird (St Helena, USA) and Peter Schneider (San Francisco, USA).
Laird examines the context and background to the IN.PACT SFA trial and outlines the study design. He notes that there was a need to change the way superficial femoral artery (SFA) disease was treated, as there were many complications “particularly with the full metal jacket stents…We wanted to create a paradigm and where we could avoid stenting and permanent implants in the SFA,” he adds.
Early expectations through to latest data
Schneider himself notes that in the beginning he was “not at all sure that we were going to be successful” in showing DCB to be superior to percutaneous balloon angioplasty (PTA). Despite having relatively modest expectations, Schneider notes the results were much better than expected, with 75% of patients in the DCB arm reintervention-free at five years. These results were “unheard of” at this time for SFA intervention in lesions up to 18cm. The trial “definitely exceeded my expectations” and “ushered in a new era and a huge advance for our patients,” believes Schneider.
A three-minute balloon inflation
Laird goes on to highlight how a three-minute balloon inflation with the IN.PACT Admiral™ DCB was chosen in order to “achieve the best angiographic and haemodynamic results”, as well as to “maximise drug uptake into the vessel wall” with a “unique formulation of paclitaxel” . The device showed “spectacular results”, at three and five years, he adds.
Safety concerns addressed
Schneider concludes by touching on the paclitaxel safety concerns raised by a meta-analysis and the lessons that have been learnt following its release. There was “ascertainment bias and treatment bias” in the meta-analysis, Schneider says, concluding that the two biases are “why we cannot find a danger signal in the massive amount of data that has been collected since 2018”.
This video is sponsored by Medtronic.
Episode 1: Go behind the scenes to delve into the birth and evolution of drug-coated balloons for Peripheral Interventions: Insight from two pioneers
Episode 2: Are all peripheral drug-coated balloons created equal?
Episode 4: Real world data show IN.PACT Admiral DCB is “very efficient” even in complex lesions
Episode 5: The impact of long-term DCB outcomes on patients’ quality of life