April 17, 2019
Preclinical Study Evaluates Patency of 0.018-Inch DCB Platforms in Porcine Models
April 18, 2019—Preclinical trial data comparing the patency of 0.018-inch drug-coated balloons (DCBs) versus 0.035-inch platforms suggest that the smaller devices may be superior in this outcome. Andrew Holden, MD, presented the findings at the 2019 Charing Cross Symposium, held April 15–18 in London, United Kingdom.
As noted in the Charing Cross Symposium press release, most studies of DCBs have involved 0.035-inch platforms, such as In.Pact Admiral (Medtronic), Lutonix (BD [Becton, Dickinson and Company]), and Stellarex (Philips). Although there are significant advantages of using a lower-profile DCB platform in routine clinical practice, it has been unclear whether using a lower-profile DCB platform would affect the efficacy of the treatment.
The preclinical study compared drug delivery using the In.Pact Pacific 0.018-inch DCB platform (Medtronic) to the Ranger 0.018-inch DCB (Boston Scientific Corporation) in a porcine model of in-stent restenosis. These data were then compared to data from an identical trial comparing the In.Pact Admiral 0.035-inch DCB and Stellarex 0.035-inch DCB platforms.
Twenty-eight days after the animals’ arteries were injured through angioplasty and stenting, they were treated with one of the test platforms. The treated site was then imaged at regular intervals to determine how it responded to these different methods of drug delivery.
As summarized in the Charing Cross Symposium announcement, Dr. Holden reported that there was considerable variability, even between devices of the same profile. Vessels treated with In.Pact Admiral showed significantly lower neointimal thickness at 90 days posttreatment relative to Stellarex. These findings are consistent with different concentrations of drug recorded in the tissue at that time, noted Dr. Holden.
Similarly, vessels treated with the In.Pact Pacific platform had lower neointimal thickness at 90 and 120 days relative to the Ranger-treated vessels. However, the neointimal thickness was lower than in vessels treated with the 0.035-inch platforms.
Dr. Holden commented in the announcement, “The patency of 0.018-inch devices is certainly noninferior to 0.035-inch devices.” He advised that both 0.018-inch platforms showed sustained patency at 120 days, as measured by quantitative vascular analysis and optical coherence tomography. Dr. Holden concluded, “Clinicians can have confidence in using these 0.018-inch platforms and replicating the excellent results achieved with 0.035-inch devices.”