Author + information
- Renu Virmani1
Drug-coated balloons (DCBs) have emerged as an effective treatment for patients with symptomatic peripheral arterial disease in the femero-popliteal arteries. However, multiple clinical and pre-clinical studies have illustrated there are differences in performance and safety between the different products. The various DCB technologies differ in their design of excipient coatings and the drug form (crystallinity) of the combinations. These design features can produce differences in effective drug delivery to target tissue while avoiding non-target effect (i.e. minimize emboli). In a previously published study, the Lutonix 035 and the IN.PACT Admiral were tested and compared for downstream embolic events. The IN.PACT DCB illustrated increased downstream embolic debris and higher paclitaxel levels.
Three times over-lapping 80-mm DCBs for each device were assessed in 24 femoral arteries of 12 swine with 28-day follow-up for downstream embolic events and debris. IN.PACT Admiral was used as a control as its downstream emboli. Histologic analysis of arterial wall and skeletal muscle and coronary band downstream from the external or internal femoral arteries was performed. This analysis was supported by an analytic measurement of paclitaxel levels.
For all DCB’s tested, regions of increased proteoglycan were accompanied by the loss of medial SMCs. Medial fibrin was present for all cohorts. The percentage of sections with downstream vascular changes in arterioles were greatest for IN.PACT > STELLAREX > RANGER (43%, 36%, and 25% respectively). Embolic crystalline material was seen for all cohorts and followed a similar trend. Drug analysis in parallel tissues illustrated the highest paclitaxel concentrations in non-target coronary band tissues for STELLAREX>IN.PACT>RANGER (962.3 ng/g, 911.3 ng/g, and 822.5 ng/g respectively).
The IN.PACT control exhibited similar behavior as published from a previous study on downstream emboli. The new DCB’s tested, STELLAREX and RANGER, exhibited downstream vascular changes and the STELLAREX DCB exhibited the highest downstream coronary band paclitaxel concentration at 28 days.
OTHER: Vascular Access