First results of preclinical study comparing drug delivery on 0.018’ and 0.035” DCB platforms

Written by: Katrina Mountford, Medical Writer

Abstract

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) has become the primary revascularisation strategy. A growing body of clinical trial and registry data has demonstrated that drug-coated balloons (DCB) are superior to plain balloon angioplasty in terms of primary patency and target lesion revascularisation. However, it is not known whether the size of the device is important in terms of outcomes.

To date, most DCBs have involved 0.035” platforms such as the IN.PACT™Admiral™ DCB (Medtronic), Lutonix® (Bard) and Stellarex™ (Phillips). However, there are potential advantages to using lower profile DCB platforms, including improved crossing and deliverability, and allowing procedures above and below the knee over the same guidewire. A smaller access sheath may also be useful in elderly women with smaller vessels.

Dr Holden presented the final results of preclinical studies comparing the drug delivery of various DCB platforms in a porcine model of in-stent restenosis. The animals’ arteries were injured through angioplasty and stenting, and were treated at 28 days with each platform. The treated site was examined at regular intervals to determine response to the DCBs in terms of luminal diameter. Patency was assessed using optical coherence tomography (OCT) and quantitative vascular angiography (QVA) analysis. The first study was a direct comparison between two 0.035” guidewire compatible devices: the IN.PACT Admiral DCB, and Stellarex devices. Vessels treated with the Admiral DCB showed a significantly greater reduction in restenosis at 90 days post-treatment compared with the Stellarex. This is not surprising given that the loading dose with the Admiral is significantly higher than with the Stellarex. This finding is consistent with different concentrations of drug recorded in the tissue.

Another study compared vessels treated with the 0,018” compatible devices: the IN.PACT™ Pacific™ DCB (Medtronic) and the Ranger™ DCB (Boston Scientific). Vessels treated with the Pacific device had lower restenosis at 90 and 120 days compared to Ranger-treated vessels, although for both devices the neointimal thickness was lower than in vessels treated with the 0.035” platforms.

In summary, this study suggests that the 0.018” Pacific DCB is noninferior to the Admiral device at 90 days . Both of the 0.018” devices sustained a lower patency with a trend for lower restenosis. The author concluded that these findings can increase confidence in transposing published data from 0.035” devices to the newer 0.018” devices.

Author
Andrew Holden