The Impact of Peripheral Vascular Motion on Acute Drug Retention of Intravascular Devices

This goal of this study was to determine the impact of vascular motion on acute drug transfer and retention of drug-coated balloons (DCB) or drug-eluting stents (DES).

Commercially available paclitaxel DCBs (Lutonix & IN.PACT) and a paclitaxel DES (Zilver) were subjected to physiological flow and vascular motion conditions using a peripheral-simulating benchtop bioreactor system. Each DCB- or DES-treated artery was subjected to three sets of movement parameters including pulsatile flow with no twisting/bending (P1), pulsatile flow with 16.8° twist, 25° bend and 3.2 mm compression (P2), and pulsatile flow with 68° twist, 35° bend, 21 mm compression (P3). After 24 h, the treated segments were removed and paclitaxel concentrations were measured using pharmacokinetic analysis.

In the group of arteries treated with the Lutonix DCB, there was a significant decrease in arterial paclitaxel concentrations between the P1 and both the P2 and P3 moving parameters (P1 = 404 ± 195 ng/mg, P2 = 14.9 ± 9.92 ng/mg, P3 = 19.2 ± 15.4 ng/mg; P1-P2 p = 0.007, P1-P3 p = 0.005). For the IN.PACT DCB group, no differences in the mean arterial paclitaxel concentrations were observed for the various movements (p = 0.55). Lastly, in the Zilver DES group, differences were only measured between the P2 and P3 moving parameters (P2 = 84.8 ± 32.7 ng/mg, P3 = 0.11 ± 0.06 ng/mg; P2-P3 p = 0.01).

Acute retention of arterial paclitaxel levels can be adversely impacted by vascular movement in both DES- and DCB- treated arteries.