Department of Engineering, 8676Wake Forest University, Winston-Salem, NC, USA.
Division of Vascular Surgery, 2647Ohio State University, Columbus, OH, USA.
J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484221119559. doi: 10.1177/10742484221119559.
The purpose of this study was to determine the impact of varying inflation parameters on paclitaxel delivery and retention using a commercially available DCB.
Drug-coated balloons (DCB) have become the standard treatment for peripheral artery disease. Clinical data suggest that varying DCB delivery parameters directly impact patient outcome. Differences in delivery parameters can potentially alter the retention of the drug coating on DCBs.
Harvested porcine carotid arteries were utilized in an pulsatile flow bioreactor system. The DCBs were then deployed at a DCB-to-artery ratio of 1:1 or 1.25:1, an inflation time of 30 seconds or 1 minute and transit time of 30 seconds or 3 minutes. The amount of drug retention in arterial tissue was evaluated by pharmacokinetic analysis at 1 hour and 1 day post DCB deployment.
Arterial paclitaxel levels were found to be less at an inflation ratio of 1:1 with 3-minute transit time as compared to 30 seconds of transit time at 1 hour (12.3 ± 1.6 ng/mg vs. 391 ± 139 ng/mg, = .036). At 1-day, DCBs deployed at a ratio of 1:1 resulted in less drug retention as compared to 1.25:1 (61.3 ± 23.1 ng/mg vs. 404 ± 195 ng/mg, = .013).
Arterial paclitaxel retention is reduced with extended transit times and sub-optimal expansion of the balloon. Optimization of delivery parameters can serve as an effective strategy to enhance clinical DCB outcomes.
本研究旨在通过使用市售的药物涂层球囊（DCB）确定不同的充气参数对紫杉醇输送和保留的影响。
药物涂层球囊（DCB）已成为治疗外周动脉疾病的标准治疗方法。临床数据表明，不同的 DCB 输送参数直接影响患者的结果。输送参数的差异可能会改变 DCB 上药物涂层的保留率。
利用脉动流生物反应器系统从猪颈动脉中提取。然后，将 DCB 以 1:1 或 1.25:1 的 DCB 与动脉比、30 秒或 1 分钟的充气时间和 30 秒或 3 分钟的输送时间进行部署。通过药物动力学分析在 DCB 部署后 1 小时和 1 天评估动脉组织中药物保留量。
与输送时间为 30 秒相比，充气比为 1:1 且输送时间为 3 分钟时动脉紫杉醇水平较低，1 小时时（12.3 ± 1.6 ng/mg 比 391 ± 139 ng/mg， =.036）。1 天时，充气比为 1:1 的 DCB 与 1.25:1 相比，药物保留量较少（61.3 ± 23.1 ng/mg 比 404 ± 195 ng/mg， =.013）。
随着输送时间的延长和球囊扩张不理想，动脉内紫杉醇的保留率降低。优化输送参数可以作为增强临床 DCB 效果的有效策略。
