A pharmacokinetic comparison between three drug delivery devices in porcine coronary arteries.

Background: Catheter-based drug delivery systems have evolved in percutaneous coronary interventions (PCI). Drug-coated balloons (DCBs) deliver agents to obstructive atherosclerotic lesions without permanent implants, but their pharmacokinetic profiles vary and may affect efficacy and safety.

Method: Twenty-seven Yucatan Miniature Swine underwent treatment with SEL-SEB (SELUTION SLR™), MT-SCB (MagicTouch™), or EES (XIENCE™) in the right coronary or left circumflex arteries. Drug levels were measured in treated arteries and downstream myocardium at 7, 60, and 90 days. MT-SCB samples were extracted with ZnSO₄/methanol, whereas SEL-SEB samples underwent two-step extraction (ZnSO₄/methanol followed by acetonitrile/acetone).

Result: A total of 54 arteries underwent pharmacokinetic evaluation (n = 6 treated arteries per time point) from 27 swine. At 7 days, the mean of arterial drug levels was 1767.5 ng/g for SEL-SEB, 1136.5 ng/g for MT-SCB, and 1057.4 ng/g for EES (p = 0.94). By 60 days, SEL-SEB and EES maintained high levels (1146.3 and 837.3 ng/g), while MT-SCB fell sharply to 5.8 ng/g (p < 0.05). At 90 days, SEL-SEB and EES remained stable (360.7 ng/g and 916.5 ng/g, respectively), although MT-SCB was negligible, 2.0 ng/g (p < 0.05). Drug levels in the downstream myocardium at 7 days were lowest with EES (0.1 ng/g), higher with SEL-SEB (11.3 ng/g), and highest with MT-SCB (281.5 ng/g) (p < 0.05).

Conclusions: SEL-SEB shows sustained arterial drug retention, more closely resembling the gold-standard EES. This data suggests that SEL-SEB should produce durable outcomes without the need for a permanent implant.