CRT 2026: Stenosis Limited Local Paclitaxel Release and Arterial Delivery From Paclitaxel Coated Balloons in a Porcine Peripheral Instent Restenosis Model

AR Tzafriri, A-M Spognardi, J Budrewicz, B Muraj, P Markham. ‘Stenosis Limited Local Paclitaxel Release and Arterial Delivery From Paclitaxel Coated Balloons in a Porcine Peripheral Instent Restenosis Model.’ Presented at: CRT 2026.

Background: We examined whether instent restenosis lesions (ISRL) can limit drug release and arterial delivery by paclitaxel coated balloon (PCB) in porcine superficial femoral arteries (SFAs).

Methods: Six porcine femoral arteries underwent bilateral balloon overstretch and implantation of overlapping nitinol stents to create complex ISRLs at Day 30. At Day 30, ISRL were predilated with POBA, resulting in minimum lumen diameters (MLDs) of 1.7 to 2.7 mm and stenoses of 59-71%. The postdilated ISRL and 8 naïve porcine SFA were treated with a commercial 4.0x60 mm PCB (1542 μg paclitaxel/PCB) under angiographic guidance. PCBs were inflated for 60 seconds, at a balloon:artery ratio of 1.17:1 for the ISRL and 1.03:1 for the naïve SFA. Used PCBs along with 3 control PCBs were assayed for paclitaxel content by liquid chromatography mass spectrometry (LC/MS-MS). Animals were euthanized 15-30 minutes after the second bilateral PCB treatment. SFA segments centered along the treatment sites (~60-70 mm long) were collected and processed for quantification of paclitaxel tissue deposition by LC/MS-MS. Paclitaxel release from PCB and tissue deposition in the naïve and ISRL groups were compared statistically using the Welch’s t-test.

Results: Treatment PCB released 5.2% (80 μg) more paclitaxel in naïve SFA vs ISRL (P=0.0067, 79.8 vs 74.6%). This resulted in 98 μg greater paclitaxel deposition in naïve SFA compared to ISRL (111.2 vs 13.1 μg, P=0.0018), illustrating a concordance between paclitaxel release and deposition trends. Moreover, in the ISRL group, the amounts of released paclitaxel and tissue deposited paclitaxel both increased with increasing MLD values and were linearly correlated.

Conclusions: The demonstration of significantly lower local drug release and deposition in porcine ISRL compared to naïve arteries is consistent with reduced contact dependent coating transfer when MLD < 70% of the nominal PCB diameter. Thus, MLD emerges as an independent predictor of acute drug delivery by PCB in porcine ISRL, providing a relevant model for the study of vessel preparation effects on drug delivery.

JACC Int. 2026 Vol. 19 No. 5_Supplement 300.14.
Presented at Cardiovascular Research Technologies (CRT), 2026 March 7-10, Washington DC.