Edge Vascular Response After Polymer-Free vs. Polymer-Based Paclitaxel-Eluting Stent Implantation

– Serial Intravascular Ultrasound Study From the Late Incomplete Stent Apposition Evaluation (LISA) Trial –

Abstract

Background:It is unknown if lack of polymer can provoke a different edge response in drug-eluting stents. The aim of this study was to compare edge vascular response between polymer-free paclitaxel-eluting stent (PF-PES) and polymer-based paclitaxel-eluting stents (PB-PES).Methods and Results:A total of 165 eligible patients undergoing percutaneous coronary intervention were prospectively randomized 1:1 to receive either PF-PES or PB-PES. Those patients with paired intravascular ultrasound (IVUS) after procedure and at 9-month follow-up were included in this analysis.Seventy-six patients with 84 lesions, divided into PB-PES (38 patients, 41 lesions) and PF-PES groups (38 patients, 43 lesions) had paired post-procedure and 9-month follow-up IVUS and were therefore included in this substudy. There was a significant lumen decrease at the proximal edge of PF-PES (from 9.02±3.06 mm²to 8.47±3.05 mm²; P=0.040), and a significant plaque increase at the distal edges of PF-PES (from 4.39±2.73 mm²to 4.78±2.63 mm²; P=0.004). At the distal edge there was a significant plaque increase in the PF-PES compared to PB-PES (+8.0% vs. –0.6%, respectively; P=0.015) with subsequent lumen reduction (–5.2% vs. +6.0%, respectively; P=0.024).Conclusions:PF-PES had significant plaque increase and lumen reduction at the distal edge as compared to PB-PES, probably due to difference in polymer-based drug-release kinetics between the 2 platforms. (Circ J 2014; 78: 2657–2664)