Late Positive Remodeling and Late Lumen Gain Contribute to Vascular Restoration by a Non-Drug Eluting Bioresorbable Scaffold

Abstract

Background— The interplay between mechanical dilatation, resorption, and arterial response following implantation of bioresorbable scaffolds is still poorly understood. Methods and Results— Long-term geometric changes in porcine coronary arteries in relation to gradual degradation of bioresorbable scaffolds were assessed in comparison with bare metal stents (BMS). Intravascular ultrasound (IVUS)-derived lumen, outer stent/scaffold, and reference vessel areas were evaluated in 94 polymer scaffolds and 46 BMS at 5 days and 3, 6, 12, 18, 24, and 55 months, in addition to polymer scaffold radial crush strength and molecular weight (M W ) at 3, 6, and 12 months. BMS outer stent area and lumen area remained constant through 55 months ( P =0.05, but within 1 standard deviation of 100%, and P =0.58, respectively), while significant increases were exhibited by polymer-scaffolded vessels with the maximum late lumen gain at 24 months, paralleled by the outer scaffold area increase, and then remaining at that increased level at 55 months ( P <0.01). By 12 months polymer scaffolds experienced significant reductions in radial strength and M W , while the animals underwent the largest weight gain. At 3 months and beyond, the patency ratio (lumen area/reference vessel area) of BMS remained constant (0.71 to 0.85, P =0.49). In contrast, that of polymer scaffolds increased and approached 1 ( P =0.13). Conclusions— Bioresorbable polymer scaffolds allow restoration of the treated segment's ability to remodel outward to achieve level lumen transition between reference vessel and scaffold-treated regions, a process mediated by animal growth and scaffold degradation. This also introduces a challenge to standard analyses of IVUS outcomes relying on constant stent diameters over time.