This article reviews the clinical use of stents in the treatment of coronary artery disease and the rationale for the use of degradable, drug-eluting polymer stents. The authors note the challenges of using off-the-shelf polymers for the development of degradable stents, as well as the interplay between polymer properties and a functional stent design. Drug-eluting metal stents are the most significant advancement in the treatment of coronary artery disease, and have significantly reduced the occurrence of in-stent restenosis after placement. Some regard drug-eluting metal stents as the final technologic advancement in the treatment of coronary artery disease, others consider the future development of degradable, drug-eluting stents as the next logical step.
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 (Pϭ0.05, but within 1 standard deviation of 100%, and Pϭ0.58, 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 (PϽ0.01). 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, Pϭ0.49). In contrast, that of polymer scaffolds increased and approached 1 (Pϭ0.13). 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. (Circ Cardiovasc Interv. 2012;5:39-46.)
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