Bioabsorbable Drug-eluting Scaffolds (BVS)-Optical Coherence Tomography (OCT) Imaging Study

I. INTRODUCTION Bioabsorbable drug-eluting scaffolds ("BVS") have emerged as a potential major breakthrough for treatment of coronary artery lesions providing a possibility to overcome the long term limitations of conventional stent implantation which precludes future surgical revascularization, eliminates reactive vasomotion, impairs noninvasive imaging and exposes patients to the risk of very late stent thrombosis. BVS have been extensively studied in clinical trials. Treatment of noncomplex obstructive coronary artery disease with BVS was within the prespecified margin for noninferiority compared to Xience stent with respect to target lesion failure at 1 year in the latest large-scale randomized trial (ABRORB III). Although the concept of self-degrading stent is attractive and the results from clinical trials have been promising, there is a paucity of data regarding the use of BVS in "real world" patients undergoing percutaneous intervention ("PCI"). The outcomes from a large BVS registry of patients with relatively unselected clinical characteristics and lesions were comparable to those reported for the second generation drug eluting stents ("DES"), however, the scaffold thrombosis rate in the first 30 days after implantation resembled that of the first generation DES suggesting that the lesion selection and procedure optimization require further improvement. BVS development has required new imaging modalities, assessment methodologies, and treatment strategies because their design, degradation rate, coating, changes in mechanical properties may affect safety and efficacy of the device. Due to its high resolution, Optical Coherence Tomography ("OCT") imaging has played a central role in understanding the short and long term performance of bioresorbable scaffolds.

II. STUDY AIM To evaluate the acute and long term outcomes of BVS implantation in consecutive coronary artery disease ("CAD") patients using OCT imaging.

III. STUDY POPULATION Fifty (50) consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD.

IV. STUDY DESIGN This is a single center retrospective analysis of data collected under the EXEMPT database (GCO# 02-0178) at the Cardiac Catheterization Laboratory at Mt. Sinai Hospital.

V. STUDY PROCEDURES Patients with stable CAD who underwent PCI with BVS implantation. Lesions were treated with pre-dilatation using conventional semicompliant or non-compliant balloon. The use of additional devices, cutting balloons or rotablator, were performed at the operator's discretion. The operator made the decision on BVS length and size. First OCT pullback (OCT-PRE) was performed before BVS implantation to analyze lesion stenosis, references, and plaque morphology including the extent and location of calcification. In addition, online co-registration of OCT with coronary angiogram was performed to confirm the correct spatial orientation of OCT findings. The second OCT pullback (OCT - POST) was performed after BVS implantation followed by post-dilatation (20 atm). Angio-OCT co-registration was used to assess acute post-procedural results.