A randomized trial comparing two stent sizing strategies in coronary bifurcation treatment with bioresorbable vascular scaffolds - The Absorb Bifurcation Coronary (ABC) trial.

ABSTRACT

BACKGROUND: Limited information is available on the use of Bioresorbable Vascular Scaffold (BVS) in bifurcations involving significant side branches. When treating bifurcation disease with metal stents, the recommendation is to choose a stent diameter based on the distal main vessel diameter. Whether this sizing strategy is applicable to BVS is currently unknown. METHODS: We randomised 37 patients undergoing elective PCI for 'false' bifurcation disease (Medina 0,1,0; 1,0,0; 1,1,0) to receive BVS based either on proximal or distal reference diameters. Optical Frequency Domain Imaging (OFDI) measurements were performed pre BVS insertion to obtain proximal and distal reference diameters and post implantation. BVS size was chosen according to the proximal or distal reference diameter as per randomisation. Implantation was performed using the PSP technique tailored to bifurcation stenting. OFDI was repeated post implantation to confirm satisfactory expansion and apposition. RESULTS: Baseline demographics between the two groups were similar. Patients were aged 62.8 ±â€¯3.3 years; 76% were male. Mean side branch diameter was 2.24 ±â€¯0.13 mm. TIMI III flow in the main vessel was achieved in all cases. Side branch occlusion occurred in 1 case (2.7%). In the distal-sizing arm, there was a greater incidence of significant malapposition (>300 µm) at the proximal end of the scaffold on OCT (2.3% versus 0.8%, p 0.023). The incidence of distal edge dissections was numerically greater in the proximal-sizing group but this was not statistically significant (31.3% vs 11.8%, p 0.17). CONCLUSION: Both proximal and distal sizing strategies have similar procedural complication rates when using the ABSORB BVS to treat coronary bifurcations. However a proximal sizing strategy is associated with less malapposition and may be preferable.