Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND single arm study

Objectives: Due to the limited distensibility of the everolimus-eluting bioresorbablevascular scaffold (ABSORB) compared to metallic platform stents, quantitative coronaryarteriography (QCA) is a mandatory requirement for ABSORB deployment in theon-going ABSORB EXTEND Single-Arm Study. Visual assessment of vessel size in theABSORB Cohort B study often lead to under and over-sizing of the 3 mm ABSORB incoronary vessels (recommended range of the vessel diameter 2.5 mm and 3.3 mm),with an increased risk of spontaneous incomplete scaffold apposition post ABSORBdeployment. We report whether mandatory QCA assessment of vessel size pre-implantation,utilizing the maximal luminal diameter (Dmax) and established interpolatedreference vessel diameter (RVD) measurements, has improved device/vessel sizing.Methods: Pre-implantation post-hoc QCA analyses of all 101 patients from ABSORBCohort B (102 lesions) and first consecutive 101 patients (108 lesions) from ABSORBEXTEND were undertaken by an independent core-laboratory; all patients had a 3 mmABSORB implanted. Comparative analyses were performed. Results: Within ABSORBCohort B, a greater number of over-sized vessels (>3.3 mm) were identified utilizingthe Dmax compared to the interpolated RVD (17 vessels, 16.7% vs. 3 vessels, 2.9%; P 50.002). Comparative analyses demonstrated a greater number of appropriate vessel-sizeselection (75 vessels, 69.4% vs. 48 vessels, 47.1%; P 5 0.001), a trend towards a reductionin implantation in small (3.3 mm) vessels(4 vessels, 3.7% vs. 17 vessels, 16.7%; P 5 0.002) in ABSORB EXTEND. Bland–Altmanplots suggested a good agreement between operator and core-laboratory calculatedDmax measurements. Conclusions: ...