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Stent design can influence side branch access as well as the side branch opening achieved. A new methodology was developed to compute the probability of a device crossing through the stent cell without strut interference. In addition, bench testing was performed to evaluate the side branch opening that can be achieved.
Side branch accessibility of metallic coronary stents were evaluated for 3.0 mm devices expanded to nominal (n=5 each): Abbott XIENCE Alpine, Boston Scientific SYNERGY MONORAIL, BIOSENSORS BioFreedom, BRAUN Coroflex ISAR, BIOTRONIK Orsiro, Medtronic Resolute Onyx, and TERUMO Ultimaster. Side branch accessibility was defined as the probability of a side branch being accessed by a device without stent strut interference. Digitized scans of deployed stents were analyzed using simulated access devices of different diameters to compute the probability of side branch access as a function of side branch device profile. A bench study was performed to measure geometric attributes associated with a stent cell expanded for side branch access.
Statistical analysis showed that with a 0.014” device, BioFreedom (49.5±0.6%) had the highest side branch accessibility, followed by Alpine (44.3±0.4%) and Synergy (43.8±2.5%, p<0.05). Ultimaster (39.0±2.4%), Coroflex (33.8±0.7%), Onyx (31.9±0.9%) and Orsiro (32.8±1.3%), had lower side branch accessibility. In addition, for side branch expansion diameters less than the nominal diameter, the maximum circular side branch diameter of Ultimaster (1.47±0.07mm), Coroflex (1.38±0.10mm), Onyx (1.45±0.10mm), and Synergy (1.46±0.04mm) were statistically smaller diameter than Orsiro (1.78±0.16mm), Alpine (1.74±0.06mm), and BioFreedom (1.76±0.14mm).
BioFreedom, Xience Alpine, and Synergy had the overall lowest strut interference during side branch access. Xience Alpine, BioFreedom, and Orsiro achieved higher side branch diameter with balloon dilation of the stent cell compared to other stents. Combining the two metrics into an overall side branch accessibility results in Xience Alpine and BioFreedom exhibiting the best performance for side branch access. Study performed at and funded by Abbott Vascular, Santa Clara.
CORONARY: Stents: Drug-Eluting