2021
DOI: 10.1016/s0735-1097(21)02324-x
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One Year Clinical Outcomes in Patients With Coronary Bifurcation Lesions: Results From the Resolute Onyx Bifurcation Study

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“…Despite the absence of device-to-device comparative data, in September of 2022, the Food and Drug Administration (FDA) cleared Resolute Onyx Frontier (Medtronic, Minneapolis, MN, United States) as first DES to receive indication for non-LM bifurcation PCI based on data from the Resolute Bifurcation Study [ 35 ]. Resolute Onyx Frontier DES demonstrated low event rates, achieving the performance goal for the primary endpoint of target vessel failure (TVF) at one year [ 36 ]. In a total of 205 patients with 207 bifurcation lesions among which 32.4% of lesions were classified to be true bifurcation lesions with disease of the SB, the rate of the primary endpoint of TVF at 1 year was 6.9% with a 1-sided upper 95% confidence interval of 10.5%, significantly lower than the pre-specified performance goal ( p 0.001).…”
Section: Clinical Datamentioning
confidence: 99%
“…Despite the absence of device-to-device comparative data, in September of 2022, the Food and Drug Administration (FDA) cleared Resolute Onyx Frontier (Medtronic, Minneapolis, MN, United States) as first DES to receive indication for non-LM bifurcation PCI based on data from the Resolute Bifurcation Study [ 35 ]. Resolute Onyx Frontier DES demonstrated low event rates, achieving the performance goal for the primary endpoint of target vessel failure (TVF) at one year [ 36 ]. In a total of 205 patients with 207 bifurcation lesions among which 32.4% of lesions were classified to be true bifurcation lesions with disease of the SB, the rate of the primary endpoint of TVF at 1 year was 6.9% with a 1-sided upper 95% confidence interval of 10.5%, significantly lower than the pre-specified performance goal ( p 0.001).…”
Section: Clinical Datamentioning
confidence: 99%