SUPRAFLEX CRUZ STENT - The FIRE Trial · 2019. 7. 1. · (STEMI, NSTEMI, UAP, SAP) Any type of...
Transcript of SUPRAFLEX CRUZ STENT - The FIRE Trial · 2019. 7. 1. · (STEMI, NSTEMI, UAP, SAP) Any type of...
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SUPRAFLEX CRUZ STENT
Main characteristics and studies
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Stent details
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Stent details
LDZ = Long Dual Z link
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Platform
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Platform – LDZ link
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Deliverability
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Strut thickness
Main benefits related to lower strut thickness
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Cell opening
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Post-Dilatation
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Polmer and drug release
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Clinical studies
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General details of the study
▪ Hypothesis
▪ Non-inferiority of device-oriented endpoint (DOCE) – a composite of cardiac
death, target vessel myocardial infarction, and clinically-indicated target
lesion revascularization – in the Supraflex arm compared with the Xience
arm at 12 months post-procedure.
▪ Sample size calculation
▪ Expected DOCE rate of Xience at 12 months: 8.3% (Resolute All-comers
(Xience arm)*
▪ Non-inferiority margin of 4.0%
▪ One-sided type I error of 0.05
▪ 85% power to detect non-inferiority
▪ Assume lost to follow-up of 3%
• A total of 1435 subjects were to be randomized.
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Non inferiority
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Baseline Characteristics
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Procedural details
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Lesion details
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Device success
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Device success
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Primary endpoint
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Non inferiority
Original Hypothesis
Post-Hoc Hypothesis
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Cardiac death
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Cardiac death
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Target vessel MI
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Stent thrombosis
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Clinically indicated TLR
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Per protocol analysis
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Future clinical studies
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Future clinical studies