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Clinical TrialOctober 2020

JOURNAL：JACC: Cardiovascular Interventions Article Link

Three-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation

XF Gao, Z Ge, and for the ULTIMATE Investigators et al. Keywords: IVUS-guided DES-PCI; all-comers; TVF

ABSTRACT

OBJECTIVES - This study aimed to explore the difference in target vessel failure (TVF) 3 years after intravascular ultrasound (IVUS) guidance versus angiography guidance for all-comers undergoing second-generation drug-eluting stent (DES) implantation.

BACKGROUND - The multicenter randomized ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions) trial showed fewer 1-year TVFs after IVUS-guided DES implantation for all-comers compared with those after angiography guidance. However, the 3-year clinical outcomes of the ULTIMATE trial remain unknown.

METHODS - A total of 1448 all-comers undergoing DES implantation who were randomly assigned to either IVUS guidance or angiography guidance in the ULTIMATE trial were followed for 3 years. The primary endpoint was the risk of TVF at 3 years. The safety endpoint was definite / probable stent thrombosis (ST).

RESULTS - At 3 years, TVF occurred in 47 (6.6%) patients in the IVUS-guided group and in 76 (10.7%) patients in the angiography-guided group (p = 0.01), mainly driven by the decrease in clinically driven target vessel revascularization (4.5% vs. 6.9%, p = 0.05). The definite or probable ST rate was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group (p = 0.02). Notably, the IVUS-defined optimal procedure was associated with a significant reduction in 3-year TVF relative to that with the suboptimal procedure.

CONCLUSIONS - IVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during a 3-year follow-up in all-comers, particularly for patients who underwent the IVUS-defined optimal procedure, compared with those with angiography guidance.

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