ULTIMATE Compares IVUS and Angiography for Guidance in DES Implantation
December 11, 2018—Results of the ULTIMATE trial, which aimed to determine the benefits intravascular ultrasound (IVUS)–guided versus angiography-guided drug-eluting stent (DES) implantation in an all-comers patient population in China, were published by Junjie Zhang, MD, et al in Journal of the American College of Cardiology (JACC) (2018;72:3126–3137).
As summarized in JACC, the ULTIMATE study was composed of a total of 1,448 patients who required DES implantation. The patients were randomly assigned (1:1 ratio) to either an IVUS guidance group or an angiography guidance group. The primary endpoint was target vessel failure (TVF) at 12 months, including cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization (TVR). The procedure was defined as a success if all IVUS-defined optimal criteria were met.
The investigators reported at 12-month follow-up that 60 TVFs (4.2%) occurred: 21 (2.9%) in the IVUS group versus 39 (5.4%) in the angiography group (hazard ratio [HR], 0.530; 95% confidence interval [CI], 0.312–0.901; P = .019).
In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures compared with 4.4% in patients who failed to achieve all optimal criteria (HR, 0.349; 95% CI, 0.135–0.898; P = .029).
The significant reduction of clinically driven TVR or definite stent thrombosis (HR, 0.407; 95% CI, 0.188–0.88; P = .018) based on lesion-level analysis by IVUS guidance was not achieved when the patient-level analysis was performed.
The study demonstrated that IVUS-guided DES implantation significantly improved clinical outcomes in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance, concluded the ULTIMATE investigators in JACC.