Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial

Abstract Background Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is associated with less major adverse cardiovascular events (MACE) compared with angiography guidance for patients with individual lesion subset. However, the beneficiary effect on MACE outcome of IVUS guidance over angiography guidance in all-comers who undergo DES implantation still remains understudied. Objectives This study aimed to determine the benefits of IVUS guidance over angiography guidance during DES implantation in all-comer patients. Methods A total of 1448 all-comer patients who required DES implantation were randomly assigned (1:1 ratio) to either IVUS guidance or Angiography guidance group. Primary endpoint was target vessel failure (TVF) at 12 months, including cardiac death, target vessel myocardial infarction (TV-MI), and clinically-driven target vessel revascularization (TVR). Procedure was defined as success if IVUS-defined all optimal criteria were met. Results At 12 months follow-up, 60 (4.2%) TVFs occurred, with 21 (2.9%) in the IVUS group and 39 (5.4%) in the Angiography group (hazard ratio [HR] 0.530, 95% confidence interval [CI] 0.312-0.901; p=0.019). In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures, compared to 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95%CI: 0.135-0.898; p=0.029). The significant reduction of clinically-driven target lesion revascularization (TLR) or definite stent thrombosis (HR: 0.407; 95% CI: 0.188-0.880; p=0.018) based-on lesion level analysis by IVUS guidance was not achieved when patient-level analysis was performed. Conclusions The present study demonstrated that IVUS-guided DES implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared to angiography guidance.