Jun-jie Zhang (Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China) and others report in the Journal of American College of Cardiology that percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS) is associated with a significantly lower rate of clinically-driven target vessel failure in all-comers patients than is angiography-guided PCI. This is the first time that benefits of the IVUS-guided PCI have been shown in an all-comers population.
Zhang et al report that data for the benefit of IVUS-guided PCI for simple lesions is “unclear”. “Moreover, whether the beneficiary effect of IVUS-guidance is still present in the modern drug-eluting era still remains to be unknown, the authors add. They write: “Accordingly, this prospective multicentre, randomised trial was designed to compare the efficacy and safety between IVUS-guided and angiography-guided second-generation drug-eluting stent implantation in all-comers patients with coronary artery disease.”
In the study, 1,448 patients were randomised to undergo angiography-guided PCI (724) or IVUS-guided PCI (724). The authors report that optimal stent implantation with angiography guidance was defined as “thrombolysis in myocardial infarction grade 3, residual stenosis <20, and the absence of ≥type B dissection” while optimal stent implantation with IVUS was defined as “minimum lumen area in the stented segment >5mm2 or 90% of the minimum lumen area at the distal reference segments, plaque burden at the 5mm proximal or distal to the stent edge <50%, and no edge dissection involving media with length >3mm”. They add that 471 lesions of 404 patients in the IVUS group did not meet all three criteria for optimal stent implantation with IVUS and, after multiple use of post dilatation, 384 (578 lesions) met all three criteria. Furthermore, Zhang et al report, larger and longer stents were used in the IVUS guidance group.
The primary endpoint was the 12-month rate of clinically-driven target vessel failure, which was significantly reduced in the IVUS group: 2.9% vs. 5.4% for the angiography group (p=0.019). Zhang et al comment: “Patients who met the optimal criteria had a lower rate of target lesion failure at 12 months (1.6%) compared to that in patients who had a suboptimal PCI procedure (4.4%; p=0.029).” In particular, patients with IVUS-defined suboptimal procedure had a similar rate of the primary endpoint as those in the angiography group. There were no significant differences between groups in the components—clinically-driven target vessel revascularisation, target vessel myocardial infarction, and cardiac death—that comprised the primary endpoint. The authors report: “IVUS guidance was critical to modify plaque (complex lesions), to guide postdilatation, subsequently leading to less composite target vessel failure. As a result, with the guidance of IVUS, precise selection of right non-compliant balloon was the basis for achieving an optimal PCI.”
There were not any significant differences between groups in the composite endpoint of definite stent thrombosis and clinically-driven target lesion revascularisation. However, in a lesion-level analysis, this composite endpoint was lower in the IVUS group: 0.9% vs. 2.3% in the angiography group (p=0.02).
“In the present multicentre randomised trial in all-comers patients, IVUS-guided drug-eluting stent implantation resulted in lower incidence of target vessel failure, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance,” Zhang et al conclude.
Coinciding with its publication in Journal of the American College of Cardiology, the study (ULTIMATE) was presented (by Zhang) at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diegeo, USA).