Objective: It is unknown whether the intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) should be routinely used in small-vessel coronary lesions in patients affected by Type 2 diabetes mellitus (T2DM). This study aimed to assess the clinical significance of the IVUS-guided PCI treatment for small-vessel coronary lesions in T2DM.
Methods: This was a prospective interventional trial. A total of 228 patients affected by T2DM with stable angina and a positive stress test in the presence of coronary arteriography (CAG) involving small vessels [online measurement reference vessel diameter ≤3.0 mm by means of quantitative coronary angiography (QCA)] were recruited and divided into two groups: an IVUS-guided group (n=120) and a CAG-guided group (n=108). Follow-up PCIs were performed via CAG or IVUS criteria, respectively. Between-group comparisons were made for the number of stents implanted, length, diameter, and high-pressure balloons used post-dilatation. Major adverse cardiac events (MACEs) defined as cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. The value of late lumen loss and proportion of in-stent restenosis (ISR) were the secondary endpoint, all of which were also evaluated during the follow-up period.
Results: There was an increased lesion length observed using the IVUS measurement when compared with QCA measurements in the IVUS-guided group (p≤0.001). The number of implanted stents, diameter, length, percentage of high-pressure balloons used during post-dilatation, value of late lumen loss, and proportion of ISR decreased in the IVUS-guided group when compared with the CAG-guided group (p=0.002, p=0.001, p=0.003, p=0.004, p=0.007, p=0.001, respectively). After a 2-year follow-up, the Kaplan–Meier curves indicated that the incidence of MACEs was significantly lower in the IVUS-guided group (log-rank p=0.029), mainly because of the TLR reduction (log-rank p=0.037).
Conclusion: The IVUS-guided PCI treatment improved the event-free survival in small-vessel coronary lesions in patients affected by T2DM.