Background: The Strategy for Intravascular ultrasound (IVUS) guided PTCA and Stenting (SIPS) trial included a prospectively designed subgroup analysis to investigate whether routine IVUS-guidance during percutaneous intervention improves long-term outcome in diabetics.
Methods and results: Consecutive diabetic patients (n = 43) with 57 lesions were randomly assigned to receive provisional stenting with angiographic guidance only (ANGIO) or with IVUS guidance provided by a combined IVUS/variable diameter balloon catheter (IVUS). The combined primary endpoint included death, nonfatal myocardial infarction and target vessel revascularisation (TVR) and was recorded for 28 months. The re-stenosis rate at 6-month follow-up angiography was defined as a secondary endpoint. A primary endpoint occurred in 6 diabetic patients (31.6%) in the IVUS-group and 11 diabetic patients (45.8%) in the ANGIO-group (relative risk for IVUS, 0.83, 95% confidence interval 0.28-2.35, p = 0.83). Kaplan-Meier analysis suggested that IVUS did slightly attenuate the negative effect of diabetes on long-term event-free survival. The quantitative assessment of follow-up angiography revealed that the incidence of re-stenosis was high in both groups (IVUS: 53% versus ANGIO: 52%, p = 0.94). There was no difference in the mean duration of hospitalisation (11.8 days with IVUS versus 11.2 days with ANGIO, p = 0.83) or total cost (US dollars 16,725 with IVUS versus US dollars 16,230 with ANGIO, p = 0.83) during follow-up.
Conclusion: Routine IVUS-guidance during provisional stenting seems to slightly attenuate the negative effect of diabetes on long-term outcome. However, the re-stenosis rate remains very high.