Long-Term Health Outcome and Mortality Evaluation After Invasive Coronary Treatment Using Drug Eluting Stents with or without the IVUS Guidance. Randomized Control Trial. HOME DES IVUS
Abstract
Objective: To assess the role of the intravascular ultrasound (IVUS) during implantation of Drug-eluting stents (DES) on long-term outcome in patients with complex coronary artery disease and high clinical risk profile with special attention to the development of late stent thrombosis (LST). Methods: Two hunderd and ten patients were randomly assigned to receive DES either with (N = 105) or without (N = 105) the IVUS guidance.
Dual antiplatelet treatment was administered for 6 months in all patients. At 18-month follow-up, the rates of Major adverse cardiac events (MACEs) (death, myocardial infarction, and reintervention) were assessed in both groups with special attention to possible LST.
Stent thrombosis was classified according to Academic Research Consortium (ARC). Results: At the 18-month follow-up, there was no significant difference between both groups regarding MACE (11% vs. 12%; P = NS).
Stent thrombosis has occurred in four patients (3.8%) in the group with and in 6 patients (5.7%; P = NS) in the group without the IVUS guidance. Conclusions: In our randomized trial we failed to demonstrate the superiority of the IVUS guidance during DES implantation over standard high-pressure postdilatation.
However we confirmed worrisome results concerning DES thrombosis after discontinuation of dual antiplatelet-treatment with documented stent thrombosis related events in almost 5% of patients with 50% of mortality in this high-risk clinical scenario.