Rationale and design: impact of intravascular ultrasound guidance on long-term clinical outcomes of everolimus-eluting stents in long coronary lesions

Abstract

BACKGROUND: Although the use of drug-eluting stents (DESs) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization, treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis. Intravascular ultrasound (IVUS) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention. However, it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes.

HYPOTHESIS: We hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions.

STUDY DESIGN: This study is a randomized, prospective, multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions (implanted stent ≥28 mm in length). The primary end point is a composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or target lesion revascularization at 1 year following intervention. A total of 1,400 patients will be required to be enrolled according to sample size calculations.

CONCLUSION: This study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance.