WAMS (World Assosciation of Medical Sciences)

Journal of Clinical Trials

Safety and Efficacy of a Single 48-mm Everolimus-Eluting Stent in Percutaneous Coronary Intervention for Diffuse Coronary Lesions: A Propensity Score Analysis

Abstract

Author(s): Daisuke Sunohara, Takashi Miura, Fumika Nomoto, Tadashi Itagaki, Toshinori Komatsu, Tomoaki Mochidome, Toshio Kasai, Uichi Ikeda

Objective: Percutaneous Coronary Intervention (PCI) for diffuse coronary lesions is challenging because it is difficult to cover all lesions with one stent. Until now, overlapping stents were used to treat diffuse coronary lesions. However, they carry a higher risk of stent thrombosis. In recent years, 48-mm everolimus-eluting stents, which are longer than the conventional stents, have become available, but their safety and efficacy have not yet been established. The aim of this study was to compare the clinical results of a single 48-mm everolimus-eluting stent with those of overlapping stents.

Methods: Between June 2018 and September 2020, 130 consecutive patients with 139 lesions underwent PCI with a single 48-mm everolimus-eluting stent (48S group) or ≥2 Overlapping Stents (OS group). The primary endpoints were adverse events (cardiac death, non-fatal myocardial infarction, target lesion revascularization, and in-stent restenosis). The secondary endpoints were contrast volume, total procedure time, and radiation dose.

Results: The 48S and OS groups had 45 lesions in 44 patients and 94 lesions in 86 patients, respectively. The risk of adverse outcomes was compared using propensity score analysis with 1:1 matching. Kaplan–Meier analysis revealed no significant differences between the groups in relation to adverse events: cardiac death (0% vs. 2.3%; p=0.34), non- fatal myocardial infarction (0% vs. 4.7%; p=0.18), target lesion revascularization (3.4% vs. 3.4%; p=0.96), and in-stent restenosis (4.4% vs. 20.0%; p=0.10). Procedures in the 48S group required less contrast volume (140 (100, 169) vs. 160 (115, 213) ml; p=0.04), a shorter total procedure time (70 (60, 90) vs. 80 (63, 110) min; p<0.05), and lower radiation dose (1.98 (1.46, 3.38) vs. 3.25 (2.12, 4.03) Gy; p<0.01).

Conclusions: The use of the 48-mm everolimus-eluting stent appears to be a safe and effective PCI strategy for diffuse coronary lesions. In comparison with overlapping stents, a very long stent can help simplify PCI procedures.