Comparison of Two Different Rota-Flush Solutions in Patients Undergoing Rotational Atherectomy: A Randomized, Controlled, Triple-Blind Trial

比较两种不同旋切冲洗液在接受旋切术患者中的应用:一项随机、对照、三盲试验

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Abstract

INTRODUCTION: This prospective study accessed the feasibility and safety of the heparin rota-flush solution in patients undergoing rotational atherectomy (RA). METHODS: Between August 2019 and November 2021, 200 patients who underwent RA were included in this study, among whom 103 (51.5%) were randomly allocated into the heparin rota-flush group and 97 (48.5%) into the traditional rota-flush group. The primary endpoint was the incidence of slow flow/no-reflow after RA; the secondary endpoints were procedural success, RA-related procedural complications, and in-hospital major adverse cardiovascular events (MACE). RESULTS: There were no significant differences in baseline clinical and angiographic characteristics between the two groups. Thirty patients (29.1%) in the heparin rota-flush group and nineteen patients (19.6%) in the traditional rota-flush groups developed slow flow/no-reflow (P = 0.117), respectively, and procedural success was also comparable (97.1% vs. 93.8%, P = 0.320). Severe hypotension (systolic blood pressure < 90 mmHg) was not significantly different (15.5% vs. 16.5%, P = 0.841), but the incidence of coronary spasm was significantly higher in the heparin rota-flush group (42.7% vs. 22.7%, P = 0.003). MACE including stent-thrombosis (ST), target-lesion revascularization (TLR), and cardiac death were also comparable between the two groups; no stroke was observed. CONCLUSIONS: The findings suggest that although continuous intracoronary infusion of heparin rota-flush solution does not increase the incidence of slow flow/no-reflow, traditional rota-flush solution without RotaGlide prevents coronary spasm more effectively compared to the heparin rota-flush without significant impact on severe hypotension. These results do not support a strategy of routine use of heparin rota-flush solution in patients receiving RA procedures.

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