Trial reportScientific reports2025
Safety and efficacy of low-temperature RA-flush solution in patients with moderate-to-severe calcified lesions (LOTA-II): a randomized, double-blind, multicenter study.
Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03701230 (Safety and Efficacy of Low Temperature Rota-flush Solution for the Treatment of RA-related Myocardial Injury in Patients With Severe Calcified Lesion Undergoing Rotational Atherectomy), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Efficacy of Low Temperature Rota-flush Solution for the Treatment of RA-related Myocardial Injury in Patients With Severe Calcified Lesion Undergoing Rotational Atherectomy (RA) (LOTA-II)
Who cites it
1 citing paper in PubMed.
- Clinical expert consensus document on rotational atherectomy from the Japanese association of cardiovascular intervention and therapeutics: update 2026.Cardiovascular intervention and therapeutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rotational atherectomy (RA) is an effective, mature, and specific treatment for calcified lesions. However, the incidence of RA-related myocardial injury remains high and has not been adequately addressed. To assess the safety and efficacy of low-temperature RA-flush solution versus room-temperature RA-flush solution during RA. A total of 132 patients with moderate-to-severe calcified lesions who underwent RA were randomly assigned to the low-temperature RA-flush solution group or the room-temperature RA-flush solution group. The primary endpoint was RA-related myocardial injury, defined as any increase in myocardial biomarkers within 72 h after percutaneous coronary intervention (PCI). Secondary endpoints included RA-related myocardial infarction (MI), RA-related transient slow/no flow, or transient coronary spasm. A total of 78 patients (59.1%) had increased cardiac troponin I (cTnI) levels, and 60 patients (45.5%) had increased creatine kinase isoenzyme (CK-MB) levels after PCI. The number of patients with myocardial injury (primary endpoint), defined as elevated cTnI (47.0% vs. 71.2%, p = 0.005) or elevated CK-MB (28.8% vs. 62.1%, p < 0.001), was significantly lower in the low temperature group than in the room temperature group. The number of patients with RA-related transient slow/no flow (6.1% vs. 34.8%, p < 0.001) and transient coronary spasm (9.1% vs. 25.8%, p = 0.012) (secondary endpoints) was significantly lower in the low temperature group than in the room temperature group; no significant difference in the incidence of RA-related MI was observed between the two groups. Compared with room-temperature RA-flush solution, low-temperature RA-flush solution is associated with reduced RA-related myocardial injury in patients treated with RA.Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03701230; first submitted registration date: 09/10/2018.
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