Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
Coronary Rotational Atherectomy Elective Versus Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure (CRATER) Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Galeote Guillermo, Zubiaur Jon, Jurado-Román Alfonso, Fernández-Portales Javier, Romani Sebastián, Salinas Pablo, García-Tejada Julio, Subinas Asier, Rodríguez Marcos, Palazuelos-Molinero Jorge, Flores Xacobe, López Manuel, Planas Ana, Arroyo Eduardo, Bastos Guillermo, Vera-Vera Silvio, Jiménez-Valero Santiago, Rivero Santana Borja, Tebar Daniel, Gonzálvez Ariana, Moreno Raúl
Аннотация
BACKGROUND: Plaque modification is crucial for successful stent expansion in calcified coronary lesions. Although rotational atherectomy (RA) improves initial procedural success compared to balloon predilatation, data comparing elective versus bailout RA, particularly in chronic kidney disease (CKD) patients, are scarce.
AIMS: To perform a cost analysis of elective RA (E-RA) versus bailout RA (B-RA) to treat severely calcified lesions in patients with CKD, comparing procedural material cost and total healthcare cost.
METHODS: This prospective, multicentre, randomized study compared the costs, safety, and efficacy of E-RA versus B-RA in severely calcified lesions in CKD patients. Participants were randomized 1:1. The primary endpoint was total healthcare cost at 30 days; secondary endpoints included procedural success, stent expansion, and in-hospital complications.
RESULTS: One hundred and twenty-four patients were enrolled (62 per group). The mean age was 77.3 ± 8.3 years; 69.4% were male. There were no baseline clinical differences between both treatment arms. Procedural success was similar (B-RA: 95.2% vs. E-RA: 93.6%; p = 0.69), but crossover was higher in B-RA (20.9% vs. 4.8%; p = 0.014). Procedural complications were more frequent in the elective group (6.5% vs. 22.5%; p = 0.04). The B-RA group tended to higher balloon cost (2100.3 vs. 1485.1€; p = 0.06), while E-RA had higher burr costs (374.2 vs. 1408.8€; p < 0.01) and tended toward higher stent costs (2396.7 vs. 2836.1€; p = 0.06). Overall, procedural material costs were higher in E-RA (6676.9 vs. 7683.3€; p = 0.02), but total healthcare costs were not significantly different (12569.1 vs. 14879.1€; p = 0.09).
CONCLUSIONS: Total healthcare costs were comparable between B-RA and E-RA. A substantial number of patients with CKD and severe CAC required crossover from B-RA, highlighting the potential benefit of E-RA. Besides, the high number of complications underscores the need for expert operators.
AIMS: To perform a cost analysis of elective RA (E-RA) versus bailout RA (B-RA) to treat severely calcified lesions in patients with CKD, comparing procedural material cost and total healthcare cost.
METHODS: This prospective, multicentre, randomized study compared the costs, safety, and efficacy of E-RA versus B-RA in severely calcified lesions in CKD patients. Participants were randomized 1:1. The primary endpoint was total healthcare cost at 30 days; secondary endpoints included procedural success, stent expansion, and in-hospital complications.
RESULTS: One hundred and twenty-four patients were enrolled (62 per group). The mean age was 77.3 ± 8.3 years; 69.4% were male. There were no baseline clinical differences between both treatment arms. Procedural success was similar (B-RA: 95.2% vs. E-RA: 93.6%; p = 0.69), but crossover was higher in B-RA (20.9% vs. 4.8%; p = 0.014). Procedural complications were more frequent in the elective group (6.5% vs. 22.5%; p = 0.04). The B-RA group tended to higher balloon cost (2100.3 vs. 1485.1€; p = 0.06), while E-RA had higher burr costs (374.2 vs. 1408.8€; p < 0.01) and tended toward higher stent costs (2396.7 vs. 2836.1€; p = 0.06). Overall, procedural material costs were higher in E-RA (6676.9 vs. 7683.3€; p = 0.02), but total healthcare costs were not significantly different (12569.1 vs. 14879.1€; p = 0.09).
CONCLUSIONS: Total healthcare costs were comparable between B-RA and E-RA. A substantial number of patients with CKD and severe CAC required crossover from B-RA, highlighting the potential benefit of E-RA. Besides, the high number of complications underscores the need for expert operators.
Предметные рубрики MeSH
HumansMaleAtherectomy, CoronaryFemaleAgedCoronary Artery DiseaseVascular CalcificationTreatment OutcomeProspective StudiesSeverity of Illness IndexAged, 80 and overTime FactorsHospital CostsCost-Benefit AnalysisElective Surgical ProceduresKidney Failure, ChronicRisk FactorsStentsRenal Insufficiency, Chronic