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: Long-Term Outcomes of CRATER Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Zubiaur Jon, Galeote Guillermo, 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, Santana Borja Rivero, Tebar Daniel, Basile Mattia, Gonzálvez Ariana, Moreno Raúl
Аннотация
BACKGROUND: Although rotational atherectomy (RA) has been proven to be a useful tool for severely calcified lesions in patients with chronic kidney disease (CKD), there is a paucity of data comparing an elective RA (E-RA) versus a bailout RA (B-RA) strategy.
AIMS: To compare the long-term outcomes between E-RA versus B-RA in patients with CKD.
METHODS: This prospective, multicentre, randomized study compared E-RA versus B-RA in severely calcified lesions in patients with CKD. Participants were randomized 1:1 and clinically followed. The primary endpoint was major cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR) or stent thrombosis.
RESULTS: 124 patients (62 per group) were enrolled and followed up for a median of 4.2 [3.4-5.3] years. Mean age was 77.3 ± 8.3 years; 69.4% were male. There were no baseline differences between groups. There were no differences in MACE (B-RA: 23.3% vs E-RA: 21.3%; log-rank p = 0.97), death (B-RA: 36.7% vs E-RA: 41.0%; log-rank p = 0.53), cardiovascular death (B-RA: 8.3% vs E-RA: 9.8%; log-rank p = 0.71) and MI during long-term follow-up between E-RA and B-RA strategies. There was a non-significant trend toward fewer TVR events (HR: 0.69; 95% CI: 0.19-2.44; p = 0.56) and TLR events (HR: 0.51; 95% CI: 0.13-2.06; p = 0.35) in the E-RA group.
CONCLUSIONS: Both E-RA and B-RA showed a high rate of clinical events in the long-term follow-up, consistent with a high-risk population. A non-significant trend toward lower rates of TVR and TLR was observed in E-RA group.
AIMS: To compare the long-term outcomes between E-RA versus B-RA in patients with CKD.
METHODS: This prospective, multicentre, randomized study compared E-RA versus B-RA in severely calcified lesions in patients with CKD. Participants were randomized 1:1 and clinically followed. The primary endpoint was major cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR) or stent thrombosis.
RESULTS: 124 patients (62 per group) were enrolled and followed up for a median of 4.2 [3.4-5.3] years. Mean age was 77.3 ± 8.3 years; 69.4% were male. There were no baseline differences between groups. There were no differences in MACE (B-RA: 23.3% vs E-RA: 21.3%; log-rank p = 0.97), death (B-RA: 36.7% vs E-RA: 41.0%; log-rank p = 0.53), cardiovascular death (B-RA: 8.3% vs E-RA: 9.8%; log-rank p = 0.71) and MI during long-term follow-up between E-RA and B-RA strategies. There was a non-significant trend toward fewer TVR events (HR: 0.69; 95% CI: 0.19-2.44; p = 0.56) and TLR events (HR: 0.51; 95% CI: 0.13-2.06; p = 0.35) in the E-RA group.
CONCLUSIONS: Both E-RA and B-RA showed a high rate of clinical events in the long-term follow-up, consistent with a high-risk population. A non-significant trend toward lower rates of TVR and TLR was observed in E-RA group.