Efficacy and safety of bivalirudin during percutaneous coronary intervention in high-bleeding-risk elderly patients with chronic total occlusion: A prospective randomized controlled trial.
Catheter Cardiovasc Interv
; 93(S1): 825-831, 2019 02 15.
Article
en En
| MEDLINE
| ID: mdl-30724035
ABSTRACT
OBJECTIVES:
To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients.BACKGROUND:
Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear.METHODS:
This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI.RESULTS:
MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH 10.9% vs. bivalirudin 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH 3.6% vs. bivalirudin 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up.CONCLUSIONS:
Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fragmentos de Péptidos
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Heparina
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Antitrombinas
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Hirudinas
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Oclusión Coronaria
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Intervención Coronaria Percutánea
/
Hemorragia
/
Anticoagulantes
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
País como asunto:
Asia
Idioma:
En
Año:
2019
Tipo del documento:
Article