Segurança e efetividade da enoxaparina versus heparina não-fracionada no tratamento de pacientes submetidos a implante eletivo de stents não-farmacológicos: resultados imediatos e tardios / Safety and efficacy of enoxaparin versus unfractionated heparin in patients undergoing elective percutaneous coronary intervention with bare-metal stent implantation: immediate and long-term clinical outcomes

RESUMO

A heparina não fracionada (HNF) é terapia anticoagulante clássica na intervenção percutânea, prevenindo complicações trombóticas agudas. Estudos sugerem que as heparinas de baixo peso molecular podem ser uma alternativa segura e eficaz. Objetivos: Avaliar a segurança e a efetividade da enoxaparina (ENO) versus HNF em pacientes tratado por intervenção percutânea eletiva nas fases hospitalar (FH) e tardia (FT). Método: No período de outubro a novembro de 2004, incluímos 57 pacientes consecutivos tratados com ENO 0,75 mg/kg (G2) versus grupo controle de 143 pacientes tratados com UI/kg (G1) nos três meses prévios. Todos receberam stents não-farmacológicos e foram pré-tratados com aspirina mais ticlopidina. Analisamos as complicações vasculares (CV) e hemorrágicas (CH) e os eventos combinados (EC) morte, infarto agudo do miocárdio (IAM), acidente vascular encefálico (AVE) e revascularização de urgência (RU) na FH e EC morte, IAM, AVE e nova revascularização na FT. No G2-ENO, mensuramos o fator anti-Xa 10 minutos após bolus EV e no fim da intervenção percutânea. Resultados: A média de idade foi de 59,8 mais ou menos 9,8 anos, 30 por cento eram diabéticos...

ABSTRACT

Background: Unfractionated heparin (UFH) is the classic anticoagulant therapy used during percutaneous intervention (PCI) to prevent acute thrombotic events. Preliminary studies with low molecular weight heparin have demonstrated the safety and efficacy of this alternative regimen during PCI. Our objective was to evaluate in-hospital and long-term safety and efficacy of enoxaparin (ENO) compared to UFH in patients (P) undergoing elective PCI. Methods: From 10/2004-11/2004, 57 P treated with ENO 0.75 mg/kg IV (G2) were enrolled and compared to a control group of 143 consecutive P treated with UFH 100 IU/kg IV (G1) during the preceding 3 months. All P received a baremetal stent and were pre-treated with ASA + ticlopidine. We analyzed the in-hospital vascular and bleeding complications as well as in-hospital and long-term composite clinical outcome of death, myocardial infarction (MI), stroke or target-vessel revascularization (TVR). Anti-Xa levels were measured in G2-ENO at the beginning (10 minutes after IV bolus) and at the end of PCI. Results: The mean age was 59.8 ± 9.8 years, 30% were diabetics, and clinical and angiographic characteristics were similar in both groups. Procedure success ocurred in 100% without in-hospital major bleedings nor vascular complications in both groups; a non-significant increase in minor bleedings in G2-ENO (p = 0.15) was observed and CKMB > 3x occurred in 2...