RESUMEN
OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.
Asunto(s)
Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Células Progenitoras Endoteliales/patología , Intervención Coronaria Percutánea/instrumentación , Sirolimus/administración & dosificación , Anciano , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/patología , Reestenosis Coronaria/etiología , Trombosis Coronaria/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Factores de Riesgo , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
A 35-year-old multiparous woman was found unresponsive, tachypnoeic, hypoxic and in shock 4 h postpartum. The ECG revealed S1 Q3 T3, a right bundle branch block pattern and right-axis deviation. The computed tomography of her pulmonary arteries revealed bilateral pulmonary artery thrombosis with dilated right ventricle. She was fibrinolyzed with intravenous Tenecteplase 30 mg bolus. Her saturation and tachypnoea improved and her ECG reverted to sinus rhythm subsequently. We discuss our use of off-label Tenecteplase in postpartum pulmonary embolism and review the literature.