A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study).

AIMS: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. METHODS AND RESULTS: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100±0.0% vs. 99.52±1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016). CONCLUSIONS: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts.

[Image-guided minimally invasive treatment of pulmonary arterial hypertension due to embolic disease]. / Tratamiento de la hipertensión arterial pulmonar postembólica mediante técnicas mínimamente invasivas guiadas por imagen.

OBJECTIVE: Although surgical pulmonary thromboendarterectomy is the treatment of choice for pulmonary hypertension due to chronic thrombotic and/or embolic disease, minimally invasive endovascular techniques such as angioplasty or placement of a metallic stent can provide acceptable results when surgery is not indicated or has been refused by the patient. PATIENTS AND METHODS: Eight patients (5 men, 3 women; mean age, 62.6 years) were treated. The patients were in New York Heart Association (NYHA) class III or IV and had a mean pulmonary artery pressure of 40 mm Hg and more, a capillary wedge pressure of 15 mm Hg or less, or a Miller index greater than 0.5. In all cases, diagnosis was based on Doppler echocardiography, pulmonary angiography, hemodynamic evaluation, and ventilation-perfusion scintigraphy. All patients received fibrinolytic therapy and underwent angioplasty. A metallic stent was implanted in 3 patients. Follow-up echocardiographic assessment and ventilation-perfusion scans were scheduled at 1, 3, 6, and 12 months. RESULTS: The procedures were technically successful in all cases. The mean follow-up period was 18.7 months. Minor complications were extrasystoles (3 cases), slight bruising at the site of puncture (1 case), and rectal bleeding that resolved without treatment (1 case). One patient died from an unknown cause 24 hours after the procedure. In all other cases, improvements were noted in NYHA functional class, in hemodynamics demonstrated by echocardiography, and in vascular structure as shown by arteriography and scintigraphy. CONCLUSIONS: Minimally invasive endovascular interventions can help improve pulmonary arterial hypertension due to chronic thrombotic and/or embolic disease in patients for whom medical or surgical treatment is not possible.

Tratamiento de la hipertensión arterial pulmonar postembólica mediante técnicas mínimamente invasivas guiadas por imagen / Image-guided minimally invasive treatment of pulmonary arterial hypertension due to embolic disease

OBJETIVO: Aunque la tromboendarterectomía pulmonar quirúrgica es el tratamiento de elección en la hipertensión arterial crónica de origen tromboembólico, cuando no hay indicación quirúrgica o el paciente rechaza la cirugía se puede recurrir a técnicas endovasculares de mínima invasión (angioplastia y prótesis metálica) con aceptables resultados. PACIENTES Y MÉTODOS: Se trató a 8 pacientes (5 varones y 3 mujeres) con una media de edad de 62,6 años, en clase III o IV de la clasificación de la New York Heart Association (NYHA), con presión arterial pulmonar media de 40 mmHg o superior, presión capilar enclavada de 15 mmHg o menor e índice de Miller mayor de 0,5. En todos los casos el diagnóstico se estableció por ecografía Doppler cardíaca, angiografía pulmonar, estudio hemodinámico y gammagrafía de ventilación-perfusión. Se realizó tratamiento fibrinolítico seguido de angioplastia en todos los casos, y se colocó una prótesis metálica en 3. Se realizaron revisiones clínicas al cabo de 1; 3; 6, y 12 meses mediante ecografía y gammagrafía. RESULTADOS: El éxito técnico del procedimiento fue del 100%. El seguimiento medio fue de 18,7 meses. Como complicaciones menores se produjeron extrasístoles en 3 casos; hematoma leve en la zona de punción en un caso, y rectorragia, que remitió sin tratamiento, en otro. Una paciente murió por causa desconocida al cabo de 24 h. En todos los casos revisados se observaron una mejoría en la clasificación de la NYHA, mejora hemodinámica evidenciada por ecografía y mejora morfológica objetivada por arteriografía y gammagrafía. CONCLUSIONES: Las técnicas endovasculares de mínima invasión pueden contribuir a mejorar la hipertensión arterial pulmonar crónica debida a tromboembolia en la que no es posible otro tratamiento (farmacológico o quirúrgico)

OBJECTIVE: Although surgical pulmonary thromboendarterectomy is the treatment of choice for pulmonary hypertension due to chronic thrombotic and/or embolic disease, minimally invasive endovascular techniques such as angioplasty or placement of a metallic stent can provide acceptable results when surgery is not indicated or has been refused by the patient. PATIENTS AND METHODS: Eight patients (5 men, 3 women; mean age, 62.6 years) were treated. The patients were in New York Heart Association (NYHA) class III or IV and had a mean pulmonary artery pressure of 40 mm Hg and more, a capillary wedge pressure of 15 mm Hg or less, or a Miller index greater than 0.5. In all cases, diagnosis was based on Doppler echocardiography, pulmonary angiography, hemodynamic evaluation, and ventilation-perfusion scintigraphy. All patients received fibrinolytic therapy and underwent angioplasty. A metallic stent was implanted in 3 patients. Follow-up echocardiographic assessment and ventilation-perfusion scans were scheduled at 1, 3, 6, and 12 months. RESULTS: The procedures were technically successful in all cases. The mean follow-up period was 18.7 months. Minor complications were extrasystoles (3 cases), slight bruising at the site of puncture (1 case), and rectal bleeding that resolved without treatment (1 case). One patient died from an unknown cause 24 hours after the procedure. In all other cases, improvements were noted in NYHA functional class, in hemodynamics demonstrated by echocardiography, and in vascular structure as shown by arteriography and scintigraphy. CONCLUSIONS: Minimally invasive endovascular interventions can help improve pulmonary arterial hypertension due to chronic thrombotic and/or embolic disease in patients for whom medical or surgical treatment is not possible