Search

Resumen Introduccion y objetivos Comparar la incidencia en 3 anos de eventos mayores en pacientes con lesiones de bifurcacion tratados con implante condicional de stents liberadores de sirolimus frente a stents liberadores de everolimus. Metodos Se llevo a cabo un analisis combinado de dos ensayos prospectivos y aleatorizados de metodologia similar (SEAside y CORpal). En dichos ensayos, se asigno aleatoriamente a 443 pacientes con lesiones de bifurcacion a tratamiento con stents liberadores de sirolimus o everolimus. El seguimiento clinico se amplio a 3 anos para evaluar los eventos adversos cardiovasculares mayores (muerte o infarto agudo de miocardio o revascularizacion de vaso diana). Resultados A los 3 anos, la supervivencia libre de eventos adversos cardiovasculares mayores fue del 93,2 y el 91,3% en los grupos de stents liberadores de everolimus y sirolimus respectivamente (p = 0,16). El analisis exploratorio de referencia para los eventos tardios (aparecidos despues de los primeros 12 meses) mostro una frecuencia de eventos adversos cardiovasculares mayores significativamente inferior en el grupo de stents liberadores de everolimus: el 1,4 frente al 5,4% en el grupo de stents liberadores de sirolimus (p = 0,02). Conclusiones El implante de stents liberadores de sirolimus o everolimus en lesiones de bifurcacion se asocia a unas tasas bajas de eventos adversos mayores a los 3 anos de seguimiento. Los resultados de un subanalisis de los eventos que se produjeron despues del primer ano indican una tasa de eventos con los stents liberadores de everolimus inferior que con los liberadores de sirolimus, lo cual indica que esta justificado realizar estudios exploratorios del beneficio clinico a largo plazo obtenido con los stents liberadores de farmacos de ultima generacion.

The research in the field of sleep medicine has increased during the whole twentieth century, principally for the involvement of sleep-related disordered breathing (SDB) in cardiovascular disease. If sleep encompasses about a third of one’s life, the reasons are mostly linked to its effects on the cardiovascular and respiratory systems. Sleep is a physiological phenomenon characterized by changes in the human body leading to a state of quiescence of the cardiovascular, respiratory and metabolic systems [1]. The importance of these events becomes more evident if we Review Article British Journal of Medicine & Medical Research, 4(1): 34-45, 2014 35 consider what happens in their absence, that is, during SDB syndromes. These syndromes include habitual snoring, sleep apnea, Cheyne-Stokes breathing syndrome and sleep hypoventilation syndrome [2]. Sleep apnea syndromes are characterized by several apneic events during the night, which consist in absence of the airflow or its reduction by more than 90% lasting more than 10 seconds, with consequent oxyhemoglobin desaturation and arousal [2]. These events provoke microawakening and sleep fragmentation that represent, along with hypoxemia, important harmful triggers on the cardiovascular system. In fact, SDB presents as a highly prevalent comorbidity in patients with heart failure (HF); both diseases are related to each other in a bidirectional way through multiple mechanisms: apneic events raise cardiac afterload, and at the same time impaired cardiac function itself may contribute to the development of sleep apnea. HF is a clinical syndrome characterized by signs or symptoms due to the inability of the heart to provide a normal tissue perfusion: the failing cardiac pump is not able to maintain an adequate output for this task. Typical features of HF are represented by shortness of breath, resting or exertion dyspnea, fatigue, fluid retention leading to pulmonary congestion or ankle swelling, and objective evidence of a structurally or functionally abnormal heart at rest [1,3].

Background The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions. Methods/Design Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area

Background Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies. Methods/Design We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months. Discussion Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia. Trial registration Clinicaltrials.gov NCT01057563.

The use of thrombus aspiration during percutaneous coronary intervention (PCI) is recommended in patients with ST-elevation myocardial infarction (STEMI) undergoing mechanical revascularization. When thrombus aspiration is adopted, the standard technique includes, after mechanical thrombus extraction, angioplasty and/or stent implantation to eliminate residual stenosis. To date, no data are available concerning the use of thrombectomy alone without additional ballooning or stenting.We report the angiographic and clinical outcome of a series of selected STEMI patients undergoing mechanical reperfusion by thrombus aspiration without additional ballooning or stenting. Four patients out of 316 consecutive STEMI patients were managed by thrombus aspiration alone (1.3%). All patients had angiographic documentation of an occlusive large intracoronary thrombus in the infarct-related artery before intervention and complete restoration of coronary flow in the absence of critical coronary stenosis after thrombus aspiration. Three of these patients had a clinical contraindication to dual antiplatelet therapy, thus suggesting that to avoid stent implantation would be advisable. Angiographic reevaluation was performed before discharge in 3 patients confirming persistent patency of the infarct-related artery (in 1 case the residual stenosis was judged to require intravascular ultrasound evaluation and subsequent elective PCI with stent implantation). The thirty-day clinical course was uneventful in all patients.In selected patients with STEMI undergoing mechanical reperfusion, thrombus aspiration without additional ballooning or stenting may be successfully performed. Further studies are needed to assess the clinical relevance of this novel approach.