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      El estudio CRUSADE, modelo de evaluación de la calidad en la intervención coronaria percutánea Translated title: The CRUSADE study, evaluation model of quality in percutaneous coronary intervention

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          Abstract

          La mejora de la calidad asistencial no finaliza con la publicación de ensayos clínicos que demuestran evidencia clínica de efectividad, ni por su respaldo por las distintas guías terapéuticas internacionales. Esta mejora de la calidad requiere una evaluación en la población real, ello se puede realizar mediante el análisis de registros clínicos, que valorarían el adecuado cumplimiento de las guías clínicas y su efectividad en la población real. El estudio CRUSADE es un estudio que evalúa la utilización, el pronóstico y los factores de predicción de la estrategia invasiva mediante la intervención coronaria percutánea (ICP) precoz (primeras 48 horas del evento isquémico), en pacientes con síndrome coronario agudo sin elevación del segmento ST (SCASEST) de alto riesgo. De los 17.926 pacientes estudiados, a 8.037 (44,8%) se les realiza cateterismo cardíaco en las primeras 48 horas del evento isquémico. La mortalidad intrahospitalaria de la estrategia invasiva fue significativamente menor que el tratamiento médico (2,5% frente a 3,7%). Los pacientes a los que se les realizó una estrategia invasiva precoz representaban una población seleccionada, al ser los factores independientes de predicción más sólidos, asociados al tratamiento invasivo precoz: la asistencia cardiológica, la edad más joven, la ausencia de insuficiencia renal, ausencia de insuficiencia cardíaca previa, o a la llegada al hospital y una frecuencia cardíaca más baja. Pudiéndose concluir finalmente, que a pesar de la disminución de la mortalidad conseguida con la estrategia invasiva precoz, ésta no se realiza en la mayoría de los pacientes, quedando reservada para subgrupos de menor comorbilidad, y para aquellos atendidos por los cardiólogos.

          Translated abstract

          Improvement of care quality does not end with the publication of clinical trials that show clinical evidence of effectiveness or with its support by the different international therapeutic guides. This quality improvement requires evaluation in the real population. This can be done by analysis of clinical registries, that would evaluate adequate compliance of the clinical guides and their effectiveness in the real population. The CRUSADE study is a study that evaluates use, prognosis and factors of prediction, of invasive strategy by early percutaneous coronary intervention (PCI) (first 48 hours of the ischemic event) in high-risk patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS). Of the 17926 patients studied, 8037 (44.8%) underwent cardiac catheterism in the first 48 hours of the ischemic event. Intrahospital mortality of the invasive strategy was significantly less than medical treatment (2.5% versus 3.7%). The patients who underwent an early invasive strategy were a selected population, as the more solid independent prediction factors were associated to early invasive treatment: cardiology care, earlier age, absence of renal failure, absence of heart failure both previously or on arrival to the hospital and lower heart rate. Finally, it could be concluded that, in spite of the decrease of mortality achieved with the early invasive strategy, this would not done in most of the patients, being reserved for subgroups with lower comorbidity and for those seen by the cardiologists.

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          Most cited references25

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          Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. The PURSUIT Trial Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy.

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          Aggregation of platelets is the pathophysiologic basis of the acute coronary syndromes. Eptifibatide, a synthetic cyclic heptapeptide, is a selective high-affinity inhibitor of the platelet glycoprotein IIb/IIIa receptor, which is involved in platelet aggregation. We tested the hypothesis that inhibition of platelet aggregation with eptifibatide would have an incremental benefit beyond that of heparin and aspirin in reducing the frequency of adverse outcomes in patients with acute coronary syndromes who did not have persistent ST-segment elevation. Patients who had presented with ischemic chest pain within the previous 24 hours and who had either electrocardiographic changes indicative of ischemia (but not persistent ST-segment elevation) or high serum concentrations of creatine kinase MB isoenzymes were enrolled in the study. They were randomly assigned, in a double-blind manner, to receive a bolus and infusion of either eptifibatide or placebo, in addition to standard therapy, for up to 72 hours (or up to 96 hours, if coronary intervention was performed near the end of the 72-hour period). The primary end point was a composite of death and nonfatal myocardial infarction occurring up to 30 days after the index event. A total of 10,948 patients were enrolled between November 1995 and January 1997. As compared with the placebo group, the eptifibatide group had a 1.5 percent absolute reduction in the incidence of the primary end point (14.2 percent, vs. 15.7 percent in the placebo group; P=0.04). The benefit was apparent by 96 hours and persisted through 30 days. The effect was consistent in most major subgroups except for women (odds ratios for death or nonfatal myocardial infarction, 0.8 [95 percent confidence interval, 0.7 to 0.9] in men, and 1.1 [0.9 to 1.31 in women). Bleeding was more common in the eptifibatide group, although there was no increase in the incidence of hemorrhagic stroke. Inhibition of platelet aggregation with eptifibatide reduced the incidence of the composite end point of death or nonfatal myocardial infarction in patients with acute coronary syndromes who did not have persistent ST-segment elevation.
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              Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators.

              In unstable coronary-artery disease early invasive procedures are common, despite lack of evidence for the superiority of this approach. We compared an early invasive with a non-invasive treatment strategy in unstable coronary-artery disease. In a prospective randomised multicentre study, we randomly assigned 2457 patients in 58 Scandinavian hospitals (median age 66 years, 70% men) an early invasive or non-invasive treatment strategy with placebo-controlled long-term low-molecular-mass heparin (dalteparin) for 3 months. Coronary angiography was done within the first 7 days in 96% and 10%, and revascularisation within the first 10 days in 71% and 9% of patients in the invasive and non-invasive groups, respectively. We followed up patients for 6 months. Analysis was by intention to treat. After 6 months there was a decrease in the composite endpoint of death or myocardial infarction of 9.4% in the invasive group, compared with 12.1% in the non-invasive group (risk ratio 0.78 [95% CI 0.62-0.98], p=0.031). There was a significant decrease in myocardial infarction alone (7.8 vs 10.1%, 0.77 [0.60-0.99]; p=0.045) and non-significantly lower mortality (1.9 vs 2.9%, 0.65 [0.39-1.09]; p=0.10). Symptoms of angina and re-admission were halved by the invasive strategy. Results were independent of the randomised dalteparin treatment. The greatest advantages were seen in high-risk patients. The early invasive approach should be the preferred strategy in most patients with unstable coronary-artery disease who have signs of ischaemia on electrocardiography or raised biochemical markers of myocardial damage.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                medinte
                Medicina Intensiva
                Med. Intensiva
                Elsevier España, S.L. (, , Spain )
                0210-5691
                September 2006
                : 30
                : 6
                : 276-279
                Affiliations
                [01] Jaén orgnameComplejo Hospitalario de Jaén orgdiv1Hospital Universitario Médico Quirúrgico orgdiv2Servicio de Cuidados Críticos y Urgencias España
                [02] Granada orgnameHospital Universitario Virgen de las Nieves orgdiv1Servicio de Cuidados Críticos y Urgencias orgdiv2Unidad de Medicina Intensiva España
                Article
                S0210-56912006000600004
                10.1016/S0210-5691(06)74524-7
                16949002
                43c6b83a-4df1-4c34-a2a3-e995ab20baec

                This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 International License.

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                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 16, Pages: 4
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                SciELO Spain


                síndrome coronario agudo,registro,intervencionismo coronario percutáneo,mortalidad,calidad,acute coronary syndrome,registry,percutaneous coronary intervention,mortality,quality

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