3. Fernandez-Avilles F, Alsonso J, Castro-Beivas A, et al, on behalf of the GRACIA (Grupo de Analisis de la Cardiopatio Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1). Lancet;2004;364:045-1053
In the last ACC/AHA guidelines for acute myocardial infarction (1999), angioplasty soon after thrombolysis is strongly discouraged (class III) because studies to date showed no significant difference in outcomes and propensity for adverse events, i.e. bleeding. However, as stated in these last recommendations, the benefits of early post-thrombolysis percutaneous transluminal coronary angioplasty (PTCA) with stenting should be reassessed as interventional strategies mature. In the current era of stents and newer antiplatelet therapies, it looks as if now is the time to take another look.
The GRACIA-1 was a randomized, multi-centered trial to assess early intervention following thrombolysis in ST-elevation myocardial infarction (STEMI). Five hundred patients were enrolled and randomized to receive either fibrin-specific thrombolytics alone in the conservative group or thrombolysis combined with early PTCA. The primary endpoint was a combined rate of death, non-fatal reinfarction, or ischemia-induced revascularization at 1 year. Pre-discharge PTCA and stenting in those demonstrating recurrent ischemia in the conservative group (n=52) was analyzed as a secondary endpoint. One-year follow-up was completed in 98% of patients. Both groups had similar major cardiac events at 30 days, with the one-year endpoint demonstrating no difference in mortality. Significant differences were seen in the primary endpoint at one year [23 (9%) in the invasive group vs. 51 (21%) in the conservative group (RR-0.44, 95% CI 0.28-0.70 p=0.00008)].
A major limitation of this study was the low-risk profile of its patients, and the fact that it was not powered to differentiate between mortality and reinfarction. It will be interesting to see if these results are replicated in future studies (CARESS-2005) and their clinical impact on the management of acute myocardial infarction in centers without interventional support.
4. Hitcho EB, Krauss MJ, Birge S, et al. Characteristics and circumstances of falls in a hospital setting: a prospective analysis. J Gen Intern Med.2004;19:732-739.
Falls in hospital patients are common and persistent problems in hospitals across the country, with significant impact on patient safety, morbidity, and health care cost. Previous studies have reported up to 30% of inpatient falls result in injury, with 4-6% resulting in serious injury. Most studies on falls are retrospective reviews. This paper detailed a prospective observational study designed to identify and analyze the patient characteristics or the circumstances that contribute to falls. Using an online adverse event reporting system, patient falls were identified. Once identified, additional data sources, including the patients’ medical records, electronic nursing records, and interviews with patient or family members and nurses, were used to collect information. A total of 183 patients fell during the study period, with 85% of the falls occurring in the patient’s room.
Half of the falls involved bowel or bladder elimination and were more likely to occur in patients over 65 years in age (adjusted odds ratio 2.4; 95% confidence interval 1.1 to 5.3). Most of the falls (59%) occurred during the evening/overnight. 58% of the patients who fell had received agents with central nervous system activity in the 24 hours prior to a fall. 12% of the patients who fell received sedative-hypnotics. Repeat fallers were more likely to be men than women (11/86 [13%] vs 4/97 [4%]; p=0.03). 42% of the falls resulted in some type of injury, ranging from pain/swelling (34%) to cardiac arrest/death (0.5%). In multivariate analysis, only elimination-related falls remained a significant predictor of being injured from a fall (aOR , 2.4; 95% CI 1.1 to 5.3). Interestingly, patients who were confused or disoriented were less likely to be injured than alert and oriented patients (crude OR, 0.5; 95% CI, 0.3 to 0.98). When examined by services, medicine and neurology had the highest fall rate at 6.12 falls per 1000 patient days and had the highest patient-to-nurse ratio of 6.5 and 5.3, respectively.