IMPORTANCE Endovascular therapy (EVT) is the standard of care for select patients who had a stroke caused by a large vessel occlusion in the anterior circulation, but there is uncertainty regarding the optimal anesthetic approach during EVT. Observational studies suggest that general anesthesia (GA) is associated with worse outcomes compared with conscious sedation (CS). OBJECTIVE To examine the effect of type of anesthesia during EVT on infarct growth and clinical outcome. DESIGN, SETTING, AND PARTICIPANTS The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial was a single-center prospective, randomized, open-label, blinded end-point evaluation that enrolled patients from March 12, 2015, to February 2, 2017. Although the trial screened 1501 patients, it included 128 consecutive patients with acute ischemic stroke caused by large vessel occlusions in the anterior circulation within 6 hours of onset; 1372 patients who did not fulfill inclusion criteria and 1 who did not provide consent were excluded. Primary analysis was unadjusted and according to the intention-to-treat principle. INTERVENTIONS Patients were randomized to either the GA group or the CS group (1:1 allocation) before EVT. MAIN OUTCOMES AND MEASURES The primary end point was infarct growth between magnetic resonance imaging scans performed before EVT and 48 to 72 hours after EVT. The hypothesis formulated before data collection was that patients who were under CS would have less infarct growth. RESULTS Of 128 patients included in the trial, 65 were randomized to GA, and 63 were randomized to CS. For the entire cohort, the mean (SD) age was 71.4 (11.4) years, and 62 (48.4%) were women. Baseline demographic and clinical variables were balanced between the GA and CS treatment arms. The median National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21). Four patients (6.3%) in the CS group were converted to the GA group. Successful reperfusion was significantly higher in the GA arm than in the CS arm (76.9% vs 60.3%; P = .04). The difference in the volume of infarct growth among patients treated under GA or CS did not reach statistical significance (median [IQR] growth, 8.2 [2.2-38.6] mL vs 19.4 [2.4-79.0] mL; P = .10). There were better clinical outcomes in the GA group, with an odds ratio for a shift to a lower modified Rankin Scale score of 1.91 (95% CI, 1.03-3.56). CONCLUSIONS AND RELEVANCE For patients who underwent thrombectomy for acute ischemic stroke caused by large vessel occlusions in the anterior circulation, GA did not result in worse tissue or clinical outcomes compared with CS. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02317237
Using data from the population-based Prescription Database of North Jutland County and the Danish Cancer Registry, we compared cancer incidence among 29 470 individuals prescribed low-dose aspirin at maximum doses of 150 mg with expected incidence based on county-specific cancer rates, during a 9-year study period. We observed 2381 cancer cases compared with 2187 expected, yielding a standardised incidence ratio (SIR) of 1.09 (95% confidence interval (CI), 1.05 -1.13). No apparent risk reductions were found for cancers of the colon (SIR, 0.9; 95% CI, 0.7 -1.1) or rectum (SIR, 1.0; 95% CI, 0.8 -1.2), or for other site-specific cancers. Increased SIRs were observed for kidney cancer (SIR, 1.4; 95% CI, 1.1 -1.7) and brain cancer (SIR, 1.7; 95% CI, 1.3 -2.2), although the excess in the latter was confined to the first year of follow-up. Stratification by number of prescriptions and duration of follow-up revealed no apparent trends. The SIR for colorectal cancer was close to unity (SIR, 0.9; 95% CI, 0.6 -1.2) among persons with 10 or more prescriptions who were followed for at least 5 years. Our results do not support a major protective effect of low-dose aspirin on the development of colorectal or other cancers. The observed excesses of kidney and brain cancers are not likely to be causally related to the use of low-dose aspirin. British Journal of Cancer (2003) Epidemiologic and experimental evidence strongly suggests that use of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) reduces the risk for colorectal cancer (Thun et al, 2002). A recent epidemiologic review (Garcia-Rodriguez and HuertaAlvarez, 2001) reported pooled relative risk estimates for colorectal cancer of 0.71 (95% CI, 0.65 -0.76) for use of aspirin and 0.63 (95% CI, 0.57 -0.70) for use of nonaspirin NSAIDs. The extent to which aspirin and other NSAIDs protect against cancers other than colorectal cancer has not been established.
BackgroundThe validity of the registration of patients in stroke-specific registries has seldom been investigated, nor compared with administrative hospital discharge registries. The objective of this study was to examine the validity of the registration of patients in a stroke-specific registry (The Danish Stroke Registry [DSR]) and a hospital discharge registry (The Danish National Patient Registry [DNRP]).MethodsAssuming that all patients with stroke were registered in either the DSR, DNRP or both, we first identified a sample of 75 patients registered with stroke in 2009; 25 patients in the DSR, 25 patients in the DNRP, and 25 patients registered in both data sources. Using the medical record as a gold standard, we then estimated the sensitivity and positive predictive value of a stroke diagnosis in the DSR and the DNRP. Secondly, we reviewed 160 medical records for all potential stroke patients discharged from four major neurologic wards within a 7-day period in 2010, and estimated the sensitivity, specificity, positive predictive value, and negative predictive value of the DSR and the DNRP.ResultsUsing the first approach, we found a sensitivity of 97% (worst/best case scenario 92%–99%) in the DSR and 79% (worst/best case scenario 73%–84%) in the DNRP. The positive predictive value was 90% (worst/best case scenario 72%–98%) in the DSR and 79% (worst/best case scenario 62%–88%) in the DNRP. Using the second approach, we found a sensitivity of 91% (95% confidence interval [CI] 81%–96%) and 58% (95% CI 46%–69%) in the DSR and DNRP, respectively. The negative predictive value was 91% (95% CI 83%–96%) in the DSR and 72% (95% CI 62%–80%) in the DNRP. The specificity and positive predictive value did not differ among the registries.ConclusionOur data suggest a higher sensitivity in the DSR than the DNRP for acute stroke diagnoses, whereas the positive predictive value was comparable in the two data sources.
Current and new users of all classes of nonaspirin NSAIDs had elevated relative risk estimates for MI. Although the increased risk estimates may partly reflect unmeasured bias, they indicate the need for further examination of the cardiovascular safety of all nonaspirin NSAIDs.
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