Dual Antiplatelet Treatment up to 72 Hours after Ischemic Stroke (INSPIRES)
Gao Y et al. NEJM (December 2023)
Bottom line: This double-blind, randomized, placebo-controlled, two-by-two factorial trial was conducted in 222 hospitals in China. The study included 6100 patients with mild ischemic stroke or high-risk transient ischemic attack (TIA) of presumed atherosclerotic cause. Patients were randomly assigned to receive either clopidogrel (300 mg on day 1 and 75 mg daily on days 2 to 90) plus aspirin (100 to 300 mg on day 1 and 100 mg daily on days 2 to 21) or aspirin alone within 72 hours after symptom onset. The primary efficacy outcome was new stroke, and the primary safety outcome was moderate-to-severe bleeding, both assessed within 90 days. A new stroke occurred in 222 patients (7.3%) in the clopidogrel–aspirin group and 279 patients (9.2%) in the aspirin group (hazard ratio, 0.79; 95% confidence interval [CI], 0.66 to 0.94; P=0.008). Moderate-to-severe bleeding occurred in 27 patients (0.9%) in the clopidogrel–aspirin group and 13 (0.4%) in the aspirin group (hazard ratio, 2.08; 95% CI, 1.07 to 4.04; P=0.03). These results showed that combined clopidogrel-aspirin therapy led to a lower risk of new stroke but a higher risk of moderate-to-severe bleeding compared to aspirin therapy alone.
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Default Palliative Care Consultation for Seriously Ill Hospitalized Patients: A Pragmatic Cluster Randomized Trial
Courtright K et al. JAMA (January 2024)
Bottom Line: This pragmatic, stepped-wedge, cluster randomized trial aimed to determine the effectiveness of ordering palliative care consultation by default for seriously ill hospitalized patients in 11 US hospitals. The study included 24,065 patients age 65 or older with serious illness including advanced chronic obstructive pulmonary disease, dementia, or kidney failure and lengths of stay of at least 72 hours. The intervention group received palliative care consultation by default (allowing clinicians to opt-out), while the comparator group received usual care (allowing clinicians to choose to order palliative care). 43.9% of patients in the default order group received palliative care consultation compared to 16.6% in the standard care group (adjusted odds ratio [aOR], 5.17 [95% CI, 4.59-5.81]). Patients in the default order group also received consultation earlier (mean [SD] of 3.4 [2.6] days after admission vs 4.6 [4.8] days; P < .001). Results showed no significant difference in hospital length of stay between the two groups. The intervention group had higher rates of do-not-resuscitate orders and discharge to hospice and similar in-hospital mortality. The study concluded that while default palliative care consult orders did not reduce length of stay, they did improve the rate and timing of consultation and end-of-life care processes.
LINK TO ARTICLE (Courtright et al.)
Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia (MINT)
Carson J et al. NEJM (December 2023)
Bottom Line: This phase 3 interventional trial compared a liberal transfusion strategy (hemoglobin cutoff, <10 g/dL) to a restrictive transfusion strategy (hemoglobin cutoff, 7 or 8 g/dL) in 3504 patients with acute myocardial infarction and a hemoglobin level of less than 10 g/dL. The primary outcome was a composite of myocardial infarction or death at 30 days. The mean (±SD) number of red-cell units transfused was 0.7±1.6 in the restrictive-strategy group compared to 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g/dL lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive strategy group and in 255 of 1755 patients (14.5%) in the liberal strategy group (risk ratio modelled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P=0.07). Safety outcomes showed no significant difference in death or myocardial infarction between the two groups. The conclusion is that a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days, but potential harms of a restrictive transfusion strategy cannot be excluded.
LINK TO ARTICLE (Carson et al.)
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Trial Files Issue #2024-04
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