Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
OBJECTIVE: The objective of this selective EBM review is to determine whether or not there is a mortality benefit with the use of aspirin in the primary prevention setting in adults without cardiovascular disease.
STUDY DESIGN: This is a systematic review of three double blind randomized controlled trials published in 2018. All three trials compared 100 mg of aspirin with placebo and were published in English.
DATA SOURCES: All three articles were identified and published through peer-reviewed sources using PubMed.
OUTCOMES MEASURED: Mortality was the outcome measured through various death identification steps such as review of death certificates, notification from next of kin, and review of medical records.
RESULTS: The ASPREE trial showed that aspirin was associated with an increase in all-cause mortality. There was 5.9% mortality in the aspirin group versus 5.2% in the placebo group with statistically significant results (p-value < 0.05) (McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med. 2018;379(16):1519-1528. doi: 10.1056/NEJMoa1803955 [doi]). The ARRIVE trial showed that participants taking aspirin had a 1% reduced risk of mortality compared to those taking the placebo (hazard ratio = 0.99) (Gaziano JM, Brotons C, Coppolecchia R, et al. Lancet. 2018;392(10152):1036-1046. doi: S0140-6736(18)31924-X [pii]). However, the results were not statistically significant with a p-value > 0.05. The ASCEND trial showed that those taking aspirin have a reduced risk of death compared to those taking the placebo (rate ratio = 0.94) (Bowman L, Mafham M, Wallendszus K, et al. N Engl J Med. 2018;379(16):1529-1539. doi: 10.1056/NEJMoa1804988 [doi]). These results were not statistically significant (p-value > 0.05).
CONCLUSIONS: The data did not show that the use of aspirin in the primary prevention setting has a mortality benefit in adults without cardiovascular disease. ASPREE was the only trial that had statistically significant results and it showed a higher rate of mortality in those taking aspirin. ASCEND and ARRIVE trials showed a small mortality benefit in those taking aspirin. However, these findings were not statistically significant. These compelling findings need to be investigated further with large scale studies using mortality as a primary investigative endpoint.
Bernardi, Lauren, "Is There a Mortality Benefit with the Use of Aspirin in the Primary Prevention Setting in Adults Without Cardiovascular Disease?" (2020). PCOM Physician Assistant Studies Student Scholarship. 522.