The real solution is to create a test that identifies EXACTLY which persons are susceptible to bleeding from aspirin rather than these blanket prohibitions. In business you'd be fired for not going directly to and solving the root cause. But I'm not medically trained so don't listen to me.
Haphazard Aspirin Add-On: Not a Great Risk-Reward Tradeoff for DOAC Users
Group suggests deprescribing aspirin with no clear indication
Direct oral anticoagulant (DOAC) users without a clear indication for aspirin were often prescribed combination therapy only to wind up with a higher risk of bleeding and no reduction in thrombotic events, an observational study showed.
People with atrial fibrillation (Afib) or venous thromboembolism (VTE) -- but no recent MI or history of heart valve replacement -- were treated with concomitant aspirin atop their DOAC in 33.8% of cases, making this a "common" phenomenon, according to Jordan Schaefer, MD, of the University of Michigan in Ann Arbor, and colleagues.
Comparison between 1,047 matched pairs revealed that combination and DOAC monotherapy groups differed in some key outcomes over a median 12 months of follow-up:
- All bleeding: 31.6 vs 26.0 per 100 patient-years (P=0.01)
- Nonmajor bleeding: 26.1 vs 21.7 per 100 person-years (P=0.02)
- Major bleeding: 4.95 vs 3.59 per 100 person-years (P=0.09)
- Thrombotic events: similar at 2.5 vs 2.3 per 100 patient-years (P=0.80)
- Hospitalizations: 9.1 vs 6.5 per 100 patient years (P=0.02)
- Mortality: 3.8 vs 3.4 per 100 patient-years (P=0.76)
"Ultimately, while emerging data seem to suggest that anticoagulant monotherapy alone may be sufficient for some patients, further confirmation of these findings is necessary," Schaefer's group wrote in JAMA Internal Medicine.
"Efforts should be made to help clinicians identify and deprescribe ASA [aspirin] for patients taking a DOAC without an indication for ASA," they maintained.
The group had previously shown excess bleeding with combination aspirin and warfarin therapy in patients lacking a clear indication for aspirin.
"It is important to acknowledge that there are numerous patient subgroups and clinical scenarios where the role of combination therapy compared with that of anticoagulant monotherapy has not been sufficiently studied," Schaefer's group noted, citing examples such as people with vascular stents, myeloproliferative neoplasms, poorly controlled vascular risk factors, and thrombophilias.
"In such scenarios, shared decision-making and individualized care should remain standard," they stated.
The study relied on the Michigan Anticoagulation Quality Improvement Initiative for registry data from four anticoagulation clinics in Michigan.
Participants were 3,280 adults with Afib or VTE without a clear indication for aspirin (51.0% men; mean age 68.2). All had started taking a DOAC -- namely apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), or rivaroxaban (Xarelto) -- in 2015-2019.
Main study results were largely supported by sensitivity analyses such as those that excluded patients with any history of MI, coronary artery disease, or peripheral artery disease; or excluded those who started or stopped aspirin after study enrollment.
Even so, investigators cautioned that the observational nature of the study left room for unmeasured confounding and was unable to capture changes in aspirin use during follow-up. Moreover, the study may not be generalizable to geographic areas outside Michigan.
"Finally, the overall rates of thrombosis and many bleeding subtypes were low. Accordingly, this study is likely underpowered to make conclusions about thrombotic outcomes and outcomes of some bleeding subtypes," according to Schaefer and colleagues.
Disclosures
The study was funded by Blue Cross Blue Shield of Michigan.
Schaefer disclosed no relevant relationships with industry. Co-authors disclosed multiple relevant relationships with industry.
Primary Source
JAMA Internal Medicine
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