Derogar M, Sandblom G, Lundell L, et al. Discontinuation of Low-Dose Aspirin Therapy After Peptic Ulcer Bleeding Increases Risk of Death and Acute Cardiovascular Events. Clinical Gastroenterology and Hepatology 2013;11:38-42
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/22975385
| Methods | Study design: Retrospective cohort study
Number of groups: Two groups |
| Participants | Number of participants: 118 enrolled
· Intervention deprescribing group: 47 enrolled · Control group: 71 enrolled Age: median 79 years Sex: 47 female, 1 male Participants with dementia: No Inclusion criteria: · Hospitalized because of symptoms of upper gastrointestinal bleeding who had an endoscopically verified peptic-ulcer · Users of low-dose aspirin (75 mg or 160 mg daily) before the actual hospital admission Exclusion criteria: · None stated Concomitant medicines: All patients had a proton pump inhibitor at discharge Country: Sweden Setting: Hospital – hospital administrative database at Karolinska University Hospital in Stockholm, Sweden |
| Interventions | Medicine: acetylsalicylic acid compared to continued therapy
Withdrawal schedule: Not described Comparator: Participants whose aspirin was ceased in hospital compared to those whose aspirin was continued from admission to discharge |
| Outcomes | Death
Acute cardiovascular events Hospitalization due to endoscopically verified recurrent peptic-ulcer bleeding |
| Dates | Dates: 2007 and 2010
Follow-up duration: Two years – median 24.4 monthsrange 0.2 to 54.8 months |
| Funding sources | Funding Omid Sadr–Azodi was supported by a postdoctoral scholarship from Olle Engkvist Byggmästare Foundation. |
| Notes | Authors stated: “Conflicts of interest The authors disclose no conflicts.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Retrospective cohort study. Not randomized. |
| Allocation concealment (selection bias) | High risk | Not concealed due to study design. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Not blinded. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | Data-linkage means this is a low risk of bias unless the person had died outside of Sweden:
“Date of death was retrievedthrough the electronic patient chart system TakeCare at Karolinska University Hospital Stockholm, Sweden. This system is continuously updatedconcerning information on death according to data from the Swedish Population Register.” |
| Selective reporting (reporting bias) | 1 out of 5 | The authors stated that ethical approval had been granted before commencing the study, and the stated objectives are reported. |
| Confounding (non-randomized) | 5 out of 5 | The two groups were unequal with a greater percentage of the continued medicine group had cancer, and at admission had signs of circulatory shock. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The representativeness of the exposed cohort seems to be truly representative of the average frail older adults with multiple comorbidities. |
| Selection of the non-exposed cohort | The control cohort is drawnfrom the same population as the intervention cohort. | |
| Ascertainment of exposure | Ascertainment of exposure was through a securerecord. | |
| Demonstration that outcome of interest was not present at start of study | As this is a retrospective study, the authors did not establish that the outcome of interest was not present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The studycontrols for aspirin discontinuation after a bleed. |
| Outcome bias | Assessment of outcome | The outcome assessment was through record linkage. |
| Was follow-up long enough for outcomes to occur | Follow-up over one year is probably adequate for events to occur. | |
| Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for. | |
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