Ab0839 safety of low-dose acetyl salicylic acid in patients with systemic sclerosis: a cross-sectional study

Background The low-dose acetyl salicylic acid (ASA) is often used among patients with Systemic sclerosis (SSc) in clinical practice since its use is not mentioned in any official document concerning the management of SSc [1] . Recently, a study from EUSTAR database demonstrated that anti-platelet therapy is a protective factor for digital ulcers onset, while Valentini et al associated the use of ASA with a lower incidence of primary cardiac involvement in SSc patients [2,3] . On the other hand SSc has been shown to be one of the autoimmune diseases with the highest CV risk [4] . The publication of 2022 EULAR Recommendations on cardiovascular (CV) involvement in rheumatic diseases asserting that “ the use of ASA in SSc is not recommended for primary prevention ” because of “ data about this topic were not find” caused uncertainty to justify the use of this drug [5] . Objectives Aim of our study was to evaluate the safety of ASA in a cohort of pts affected by SSc. Methods We retrospectively analyzed data from patients with SSc, fulfilling the 2013 ACR/EULAR classification criteria [6] , followed in our Scleroderma Clinic, receiving ASA. Analysis included data from subjects that were not treated with ASA, as control group. Exclusion criteria were CV disorders and/or major bleeding occurred before the evaluation, treatment with ASA started before the diagnosis of SSc, Helicobacter pylori-related gastritis or other causes of gastritis not SSc-related, tumors, anticoagulant or other anti-platelet therapies. Demographic, clinical, ongoing therapies data were examined; conventional cardiovascular risk factors, instrumental and laboratory assessments were collected and the CV risk was calculated using the SCORE2 and/or SCORE2-OP [7] . All data were collected for a follow-up time variable from 2 to 10 years since ASA was prescribed (for cases ) and since the first rheumatologic visit after diagnosis was done for controls (T0). Safety data included the following variables: - major bleeding (requiring blood transfusion and/or leading to death) - minor bleeding - intracranial hemorrhage - ocular hemorrhage requiring immediate treatment - gastroenteric tract hemorrhage - gastroenteric tract neoplasm - gastric ulcer - allergy to ASA Results Data were collected from 121 SSc pts, 71 cases and 50 controls . From the analysis of gastroenteric involvement at T0 control pts showed more frequently endoscopic gastroenteric lesions of the upper gastroenteric tract respect to cases (N-% controls vs cases : 8-16% vs 4-6%; p-value 0.0039). Among traditional CV risk factors we found that cases were more frequently smokers than control s (N-% cases vs controls : 15-21% vs 2-4%; p-value 0.007), but no difference was found with either of the other traditional CV risk factors or with the CV risk scores, calculated with SCORE2, between cases and controls. Our analysis didn’t reveal any significant difference on the occurrence of adverse events concerning ASA safety between the two groups: after 1 year of treatment with ASA, 4 subjects showed minor bleeding and in one case a gastric neoplasm was diagnosed; after 2 years of treatment 2 pts reported minor bleeding, while just 1 case showed minor bleeding after 5 years of treatment. Among controls , the onset of gastric ulcers in one subject only was reported after 2 years of follow-up. Conclusion Despite the long period of ASA treatment, we didn’t find a significative increase in the frequency of related adverse events in our pts. ASA seems to be a manageable therapy and, since the high CV risk associated with SSc [4] , very similar to that showed by pts with diabetes mellitus where in some cases the use of ASA in primary prevention is recommended, we suggest a reassessment of EULAR Recommendations together with other studies on larger cohort of SSc pts, in order to confirm the safety of ASA. References [1] Kowal-Bielecka et al. Ann. Rheum. Dis, 2017 [2] Garaiman et al. Rheumatol, 2022 [3] Valentini et al. Ann Rheum Dis, 2019 [4]Conrad et al. Lancet, 2022 [5] Drosos et al. Ann Rheum Dis. 2022 [6] van den Hoogen et al, Arthritis Rheum, 2013 [7]https://www.heartscore.org/en_GB/ Acknowledgements: NIL. Disclosure of Interests None Declared.