Aspirin Continuation or Discontinuation in Surgically Treated Chronic Subdural Hematoma: A Randomized Clinical Trial.

Abstract

Importance Discontinuation of low-dose acetylsalicylic acid (ASA) during the perioperative phase of treatment for chronic subdural hematoma (cSDH) may reduce recurrence rates but may also increase the risk of cardiovascular or thromboembolic events. However, the efficacy and safety of discontinuing ASA in this patient population remain unclear. Objective To assess the risk of recurrence of cSDH and cardiovascular events in patients undergoing surgical treatment of cSDH with continuous vs discontinuous ASA treatment. Design, Setting, and Participants The SECA (Surgical Evacuation of Chronic Subdural Hematoma and Aspirin) trial was an investigator-initiated, multicenter, placebo-controlled randomized clinical trial conducted from February 2018 to June 2023 at 6 neurosurgical centers in Switzerland. Adults undergoing burr hole drainage for cSDH and receiving ASA treatment prior to cSDH onset were included. Of 1363 screened patients, 155 were included. Both assessors and participants were blinded to the treatment arms. Intervention Participants were randomized 1:1 to receive either continuous ASA or placebo for 12 days during the perioperative phase. Main Outcome and Measures The main outcome was the recurrence rate of cSDH necessitating reoperation within 6 months. An intention-to-treat analysis was performed, calculating risk differences. Secondary outcomes were cardiovascular or thromboembolic events, other bleeding events, and mortality. Results Of 155 participants, 78 were assigned to continuous ASA and 77 to placebo treatment. The mean (SD) participant age was 77.9 (8.2) years and 77.6 (9.7) years for the ASA and placebo groups, respectively, and 25 participants (16.1%) were female. A primary outcome event occurred in 13.9% of participants for the ASA group and 9.5% for the placebo group (weighted risk difference, 4.4%; 95% CI, -7.2% to 15.9%; P = .56). The incidence of any cardiovascular or thromboembolic event was 0.27 per person half-year in the ASA group and 0.28 in the placebo group. The incidence of a cardiovascular event indicating ASA treatment was 0.02 per person half-year in the ASA group and 0.06 in the placebo group. Other bleeding events showed an incidence of 0.10 per person half-year in the ASA group and 0.08 in the placebo group. All-cause mortality occurred at an incidence of 0.06 per person half-year in the ASA group and 0.03 in the placebo group. Conclusions and Relevance The SECA randomized clinical trial suggests that discontinuing ASA treatment did not reduce the recurrence rate of surgically treated cSDH within 6 months. Recurrence risk estimates for continuous ASA treatment in this trial were distinctly lower than previously reported. Trial Registration ClinicalTrials.gov Identifier: NCT03120182.