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Aspirin Continuation or Discontinuation in Surgically Treated Chronic Subdural Hematoma: A Randomized Clinical Trial
Maria Kamenova1,2, Lea Pacan2, Christian Mueller2,3
1Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland.
Insights
Discontinuing low-dose acetylsalicylic acid (ASA) did not lower chronic subdural hematoma recurrence. Continuous ASA treatment showed lower recurrence risk than previously reported in this surgical patient group.
Area of Science:
- Neurosurgery
- Cardiovascular Medicine
- Clinical Trials
Background:
- Discontinuation of acetylsalicylic acid (ASA) in perioperative chronic subdural hematoma (cSDH) management may impact recurrence and cardiovascular event risks.
- The efficacy and safety of perioperative ASA management for cSDH remain unclear.
Purpose of the Study:
- To evaluate the risk of cSDH recurrence and cardiovascular events in patients undergoing surgical treatment for cSDH.
- To compare continuous ASA treatment versus placebo during the perioperative phase.
Main Methods:
- The SECA trial was a multicenter, randomized, placebo-controlled trial involving 155 adult patients undergoing burr hole drainage for cSDH.
- Participants receiving ASA prior to cSDH onset were randomized to continuous ASA or placebo for 12 days.
- Outcomes included cSDH recurrence requiring reoperation within 6 months, cardiovascular events, bleeding, and mortality.
Main Results:
- A primary outcome event occurred in 13.9% of the continuous ASA group versus 9.5% in the placebo group (risk difference, 4.4%; P=.56).
- Incidence of cardiovascular or thromboembolic events was similar between groups (0.27 vs 0.28 per person-half-year).
- Incidence of cardiovascular events specifically indicating ASA treatment was lower in the ASA group (0.02 vs 0.06 per person-half-year).
Conclusions:
- Discontinuing ASA treatment did not reduce the recurrence rate of surgically treated cSDH within 6 months.
- Continuous ASA treatment demonstrated a lower recurrence risk estimate compared to previous reports.
- The study provides insights into perioperative ASA management for patients with cSDH.
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.
