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

Maria Kamenova, MD1,2; Lea Pacan, BMed2; Christian Mueller, MD2,3; et al

2025년04월 27일

JAMA Neurol. Published online April 27, 2025.

DOI: 10.1001/jamaneurol.2025.0850

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.

Figure 2.  Primary and Secondary Outcomes, Main Estimands, and Weighted Risk Difference of Primary Outcome (A) and Number and Incidence Rate of Secondary Outcomes (B)

Figure 3.  Cumulative Incidence of the Primary Outcome of the Intention-to-Treat Population, Considering Any Loss to Follow-Up as a Competing Risk

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

Key Points

Question  Does discontinuation of low-dose acetylsalicylic acid (ASA) during the perioperative phase of surgical treatment of chronic subdural hematoma (cSDH) reduce recurrence rates?

Findings  In this randomized clinical trial of 155 adults, the proportion with recurrence of cSDH at 6 months was 13.9% in the ASA group and 9.5% in the placebo group, showing no statistical difference.

Meaning  Discontinuing ASA treatment did not seem to reduce the recurrence rate of surgically treated cSDH within 6 months, while recurrence risk estimates for continuous ASA treatment in this trial were distinctly lower than previously reported.

요약

·         중요성 : 만성 경막하혈종(cSDH) 수술 전후(주변 수술기) 동안 저용량 아세틸살리실산(ASA, 아스피린) 복용을 중단하면 재발률을 낮출 수 있지만, 반대로 심혈관계 또는 혈전색전증 사건의 위험을 높일 수 있다. 그러나 이 환자군에서 ASA 복용 중단의 효과성과 안전성은 아직 명확하지 않다.

·         목적 :  만성 경막하혈종(cSDH) 수술 치료를 받는 환자에서 ASA 치료를 지속하는 경우와 중단하는 경우 각각, 혈종 재발 위험과 심혈관 사건 위험을 평가하는 것

·         설계, 환경 및 참가자 : ECA(Surgical Evacuation of Chronic Subdural Hematoma and Aspirin) 임상시험은 연구자가 주도한 다기관, 위약 대조 무작위 임상시험(RCT)으로, 2018년 2월부터 2023년 6월까지 스위스 내 6개 신경외과 센터에서 진행되었다. 수술 전 ASA를 복용하고 있었으며 천공 배액술(burr hole drainage)을 받은 성인 환자가 대상이었다. 총 1363명의 환자가 선별되었고, 이 중 155명이 포함되었다. 평가자와 참가자 모두 무작위 배정군을 모르는 이중맹검 방식이었다.

·         중재 :  참가자들은 1:1 비율로 무작위 배정되어 수술 전후 12일 동안 ASA 지속 복용군 또는 위약군 중 하나에 할당되었다.

·         주요 결과 및 측정 :  주요 결과는 6개월 이내에 재수술이 필요한 cSDH 재발률이었다. 분석은 의도한 치료(ITT) 방식으로 수행되었고, 위험 차이를 계산했다. 이차 결과로는 심혈관 또는 혈전색전증 사건, 기타 출혈 사건, 사망률을 평가했다.

·         결과 :  155명의 참가자 중 78명은 ASA 지속 복용군, 77명은 위약군에 배정되었다. 참가자 평균 연령(표준편차)은 ASA군이 77.9세(8.2), 위약군이 77.6세(9.7)였으며, 전체 참가자의 16.1%(25명)가 여성이었다.주요 결과 사건(재수술 필요 재발)은 ASA군 13.9%, 위약군 9.5%에서 발생했다(가중 위험 차이 4.4%, 95% 신뢰구간 −7.2%~15.9%, P = .56).심혈관 또는 혈전색전증 사건 발생률은 ASA군 0.27, 위약군 0.28(1인 반년 기준)이었다. ASA 복용이 필요한 심혈관 사건 발생률은 ASA군 0.02, 위약군 0.06이었다. 기타 출혈 사건 발생률은 ASA군 0.10, 위약군 0.08이었고, 전체 사망률은 ASA군 0.06, 위약군 0.03이었다.

·        결론 및 의의: SECA 무작위 임상시험 결과, 수술적 치료를 받은 cSDH 환자에서 ASA 복용을 중단해도 6개월 이내 재발률을 감소시키지 못했다. 또한, 본 연구에서 ASA 지속 복용군의 재발 위험 추정치는 과거 보고된 수치보다 상당히 낮은 것으로 나타났다.