Risk Factor Analysis of the Conservative Treatment in Chronic Subdural Hematomas: A Substudy of the ATOCH Trial

Adv Ther. 2022 Apr;39(4):1630-1641. doi: 10.1007/s12325-022-02057-w. Epub 2022 Feb 8.

Abstract

Introduction: The objective of the study was to analyze the risk factors for worsening of the disease progression in patients with chronic subdural hematomas (CSDH) during wait-and-observation treatment regimen and conservative treatment with atorvastatin.

Methods: A total of 196 patients with CSDH were recruited (98 in the atorvastatin group and 98 in the blank placebo group). Receiver operating characteristic (ROC) curve analysis was used to identify the optimal cutoff for the hematoma volume by testing surgical and nonsurgical outcomes. Other measures, including univariate and multivariate analyses, were performed to identify the potential significant factors indicative of the outcome of therapeutic efficacy of conservative treatment through the characteristics of the baseline indicators at enrollment.

Results: Over a median treatment duration of 2 months, lower total cholesterol, higher hematoma volume, and more midline shift were independent risk factors for worse outcomes of atorvastatin treatment for CSDH, and only a higher hematoma volume was an independent risk factor for spontaneous absorption in the placebo group. ROC analysis of all of the data showed that the optimal threshold of hematoma volume was 68.5 ml (sensitivity 73.5%, specificity 74%) in response to the greatest chance of switching to surgery.

Conclusions: Critical independent predictors of atorvastatin monotherapy treatment success included higher total cholesterol, lower hematoma volume, and less midline shift in atorvastatin monotherapy, and higher hematoma volume was the only independent risk factor in close follow-up observation patients without any pharmacotherapy. Initial hematoma volume more than 68.5 ml may help clinicians to determine individual risk assessments and to make optimal treatment decisions.

Trial registration: http://www.

Clinicaltrials: gov . Identifier NCT02024373.

Keywords: Atorvastatin; Chronic subdural hematoma; Conservative treatments; Epidemiology; Randomized controlled trial.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Atorvastatin / therapeutic use
  • Cholesterol
  • Conservative Treatment
  • Factor Analysis, Statistical
  • Hematoma, Subdural, Chronic* / diagnostic imaging
  • Hematoma, Subdural, Chronic* / drug therapy
  • Humans
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Treatment Outcome

Substances

  • Cholesterol
  • Atorvastatin

Associated data

  • ClinicalTrials.gov/NCT02024373