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Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve

Jordan B Strom1,2,3, Yuansong Zhao1,2,3, Kamil F Faridi1,2,3

  • 1The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.).

Circulation. Cardiovascular Interventions
|November 8, 2019
PubMed

Insights

Billing claims can identify cerebrovascular events (CVEs) after aortic valve replacement with high accuracy. While imperfect sensitivity limits their use alone, high specificity suggests claims can aid in evaluating neurological events and improving trial efficiency.

Area of Science:

  • Cardiovascular Surgery
  • Clinical Trials
  • Health Informatics

Background:

  • Cerebrovascular events (CVEs) are significant complications following aortic valve replacement (AVR).
  • Accurate identification of CVEs is crucial for evaluating interventions in structural heart disease trials.
  • This study investigates the utility of billing claims for CVE detection in clinical trials.

Purpose of the Study:

  • To assess the accuracy of billing claims in identifying CVEs compared to clinical adjudication in AVR trials.
  • To determine the sensitivity, specificity, and predictive values of ICD-9-CM and ICD-10-CM codes for CVE detection.
  • To evaluate the potential role of claims data in improving the efficiency of clinical trials for AVR.

Main Methods:

  • Adult participants from the US CoreValve High Risk and SURTAVI trials were linked to Medicare inpatient claims (2006-2016).
  • CVEs identified by billing codes were matched against trial-adjudicated CVEs within 14 days.
  • Performance metrics (sensitivity, specificity, PPV, NPV) of ICD-9-CM and ICD-10-CM codes were calculated against the criterion standard.

Main Results:

  • Among 4230 linked participants, 630 CVEs occurred over 5 years.
  • An ICD-9-CM algorithm using 4 codes showed 60.9% sensitivity and 99.0% specificity for ischemic stroke.
  • An ICD-10-CM algorithm using 3 codes demonstrated 66.7% sensitivity and 99.4% specificity for ischemic stroke.

Conclusions:

  • Billing codes identify approximately half of trial-adjudicated CVEs with high specificity but imperfect sensitivity.
  • High specificity suggests claims data can trigger neurological event evaluations, potentially enhancing trial efficiency.
  • Claims data may not fully replace traditional adjudication but can supplement event detection in structural heart disease trials.
Abstract

Keywords:
International Classification of DiseasesMedicareclinical trialsheart diseasestroke

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