External validation of three risk stratification rules in patients presenting with pulmonary embolism and cancer
Numerous risk stratification rules exist to predict post-pulmonary embolism (PE) mortality; however, few were designed for use in cancer patients. In the EPIPHANY registry, adapted versions of common rules (the Hestia criteria, Pulmonary Embolism Severity Index [PESI], and simplified PESI [sPESI]) displayed high sensitivity for prognosticating mortality in PE patients with cancer. These adapted rules have yet to be externally validated. Therefore, we sought to evaluate the performance of an adapted Hestia criteria, PESI, and sPESI for predicting 30-day post-PE mortality in patients with cancer. We identified consecutive, adults presenting with objectively confirmed PE and cancer to our institution (November 2010 to January 2014). The proportion of patients categorized as low or high risk by these three risk stratification rules was calculated, and each rule’s accuracy for predicting 30-day all-cause mortality was determined. Of the 124 patients with PE and active cancer identified, 25 (20%) experienced mortality at 30 days. The adapted Hestia criteria categorized 23 (19%) patients as low risk, while exhibiting a sensitivity of 88% (95% confidence interval [CI] = 68–97%), a negative predictive value NPV of 87% (95% CI = 65–97%), and a specificity of 20% (95% CI = 13–30%). A total of 38 (31%) and 30 (24%) patients were low risk by the adapted PESI and sPESI, with both displaying sensitivities of 92% and NPVs > 93%. Specificities were 36% (95% CI = 27–47%) and 28% (95% CI = 20–38%) for PESI and sPESI. In our external validation, the adapted Hestia, PESI, and sPESI demonstrated high sensitivity but low specificity for 30-day PE mortality in patients with cancer. Larger, prospective trials are needed to optimize strategies for risk stratification in this population.
KeywordsMortality Pulmonary embolism Prognosis Risk assessment Severity of illness index
Study concept and design: ERW, CGK, CIC, and EN. Acquisition of data: ERW, CGK, JTC, CIC, and EN. Analysis and interpretation of data: ERW, CGK, JTC, CIC, and EN. Drafting the manuscript: ERW, CGK, JTC, GHL, NMK, CIC, and EN. Critical revision of the manuscript for important intellectual content: ERW, CGK, JTC, GHL, NMK, CIC, and EN. Administrative, technical, or material support: ERW, CGK, and CIC. Study supervision: CGK. CGK had full access to all the study data and take full responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICJME) and were fully responsible for all content and editorial decisions and were involved in all stages of the manuscript development.
Compliance with ethical standards
Conflicts of interest
CIC has received grant funding and consultancy fees from Janssen Scientific Affairs, LLC; Bayer Pharma AG; and Boehringer-Ingelheim Pharmaceuticals, Inc. ERW has received support for research from Pfizer Inc. NMK reports personal fees from Janssen, Myriad, Daiichi, Coherus, and Halozyme. No other authors have conflicts of interest germane to this manuscript.
Research involving human participants and/or animals/informed consent
This study was approved by the Institutional Review Board at our Institution. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, formal consent was not required.
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