Outcome of Patients Presenting With High-Risk Pulmonary Embolism Treated With Mechanical Thrombectomy: A Subgroup Analysis From the STRIKE-PE Study

Figures

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  Figure 1. Flow diagram. Patient numbers for screening, enrollment, and follow-up are summarized along with exclusion reasons. CTPA, computed tomography pulmonary angiography; CPR, cardiopulmonary resuscitation; PE, pulmonary embolism. aSpecific criteria for risk classification were provided to site investigators in addition to site-specific classifications; high-risk/massive PE risk classification was confirmed by the global principal investigators (for adapted European Society of Cardiology criteria, end-organ hypoperfusion was not a prerequisite for obstructive shock classification, as those data were not collected). bNot caused by new-onset arrhythmia, hypovolemia, or sepsis.

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  Figure 2. On-table hemodynamic status. Mean reduction in systolic pulmonary artery pressure (PAP) and mean PAP from prior to computer-assisted vacuum thrombectomy (pre-CAVT) to after CAVT (post-CAVT; both P = .002). Error bars indicate SD. Paired data = 46. P values were calculated using a 2-tailed paired t test.

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  Figure 3. Change in right-to-left ventricular (RV/LV) ratio (primary effectiveness). Mean RV/LV ratio reduction from baseline to 48 hours (P < .001). Error bars indicate SD. Paired data = 42. P value was calculated using a 2-tailed paired t test.

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  Figure 4. Changes in the Borg scale at rest and after the 6-minute walk test (6MWT). (A) Median reduction in Borg scale at rest from baseline to discharge (P < .001), baseline to 90-day follow-up (P < .001), and discharge to 90-day follow-up (P = .045). Complete case data = 38. (B) Median reduction in Borg scale after 6MWT at discharge to 90-day follow-up (P < .001). Paired data = 20. P value was calculated using a 2-tailed Wilcoxon signed-rank test. For the box plots, the line in the middle of each box indicates the median, the diamond indicates the mean, the lower edge of each box indicates Q1 (25th percentile), the upper edge of each box indicates Q3 (75th percentile), the whiskers indicate the minimum (Q1 – 1.5 × IQR) and maximum (Q3 + 1.5 × IQR), and the dot/circle are outliers. The outliers are not omitted in the box plots.

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  Figure 5. Changes in the 6-minute walk test. Mean increase in distance walked from discharge to 90-day follow-up (P < .001). Error bars indicate SD. Paired data = 22. P value was calculated using a 2-tailed paired t test.

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  Figure 6. Changes in the New York Heart Association (NYHA) classification. (A) Shift of NYHA classification at pre-PE event (before the pulmonary embolism [PE] event) to discharge (P = .125), Discharge to 90-day follow-up (P = .088), and pre-PE event to 90-day follow-up (P = .809). (B) Shift of patients with NYHA none or class I from pre-PE event to discharge (P = .005), Discharge to 90-day follow-up (P = .011), and pre-PE event to 90-day follow-up (P > .999). Complete case = 41. P values for symmetry of all categories of the NYHA class distribution (I or none vs II vs III vs IV) were derived between baseline and discharge, baseline and 90 days, and discharge and 90 days using the Bowker test of symmetry. P values for the change of NYHA class I or none category between timepoints were calculated using the McNemar test.

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  Central Illustration. Change in right-to-left ventricular (RV/LV) ratio (primary effectiveness). RV/LV ratio reduction from baseline to 48 hours (mean; P < .001). Error bars indicate SD. Paired data = 42. P value was calculated using a 2-tailed paired t test. Primary and secondary safety end points were reported as percentages. Functional recovery measured by Borg scale (median), 6-minute walk test (6MWT) improved to 403 m (mean) at 90 days, New York Heart Association (NYHA) none or class I results at 90 days, and quality of life at 90 days measured by EuroQoL Visual Analog Scale (EQ VAS) (mean), EuroQol 5-dimension 5-level (EQ-5D-5L) (mean), and total Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire (mean). CAVT, computer-assisted vacuum thrombectomy; PE, pulmonary embolism; SAE, serious adverse event.